@Article{info:doi/10.2196/71684,
author="Pang, Yan
and He, Honggu
and Ng, Ruey-Pyng
and Lee, Luan Nicole Kim
and Htein, Win Me Me
and Zhao, Xiao-Xin
and Li, Ying-Hong
and Chan, Jiahui Elizabeth
and Zhu, Lixia
and Liu, Yu Guang
and Pikkarainen, Minna
and Lim, Swee-Ho",
title="Effectiveness of an Innovative Mobile-Based Perioperative Care Program for Women Undergoing Breast Cancer Surgery (iCareBreast): Randomized Controlled Trial",
journal="J Med Internet Res",
year="2025",
month="Apr",
day="21",
volume="27",
pages="e71684",
keywords="breast cancer",
keywords="digital health",
keywords="mHealth",
keywords="mobile health",
keywords="psychosocial",
keywords="randomized controlled trial",
keywords="self-efficacy",
keywords="mobile phone",
abstract="Background: Breast cancer is one of the most prevalent cancers among women and significantly impacts psychological well-being and health-related quality of life (HR-QoL) during the perioperative period. Mobile health interventions offer a promising approach to providing education and psychosocial support, yet their effectiveness in this context remains underexplored. Objective: This study aimed to develop and evaluate the effectiveness of an innovative, mobile-based, perioperative care program for women undergoing breast cancer surgery (iCareBreast). The assessment focused on perioperative self-efficacy, anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction. Methods: A two-group randomized control trial was conducted at a tertiary hospital in Singapore. The intervention group used the iCareBreast app, offering four main resources: perioperative care guidance, breast cancer and surgery education, psychological support, and social support. The control group received standard hospital care. Participants in the intervention group engaged with the fully automated app daily for 29 days (two weeks before surgery, on the day of surgery, and two weeks after surgery). Data were collected face-to-face or on the web at three time points: baseline, immediately after the intervention (T1; two weeks after surgery), and at a 2.5-month follow-up (T2; three months after surgery). The primary outcome was perioperative care self-efficacy, while secondary outcomes included anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction. Results: A total of 123 patients with early-stage breast cancer scheduled for breast surgery were enrolled in the study, with 62 patients assigned to the iCareBreast group and 61 patients to the control group. The results showed no significant differences between the groups in the primary outcome---perioperative self-efficacy---at any time point. Baseline scores were similar (P=.80), and while the iCareBreast group showed slightly lower scores at T1 (mean difference [MD] --1.63, 95\% CI --3.43 to 0.18; P=.08) and T2 (MD --1.90, 95\% CI --4.06 to 0.26; P=.09), the differences were not statistically significant. Similarly, secondary outcomes, including anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction, showed no significant changes between groups (all P>.05). However, the iCareBreast group reported higher perioperative care satisfaction during the postintervention assessment. Satisfaction scores were comparable at T1 (P=.68), while at T2, the iCareBreast group showed a slight increase compared to the control group (MD 0.35, 95\% CI 0.04-0.73; P=.08), though the difference was not statistically significant. Conclusions: The mobile-based psychosocial intervention, although satisfied by users, did not demonstrate significant benefits compared to standard care. This highlights the need to refine the iCareBreast app in future iterations to enhance its effectiveness in addressing the targeted health outcomes. Future mobile health research should prioritize optimizing user engagement strategies and incorporating personalized approaches to better address the perioperative care needs of patients with breast cancer. Trial Registration: ClinicalTrials.gov NCT04172350; https://clinicaltrials.gov/study/NCT04172350 ",
doi="10.2196/71684",
url="https://www.jmir.org/2025/1/e71684"
}


@Article{info:doi/10.2196/56098,
author="Sommers, Jonathan
and Dizon, S. Don
and Lewis, A. Mark
and Stone, Erik
and Andreoli, Richard
and Henderson, Vida",
title="Assessing Health Information Seeking Behaviors Among Targeted Social Media Users Using an Infotainment Video About a Cancer Clinical Trial: Population-Based Descriptive Study",
journal="JMIR Cancer",
year="2025",
month="Mar",
day="3",
volume="11",
pages="e56098",
keywords="cancer clinical trials",
keywords="digital media",
keywords="social media",
keywords="infotainment",
keywords="recruitment",
keywords="education and awareness",
keywords="edutainment",
keywords="public engagement",
keywords="cancer",
keywords="lack of information",
keywords="health information",
keywords="medical awareness",
keywords="video series",
keywords="public audience",
keywords="low cost",
keywords="research participants",
abstract="Background: The lack of information and awareness about clinical trials, as well as misconceptions about them, are major barriers to cancer clinical trial participation. Digital and social media are dominant sources of health information and offer optimal opportunities to improve public medical awareness and education by providing accurate and trustworthy health information from reliable sources. Infotainment, material intended to both entertain and inform, is an effective strategy for engaging and educating audiences that can be easily disseminated using social media and may be a novel way to improve awareness of and recruitment in clinical trials. Objective: The purpose of this study was to evaluate whether an infotainment video promoting a clinical trial, disseminated using social media, could drive health information seeking behaviors. Methods: As part of a video series, we created an infotainment video focused on the promotion of a specific cancer clinical trial. We instituted a dissemination and marketing process on Facebook to measure video engagement and health information seeking behaviors among targeted audiences who expressed interest in breast cancer research and organizations. To evaluate video engagement, we measured reach, retention, outbound clicks, and outbound click-through rate. Frequencies and descriptive statistics were used to summarize each measure. Results: The video substantially increased health information seeking behavior by increasing viewership from 1 visitor one month prior to launch to 414 outbound clicks from the video to the clinical trial web page during the 21-day social media campaign period. Conclusions: Our study shows that digital and social media tools can be tailored for specific target audiences, are scalable, and can be disseminated at low cost, making it an accessible educational, recruitment, and retention strategy focused on improving the awareness of clinical trials. Trial Registration: ClinicalTrials.gov NCT03418961; https://clinicaltrials.gov/study/NCT03418961 ",
doi="10.2196/56098",
url="https://cancer.jmir.org/2025/1/e56098"
}


@Article{info:doi/10.2196/65118,
author="Aye, Sin Phyu
and Barnes, Joanne
and Laking, George
and Cameron, Laird
and Anderson, Malcolm
and Luey, Brendan
and Delany, Stephen
and Harris, Dean
and McLaren, Blair
and Brenman, Elliott
and Wong, Jayden
and Lawrenson, Ross
and Arendse, Michael
and Tin Tin, Sandar
and Elwood, Mark
and Hope, Philip
and McKeage, James Mark",
title="Treatment Outcomes From Erlotinib and Gefitinib in Advanced Epidermal Growth Factor Receptor--Mutated Nonsquamous Non--Small Cell Lung Cancer in Aotearoa New Zealand From 2010 to 2020: Nationwide Whole-of-Patient-Population Retrospective Cohort Study",
journal="JMIR Cancer",
year="2025",
month="Mar",
day="3",
volume="11",
pages="e65118",
keywords="non--small cell lung cancer",
keywords="mutations",
keywords="epidemiology",
keywords="target therapy",
keywords="retrospective cohort study",
abstract="Background: Health care system--wide outcomes from routine treatment with erlotinib and gefitinib are incompletely understood. Objective: The aim of the study is to describe the effectiveness of erlotinib and gefitinib during the first decade of their routine use for treating advanced epidermal growth factor receptor (EGFR) mutation-positive nonsquamous non--small cell lung cancer in the entire cohort of patients treated in Aotearoa New Zealand. Methods: Patients were identified, and data collated from national pharmaceutical dispensing, cancer registration, and mortality registration electronic databases by deterministic data linkage using National Health Index numbers. Time-to-treatment discontinuation and overall survival were measured from the date of first dispensing of erlotinib or gefitinib and analyzed by Kaplan-Meier curves. Associations of treatment outcomes with baseline factors were evaluated using univariable and multivariable Cox regressions. Results: Overall, 752 patients were included who started treatment with erlotinib (n=418) or gefitinib (n=334) before October 2020. Median time-to-treatment discontinuation was 11.6 (95\% CI 10.8?12.4) months, and median overall survival was 20.1 (95\% CI 18.1?21.6) months. Shorter time-to-treatment discontinuation was independently associated with high socioeconomic deprivation (hazard ratio [HR] 1.3, 95\% CI 1.1?1.5 compared to the New Zealand Index of Deprivation 1?4 group), EGFR L858R mutations (HR 1.3, 95\% CI 1.1?1.6 compared to exon 19 deletion), and distant disease at cancer diagnosis (HR 1.4, 95\% CI 1.2?1.7 compared to localized or regional disease). The same factors were independently associated with shorter overall survival. Outcome estimates and predictors remained unchanged in sensitivity analyses. Conclusions: Outcomes from routine treatment with erlotinib and gefitinib in New Zealand patients with advanced EGFR-mutant nonsquamous non--small cell lung cancer are comparable with those reported in randomized trials and other health care system--wide retrospective cohort studies. Socioeconomic status, EGFR mutation subtype, and disease extent at cancer diagnosis were independent predictors of treatment outcomes in that setting. Trial Registration: Australia New Zealand Clinical Trials Registry ACTRN12615000998549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368928\&isReview=true International Registered Report Identifier (IRRID): RR2-10.2196/51381 ",
doi="10.2196/65118",
url="https://cancer.jmir.org/2025/1/e65118"
}


