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Distress is common immediately after diagnosis of testicular cancer. It has historically been difficult to engage people in care models to alleviate distress because of complex factors, including differential coping strategies and influences of social gender norms. Existing support specifically focuses on long-term survivors of testicular cancer, leaving an unmet need for age-appropriate and sex-sensitized support for individuals with distress shortly after diagnosis.
We evaluated a web-based intervention, Nuts & Bolts, designed to provide support and alleviate distress after diagnosis of testicular cancer.
Using a mixed methods design to evaluate the acceptability, feasibility, and impact of Nuts & Bolts on distress, we randomly assigned participants with recently diagnosed testicular cancer (1:1) access to Nuts & Bolts at the time of consent (
Overall, 39 participants were enrolled in this study. The median time from orchidectomy to study consent was 14.8 (range 3-62) days. Moderate or high levels of distress evaluated using DT were reported in 58% (23/39) of participants at consent and reduced to 13% (5/38) after 1 week of observation.
Distress is common following the diagnosis of testicular cancer; however, it decreases over time. Nuts & Bolts was considered useful, acceptable, and relevant by individuals diagnosed with testicular cancer, with strong support for the intervention rendered by thematic analyses of semistructured interviews. The best time to introduce support, such as Nuts & Bolts, is yet to be determined; however, it may be most beneficial as soon as testicular cancer is strongly suspected or diagnosed.
There have been significant advances in the treatment of testicular cancer in recent decades, such that >97% of individuals can expect a cure [
Existing support for distress focuses on these long-term survivors, leaving individuals shortly after their diagnosis without adequate resources to support their distress, if required [
Nuts & Bolts is a web-based intervention funded and operated by the Movember Foundation that could help address this unmet need in patients with recently diagnosed testicular cancer [
Information provision, where individuals can access accurate information about testicular cancer statistics, diagnosis, treatment, and prognosis.
“Ask an Expert,” where individuals access responses to frequently asked questions or pose new questions to specialized cancer clinicians and trained peers (with lived experience) and receive personalized responses.
“Connect with a Man,” where individuals can access one-on-one peer support from a trained survivor of testicular cancer.
The website requires individuals to self-navigate through the 3 domains according to their specific needs. It was not readily available to the public at the time this study was recruiting; however, the website has since been made available following an official launch.
We undertook a prospective, multicenter, randomized controlled trial to evaluate the acceptability, feasibility, and impact of Nuts & Bolts on distress levels in the weeks following diagnosis of testicular cancer; however, because of poor accrual and anticipated impacts of the COVID-19 pandemic on research personnel, the trial closed early. We then evaluated the prevalence of distress, anxiety, and depression following a recent diagnosis of testicular cancer, changes in symptoms across a period of observation, and an exploration of the lived experience of individuals with newly diagnosed testicular cancer through thematic analysis of semistructured interviews.
This study was designed as a mixed methods, convergent parallel, randomized controlled trial. Eligible participants were aged >18 years, had histologically confirmed testicular cancer within 4 weeks of study consent, were proficient in English and had access to the internet.
Eligible participants were assigned (1:1) to either
Quantitative data were collected using the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) score (0-10) and problem list [
Study scheme. DT: Distress Thermometer; HADS-A: Hospital Anxiety and Depression Scale–Anxiety; HADS-D: Hospital Anxiety and Depression Scale–Depression.
The primary end point was the change in DT score between study consent and day 8 in the
Qualitative data were collected after completion of the quantitative assessments. Participants were invited to undertake optional, ethically approved semistructured interviews, which were thematically analyzed [
We estimated that a sample of 86 participants, allowing for a 20% loss to follow-up, would provide ≥80% power to detect a mean difference of 1.8 between
Qualitative semistructured interview data were thematically analyzed, systematically identifying, organizing, and providing insight into patterns of meaning (themes) across the data set [
Study data were collected and managed using REDCap (Research Electronic Data Capture; Vanderbilt University) [
This study was approved by the Melbourne Health Human Research Ethics Committee (MH-2018-157301). Local ethical and governance approval was obtained from all participating sites. All participants provided written informed consent based on the Declaration of Helsinki principles [
Between April 2019 and April 2020, of the 56 invited participants, 39 (70%) participants from 4 sites consented to the trial and were randomly assigned to
CONSORT (Consolidated Standards of Reporting Trials) diagram.
