Participant Motivators and Expectations in the MEL-SELF Randomized Clinical Trial of Patient-Led Surveillance for Recurrent Melanoma: Content Analysis of Survey Responses.

Abstract

Background: Limited data exist on the motivations and expectations of participants when enrolling in dermatology clinical trials, including melanoma early detection trials. Understanding participant motivators for research engagement has been identified as a prioritized area for trial methodology research.

Objective: The study aimed to determine motivators of participation and expectations from trial involvement among patients enrolled in the MEL-SELF randomized clinical trial of patient-led surveillance for new or recurrent melanoma.

Methods: The MEL-SELF trial is recruiting patients previously treated for localized melanoma, who own a smartphone, have a partner to assist with skin self-examination (SSE), and attend routinely scheduled follow-up at specialist and primary care skin clinics in Australia. We evaluated responses from the first 100 randomized participants to 2 open-ended questions about their motivations and expectations for participating in the trial, administered through the internet-based baseline questionnaire. A total of 3 coders independently coded the free-text responses and resolved discrepancies through consensus. Qualitative content analysis by an iterative process was used to group responses into themes. Responses from potential participants who were not randomized and the 404 participants randomized subsequently into the trial, were also checked for new themes. Coding and analysis were conducted in Microsoft Excel.

Results: Out of the 100 survey participants, 98 (98%) answered at least 1 of the 2 questions. Overall, responses across the motivation and expectation items indicated 3 broad themes: community benefit, perceived personal benefit, and trusting relationship with their health care provider. The most common motivators for participation were related to community benefit. These included progressing medical research, benefitting future melanoma patients who may have similar experiences, and broader altruistic sentiments such as "helping others" or "giving back." The most common expectations from the trial related to personal benefit. These included perceived improved outcomes such as earlier diagnosis and treatment, access to additional care, and increased self-empowerment to take actions themselves that benefit their health. Patients expressed a desire to gain health-related knowledge and skills and were interested in the potential advantages of teledermatology. There were no new themes in responses from those who were not randomized or were randomized subsequent to the first 100.

Conclusions: We report a tailorable, patient-focused approach to identify drivers of research engagement in clinical research. Clinical trials offer an opportunity to collate a substantial evidence base on determinants of research participation and to identify context-specific factors. Results from the MEL-SELF trial emphasized notable altruism, self-empowerment, and perceived advantages of teledermatology as specific motivators. These findings informed consent processes, recruitment, retention, response to trial tasks, and intervention adherence for the MEL-SELF host trial.

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379527.