@Article{info:doi/10.2196/64611,
author="Byrom, Bill
and Everhart, Anthony
and Cordero, Paul
and Garratt, Chris
and Meyer, Tim",
title="Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials",
journal="JMIR Cancer",
year="2025",
month="Feb",
day="28",
volume="11",
pages="e64611",
keywords="clinical trials",
keywords="early phase",
keywords="dose finding",
keywords="patient-reported outcome",
keywords="PRO",
keywords="electronic patient-reported outcome",
keywords="ePRO",
keywords="PRO-CTCAE",
keywords="adverse events",
keywords="tolerability",
keywords="optimal dose",
keywords="cancer trials",
keywords="dose toxicity",
keywords="oncology",
keywords="drug development",
keywords="electronic collection",
keywords="dose level",
keywords="pharmacodynamic",
keywords="cytotoxic chemotherapy drugs",
keywords="cytotoxic",
keywords="chemotherapy drug",
keywords="life-threatening disease",
keywords="Common Terminology Criteria for Adverse Events",
doi="10.2196/64611",
url="https://cancer.jmir.org/2025/1/e64611"
}


@Article{info:doi/10.2196/66681,
author="Wyse, Rebecca
and Forbes, Erin
and Norton, Grace
and Viana Da Silva, Priscilla
and Fakes, Kristy
and Johnston, Ann Sally
and Smith, R. Stephen
and Zucca, Alison",
title="Effect on Response Rates of Adding a QR Code to Patient Consent Forms for Qualitative Research in Patients With Cancer: Pilot Randomized Controlled Trial",
journal="JMIR Form Res",
year="2025",
month="Feb",
day="21",
volume="9",
pages="e66681",
keywords="QR code",
keywords="qualitative research",
keywords="cancer",
keywords="randomized controlled trial",
keywords="RCT",
keywords="patient recruitment",
keywords="consent forms",
keywords="response rates",
abstract="Background: The successful conduct of health and medical research is largely dependent on participant recruitment. Effective, yet inexpensive methods of increasing response rates for all types of research are required. QR codes are now commonplace, and despite having been extensively used to recruit study participants, a search of the literature failed to reveal any randomized trial investigating the effect of adding a QR code on qualitative research response rates. Objective: This study aimed to collect data on rates of response, consent, and decline among patients with cancer, and the average time taken to respond following randomization to receive either a QR code or no QR code on the patient consent form for a qualitative research study. Methods: This was a pilot randomized controlled trial (RCT) embedded within a qualitative research study. In total, 40 eligible patients received a recruitment pack for the qualitative study, which included an information statement, a consent form, and an addressed, stamped envelope to return their consent form. Patients were randomized 1:1 to the control (standard recruitment pack only) or intervention group (standard recruitment pack including modified consent form with a QR code). Results: In total, 27 out of 40 patients (age: mean 63.0, SD 14.8 years; 45\% female) responded to the consent form. A lower proportion of the QR code group (60\%) responded (odd ratio [OR] 0.57, 95\% CI 0.14-2.37; P=.44), compared to 75\% of the standard recruitment group. However, a higher proportion of the QR group (35\%) consented (OR 1.84, 95\% CI 0.41-8.29; P=.43), compared to the standard recruitment group (20\%). A lower proportion of the QR group (25\%) declined (OR 0.34, 95\% CI 0.09-1.38; P=.13) relative to the standard recruitment group (55\%). The mean response time of the QR code group was 16 days (rate ratio [RR] 0.79, 95\% CI 0.47-1.35; P=.39) compared to 19 days for the standard recruitment group. None of the age-adjusted analyses were statistically significant. Conclusions: This underpowered pilot study did not find any evidence that offering an option to respond through a QR code on a patient consent form for a qualitative study increased the overall patient response rate (combined rate of consent and decline). However, there was a nonsignificant trend, indicating that more patients who received the QR code consented compared to those who did not receive the QR code. This study provides useful preliminary data on the potential impact of QR codes on patient response rates to invitations to participate in qualitative research and can be used to inform fully powered RCTs. Trial Registration: OSF Registries 10.17605/OSF.IO/PJ25X; https://doi.org/10.17605/OSF.IO/PJ25X ",
doi="10.2196/66681",
url="https://formative.jmir.org/2025/1/e66681"
}


@Article{info:doi/10.2196/64662,
author="Smits, M. Michelle J.
and Bolman, W. Catherine A.
and Mesters, Ilse
and Lechner, Lilian",
title="Blended Care Intervention for Cancer Aftercare in General Practice Centers: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="12",
volume="14",
pages="e64662",
keywords="cancer aftercare",
keywords="general practice",
keywords="blended care",
keywords="eHealth",
keywords="randomized controlled trial",
keywords="cost effectiveness",
keywords="general practitioners",
keywords="online intervention",
abstract="Background: Combining effective eHealth programs with face-to-face consultations in general practice may help general practitioners care for survivors of cancer. Objective: This study protocol describes a 2-armed randomized controlled trial to evaluate the cost-effectiveness of a blended intervention integrating the Cancer Aftercare Guide in general practice centers (GPCs). Methods: A parallel-group design will compare an intervention group with a waiting list control group. Participants will be nested within GPCs and randomization will occur at the GPC level. The participants in the intervention group will receive a blended care intervention. In contrast, the participants in the waiting list control group will receive care as usual for the duration of this study and will receive the online intervention afterward. All participants will be asked to complete an online questionnaire at baseline, 6 months, and 12 months after baseline, measuring self-reported adherence to lifestyle recommendations, psychosocial well-being, and quality of life. A process evaluation and cost evaluation are also included in this study. The effects will be evaluated based on differences in residual change scores between intervention and control group participants, using multilevel linear regression analyses. Moreover, effect analyses will be supplemented with Bayes factor analyses. Finally, an economic evaluation will be conducted from a societal perspective and will include medical costs, productivity costs, and costs of the blended care intervention. Results: This study was funded in July 2020. Data collection started in August 2022 and is likely to be completed by April 2025. As of December 2024, a total of 127 participants have been included in this study, recruited across 26 GPCs in the Netherlands. Data analysis will commence once data collection is completed. Data analysis is estimated to start in the spring of 2025. The results will likely be published in 2026. Conclusions: The results will provide insight into the effectiveness of blended care and may be relevant to cancer aftercare, general practice, and the field of eHealth implementation in general. Potential challenges lie in recruitment due to the strain on the health care system since the COVID-19 pandemic. Trial Registration: ISRCTN ISRCTN12451453; https://www.isrctn.com/ISRCTN12451453 International Registered Report Identifier (IRRID): DERR1-10.2196/64662 ",
doi="10.2196/64662",
url="https://www.researchprotocols.org/2025/1/e64662"
}


@Article{info:doi/10.2196/64265,
author="Beauchemin, P. Melissa
and Walker, Desiree
and Rosen, Allison
and Frazer, Maria
and Eisenberger, Meital
and Khurana, K. Rhea
and Bentlyewski, Edward
and Fedorko, Victoria
and Basch, H. Corey
and Hillyer, C. Grace",
title="Insights From Diverse Perspectives on Social Media Messages to Inform Young Adults With Cancer About Clinical Trials: Focus Group Study",
journal="JMIR Form Res",
year="2025",
month="Jan",
day="20",
volume="9",
pages="e64265",
keywords="young adults",
keywords="adolescent and young adult cancer",
keywords="cancer",
keywords="cancer treatment",
keywords="clinical trials",
keywords="clinical trial awareness",
keywords="clinical trial enrollment",
keywords="clinical trial knowledge",
keywords="clinical trial attitudes",
keywords="clinical trial enrollment barriers",
keywords="social media",
keywords="social media messages",
keywords="psychosocial",
keywords="United States",
abstract="Background: Low rates of adolescent and young adult (YA; aged 15-39 y) clinical trial enrollment (CTE), particularly among underserved groups, have resulted in a lack of standardized cancer treatments and follow-up guidelines for this group that may limit improvement in cancer treatments and survival outcomes for YAs. Objective: To understand and address unique barriers to CTE, we conducted focus groups to learn about informational, financial, and psychosocial needs of YAs surrounding CTE and identify strategies to address these barriers. Methods: We conducted 5 focus groups in 2023 among a diverse sample of YA patients from across the United States. An interview guide was developed collaboratively with YA advocates. Specifically, informational needs, financial concerns, and psychosocial issues were explored, and participants were probed to suggest strategies, especially those that leverage technology, to address these barriers. Sessions were audio recorded, transcribed, and coded using direct content analysis. Findings were synthesized through consensus discussions. Results: We confirmed the previously proposed thematic barriers regarding YA CTE and identified 9 subthemes: awareness, lack of clear and accessible CTE information, fear of the unknown, assumptions about costs, insurance coverage, navigating financial responsibilities, clinical trial discussions, clinical trial misconceptions, and desire for a support network. Throughout, YAs mentioned needs that might be addressed through informational outreach leveraging digital technology, the internet, and social media. Conclusions: This study expands knowledge of YA perceived barriers to CTE. These findings suggest that leveraging digital technology to disseminate reliable information to address needs may be an effective strategy to improve clinical trial participation in the YA population. ",
doi="10.2196/64265",
url="https://formative.jmir.org/2025/1/e64265"
}


