Nested qualitative studies within clinical trials provide the opportunity to better understand participant experiences of participation and identify areas where improved support is required. The purpose of this qualitative study is to describe the lived experiences of men with advanced prostate cancer participating in the TheraP trial; a randomised trial of 177Lu-PSMA-617 compared with cabazitaxel chemotherapy.
Fifteen men with advanced prostate cancer were recruited from the TheraP clinical trial and interviewed at three time points during the trial. Interviews were inductively analysed using thematic analysis. This research paper reports the results from the baseline interview at commencement of the trial, focusing specifically on participants' enrolment experiences.
Four themes were identified representing the lived experiences of men with advanced prostate cancer deciding to participate in the TheraP trial: (1) hoping to survive; (2) needing to feel informed; (3) choosing to participate and (4) being randomised. The process of deciding to enrol in a clinical trial is filled with indecision, emotional difficulties and focused on a desire to live.
For men with advanced prostate cancer, the experience of deciding to enrol in a clinical trial is principally driven by a desire to survive but interlinked with the need to make an informed decision as participants in this study expressed a preference for allocation to the experimental arm. Men seeking to enrol in clinical trials of new prostate cancer treatments would benefit from improved informational and decision support.
NCT03392428, ANZUP1603.
BMJ supportive & palliative care. 2021 Aug 09 [Epub ahead of print]
Bianca Viljoen, Michael S Hofman, Suzanne K Chambers, Jeff Dunn, Haryana Dhillon, Ian D Davis, Nicholas Ralph
School of Nursing and Midwifery, University of Southern Queensland, Toowoomba, Queensland, Australia., Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia., Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia., Centre for Health Research, University of Southern Queensland, Toowoomba, Queensland, Australia., CeMPED, The University of Sydney, Sydney, New South Wales, Australia., Department of Medical Oncology, Monash University, Clayton, Victoria, Australia., School of Nursing and Midwifery, University of Southern Queensland, Toowoomba, Queensland, Australia .