Baseline characteristics (N=39).
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Eligible participants (n=39) | |||
Age at consent (years), median (range) | 32.4 (24-55)a | |||
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I | 32 (82) | ||
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II-III | 4 (10) | ||
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Not stated | 3 (8) | ||
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White | 34 (87) | ||
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Asian | 4 (10) | ||
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Other | 1 (3) | ||
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Single | 12 (31) | ||
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Married or de facto | 21 (54) | ||
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In a relationship | 6 (15) | ||
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High school | 5 (13) | ||
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Apprenticeship | 4 (10) | ||
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Tertiary | 30 (77) | ||
Paid employment, n (%) | 36 (92) | |||
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Previous history of mental ill health | 8 (21) | ||
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Currently receiving mental health support | 9 (23) | ||
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Yes | 36 (92) | ||
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Not stated | 3 (8) | ||
Time from orchidectomy (days), median (range) | 14.8 (3-62) | |||
Medical oncologist involvement at time of enrollment, n (%) | 24 (62) | |||
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Surveillance | 30 (77) | ||
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Chemotherapy | 5 (13) | ||
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Not stated | 4 (10) | ||
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Median score: all participants, median (range) | 5 (0-8) | |
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Mean score: consented <14 days since orchidectomy, mean (range) | 5.2 (1-8) | |
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Mean score: consented >14 days since orchidectomy, mean (range) | 3.7 (0-7) | |
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Median score: all participants, median (range) | 5 (0-15) | |
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Mean score: consented <14 days since orchidectomy, mean (range) | 6.9 (2-15) | |
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Mean score: consented 14 days since orchidectomy, mean (range) | 4.4 (0-11) | |
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Median score: all participants, median (range) | 3 (0-10) | |
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Mean score: consented <14 days since orchidectomy, mean (range) | 4.6 (0-9) | |
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Mean score: consented >14 days since orchidectomy, mean (range) | 3.1 (0-10) | |
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DT≥5 | 23 (59) | |
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HADS-Tf≥11 | 15 (38) |
aExcluding 2 participants in whose date of birth was incorrectly recorded.
bTNM: tumor, node, metastases.
cDT: Distress Thermometer.
dHADS-A: Hospital Anxiety and Depression Scale–Anxiety.
eHADS-D: Hospital Anxiety and Depression Scale–Depression.
fHADS-T: Hospital Anxiety and Depression Scale–Total.
Distress was reported by most participants at baseline on DT. The median DT score was 5 (range 0-8), with 53% (21/39) of all participants reporting moderate (DT score≥5 and <8) and 5% (2/39) reporting high-level (DT score≥8) distress. Baseline DT scores were not associated with key demographic risk factors for distress, including preexisting mental health history (moderate distress: OR 2.5, 95% CI 0.4-14.2), lower level of education (moderate distress: OR 0.8, 95% CI 0.3-3.9), or relationship status (moderate distress: OR 1.0, 95% CI 0.3-4.1) in our study (Table S1 in
Emotional and physical problems dominated the NCCN problem list at baseline, with nervousness, worry, fear, sadness, fatigue, feeling swollen, and pain reported by at least half of the participants (at least 22/39, 56%; Table S2 in
Early intervention with Nuts & Bolts did not significantly reduce mean DT scores on day 8 compared with those for delayed intervention after adjusting for baseline DT score (
When analyzed as a whole, regardless of the group assignment, levels of distress evaluated using DT significantly declined between baseline evaluation and after 1 week in a paired 2-tailed
In contrast to the baseline evaluation, only 13% (5/38) of the participants reported moderate distress on DT after 1 week of observation, and none of the participants reported high levels of distress. Levels of anxiety evaluated using HADS-A did not change between baseline and 1-week later (5.7 vs 5.1;
When analyzed by time from orchidectomy rather than time from study entry, median DT, HADS-A, and HADS-D scores reduced most between 1 and 4 weeks following orchidectomy and then remained largely stable throughout the remainder of the observation period (
Median levels of distress, anxiety, and distress during observation.