@Article{info:doi/10.2196/54609,
author="Kumar, Naresh
and Hui, Jian Si
and Lee, Renick
and Athia, Sahil
and Tan, Hao Joel Yong
and Tan, Hao Jonathan Jiong",
title="Evaluation of the Feasibility of Transfusing Leukocyte Depletion Filter--Processed Intraoperative Cell Salvage Blood in Metastatic Spine Tumor Surgery: Protocol for a Non--Randomized Study",
journal="JMIR Res Protoc",
year="2025",
month="Jan",
day="17",
volume="14",
pages="e54609",
keywords="blood transfusion",
keywords="autologous blood transfusion",
keywords="operative blood salvage",
keywords="leukocyte reduction filtration",
keywords="intraoperative blood cell salvage",
keywords="extramedullary spinal cord compression",
keywords="metastases",
keywords="tumors",
keywords="leukocytes",
abstract="Background: Metastatic spine tumor surgery (MSTS) is often complex and extensive leading to significant blood loss. Allogeneic blood transfusion (ABT) is the mainstay of blood replenishment but with immune-mediated postoperative complications. Alternative blood management techniques (salvaged blood transfusion [SBT]) allow us to overcome such complications. Despite widespread use of intraoperative cell salvage (IOCS) in oncological and nononcological surgical procedures, surgeons remain reluctant to use IOCS in MSTS. Objective: This study aims to analyze safety of IOCS-leukocyte depletion filter (LDF)--processed blood transfusion for patients undergoing MSTS by assessing clinical outcomes---disease progression: tumor progression and overall survival. This study evaluates whether reinfusion of IOCS-LDF--processed blood reduces ABT rates in patients undergoing MSTS by sorting patients undergoing MSTS who require ABT into patients who consent to receive or not receive SBT. Methods: We aim to recruit a minimum of 90 patients---30 patients for SBT, 30 patients for ABT, and 30 patients with no blood transfusion. SBT and ABT form the 2 experimental arms, whereas no blood transfusion forms the control cohort. Available patient data will be reviewed to determine tumor burden secondary to metastasis and postoperative survival and disease progression, improvement in pain, and neurological and ambulatory status. Data collected will be studied postoperatively at 3, 6, 12, 24, 36, and 48 months or until demise, whichever occurs first. Outcomes of the experimental groups will be compared with those of the control group. Outcomes will be analyzed using 1-way ANOVA and Fisher exact test. The Kaplan-Meier curve and a log-rank test will be used to study overall survival. A multivariate and competing risk analysis will be used to study the association between blood transfusion type and tumor progression. All statistical analyses will be done using Stata Special Edition 14.0 (StataCorp LP). Results: This is the largest clinical study on use of IOCS in MSTS from various primary malignancies to date. It will provide significant clinical evidence regarding the safety and applicability of IOCS in MSTS. It will help reduce use of ABT, improving overall blood management of patients undergoing MSTS. A limitation of this study is that not all patients undergoing MSTS will survive for the follow-up period (4 years), theoretically leading to underreporting of disease progression. Study commenced in 2016 and patient recruitment continued till 2019. As of September 2019, we have collected operative data on 140 patients. However, the 2-year outcomes of about 40.0\% (56/140) of patients are in the process of collection. The study is aimed to be published in the years 2023-2024. Conclusions: Results will be disseminated via peer-reviewed publications, paving the way for future studies. International Registered Report Identifier (IRRID): DERR1-10.2196/54609 ",
doi="10.2196/54609",
url="https://www.researchprotocols.org/2025/1/e54609"
}


@Article{info:doi/10.2196/51877,
author="Ma, Chunxuan
and Adler, H. Rachel
and Neidre, B. Daria
and Chen, C. Ronald
and Northouse, L. Laurel
and Rini, Christine
and Tan, Xianming
and Song, Lixin",
title="Challenges and Approaches to Recruitment for and Retention in a Dyad-Focused eHealth Intervention During COVID-19: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2024",
month="Dec",
day="3",
volume="26",
pages="e51877",
keywords="randomized controlled trials",
keywords="RCT",
keywords="prostate cancer",
keywords="accrual",
keywords="retention",
keywords="COVID-19 pandemic",
keywords="family-based research",
abstract="Background: Family-based randomized controlled trials (RCTs) encounter recruitment and retention challenges. Cancer-focused RCTs typically recruit convenience samples from local cancer centers and hospitals. Objective: This study aimed to examine the recruitment and retention of a population-based, patient-partner dyad cohort in an RCT testing a dyadic eHealth intervention to improve the quality of life in patients with prostate cancer and their partners. Methods: In this 2-arm, parallel-group RCT, men who recently completed treatment for localized prostate cancer statewide were recruited through North Carolina Central Cancer Registry rapid case ascertainment between April 2018 and April 2021, coinciding with the COVID-19 pandemic. Patient-partner dyads underwent baseline assessments and were randomly assigned to either the intervention or control groups. Follow-up surveys were conducted at 4, 8, and 12 months after baseline. Descriptive and logistic regression analyses were used to achieve the study's aims. Results: Of the 3078 patients referred from rapid case ascertainment, 2899 were screened. A total of 357 partners were approached after obtaining the eligible patients' permission, 280 dyads completed baseline assessments and were randomized (dyad enrollment rate: 85.11\%, 95\% CI 81.3\%-88.9\%), and 221 dyads completed the 12-month follow-up (retention rate: 78.93\%, 95\% CI 74.2\%-83.7\%). Regarding the factors associated with retention, compared with White participants, people self-reporting as ``other races'' (including American Indian, Asian, and multiracial) were more likely to drop out of the study (odds ratio 2.78, 95\% CI 1.10-7.04), and older participants were less likely to withdraw (odds ratio 0.96, 95\% CI 0.92-0.99). Conclusions: Despite the negative impact of the pandemic, we successfully recruited enough patient-partner dyads to test our RCT hypotheses. Our recruitment and retention rates were equivalent to or higher than those in most dyadic intervention studies. A well-functioning research team and specific strategies (eg, eHealth intervention, internet phone, and online surveys) facilitated the recruitment and retention of patients with prostate cancer and their partners during the unprecedented pandemic. Trial Registration: ClinicalTrials.gov NCT03489057; https://clinicaltrials.gov/study/NCT03489057 International Registered Report Identifier (IRRID): RR2-https://doi.org/10.1186/s13063-021-05948-5 ",
doi="10.2196/51877",
url="https://www.jmir.org/2024/1/e51877",
url="http://www.ncbi.nlm.nih.gov/pubmed/39625741"
}


@Article{info:doi/10.2196/60695,
author="Hung, W. Tony K.
and Kuperman, J. Gilad
and Sherman, J. Eric
and Ho, L. Alan
and Weng, Chunhua
and Pfister, G. David
and Mao, J. Jun",
title="Performance of Retrieval-Augmented Large Language Models to Recommend Head and Neck Cancer Clinical Trials",
journal="J Med Internet Res",
year="2024",
month="Oct",
day="15",
volume="26",
pages="e60695",
keywords="large language model",
keywords="LLM",
keywords="ChatGPT",
keywords="GPT-4",
keywords="artificial intelligence",
keywords="AI",
keywords="clinical trials",
keywords="decision support",
keywords="LookUpTrials",
keywords="cancer care delivery",
keywords="head and neck oncology",
keywords="head and neck cancer",
keywords="retrieval augmented generation",
doi="10.2196/60695",
url="https://www.jmir.org/2024/1/e60695"
}


@Article{info:doi/10.2196/57183,
author="Bertolaccini, Luca
and Ciani, Oriana
and Lucchi, Marco
and Zaraca, Francesco
and Bertani, Alessandro
and Crisci, Roberto
and Spaggiari, Lorenzo
and ",
title="Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT)",
journal="JMIR Res Protoc",
year="2024",
month="Oct",
day="8",
volume="13",
pages="e57183",
keywords="lung cancer",
keywords="quality of life",
keywords="observational study",
keywords="economic aspects",
keywords="multicenter study",
abstract="Background: Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy. Objective: With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care. Methods: LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population. Results: The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028. Conclusions: LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management. Trial Registration: ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140 International Registered Report Identifier (IRRID): PRR1-10.2196/57183 ",
doi="10.2196/57183",
url="https://www.researchprotocols.org/2024/1/e57183"
}


