Oral systemic treatment is becoming an increasingly common modality of anticancer therapy [1]. It may be preferred to traditional intravenous administration due to patient convenience, its noninvasive nature, the safety of prodrugs relative to intravenous “full drugs,” and reducing the costs that accompany additional outpatient appointments and inpatient resource usage [2]. However, it is not without its drawbacks. Adherence can be difficult, absorption can be variable, and administration may be impossible in patients with dysphagia. In addition, administration may be confusing for patients, for example, some drugs (sorafenib) present challenges when taken with food while others (imatinib) must be taken with food [2].

Shared decision-making (SDM), a process through which providers and patients weigh evidence and make decisions together [3] that is becoming increasingly important in clinical practice, can help patients balance these strengths and shortcomings. Studies have shown that patients like playing an active role in care-related decision-making [4,5], clinician education is becoming geared toward facilitating SDM [6], and a lack of SDM has been associated with lower medication adherence, even when concrete decisions are made [7]. To help facilitate SDM, interventions such as mobile apps, videos, or informative visuals, known as decision aids (DAs), can provide patients with information regarding treatment options, their associated risks and benefits, and how drug administration aligns with a patient’s goals and values [8].

In oncology, DAs have been used since at least the advent of the “Decision Board” in 1992 for adjuvant chemotherapy in node-negative breast cancer [9,10], and although considerable research exists on their use and efficacy in oncology as a whole, and products do exist commercially [11], there is little in the current literature examining the development and efficacy of DAs targeting the unique challenges of oral chemotherapy. This article addresses this gap by reviewing what is known about the use of DAs in oncology and using the example of oral anticoagulation DAs to examine how they may be best leveraged to facilitate SDM in oral chemotherapy.

In considering how to approach the development of a DA for oral chemotherapy, we should first consider the preferences of the target population and how DAs have been successfully implemented in the field of oncology. A study involving patients with all tumor types revealed that patients want their DAs to be specific, which may include the pros and cons of each treatment choice and a list of questions to ask their provider [4]. Another study, although only specific to men with prostate cancer, indicated that patients like when DAs include information regarding potential side effects and a clear discussion of the expected quality of life resulting from treatment [12]. These findings could be especially important for patients considering oral chemotherapy, as focusing only on deciding between systemic therapy as a general category versus surgery or observation may miss the unique factors that make a rigid, daily oral medication schedule challenging when compared with hospital-based intravenous treatment. Expected quality of life may be of particular importance to this patient population, as prostate cancer has a more favorable prognosis than many other malignancies. However, it stands to reason that it could be important to patients with less favorable prognoses as well, especially when considering whether they would like such therapy to be a part of the time that they do have left. In addition, patients report that they prefer DAs that are targeted to their specific needs [4], which may extend beyond only their disease process, as there have been calls for DAs in oncology to account for the diversity of patient populations [13].

Regarding how much information to disseminate to patients, a study of men with advanced cancer found that full discussions regarding prognosis decreased depressive symptoms; however, patient anxiety was found to be higher if the clinician felt that such a discussion had taken place [14]. However, it should be noted that this study did not address baseline anxiety or depression before their diagnosis. While this study was specific to men, another study that included men and women found that clinician-driven encouragement to participate in treatment decisions was associated with increased patient anxiety persisting after a 2-week period, suggesting that this change may be independent of baseline anxiety [15]. This raises some concern that providing too much information and involving patients more in decisions regarding their care could be overwhelming or distressing and could ultimately do more harm than good. However, Cripe et al [14] suggest that such results may be due to the content of the provider’s encouragement and discussion: it may not align with patient preferences and therefore contribute to anxiety development. This is supported by the findings of Gattellari et al [15] that information disclosure itself was not associated with increased anxiety. Ultimately, Cripe et al [14] propose that patient anxiety is a signal that further discussions regarding patient goals and preferences should occur. DAs may help facilitate such discussions by including surveys that specifically elicit individual patient values [16], and multigender studies in patients with advanced cancer, including a systematic review, have shown that providing more information through DAs does not do harm [17,18]. Likewise, although it has been observed that patients with advanced gastrointestinal cancer reported lower quality of life scores and higher anxiety if they acknowledged that their illness was terminal [19], DAs can help mitigate this as well, as it has been shown through a meta-analysis of 16 studies of adult patients of varying tumor types that DAs may help reduce anxiety and fear, especially in newly diagnosed patients [16]. Finally, for many patients, additional information may be seen as a positive: 1 study, which interviewed 27 patients with cancer, found that patients nearly always wanted to know as much as possible about cancer as a whole, their prognosis, treatment benefits, and side effects [20].

DAs in oncology have been reported acceptable by both patients and providers [21], have been shown to increase patient knowledge [9,16], and lower decisional conflict, aligning patients’ ultimate decisions with their personal values [16,22]. In addition, DAs in cancer care have been shown to increase patient satisfaction with both the information presented and their treatment decision [4,9,16]. However, it is worth acknowledging that the mere presence of a DA is insufficient. A study of a DA for oral complementary and alternative medications for patients on chemotherapy, which provided predominantly general information, did not help decrease decisional conflict or patient regret [23]. DAs presenting unclear or overly optimistic information, especially regarding side effects, have been shown to provide patients with a worse experience, as this can lead to a misperception of the risks and benefits of treatment and may ultimately affect decision-making [17].