Weeks following orchidectomy | Number of observations | DTa score, median (range) | HADS-Ab score, median (range) | HADS-Dc score, median (range) |
≤1 | 10 | 5 (1-8) | 6.5 (2-10) | 4.5 (0-9) |
>1 to ≤2 | 14 | 4.5 (1-8) | 6.5 (0-15) | 4.5 (1-9) |
>2 to ≤3 | 20 | 2 (0-6) | 4 (0-10) | 2 (0-7) |
>3 to ≤4 | 19 | 3 (0-7) | 6 (2-11) | 2 (0-10) |
>4 to ≤5 | 24 | 2 (0-7) | 5 (0-12) | 2 (0-9) |
>5 to ≤6 | 11 | 2 (0-5) | 4 (0-11) | 2 (0-10) |
>6 | 21 | 1 (0-5) | 4 (0-11) | 2 (0-14) |
aDT: Distress Thermometer.
bHADS-A: Hospital Anxiety and Depression Scale–Anxiety.
cHADS-D: Hospital Anxiety and Depression Scale-Depression.
Overall, 95% (37/39) of the participants completed the evaluation of acceptability and feasibility at the conclusion of the study. Most participants expressed that Nuts & Bolts was easy to use (37/37, 100%), relevant (36/37, 97%), and useful (31/37, 84%). Almost two-thirds (24/37, 65%) used the “Ask an Expert” module, with 87% (20/24) of responders agreeing that this module was useful, although some noted that their questions were not answered. A smaller proportion used the “Connect with a Man” module (5/37, 14%) and all agreed that this module was useful (5/5, 100%;
Responses to poststudy questionnaire of acceptability and feasibility.
Statement asked | Response | |||||
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Strongly disagree, n (%) | Disagree, n (%) | Unsure, n (%) | Agree, n (%) | Strongly agree, n (%) | Respondents, n (% of users) |
Nuts & Bolts was useful to me | 0 (0) | 3 (8) | 3 (8) | 13 (35) | 18 (49) | 37 (95) |
Nuts & Bolts was relevant to me | 0 (0) | 0 (0) | 1 (3) | 24 (65) | 12 (32) | 37 (95) |
Nuts & Bolts was easy to use | 0 (0) | 0 (0) | 0 (0) | 11 (30) | 26 (70) | 37 (95) |
I could understand the information provided by Nuts & Bolts | 0 (0) | 0 (0) | 0 (0) | 10 (27) | 27 (73) | 37 (95) |
The length of the content on Nuts & Bolts was appropriate to me | 0 (0) | 1 (3) | 3 (8) | 9 (25) | 23 (64) | 36 (92) |
I found the “Ask an Expert” section useful | 0 (0) | 1 (4) | 2 (9) | 14 (61) | 6 (26) | 23 (96) |
I found the “Connect with a Man” section useful | 0 (0) | 0 (0) | 0 (0) | 2 (40) | 3 (60) | 5 (100) |
Over three-fourths of the participants (30/39, 77%) provided consent to participate in the optional, semistructured interviews, and using convenience sampling, 16 interviews were conducted. This group was representative of the studied population with a median age of 30.5 (range 24.1-54.5) years, and 50% (8/16) were assigned to each study group. Most participants were White (14/16, 88%), married or in a de facto relationship (11/16, 69%), and diagnosed with stage I testicular cancer (10/16, 63%; data not shown).
Thematic analysis of interviews generated 4 main themes regarding participants’ experiences following the diagnosis of testicular cancer and use of Nuts & Bolts (
Thematic map.
Themes, subthemes, and illustrative quotes from thematic analyses.