@Article{info:doi/10.2196/57959,
author="Vives, Nuria
and Travier, Noemie
and Farre, Albert
and Binefa, Gemma
and Vidal, Carmen
and P{\'e}rez Lacasta, Jose Maria
and Ib{\'a}{\~n}ez-Sanz, Gemma
and Ni{\~n}o de Guzm{\'a}n, Pery Ena
and Panera, Aritz Jon
and Garcia, Montse
and ",
title="Effectiveness and Acceptability of Targeted Text Message Reminders in Colorectal Cancer Screening: Randomized Controlled Trial (M-TICS Study)",
journal="JMIR Public Health Surveill",
year="2024",
month="Jul",
day="31",
volume="10",
pages="e57959",
keywords="text message",
keywords="mobile health",
keywords="mHealth",
keywords="colorectal cancer screening",
keywords="participation",
keywords="colon",
keywords="rectum",
keywords="cancer",
keywords="mobile phone",
keywords="mobile phones",
keywords="randomized controlled trial",
keywords="RCT",
keywords="text messages",
keywords="screening",
keywords="Spain",
keywords="adult",
keywords="adults",
keywords="elder",
keywords="elderly",
keywords="gerontology",
keywords="intention-to-treat analysis",
keywords="telephone survey",
keywords="intervention",
keywords="cost-effectiveness",
keywords="SMS",
keywords="digital health",
abstract="Background: Mobile phone--based SMS text message reminders have the potential to improve colorectal cancer screening participation rates. Objective: This study assessed the effectiveness and acceptability of adding targeted SMS text message reminders to the standard procedure for those who picked up but did not return their screening kit at the pharmacy within 14 days in a colorectal cancer screening program in Catalonia, Spain. Methods: We performed a randomized control trial among individuals who picked up a fecal immunochemical test (FIT) kit for colorectal cancer screening at the pharmacy but did not return it within 14 days. The intervention group (n=4563) received an SMS text message reminder on the 14th day of kit pick up and the control group (n=4806) received no reminder. A 30-day reminder letter was sent to both groups if necessary. The main primary outcome was the FIT completion rate within 30, 60, and 126 days from FIT kit pick up (intention-to-treat analysis). A telephone survey assessed the acceptability and appropriateness of the intervention. The cost-effectiveness of adding an SMS text message reminder to FIT completion was also performed. Results: The intervention group had higher FIT completion rates than the control group at 30 (64.2\% vs 53.7\%; P<.001), 60 (78.6\% vs 72.0\%; P<.001), and 126 (82.6\% vs 77.7\%; P<.001) days. Participation rates were higher in the intervention arm independent of sex, age, socioeconomic level, and previous screening behavior. A total of 339 (89.2\%) interviewees considered it important and useful to receive SMS text message reminders for FIT completion and 355 (93.4\%) preferred SMS text messages to postal letters. We observed a reduction of US \$2.4 per participant gained in the intervention arm for invitation costs compared to the control arm. Conclusions: Adding an SMS text message reminder to the standard procedure significantly increased FIT kit return rates and was a cost-effective strategy. SMS text messages also proved to be an acceptable and appropriate communication channel for cancer screening programs. Trial Registration: ClinicalTrials.gov NCT04343950; https://www.clinicaltrials.gov/study/NCT04343950 International Registered Report Identifier (IRRID): RR2-10.1371/journal.pone.0245806 ",
doi="10.2196/57959",
url="https://publichealth.jmir.org/2024/1/e57959",
url="http://www.ncbi.nlm.nih.gov/pubmed/39083331"
}


@Article{info:doi/10.2196/54086,
author="Jain, Rishabh
and Kumar, Akash
and Sharma, Atul
and Sahoo, Kumar Ranjit
and Sharma, Aparna
and Seth, Amlesh
and Nayak, Brusabhanu
and Shamim, A. Shamim
and Kaushal, Seema
and KP, Haresh
and Das, J. Chandan
and Batra, Atul",
title="Carboplatin in Patients With Metastatic Castration-Resistant Prostate Cancer Harboring Somatic or Germline Homologous Recombination Repair Gene Mutations: Phase II Single-Arm Trial",
journal="JMIR Res Protoc",
year="2024",
month="Apr",
day="18",
volume="13",
pages="e54086",
keywords="carboplatin",
keywords="mCRPC",
keywords="prostate cancer",
keywords="homologous recombinant gene repair",
keywords="metastatic castration-resistant prostate cancer",
keywords="incurable",
keywords="deleterious mutation",
keywords="synthetic lethality",
keywords="tumor",
keywords="DNA",
keywords="low-income",
keywords="middle-income",
keywords="chemotherapeutic",
keywords="drug",
keywords="retrospective study",
keywords="taxane",
keywords="novel antiandrogen",
keywords="single-arm study",
keywords="health-related",
keywords="quality of life",
keywords="bone lesion",
abstract="Background: Approximately 20\%-25\% of patients with metastatic castration-resistant prostate cancer (mCRPC) harbor a deleterious germline or somatic mutation in the homologous recombination repair (HRR) pathway genes, which is involved in the repair of double-stranded DNA damage. Half of these mutations are germline, while the remaining are exclusively somatic. While polyadenosine 5'diphosphoribose [poly (ADP-ribose)] polymerase inhibitors, such as olaparib and rucaparib, are effective in this subgroup, their widespread use is limited due to the associated high cost, especially in resource-constrained settings. Notably, platinum agents like carboplatin have exquisite sensitivity to cells with defective DNA repair machinery. Carboplatin, a conventional, inexpensive chemotherapeutic agent, offers a potential alternative treatment in such patients. Several retrospective small case series support this hypothesis. However, there are no prospective clinical trials of carboplatin in patients with mCRPC with HRR mutations. Objective: The primary objective is to assess the objective response rate of 3 weekly carboplatin treatments in patients with mCRPC harboring deleterious mutations in the HRR pathway genes and previously treated with a taxane or a novel antiandrogen agent. The secondary objectives include progression-free survival, health-related quality of life, and safety profile of carboplatin. Methods: Patients diagnosed with mCRPC harboring HRR pathway mutations previously treated with docetaxel or novel antiandrogen agents (abiraterone, enzalutamide, apalutamide, or darolutamide) or both will be eligible. Genes involved directly or indirectly in the HRR pathway will be tested. In this single-arm phase II study, we will screen approximately 200 patients to enroll 49 patients, and carboplatin (dosing at the area under curve=5) will be administered every 3 weeks until progression or intolerable side effects. The primary end point will be assessed as the proportion of patients with a reduction of serum prostate-specific antigen by more than 50\% from enrollment. Secondary outcomes include progression-free survival---soft-tissue disease progression (by response evaluation criteria in solid tumors, version 1.1, and bone lesion progression using Prostate Cancer Clinical Trials Working Group 3 criteria), health-related quality of life during carboplatin treatment using the Functional Assessment of Cancer Therapy---Prostate questionnaire and the European Organisation for Research and Treatment of Cancer questionnaire and safety profile of carboplatin (National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0). Results: The trial started enrollment in September 2023. This trial is ongoing, and 12 patients have been recruited to date. All 49 participants will be enrolled according to plan. Conclusions: This prospective phase II trial represents a critical step toward addressing the therapeutic gap in patients with mCRPC harboring HRR pathway mutations, particularly in demographic regions with limited access to poly (ADP-ribose) polymerase inhibitors. Outcomes from this study will inform clinical practice and guide future phase III randomized trials, ultimately improving patient outcomes globally. Trial Registration: Clinical Trials Registry of India CTRI/2023/04/051507; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njc0NjU=\&Enc=\&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/54086 ",
doi="10.2196/54086",
url="https://www.researchprotocols.org/2024/1/e54086",
url="http://www.ncbi.nlm.nih.gov/pubmed/38453159"
}


@Article{info:doi/10.2196/51604,
author="Parsell, C. Maren
and Greenleaf, N. Morgan
and Kombara, G. Greeshma
and Sukhatme, P. Vikas
and Lam, A. Wilbur",
title="Engaging Cancer Care Physicians in Off-Label Drug Clinical Trials: Human-Centered Design Approach",
journal="JMIR Form Res",
year="2024",
month="Feb",
day="15",
volume="8",
pages="e51604",
keywords="human-centered design",
keywords="clinical trial design",
keywords="design methods",
keywords="clinical trial",
keywords="trial methodology",
keywords="barriers",
keywords="off-label drugs",
keywords="stakeholders",
keywords="cancer",
keywords="medications",
abstract="Background: Using a human-centered design (HCD) approach can provide clinical trial design teams with a better understanding of the needs, preferences, and attitudes of clinical trial stakeholders. It can also be used to understand the challenges and barriers physician stakeholders face in initiating and completing clinical trials, especially for using off-label drugs (OLDs) to treat unmet clinical needs in cancer treatment. However, the HCD approach is not commonly taught in the context of clinical trial design, and few step-by-step guides similar to this study are available to demonstrate its application. Objective: This study aims to demonstrate the feasibility and process of applying an HCD approach to creating clinical trial support resources for physician stakeholders to overcome barriers to pursuing clinical trials for OLDs to treat cancer. Methods: An HCD approach was used to develop OLD clinical trial support concepts. In total, 45 cancer care physicians were contacted, of which 15 participated in semistructured interviews to identify barriers to prescribing OLDs or participating in cancer OLD clinical trials. Design research is qualitative---it seeks to answer ``why'' and ``how'' questions; thus, a sample size of 15 was sufficient to provide insight saturation to address the design problem. The team used affinity mapping and thematic analysis of qualitative data gathered from the interviews to inform subsequent web-based co-design sessions, which included creative matrix exercises and voting to refine and prioritize the ideas used in the final 3 recommended concepts. Results: The findings demonstrate the potential of HCD methods to uncover important insights into the barriers physicians face in participating in OLD clinical trials or prescribing OLDs, such as recruitment challenges, low willingness to prescribe without clinical data, and stigma. Notably, only palliative care participants self-identified as ``frequent prescribers'' of OLDs, despite high national OLD prescription rates among patients with cancer. Participants found the HCD approach engaging, with 60\% (9/15) completing this study; scheduling conflicts caused most of the dropouts. Over 150 ideas were generated in 3 co-design sessions, with the groups voting on 15 priority ideas that the design team then refined into 3 final recommendations, especially focused on increasing the participation of physicians in OLD clinical trials. Conclusions: Using participatory HCD methods, we delivered 3 concepts for clinical trial support resources to help physician stakeholders overcome barriers to pursuing clinical trials for OLDs to treat cancer. Overall, integrating the HCD approach can aid in identifying important stakeholders, such as prescribing physicians; facilitating their engagement; and incorporating their perspectives and needs into the solution design process. This paper highlights the process, methods, and potential of HCD to improve cancer clinical trial design. Future work is needed to train clinical trial designers in the HCD approach and encourage adoption in the field. ",
doi="10.2196/51604",
url="https://formative.jmir.org/2024/1/e51604",
url="http://www.ncbi.nlm.nih.gov/pubmed/38358789"
}


