How to Support Participants in Urogenital and Prostate Clinical Trials: A Qualitative Perspective.

Background: Clinical trials are fundamental to improving cancer treatment and clinical outcomes. Whilst clinical trials offer treatment options to affected individuals, less is known about how to best support those who participate.

Aim: To explore the experiences of participants in urogenital and prostate cancer clinical trials to identify opportunities to improve care for this cohort of patients.

Methods: This qualitative study was conducted in Australian hospitals. Participants were included if they had consented to participate in an Australian collaborative investigator led clinical trial for prostate or other urogenital cancer. Semi-structured interviews with participants were completed by telephone. Using verbatim transcriptions, their experiences relative to key stages of a clinical trial were analysed using a Framework Method. Findings were interpreted to develop key recommendations for use by investigators developing a clinical trial.

Results: 22 people consented and participated in interviews. They came from rural, regional, and metropolitan areas across Australia. Participants were being treated for advanced uro-genital and prostate cancers. Across interviews, participants spoke about their supportive care needs and how they valued their relationships with the multi-disciplinary research team and the clinical oncology and urology teams. There was variation in participant needs according to the stage of the clinical trial. Despite times of uncertainty, it was reported clinical trial participation was meaningful. Receiving information about overall findings of the clinical trial was important to participants allowing them to understand the impact of their contribution.

Conclusion: Understanding the experiences of clinical trial participants can improve the design of trial protocol processes and procedures. Participants want to stay connected with their clinical trial.