Theme and subthemes | Illustrative quotes | |
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A. Ease of access to consolidated information | “The most helpful thing about the site is the fact that it consolidates the information that you’re after for this specific condition and that’s something that’s not readily available.” [Tertiary educated, in a relationship, aged 55 years] |
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B. Mental health benefits | “And I think...[the website] was good because when I was about to start to get a bit anxious so that like ‘Oh, God, what if, what if, what ifs,’ I could read the information to just reassure myself, I guess, with the general facts...” [Tertiary educated, in a relationship, aged 34 years] |
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C. Enabling communication with health care professionals | “...[The website] gave me the proper questions that I need to ask, not only the oncologist, but also the nurses when I went into chemo.” [High school educated, in a relationship, aged 49 years] |
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A. Accessing the website earlier in the testicular cancer journey would be beneficial | “I reckon...[the website] would be most useful pretty much as soon as you get diagnosed...Look, I would suggest probably once you’ve had some tests done with your GP, if it’s made available, then I think that would be beneficial...before going to see a urologist...” [Tertiary educated, single, aged 30 years] |
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B. Step-by-step layout and varied mode of information delivery ensured acceptability | “...[the website] has a step by step, and it explains each stage, and then you can drill down on the information...and then it explains as you go through the journey...And I think...[the website] is kind of like, ‘Here, we’ll help you’—like just a path. It just lays out the path that you need to go along.” [Tertiary educated, single, aged 33 years]; “I’d say definitely those videos, it just sort of put a human touch on the whole situation...” [High school educated, in a relationship, aged 30 years] |
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C. Comprehensiveness of the website | “I think everything is pretty good. I didn’t feel like anything was lacking.” [Tertiary educated, in a relationship, aged 30 years; “delayed intervention”]; “...some mental health support would have been good on the website...even if it was just like maybe a link or something like that to like—a support group...a psychologist or who to talk to...” [Tertiary educated, in a relationship, aged 33 years] |
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A. Quick process of testing, diagnosis, and treatment | “Yeah, it was quick. I didn’t expect it to be so soon, like it’s good that it was. So I saw her [his GP] on a Monday and then the Wednesday, it was the surgery booking...” [Tertiary educated, in a relationship, aged 30 years] |
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B. Prepared for treatment and awareness of testicle removal | “...once I found out they were gonna need to remove it, you sort of don’t really care. So, all that aesthetic stuff that normally comes with being a bloke, when you find out you have something like that in your body, you don’t really care. You just wanna get rid of it.” [High school educated, male, in a relationship, aged 30 years]; “I knew it had to be removed and, I suppose, I didn’t feel great about it.” [High school educated, in a relationship, aged 49 years] |
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C. Google searches and Cancer Council website were used as initial sources of information | “...both my partner and I did a bit of reading online. We didn’t do a lot because we didn’t wanna...scare ourselves...I had a brief read of the Cancer Council site, which was probably the most informative that I came across. And I sort of—after I got the general gist, I went, ‘Yep, all right, that’s enough.’” [High school educated, in a relationship, aged 30 years] |
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A. Disclosing the diagnosis to others | “I found it really hard trying to control the people around me. I found that the biggest stress for me because they would hear the word cancer and kind of freak out a little bit.” [Tertiary educated, male, in a relationship, unknown age] |
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B. Facing chemotherapy and having treatment during the COVID-19 pandemic was most distressing | “I was quite worried about that and how my body was gonna handle [the chemotherapy].” [High school educated, in a relationship, aged 49 years]; “Honestly with the COVID-19 scenario at the moment, it’s a little bit hard to me as well. My parents are stuck over in Western Australia, so they can’t actually come here. So I’m, unfortunately, living on my own at the moment, so I’m having to look after myself a bit which is a little bit distressing but, look, you have to acclimatise and it is what it is.” [Tertiary educated, male, single, receiving chemotherapy, aged 30 years] |
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C. Concerns about cancer recurrence or spread | “I’ve got positive results and it looked good, there’s no point living in fear, I suppose, or whether it affects your life...But with that said, I do have a level of fear that it will come back, or it will manifest somewhere else.” [Tertiary educated, in a relationship, aged 38 years] |
Nuts & Bolts was considered valuable throughout the journey with testicular cancer, including in participants with recurrent testicular cancer and those with high health literacy:
I think [Nuts & Bolts is useful at] every stage of the journey to be honest. Right from being given diagnosis through to any potential surgery and then post-surgery and the chemo and even recovery.