@Article{info:doi/10.2196/34292,
author="Regueiro, Cristina
and Codesido, Laura
and Garc{\'i}a-Nimo, Laura
and Zarraqui{\~n}os, Sara
and Remedios, David
and Rodr{\'i}guez-Blanco, Arturo
and Sinde, Esteban
and Fern{\'a}ndez-de-Ana, Catalina
and Cubiella, Joaqu{\'i}n",
title="Effect of the Nutraceutical Micodigest 2.0 on the Complication Rate of Colorectal Cancer Surgery With Curative Intent: Protocol for a Placebo-Controlled Double-blind Randomized Clinical Trial",
journal="JMIR Res Protoc",
year="2022",
month="May",
day="16",
volume="11",
number="5",
pages="e34292",
keywords="colorectal cancer",
keywords="surgery complications",
keywords="gut microbiota",
keywords="inflammatory pattern",
keywords="nutritional status",
keywords="nutraceutical",
keywords="postsurgery",
keywords="colorectal",
keywords="cancer",
keywords="colon",
abstract="Background: Most colorectal cancer patients diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used for the prevention of infectious postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in colorectal cancer patients. The combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Objective: Based on this hypothesis, we have designed a double-bind, randomized clinical trial to evaluate the effect of the nutraceutical fungal extract Micodigest 2.0 on complications of surgery for colorectal cancer resection. Methods: Colorectal cancer candidates for surgery will be considered for inclusion in the study. After evaluation by the multidisciplinary tumor board, patients who meet selection criteria will be screened, stratified according to tumor location, and randomly allocated to be treated with Micodigest 2.0 or placebo. Treatment will be continued until admission for surgery (4-6 weeks). Participants will undergo a medical and clinical evaluation including baseline and preadmission quality of life, microbiome composition, inflammatory and nutritional status, adverse events, and adherence assessments. The main end point of the study is the surgery complication rate. We will evaluate complications using the Clavien-Dindo classification. It will be necessary to recruit 144 patients to find a relevant clinical difference. We will also evaluate the effect of the nutraceutical on microbiome composition, inflammatory response, nutritional status, and quality of life, as well as the effect of these variables on surgical complications. Results: This study was funded in 2020 by the Center for Industrial Technology Development. Recruitment began in September 2021 and is expected to be completed in September 2022. Data will be analyzed and the results will be disseminated in 2023. Conclusions: The results of this protocol study could help to reduce surgery complications in patients with colorectal cancer using the new treatment Micodigest. This study could also identify new features associated with colorectal surgery complications. In summary, this study trial could improve the management of colorectal cancer patients. Trial Registration: Clinical Trials.gov NCT04821258; https://clinicaltrials.gov/ct2/show/NCT04821258 International Registered Report Identifier (IRRID): DERR1-10.2196/34292 ",
doi="10.2196/34292",
url="https://www.researchprotocols.org/2022/5/e34292",
url="http://www.ncbi.nlm.nih.gov/pubmed/35576566"
}


@Article{info:doi/10.2196/25621,
author="Perez, A. Edith
and Jaffee, M. Elizabeth
and Whyte, John
and Boyce, A. Cheryl
and Carpten, D. John
and Lozano, Guillermina
and Williams, M. Raymond
and Winkfield, M. Karen
and Bernstein, David
and Poblete, Sung",
title="Analysis of Population Differences in Digital Conversations About Cancer Clinical Trials: Advanced Data Mining and Extraction Study",
journal="JMIR Cancer",
year="2021",
month="Sep",
day="23",
volume="7",
number="3",
pages="e25621",
keywords="cancer",
keywords="clinical trials",
keywords="data mining",
keywords="text extraction",
keywords="social media",
keywords="race and ethnicity",
keywords="health communication",
keywords="health care disparities",
keywords="natural language processing",
abstract="Background: Racial and ethnic diversity in clinical trials for cancer treatment is essential for the development of treatments that are effective for all patients and for identifying potential differences in toxicity between different demographics. Mining of social media discussions about clinical trials has been used previously to identify patient barriers to enrollment in clinical trials; however, a comprehensive breakdown of sentiments and barriers by various racial and ethnic groups is lacking. Objective: The aim of this study is to use an innovative methodology to analyze web-based conversations about cancer clinical trials and to identify and compare conversation topics, barriers, and sentiments between different racial and ethnic populations. Methods: We analyzed 372,283 web-based conversations about cancer clinical trials, of which 179,339 (48.17\%) of the discussions had identifiable race information about the individual posting the conversations. Using sophisticated machine learning software and analyses, we were able to identify key sentiments and feelings, topics of interest, and barriers to clinical trials across racial groups. The stage of treatment could also be identified in many of the discussions, allowing for a unique insight into how the sentiments and challenges of patients change throughout the treatment process for each racial group. Results: We observed that only 4.01\% (372,283/9,284,284) of cancer-related discussions referenced clinical trials. Within these discussions, topics of interest and identified clinical trial barriers discussed by all racial and ethnic groups throughout the treatment process included health care professional interactions, cost of care, fear, anxiety and lack of awareness, risks, treatment experiences, and the clinical trial enrollment process. Health care professional interactions, cost of care, and enrollment processes were notably discussed more frequently in minority populations. Other minor variations in the frequency of discussion topics between ethnic and racial groups throughout the treatment process were identified. Conclusions: This study demonstrates the power of digital search technology in health care research. The results are also valuable for identifying the ideal content and timing for the delivery of clinical trial information and resources for different racial and ethnic groups. ",
doi="10.2196/25621",
url="https://cancer.jmir.org/2021/3/e25621",
url="http://www.ncbi.nlm.nih.gov/pubmed/34554099"
}


@Article{info:doi/10.2196/27767,
author="Haddad, Tufia
and Helgeson, M. Jane
and Pomerleau, E. Katharine
and Preininger, M. Anita
and Roebuck, Christopher M.
and Dankwa-Mullan, Irene
and Jackson, Purcell Gretchen
and Goetz, P. Matthew",
title="Accuracy of an Artificial Intelligence System for Cancer Clinical Trial Eligibility Screening: Retrospective Pilot Study",
journal="JMIR Med Inform",
year="2021",
month="Mar",
day="26",
volume="9",
number="3",
pages="e27767",
keywords="clinical trial matching",
keywords="clinical decision support system",
keywords="machine learning",
keywords="artificial intelligence",
keywords="screening",
keywords="clinical trials",
keywords="eligibility",
keywords="breast cancer",
abstract="Background: Screening patients for eligibility for clinical trials is labor intensive. It requires abstraction of data elements from multiple components of the longitudinal health record and matching them to inclusion and exclusion criteria for each trial. Artificial intelligence (AI) systems have been developed to improve the efficiency and accuracy of this process. Objective: This study aims to evaluate the ability of an AI clinical decision support system (CDSS) to identify eligible patients for a set of clinical trials. Methods: This study included the deidentified data from a cohort of patients with breast cancer seen at the medical oncology clinic of an academic medical center between May and July 2017 and assessed patient eligibility for 4 breast cancer clinical trials. CDSS eligibility screening performance was validated against manual screening. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for eligibility determinations were calculated. Disagreements between manual screeners and the CDSS were examined to identify sources of discrepancies. Interrater reliability between manual reviewers was analyzed using Cohen (pairwise) and Fleiss (three-way) $\kappa$, and the significance of differences was determined by Wilcoxon signed-rank test. Results: In total, 318 patients with breast cancer were included. Interrater reliability for manual screening ranged from 0.60-0.77, indicating substantial agreement. The overall accuracy of breast cancer trial eligibility determinations by the CDSS was 87.6\%. CDSS sensitivity was 81.1\% and specificity was 89\%. Conclusions: The AI CDSS in this study demonstrated accuracy, sensitivity, and specificity of greater than 80\% in determining the eligibility of patients for breast cancer clinical trials. CDSSs can accurately exclude ineligible patients for clinical trials and offer the potential to increase screening efficiency and accuracy. Additional research is needed to explore whether increased efficiency in screening and trial matching translates to improvements in trial enrollment, accruals, feasibility assessments, and cost. ",
doi="10.2196/27767",
url="https://medinform.jmir.org/2021/3/e27767",
url="http://www.ncbi.nlm.nih.gov/pubmed/33769304"
}