With similar treatment schedules, required monitoring, and experience of self-administering medication, oral anticoagulation presents similar advantages and challenges to oral chemotherapy. As significant data exists regarding the efficacy and implementation of DAs in oral anticoagulation, these findings can be used to help inform the development of evidence-based DAs in oral chemotherapy. Using DAs in oral anticoagulation has been shown to help with improving patient knowledge [21,24,25], lowering decisional conflict [21,24-27], increasing medication adherence [24], and increasing the likelihood of making a choice [25].

Oral anticoagulation DAs considered effective, defined as improving health outcomes or at least increasing or enhancing SDM, have focused on covering a broad range of 6 SDM elements, that are situation diagnosis, choice awareness, option clarification, discussion of harms and benefits, deliberation of patient preferences, and decision-making [24]. In a study of 10 DAs in which 7 were deemed successful, 6 included discussions of harms and benefits and at least one of choice awareness and deliberation of patient preferences. This suggests that, although all merit inclusion, these 3 may be the most critical to consider when developing DAs for patients contemplating oral therapy [24].

Oral anticoagulation DA studies can also demonstrate what has not been successful in DA development. Logically, including a narrower range of the 6 elements of SDM does not support efficacy [24]. In addition, a review of 14 SDM tools focused on choosing between Warfarin and direct oral anticoagulants from Torres Roldan et al [28] showed that the current DA developmental process rarely includes patients. The studies observed were overall unsuccessful, as only 2 of the 14 DAs reviewed improved adherence, and 3 of the 14 did not support SDM. The authors note that a common shortcoming of these DAs was that they lack information on the day-to-day patient experience, including “what it means to take a pill every day” and “what it takes to attend periodic clinic appointments” [28]. This demonstrates that, despite the fact that they usually did include good information regarding treatment options, outcomes, prognosis, costs, dosing, and side effects, these DAs may have fallen short of their potential maximum effect [28]. Involving the patient in the developmental process could help fine-tune DA content to include information that will most benefit patients.

Although it should be noted that the disease processes themselves (hypercoagulable state vs malignancy) carry significantly different clinical implications, which could influence patient priorities when using DAs, the advantages and challenges of the administration of oral anticoagulation and oral chemotherapy are similar. Therefore, this information should be used in conjunction with what is known about DA use in oncology to develop DAs ideally suited for patients with cancer contemplating oral therapy.

Once the initial developmental process is complete, trialing the DA could commence. User experience trials evaluating DA design, experience with the interface, and perceptions of ease of use would likely occur first and would be best optimized with user response surveys. To optimize feedback and maximize the impact of patient perspectives, qualitative and quantitative data should be collected. Panels that include user experience specialists, product designers, physicians, and volunteer patients could then meet on developmental committees to fine-tune the pilot DA based on this feedback. Although practical considerations would likely limit patient selection at this stage to a convenience sample, it would provide valuable insight into the patient experience of using the DA before optimizing its clinical use.

This would be followed by knowledge assessments conducted through randomized controlled trials in a simulated environment. Knowledge retention would be compared between individuals provided information through standardized clinical encounters with a physician versus those who were also provided with the DA. If this trial demonstrates efficacy (improved SDM), the product then can move to clinical practice in select environments, with ongoing quality improvement studies to optimize their use. These would ideally be set up as prospective cohort studies but could also use a case-control or retrospective cohort design if institution-specific questions regarding their use and implementation arise.

In addition, many questions remain unanswered, warranting further critical discussion and investigation. Providing DAs ahead of appointments may be beneficial relative to during appointments [24], but is there a need for further outreach to maximize the uptake rate and limit potential patient anxiety? Although difficult to concretely define the specific needs of individual patients [4], would involving technological user experience specialists in development help get us closer to doing so? As Bennett et al [13] allude to, how can we leverage DAs to address inherent shortcomings in communication, especially bias, from the clinician side?

As this paper is presented as a viewpoint, a review of relevant literature was conducted in a nonsystematic manner. This may subject the paper to reviewer bias and does render it possible that potentially pertinent articles were not included. However, the purpose of this viewpoint and the associated literature review is not to provide a definitive, comprehensive state of multiple fields, as there is no extant literature on the development and implementation of DAs for oral chemotherapy. Rather, its purpose is to take the initial steps to address this gap in the literature by using evidence from related fields (DA use in oncology and oral anticoagulation) to provide suggestions for the development of oral chemotherapy–specific DAs. Ultimately, its aim is to inform future research so that evidence-based guidelines may be developed in the future.

There is a need for evidence-based, effective DAs to facilitate SDM for patients considering oral chemotherapy. Important considerations in the development of these DAs include including a broad range of SDM elements, involving patients in the development process, tailoring content to specific patient needs, and anticipating and addressing potential barriers to efficacy. Further research is needed to investigate the efficacy of DAs developed specifically for oral chemotherapy.