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Making decisions about medical treatment can be challenging and stressful. Furthermore, challenge and stress are magnified when deciding to enroll in a clinical trial, particularly when facing a life-threatening illness such as cancer. Given the investigative nature of a cancer clinical trial (CCT), even though numerous safeguards are in place, benefits may be unproven, and risks may not be fully known.[1] Such unknowns complicate the choice process for those considering CCT enrollment. Thus, understanding the decision-making of potential participants can help make the process easier and improve enrollment rates.
A Shift in Approach
For many years in medicine, treatment decisions were “top down,” where healthcare providers made choices for patients with minimal-to-no input from the patients themselves.[2] In recent decades, research has shown that many patients wish to take an active role in treatment decisions, making the process far more collaborative.[3],[4] Such collaboration has been shown to result in greater patient satisfaction, higher quality of life, higher physical and social functioning, and even fewer reported side effects.[5],[6]
Timing
Logan et al.[7] evaluated factors influencing enrollment; they found that trial information presented to prospective CCT participants at an early appointment was linked to a greater likelihood of trial enrollment. These authors state, “Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.” However, a retrospective analysis looking at 36 studies over 10 years of enrollment in urologic CCTs found that CCT options were often discussed after a course of medical treatment had already been decided, thus eliminating patients from referral to some CCTs.[8]
Information
Fallowfield et al.[9]suggest that most people with cancer desire as much information as possible about their diagnosis, prognosis, and treatment options. Cox[10] adds that patient decisions are influenced by the complexity of the information, with written information often being difficult to understand, highlighting the importance of verbal explanations in facilitating patient understanding before making enrollment decisions. Complicated consent forms often result in greater patient anxiety, which inhibits willingness to participate.[11] Thus, decision-making can be enhanced by balancing comprehensive information with understandable writing joined to verbal explanations from healthcare professionals.
Fears
Fear of randomization is a significant factor when patients decide to not participate in CCTs.[12] Fear of the side effects of experimental therapies has also been identified as influencing CCT participation. [13],[14] Based on such findings, Quinn et al.[15] argue that healthcare providers consider directly addressing the role of fear in patients considering clinical trial participation. Unsurprisingly, believing that the best treatment option will come via a clinical trial lowers anxiety and notably enhances willingness to participate in a CCT.[16]
Clinical Trial Awareness
Clinical trial awareness is a major factor in the decision-making of people with cancer. Patients are less likely to enroll in a trial when they lack knowledge about ongoing studies.[17] Specifically, when patients do not fully understand a CCT’s purpose and/or their treatment and trial options, they are less likely to enroll.[18] Additionally, awareness factors are more significant when trial materials are not available in a patient’s native language.[19]
Enrollment Demographics
Research of people with breast, colon, lung, or prostate cancer by the Cancer Therapy Evaluation Program found that people aged 30-64 were most likely to decide on participation in a CCT, and men were more likely to participate than women. Ethnic minorities were less likely to participate.[20] Amongst ethnic minorities, a review of 65 studies by Ford et al.[21] found that mistrust of research and the medical system, concern about risks/harms, and costs of participating were the most frequent reasons ethnic minorities declined to participate in CCTs. In this study, a lack of awareness of available CCTs was also identified as a factor in reducing CCT enrollment. This awareness deficit included a lack of education regarding CCTs, a lack of culturally appropriate information, a lack of knowledge about cancer, and poor physician awareness of CCTs.
Awareness Enhancing CCT Decision-Making
Numerous factors influence the choice of a person with cancer to participate in a CCT, but a common thread may be various aspects of awareness. Research shows that awareness issues play a major role in CCT decision-making—giving patients options for enrollment as soon as possible in a comprehensive, collaborative, and easy-to-understand manner. This awareness includes understanding and helping patients deal with their fears about CCT participation. Finally, given the well-established underrepresentation of ethnic minorities in CCTs, new trials should work to increase awareness in diverse populations as well as in those who provide care for these populations while providing CCT materials in a culturally appropriate manner and/or native languages. Creative and well-thought-out ways to improve awareness of CCTs can help improve notoriously slow and low enrollment rates in CCTs resulting in more efficient and effective clinical trials.
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