@Article{info:doi/10.2196/22006,
author="Beauchamp, Lyng Ulrikke
and Pappot, Helle
and Holl{\"a}nder-Mieritz, Cecilie",
title="The Use of Wearables in Clinical Trials During Cancer Treatment: Systematic Review",
journal="JMIR Mhealth Uhealth",
year="2020",
month="Nov",
day="11",
volume="8",
number="11",
pages="e22006",
keywords="cancer treatment",
keywords="wearables",
keywords="adherence",
keywords="sensor technology",
abstract="Background: Interest in the use of wearables in medical care is increasing. Wearables can be used to monitor different variables, such as vital signs and physical activity. A crucial point for using wearables in oncology is if patients already under the burden of severe disease and oncological treatment can accept and adhere to the device. At present, there are no specific recommendations for the use of wearables in oncology, and little research has examined the purpose of using wearables in oncology. Objective: The purpose of this review is to explore the use of wearables in clinical trials during cancer treatment, with a special focus on adherence. Methods: PubMed and EMBASE databases were searched prior and up to October 3, 2019, with no limitation in the date of publication. The search strategy was aimed at studies using wearables for monitoring adult patients with cancer during active antineoplastic treatment. Studies were screened independently by 2 reviewers by title and abstract, selected for inclusion and exclusion, and the full-text was assessed for eligibility. Data on study design, type of wearable used, primary outcome, adherence, and device outcome were extracted. Results were presented descriptively. Results: Our systematic search identified 1269 studies, of which 25 studies met our inclusion criteria. The types of cancer represented in the studies were breast (7/25), gastrointestinal (4/25), lung (4/25), and gynecologic (1/25); 9 studies had multiple types of cancer. Oncologic treatment was primarily chemotherapy (17/25). The study-type distribution was pilot/feasibility study (12/25), observational study (10/25), and randomized controlled trial (3/25). The median sample size was 40 patients (range 7-180). All studies used a wearable with an accelerometer. Adherence varied across studies, from 60\%-100\% for patients wearing the wearable/evaluable sensor data and 45\%-94\% for evaluable days, but was differently measured and reported. Of the 25 studies, the most frequent duration for planned monitoring with a wearable was 8-30 days (13/25). Topics for wearable outcomes were physical activity (19/25), circadian rhythm (8/25), sleep (6/25), and skin temperature (1/25). Patient-reported outcomes (PRO) were used in 17 studies; of the 17 PRO studies, only 9 studies reported correlations between the wearable outcome and the PRO. Conclusions: We found that definitions of outcome measures and adherence varied across studies, and limited consensus among studies existed on which variables to monitor during treatment. Less heterogeneity, better consensus in terms of the use of wearables, and established standards for the definitions of wearable outcomes and adherence would improve comparisons of outcomes from studies using wearables. Adherence, and the definition of such, seems crucial to conclude on data from wearable studies in oncology. Additionally, research using advanced wearable devices and active use of the data are encouraged to further explore the potential of wearables in oncology during treatment. Particularly, randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice. ",
doi="10.2196/22006",
url="http://mhealth.jmir.org/2020/11/e22006/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33174852"
}


@Article{info:doi/10.2196/18938,
author="Hirano, Tomonobu
and Motohashi, Tomomitsu
and Okumura, Kosuke
and Takajo, Kentaro
and Kuroki, Taiyo
and Ichikawa, Daisuke
and Matsuoka, Yutaka
and Ochi, Eisuke
and Ueno, Taro",
title="Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox",
journal="J Med Internet Res",
year="2020",
month="Jun",
day="2",
volume="22",
number="6",
pages="e18938",
keywords="blockchain",
keywords="clinical trial",
keywords="data management",
keywords="validation",
keywords="breast cancer",
keywords="regulatory sandbox",
abstract="Background: The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. Objective: The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. Methods: We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. Results: We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. Conclusions: We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials. ",
doi="10.2196/18938",
url="https://www.jmir.org/2020/6/e18938",
url="http://www.ncbi.nlm.nih.gov/pubmed/32340974"
}


@Article{info:doi/10.2196/12044,
author="McKay, Rana
and Mills, Hannah
and Werner, Lillian
and Choudhury, Atish
and Choueiri, Toni
and Jacobus, Susanna
and Pace, Amanda
and Polacek, Laura
and Pomerantz, Mark
and Prisby, Judith
and Sweeney, Christopher
and Walsh, Meghara
and Taplin, Mary-Ellen",
title="Evaluating a Video-Based, Personalized Webpage in Genitourinary Oncology Clinical Trials: A Phase 2 Randomized Trial",
journal="J Med Internet Res",
year="2019",
month="May",
day="02",
volume="21",
number="5",
pages="e12044",
keywords="cancer",
keywords="prostatic neoplasms",
keywords="kidney neoplasms",
keywords="clinical trial",
keywords="instructional films and videos",
keywords="education",
abstract="Background: The pace of drug discovery and approvals has led to expanding treatments for cancer patients. Although extensive research exists regarding barriers to enrollment in oncology clinical trials, there are limited studies evaluating processes to optimize patient education, oral anticancer therapy administration, and adherence for patients enrolled in clinical trials. In this study, we assess the feasibility of a video-based, personalized webpage for patients enrolled in genitourinary oncology clinical trials involving 1 or more oral anticancer therapy. Objective: The primary objective of this trial was to assess the differences in the number of patient-initiated violations in the intervention arm compared with a control arm over 4 treatment cycles. Secondary objectives included patient satisfaction, frequently asked questions by patients on the intervention arm, patient-initiated calls to study team members, and patient-reported stress levels. Methods: Eligible patients enrolling on a therapeutic clinical trial for a genitourinary malignancy were randomized 2:1 to the intervention arm or control arm. Patients randomized to the intervention arm received access to a video-based, personalized webpage, which included videos of patients' own clinic encounters with their providers, instructional videos on medication administration and side effects, and electronic versions of educational documents. Results: A total of 99 patients were enrolled (89 were evaluable; 66 completed 4 cycles). In total, 71\% (40/56) of patients in the intervention arm had 1 or more patient-initiated violation compared with 70\% (23/33) in the control arm. There was no difference in the total number of violations across 4 cycles between the 2 arms (estimate=?0.0939, 95\% CI?0.6295 to 0.4418, P value=.73). Median baseline satisfaction scores for the intervention and control arms were 72 and 73, respectively, indicating high levels of patient satisfaction in both arms. Median baseline patient-reported stress levels were 10 and 13 for the intervention and control arms, respectively, indicating low stress levels in both arms at baseline. Conclusions: This study is among the first to evaluate a video-based, personalized webpage that provides patients with educational videos and video recordings of clinical trial appointments. Despite not meeting the primary endpoint of reduced patient-initiated violations, this study demonstrates the feasibility of a video-based, personalized webpage in clinical trials. Future research assessing this tool might be better suited for realms outside of clinical trials and might consider the use of an endpoint that assesses patient-reported outcomes directly. A major limitation of this study was the lack of prior data for estimating the null hypothesis in this population. ",
doi="10.2196/12044",
url="https://www.jmir.org/2019/5/e12044/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31045501"
}


@Article{info:doi/10.2196/10085,
author="Woodford, Joanne
and Wikman, Anna
and Einhorn, Kim
and Cernvall, Martin
and Gr{\"o}nqvist, Helena
and Romppala, Amanda
and von Essen, Louise",
title="Attitudes and Preferences Toward a Hypothetical Trial of an Internet-Administered Psychological Intervention for Parents of Children Treated for Cancer: Web-Based Survey",
journal="JMIR Ment Health",
year="2018",
month="Dec",
day="18",
volume="5",
number="4",
pages="e10085",
keywords="anxiety",
keywords="cancer",
keywords="clinical trial",
keywords="depression",
keywords="eHealth",
keywords="parents",
abstract="Background: Clinical trials are often challenged with issues of recruitment and retention. Little is known concerning general attitudes and preferences toward trial design and willingness to participate among parents of children treated for cancer. Furthermore, willingness to participate in internet-administered psychological interventions remains unexplored. In this study, we examined attitudes and preferences of the population regarding study procedures for a hypothetical trial of an internet-administered psychological intervention. In addition, differences in the response rate between modes of study invitation and willingness to engage in internet-administered interventions were examined. Objective: The primary objective of this study was to examine attitudes and preferences toward participating in an internet-administrated psychological intervention. The secondary objective was to examine the response rates and help-seeking behavior among parents of children treated for cancer. Methods: A cross-sectional, Web-based survey was conducted with parents of children who had completed cancer treatment. This Web-based survey examined self-reported emotional distress, prior help-seeking and receipt of psychological support, past research participation, attitudes toward research, preferences concerning recruitment procedures, and attitudes toward different types of trial design. Results: Of all the parents invited, 32.0\% (112/350) completed the survey, with no difference in response rate between modes of study invitation ($\chi$21=0.6, P=.45). The majority (80/112, 71.4\%) of parents responded that they had experienced past emotional distress. Responses indicated high (56/112, 50.0\%) or somewhat high trust in research (51/112, 45.5\%), and the majority of parents would accept, or maybe accept, internet-administered psychological support if offered (83/112, 74.1\%). In addition, responses showed a preference for postal study invitation letters (86/112, 76.8\%), sent by a researcher (84/112, 75.0\%) with additional study information provided on the Web via text (81/112, 72.3\%) and video (66/112, 58.9\%). Overall, parents responded that trials utilizing a waiting list control, active alternative treatment control, or a patient-preference design were acceptable. Conclusions: Parents of children treated for cancer appear willing to participate in trials examining internet-administered psychological support. Findings of this study will inform the design of a feasibility trial examining internet-administered psychological support for the population. ",
doi="10.2196/10085",
url="http://mental.jmir.org/2018/4/e10085/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30563814"
}


