Objectives 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.
Methods 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.
Results 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.
Conclusions 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.
Trial registration number NCT03392428, ANZUP1603.
- supportive care
- clinical decisions
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information. Not applicable.
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Contributors NR and SKC are joint principal investigators and conceived the study. NR and MSH curated the data. BV and NR performed the formal analysis. All authors acquired funding. NR and SKC designed the methodology. BV and NR managed and coordinated the project. NR procured resources to carry out the study. NR, SKC and JD provided oversight and leadership of the project. BV and NR prepared coding frameworks. BV and NR wrote the first draft of the manuscript. All the authors wrote (reviewed and edited) the manuscript. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding Funding support was received from a ANZUP Below the Belt Grant (QualTheraP: a nested, multiperspective longitudinal qualitative study of participants). The National Health and Medical Research Council (NHMRC) Centre of Research Excellence provided further funding support through a PhD Scholarship. IDD is supported by an NHMRC Practitioner Fellowship (APP1102604). The TheraP study received support from the Australian Nuclear Science and Technology Organization (ANSTO), Endocyte Inc., a Novartis Company, Movember, The Distinguished Gentleman’s Ride, It’s a Bloke Thing and CAN4CANCER. MSH is supported by grants from the Prostate Cancer Foundation (PCF) and the Peter MacCallum Foundation. IDD is supported by an NHMRC Practitioner Fellowship (No. 1102604).
Competing interests Authors report no direct relevant competing interests. MSH reports grants from Movember, Prostate Cancer Foundation of Australia, Endocyte (a Novartis Company), Peter MacCallum Foundation and non-financial support from ANSTO, during the conduct of the study; grants from Prostate Cancer Foundation, Movember, Prostate Cancer Foundation of Australia, US Department of Defence; personal fees from Janssen, Sanofi Genzyme, Mundipharma, Astellas, Merck/MSD, outside the submitted work. IDD reports grants from National Health and Medical Research Council, during the conduct of the study; institutional payments to support prostate cancer trials from Pfizer, ANZUP Cancer Trials Group, Bayer, Astellas, Janssen, Movember Foundation, Merck Sharp & Dohme outside the submitted work; unremunerated chair of ANZUP Cancer Trials Group. Other authors declare there are no competing interests.
Provenance and peer review Not commissioned; externally peer reviewed.