A total of 3 main subthemes were identified in this study. Participants reported that Nuts & Bolts provided consolidated access to reliable information (subtheme 1A). Specifically, many liked how the webpage explained what to expect for different disease stages (localized and advanced) and the role of various team members in their care. In addition, participants described feeling less anxious and distressed after accessing the resource (subtheme 1B), as the information provided offered them realistic expectations about treatment and prognosis. Some participants reported that Nuts & Bolts also helped lessen the fear of cancer recurrence and improved their baseline knowledge of testicular cancer, which made it easier to ask questions and communicate with their health care team (subtheme 1C).
All participants accessed Nuts & Bolts after study enrollment, with timing dependent on their group assignments. Most individuals had already commenced treatment, most commonly orchidectomy, when they first accessed the website:
...
A total of 3 main subthemes were identified. Some participants assigned to either intervention groups perceived the timing of introduction to Nuts & Bolts as “late” with consensus that the optimal timing would be before seeing a urologist and orchidectomy (subtheme 2A). Despite this, participants considered Nuts & Bolts valuable and acknowledged the logistical barriers to providing earlier access because of the rapidity of diagnosis and treatment. The clear, step-by-step layout and varied mode of information delivery through images, videos, and patient testimonials was also highly acceptable (subtheme 2B). Nuts & Bolts was generally considered comprehensive (subtheme 2C); however, some participants suggested that additional information about the recovery time after treatment, chemotherapy, testicular cancer subtypes, and mental health support would be helpful.
A total of 3 main subthemes were identified. Most participants perceived the diagnosis process and commencing treatment to be rapid (subtheme 3A), with some expressing “disbelief” or “shock” following their diagnosis. However, this rapid pace was valued by other participants, who were keen to
Before study enrollment, Google searches and government-endorsed websites such as the Australian “Cancer Council” were commonly used to seek information (subtheme 3C). However, a few participants were hesitant because of concerns about negative anecdotes and information quality. Some participants accessed information from family, friends, or other physicians, others did not actively seek information before their diagnosis, citing a preference not to be overwhelmed by information. A participant voiced that they would seek out Nuts & Bolts as their first resource if they experienced recurrence or contralateral testicular cancer, obviating the need for broad Google searches.
The participants expressed that various emotions and stressors arose following their diagnosis of testicular cancer. The most distressing concerns were related to social impact following diagnosis and treatment-related concerns.
A total of 3 main subthemes were identified. Many participants described communicating information to friends and family and concerns about managing their emotional reactions as a significant source of distress (subtheme 4A). Some participants reported that investigations, particularly scans and chemotherapy treatments, added additional sources of stress during their journey. For participants enrolled in 2020, the impact of the COVID-19 pandemic and risk associated with attending hospitals for treatment during this period added further complexity to their experience (subtheme 4B). Finally, many participants reported fear of cancer recurrence or spread; however, this did not appear to cause sustained distress or functional impairment in most cases (subtheme 4C). Several participants indicated they were explicitly maintaining a “positive attitude” and avoiding thoughts about recurrence. Other concerns raised by the participants included the risk of infertility and contralateral testicular cancer in the future.