@Article{info:doi/10.2196/resprot.9762,
author="Reuter, Katja
and Angyan, Praveen
and Le, NamQuyen
and MacLennan, Alicia
and Cole, Sarah
and Bluthenthal, N. Ricky
and Lane, J. Christianne
and El-Khoueiry, B. Anthony
and Buchanan, A. Thomas",
title="Monitoring Twitter Conversations for Targeted Recruitment in Cancer Trials in Los Angeles County: Protocol for a Mixed-Methods Pilot Study",
journal="JMIR Res Protoc",
year="2018",
month="Sep",
day="25",
volume="7",
number="9",
pages="e177",
keywords="breast cancer",
keywords="cancer",
keywords="clinical research",
keywords="clinical trial",
keywords="colon cancer",
keywords="kidney cancer",
keywords="listening",
keywords="lung cancer",
keywords="lymphoma",
keywords="monitoring",
keywords="outreach",
keywords="prostate cancer",
keywords="recruitment",
keywords="research participation",
keywords="surveillance",
keywords="Twitter",
keywords="social media",
keywords="social network",
abstract="Background: Insufficient recruitment of participants remains a critical roadblock to successful clinical research, particularly clinical trials. Social media provide new ways for connecting potential participants with research opportunities. Researchers suggest that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues and increasing enrollment in cancer clinical trials. However, there is a lack of evidence that Twitter offers practical utility and impact. Objective: This pilot study aimed to examine the feasibility and impact of using Twitter monitoring data (ie, user activity and their conversations about cancer-related conditions and concerns expressed by Twitter users in Los Angeles County) as a tool for enhancing clinical trial recruitment at a comprehensive cancer center. Methods: We will conduct a mixed-methods interrupted time series study design with a before-and-after social media recruitment intervention. On the basis of a preliminary analysis of eligible trials, we plan to onboard at least 84 clinical trials across 6 disease categories: breast cancer, colon cancer, kidney cancer, lymphoma, non-small cell lung cancer, and prostate cancer that are open to accrual at the University of Southern California (USC) Norris Comprehensive Cancer Center. We will monitor messages about these 6 cancer conditions posted by Twitter users in Los Angeles County. Recruitment for the trials will occur through the Twitter account (@USCTrials). Primary study outcomes---feasibility and acceptance of the social media intervention among targeted Twitter users and the study teams of the onboarded trials---will be assessed using qualitative interviews and the 4-point Likert scale and by calculating the proportion of targeted Twitter users who engaged with outreach messages. Second, impact of the social media intervention will be measured by calculating the proportion of enrollees in trials. The enrollment rate will be compared between the active intervention period and the prior 10 months as historical control for each disease trial group. This study has been funded by the National Center for Advancing Translational Science through a Clinical and Translational Science Award. Study approval was obtained from the clinical investigations committee at USC Norris and the institutional review board at USC. Results: Recruitment on Twitter started in February 2018. Data collection will be completed in November 2018. Conclusions: This pilot project will provide preliminary data and practical insight into the application of publicly available Twitter data to identify and recruit clinical trial participants across 6 cancer disease types. We will shed light on the acceptance of the social media intervention among Twitter users and study team members of the onboarded trials. If successful, the findings will inform a multisite randomized controlled trial to determine the efficacy of the social media intervention across different locations and populations. Trial Registration: ClinicalTrials.gov NCT03408561; https://clinicaltrials.gov/ct2/show/NCT03408561 (Archived by WebCite at http://www.webcitation.org/72LihauzW) Registered Report Identifier: RR1-10.2196/9762 ",
doi="10.2196/resprot.9762",
url="http://www.researchprotocols.org/2018/9/e177/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30274964"
}


@Article{info:doi/10.2196/11191,
author="Hara, Isao
and Yamashita, Shimpei
and Nishizawa, Satoshi
and Kikkawa, Kazuro
and Shimokawa, Toshio
and Kohjimoto, Yasuo",
title="Enzalutamide Versus Abiraterone as a First-Line Endocrine Therapy for Castration-Resistant Prostate Cancer: Protocol for a Multicenter Randomized Phase 3 Trial",
journal="JMIR Res Protoc",
year="2018",
month="Jul",
day="27",
volume="7",
number="7",
pages="e11191",
keywords="castration resistant prostate cancer",
keywords="abiraterone",
keywords="enzalutamide",
keywords="prostatic neoplasms, castration-resistant",
keywords="clinical protocols",
abstract="Background: Recent large-scale randomized studies have demonstrated that 2 new hormone preparations (abiraterone and enzalutamide) prolong survival in docetaxel-treated or -na{\"i}ve castration-resistant prostate cancer patients. However, no studies have directly compared antitumor effects between these 2 agents, and no clear guidelines are available for choosing between them. Objective: The objective of this clinical study is to compare antitumor effects and adverse events between abiraterone and enzalutamide by allocating castration-resistant prostate cancer patients deemed not indicated for docetaxel treatment to receive either of the 2 agents. Methods: This study is an open-label, comparative study allocating castration-resistant prostate cancer patients to abiraterone or enzalutamide treatment arms (allocation factors: age <70 vs ?70 years, and presence vs absence of metastases) and assessing the treatment results. Each arm will contain 25 patients. On confirmation of prostate-specific antigen failure or progression on imaging, patients undergo crossover to receive the alternative study drug. The primary end point is prostate-specific antigen response rate (percentage of patients with a decrease in prostate-specific antigen level by ?50\%) in the abiraterone and enzalutamide treatment arms. Results: Recruitment started in May 2016, and 13 patients have been recruited so far. We expect to complete enrollment by December 2020. Conclusions: Recently, cross-resistance between abiraterone and enzalutamide has been an issue of focus. Urologists thus tend to prefer docetaxel rather than sequential therapies using 2 hormonal preparations after the progression of a first hormonal preparation. From that perspective, our clinical trial is rather out of fashion. Nevertheless, we assume that many patients receive hormonal sequential therapy in the actual clinical setting, since most such patients cannot receive chemotherapeutic agents due to old age or poor performance status. This is why we are attempting this randomized clinical trial comparing abiraterone versus enzalutamide. We will try to identify which drug is suitable for initial hormonal therapy among castration-resistant prostate cancer patients who do not meet the indications for docetaxel therapy in terms of not only antitumor effect, but also adverse events and quality of life. Trial Registration: University Hospital Medical Information Network UMIN000022102; https://upload.umin.ac.jp /cgi-open-bin/ctr\_e/ctr\_view.cgi?recptno=R000025463 (Archived by WebCite at http://www.webcitation.org/70xaQfGlJ) ",
doi="10.2196/11191",
url="http://www.researchprotocols.org/2018/7/e11191/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30054264"
}


@Article{info:doi/10.2196/10070,
author="Schoen, W. Martin
and Basch, Ethan
and Hudson, L. Lori
and Chung, E. Arlene
and Mendoza, R. Tito
and Mitchell, A. Sandra
and St. Germain, Diane
and Baumgartner, Paul
and Sit, Laura
and Rogak, J. Lauren
and Shouery, Marwan
and Shalley, Eve
and Reeve, B. Bryce
and Fawzy, R. Maria
and Bhavsar, A. Nrupen
and Cleeland, Charles
and Schrag, Deborah
and Dueck, C. Amylou
and Abernethy, P. Amy",
title="Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study",
journal="JMIR Hum Factors",
year="2018",
month="Jul",
day="16",
volume="5",
number="3",
pages="e10070",
keywords="usability",
keywords="patient-reported outcomes",
keywords="symptoms",
keywords="adverse events",
keywords="PRO-CTCAE",
keywords="cancer clinical trials",
abstract="Background: The US National Cancer Institute (NCI) developed software to gather symptomatic adverse events directly from patients participating in clinical trials. The software administers surveys to patients using items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) through Web-based or automated telephone interfaces and facilitates the management of survey administration and the resultant data by professionals (clinicians and research associates). Objective: The purpose of this study was to iteratively evaluate and improve the usability of the PRO-CTCAE software. Methods: Heuristic evaluation of the software functionality was followed by semiscripted, think-aloud protocols in two consecutive rounds of usability testing among patients with cancer, clinicians, and research associates at 3 cancer centers. We conducted testing with patients both in clinics and at home (remotely) for both Web-based and telephone interfaces. Furthermore, we refined the software between rounds and retested. Results: Heuristic evaluation identified deviations from the best practices across 10 standardized categories, which informed initial software improvement. Subsequently, we conducted user-based testing among 169 patients and 47 professionals. Software modifications between rounds addressed identified issues, including difficulty using radio buttons, absence of survey progress indicators, and login problems (for patients) as well as scheduling of patient surveys (for professionals). The initial System Usability Scale (SUS) score for the patient Web-based interface was 86 and 82 (P=.22) before and after modifications, respectively, whereas the task completion score was 4.47, which improved to 4.58 (P=.39) after modifications. Following modifications for professional users, the SUS scores improved from 71 to 75 (P=.47), and the mean task performance improved significantly (4.40 vs 4.02; P=.001). Conclusions: Software modifications, informed by rigorous assessment, rendered a usable system, which is currently used in multiple NCI-sponsored multicenter cancer clinical trials. Trial Registration: ClinicalTrials.gov NCT01031641; https://clinicaltrials.gov/ct2/show/NCT01031641 (Archived by WebCite at http://www.webcitation.org/708hTjlTl) ",
doi="10.2196/10070",
url="http://humanfactors.jmir.org/2018/3/e10070/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30012546"
}


