Impact of the diagnostic label for a low-risk prostate lesion: protocol for two online factorial randomised experiments

• Published in: BMJ open 2024-08, Vol.14 (8), p.e085947
• Main Authors: Bullen, James, Nickel, Brooke, McCaffery, Kirsten, Wilt, Timothy J, Smith, Jenna, Boroumand, Farzaneh, Parker, Lisa, Millar, Jeremy, Brodersen, John Brandt, Dahm, Philipp, Delahunt, Brett, Varma, Murali, Glasziou, Paul, Warden, Andrew, Diller, Lawrence, Billington, Larry, van Rensburg, Christo, Bell, Katy
• Format: Article
• Language: English
• Subjects: Adverse events; Anxiety; Australia; Cancer therapies; Clinical Decision-Making; Clinical Trial; Evidence Based Practice; Female; Humans; Male; Medical diagnosis; Middle Aged; Mortality; Neoplasm Grading; Patient-Centered Care; Patients; Prostate cancer; Prostate-Specific Antigen - blood; Prostatectomy - methods; Prostatic Neoplasms; Prostatic Neoplasms - diagnosis; Protocol; Radiation; Randomized Controlled Trials as Topic; Risk Assessment - methods; Surgery; Surgical pathology; Surveillance; Terminology; Tumors; Watchful Waiting - methods; Well being; Womens health
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2024-085947

IntroductionMany types of prostate cancer present minimal risk to a man’s lifespan or well-being, but existing terminology makes it difficult for men to distinguish these from high-risk prostate cancers. This study aims to explore whether using an alternative label for low-risk prostate cancer influences management choice and anxiety levels among Australian men and their partners.Methods and analysisWe will run two separate studies for Australian men and Australian women with a male partner. Both studies are between-subjects factorial (3×2) randomised online hypothetical experiments. Following consent, eligible participants will be randomised 1:1:1 to three labels: ‘low-risk prostate cancer, Gleason Group 1’, ‘low-risk prostate neoplasm’ or ‘low-risk prostate lesion’. Participants will then undergo a second randomisation step with 1:1 allocation to the provision of detailed information on the benefits and harms of different management choices versus the provision of less detailed information about management choices. The required sample sizes are 1290 men and 1410 women. The primary outcome is the participant choice of their preferred management strategy: no immediate treatment (prostate-specific antigen (PSA)-based monitoring or active surveillance using PSA, MRI, biopsy with delayed treatment for disease progression) versus immediate treatment (prostatectomy or radiation therapy). Secondary outcomes include preferred management choice (from the four options listed above), diagnosis anxiety, management choice anxiety and management choice at a later time point (for participants who initially choose a monitoring strategy).Ethics and disseminationEthics approval has been received from The University of Sydney Human Research Ethics Committee (2023/572). The results of the study will be published in a peer-reviewed medical journal and a plain language summary of the findings will be shared on the Wiser Healthcare publications page http://www.wiserhealthcare.org.au/category/publications/ Trial registration numbersAustralian New Zealand Clinical Trials Registry (ID 386701 and 386889).