Distress identification is vital when caring for patients diagnosed with cancer [
Although the primary outcome of this study was not met and earlier introduction to Nuts & Bolts did not lead to a significant reduction in distress on day 8, thematic analysis of semistructured interviews occurring after completion of quantitative assessments emphasized a high level of perceived utility for Nuts & Bolts. Multiple participants indicated a strong preference for access to Nuts & Bolts at the time of diagnosis, when their distress was highest, while acknowledging its usefulness during and after treatment. Importantly, the introduction of Nuts & Bolts did not negatively affect distress, and thematic analysis and poststudy evaluations strongly endorse its ongoing role in supporting individuals following the diagnosis of testicular cancer. Partnerships between researchers and nongovernment and industry organizations are key to the sustained dissemination of web-based interventions in cancer care [
Making Nuts & Bolts available to individuals earlier in the process of diagnosing and treating testicular cancer may increase its clinical utility. The perceived “late” introduction to Nuts & Bolts may have lessened its clinical utility. A preference for earlier intervention, that is, before orchidectomy, was highlighted by participants in semistructured interviews and may be appropriate to help ameliorate the significant distress and whirlwind of diagnosis they experience in some individuals where a testicular cancer diagnosis is
The potential sources of distress elicited from participants were wide ranging, with domains of emotional problems, such as nervousness, worry, fear and sadness and physical problems, such as pain, fatigue and “feeling swollen” dominating the NCCN problem list tool at study entry. Notably, these stressors reduced over time, with a comparatively small number of participants reporting these problems after 4 weeks of observation. This may relate to the resolution of postoperative symptoms, particularly pain and “feeling swollen,” and adjustment to the new diagnosis over time. In addition, thematic analysis revealed important concerns regarding communicating with family and friends, fear of cancer recurrence or spread, potential toxicity from chemotherapy, and risks posed by the COVID-19 pandemic while undergoing treatment. Although only raised by a small number of participants in the semistructured interviews in our study, previous research has identified significant concerns about fertility and sexual health following a cancer diagnosis [
Overall, Nuts & Bolts was considered relevant, user-friendly, and acceptable by most participants. These findings are consistent with previous studies, which reported high levels of patient satisfaction with web-based and mobile-based psychosocial interventions [
Our study had several strengths, including its prospective design with limited missing data and the inclusion of a mixed methods analysis derived from questionnaires and thematic analysis of semistructured interviews highlighting key issues for survivors after diagnosis. Unfortunately, owing to poor accrual and anticipated impacts of the COVID-19 pandemic on hospital resources and recruiting and coordinating centers, the study was closed early, and consequently, the primary end point was underpowered, and we were unable to draw firm conclusions about the differential impact of Nuts & Bolts on distress after 1 week. The instruments that have been validated in multiple clinical settings may also have been too crude to adequately evaluate changes over a short period, which may have also limited the interpretation [
In addition, our primary end point may have been inadvertently hampered by the study design. When designing the study, we felt that withholding access to a potentially valuable clinical resource from patients in the
High levels of distress are observed following a diagnosis of testicular cancer; however, this decreases over time. Nuts & Bolts is an acceptable and feasible tool to help address distress in individuals recently diagnosed with testicular cancer, empowering them to seek information relating to their diagnosis and potentially improve preparedness for treatment using a model appropriate for its target population. The optimal timing of introduction remains unclear; however, early access to appropriate support appears to be key to maximizing benefit and ameliorating the whirlwind associated with diagnosis and treatment. On the basis of these outcomes, the intervention was rolled out in a broader community of individuals diagnosed with testicular cancer.
Baseline characteristics (N=39).
Distress Thermometer
Hospital Anxiety and Depression Scale–Anxiety
Hospital Anxiety and Depression Scale-Depression
National Comprehensive Cancer Network
odds ratio
Research Electronic Data Capture
The authors thank the Movember Foundation, Ms Anne Hart, Ms Maria Edmonds, and Ms Kristina Zlatic for their contributions to the study. This study was funded by the Movember Foundation.
EL was partly reimbursed by Pfizer for attending the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2020 ASCO Genitourinary Cancers Symposium. AA reports honoraria from Amgen and Janssen and institutional research funding from Mundipharma. BTr reports grants and personal fees from Amgen, grants and personal fees from Astra Zeneca, grants from Astellas, grants and personal fees from BMS, grants and personal fees from Janssen, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Ipsen, personal fees from IQVIA, personal fees from Sanofi, personal fees from Tolmar, personal fees from Novartis, grants and personal fees from Bayer, and personal fees from Roche outside the submitted work.