@Article{info:doi/10.2196/10060,
author="Hillyer, Clarke Grace
and MacLean, A. Sarah
and Beauchemin, Melissa
and Basch, H. Corey
and Schmitt, M. Karen
and Segall, Leslie
and Kelsen, Moshe
and Brogan, L. Frances
and Schwartz, K. Gary",
title="YouTube Videos as a Source of Information About Clinical Trials: Observational Study",
journal="JMIR Cancer",
year="2018",
month="Jun",
day="26",
volume="4",
number="1",
pages="e10060",
keywords="clinical trial",
keywords="cancer clinical trial",
keywords="social media",
keywords="internet",
keywords="YouTube videos",
keywords="health information",
abstract="Background: Clinical trials are essential to the advancement of cancer treatment but fewer than 5\% of adult cancer patients enroll in a trial. A commonly cited barrier to participation is the lack of understanding about clinical trials. Objective: Since the internet is a popular source of health-related information and YouTube is the second most visited website in the world, we examined the content of the top 115 YouTube videos about clinical trials to evaluate clinical trial information available through this medium. Methods: YouTube videos posted prior to March 2017 were searched using selected keywords. A snowballing technique was used to identify videos wherein sequential screening of the autofill search results for each set of keywords was conducted. Video characteristics (eg, number of views and video length) were recorded. The content was broadly grouped as related to purpose, phases, design, safety and ethics, and participant considerations. Stepwise multivariable logistic regression analysis was conducted to assess associations between video type (cancer vs noncancer) and video characteristics and content. Results: In total, 115 videos were reviewed. Of these, 46/115 (40.0\%) were cancer clinical trials videos and 69/115 (60.0\%) were noncancer/general clinical trial videos. Most videos were created by health care organizations/cancer centers (34/115, 29.6\%), were oriented toward patients (67/115, 58.3\%) and the general public (68/115, 59.1\%), and were informational (79/115, 68.7\%); altruism was a common theme (31/115, 27.0\%). Compared with noncancer videos, cancer clinical trials videos more frequently used an affective communication style and mentioned the benefits of participation. Cancer clinical trial videos were also much more likely to raise the issue of costs associated with participation (odds ratio [OR] 5.93, 95\% CI 1.15-29.46) and advise patients to communicate with their physician about cancer clinical trials (OR 4.94, 95\% CI 1.39-17.56). Conclusions: Collectively, YouTube clinical trial videos provided information on many aspects of trials; however, individual videos tended to focus on selected topics with varying levels of detail. Cancer clinical trial videos were more emotional in style and positive in tone and provided information on the important topics of cost and communication. Patients are encouraged to verify and supplement YouTube video information in consultations with their health care professionals to obtain a full and accurate picture of cancer clinical trials to make an adequately informed decision about participation. ",
doi="10.2196/10060",
url="http://cancer.jmir.org/2018/1/e10060/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29945855"
}


@Article{info:doi/10.2196/resprot.7289,
author="Li, Bin
and Eschrich, A. Steven
and Berglund, Anders
and Mitchell, Melissa
and Fenstermacher, David
and Danaee, Hadi
and Dai, Hongyue
and Sullivan, Daniel
and Trepicchio, L. William
and Dalton, S. William",
title="Use of the Total Cancer Care System to Enrich Screening for CD30-Positive Solid Tumors for Patient Enrollment Into a Brentuximab Vedotin Clinical Trial: A Pilot Study to Evaluate Feasibility",
journal="JMIR Res Protoc",
year="2017",
month="Mar",
day="20",
volume="6",
number="3",
pages="e45",
keywords="antitumor agents",
keywords="CD30 antigen",
keywords="clinical trial",
keywords="database management systems",
keywords="medical oncology",
abstract="Background: One approach to identify patients who meet specific eligibility criteria for target-based clinical trials is to use patient and tumor registries to prescreen patient populations. Objective: Here we demonstrate that the Total Cancer Care (TCC) Protocol, an ongoing, observational study, may provide a solution for rapidly identifying patients with CD30-positive tumors eligible for CD30-targeted therapies such as brentuximab vedotin. Methods: The TCC patient gene expression profiling database was retrospectively screened for CD30 gene expression determined using HuRSTA-2a520709 Affymetrix arrays (GPL15048). Banked tumor tissue samples were used to determine CD30 protein expression by semiquantitative immunohistochemistry. Statistical comparisons of Z- and H-scores were performed using R statistical software (The R Foundation), and the predictive value, accuracy, sensitivity, and specificity of CD30 gene expression versus protein expression was estimated. Results: As of March 2015, 120,887 patients have consented to the institutional review board--approved TCC Protocol. A total of 39,157 fresh frozen tumor specimens have been collected, from which over 14,000 samples have gene expression data available. CD30 RNA was expressed in a number of solid tumors; the highest median CD30 RNA expression was observed in primary tumors from lymph node, soft tissue (many sarcomas), lung, skin, and esophagus (median Z-scores 1.011, 0.399, 0.202, 0.152, and 1.011, respectively). High level CD30 gene expression significantly enriches for CD30-positive protein expression in breast, lung, skin, and ovarian cancer; accuracy ranged from 72\% to 79\%, sensitivity from 75\% to 100\%, specificity from 70\% to 76\%, positive predictive value from 20\% to 40\%, and negative predictive value from 95\% to 100\%. Conclusions: The TCC gene expression profiling database guided tissue selection that enriched for CD30 protein expression in a number of solid tumor types. Such an approach may improve screening efficiency for enrolling patients into biomarker-based clinical trials. ",
doi="10.2196/resprot.7289",
url="http://www.researchprotocols.org/2017/3/e45/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28320689"
}


@Article{info:doi/10.2196/cancer.6701,
author="Perez, P. Raymond
and Finnigan, Shanda
and Patel, Krupa
and Whitney, Shanell
and Forrest, Annemarie",
title="Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project",
journal="JMIR Cancer",
year="2016",
month="Dec",
day="15",
volume="2",
number="2",
pages="e16",
keywords="clinical trials",
keywords="investigational new drug application",
keywords="risk management",
abstract="Background: Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. Objective: The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. Methods: CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. Results: The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Conclusions: Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by all sponsors. Until this is feasible, electronic reporting portals should at least have consistent functionality. CTTI has issued recommendations to improve the quality and use of electronic portals. ",
doi="10.2196/cancer.6701",
url="http://cancer.jmir.org/2016/2/e16/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28410179"
}


@Article{info:doi/10.2196/resprot.5494,
author="Singla, Apresh",
title="Protocol for Autologous Fat Grafting for Immediate Reconstruction of Lumpectomy Defects Following Surgery for Breast Cancer",
journal="JMIR Res Protoc",
year="2016",
month="Jul",
day="05",
volume="5",
number="3",
pages="e109",
keywords="Fat grafting",
keywords="lumpectomy defects",
abstract="Background: For women undergoing breast conservative surgery or lumpectomy for early stage breast carcinoma, there are limited options for reconstruction. Options include the use of flap surgery and/or implants, and have a significant associated morbidity and cost. Autologous fat grafting is a new alternative that can achieve a good cosmetic result, while reducing patient morbidity and cost by avoiding more extensive surgery. Objective: The primary objectives are to assess patient satisfaction using the Breast-Q questionnaire and to evaluate fat graft volume. The secondary objectives are fat survival and assessment for complication (eg, fat necrosis, cysts), local recurrence, and the number of sessions needed for a satisfactory outcome. Methods: This study is a case series of 100 patients, at a single-center institute spanning one year. The inclusion criteria include: female sex, age 18 to 75, early state breast cancer (confirmed on ultrasound/ positron emission tomography-computed tomography and cytology), amenable to breast conservative surgery, and at least 6 months post-completion of radiotherapy/ hormone/chemotherapy. Exclusion criteria include patients with more advanced stages of breast cancer necessitating total mastectomy, those unsuitable for surgical excision, and those in whom lumpectomy is not feasible. The patients will have follow-up data collected at 6 months, 12 months and 5 years post-operatively. Results: This study will begin enrolment in January 2017. We anticipate that there will be good patient satisfaction with fat grafting. The risk for long-term breast cancer recurrence hasn't been evaluated extensively in literature, however some clinical studies have shown no increased risk of breast cancer in appropriately selected patients at one year. Although some patients may develop complications from fat grafting (eg, necrosis/cysts) this should not confuse the radiological detection of breast cancer recurrence. Conclusions: Fat grafting is proving to be a viable option for reconstruction of lumpectomy defects with good patient satisfaction. The heterogeneous methods of reporting the harvesting of fat in literature may account for the variable outcomes described, and makes it difficult to compare results with similar studies. The long-term risk of breast cancer recurrence with fat grafting for lumpectomy defects is unknown. ",
doi="10.2196/resprot.5494",
url="http://www.researchprotocols.org/2016/3/e109/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27380864"
}