Impact of the diagnostic label for a low-risk prostate lesion: protocol for two online factorial randomised experiments
Brooke Nickel,
Kirsten McCaffery,
Lisa Parker,
Paul Glasziou,
Katy Bell,
Murali Varma,
Brett Delahunt,
Jeremy Millar,
Jenna Smith,
Philipp Dahm,
Timothy J Wilt,
John Brandt Brodersen,
James Bullen,
Farzaneh Boroumand,
Andrew Warden,
Lawrence Diller,
Larry Billington,
Christo van Rensburg
Affiliations
Brooke Nickel
3 Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia
Kirsten McCaffery
2 Sydney Health Literacy Lab, School of Public Health, University of Sydney, Sydney, New South Wales, Australia
Lisa Parker
6 School of Pharmacy, Faculty of Medicine and Health, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia
Paul Glasziou
16 Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia
Katy Bell
1 School of Public Health, University of Sydney, Sydney, New South Wales, Australia
Murali Varma
15 Department of Cellular Pathology, University Hospital of Wales, Cardiff, UK
Brett Delahunt
14 Wellington School of Medicine and Health Sciences, University of Otago Wellington, Wellington, New Zealand
Jeremy Millar
8 Radiation Oncology, Alfred Health, Melbourne, Victoria, Australia
Jenna Smith
2 Sydney Health Literacy Lab, School of Public Health, University of Sydney, Sydney, New South Wales, Australia
Philipp Dahm
12 Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA
Timothy J Wilt
4 Center for Chronic Disease Outcomes Research and Minneapolis VA High Value Care Initiative, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA
John Brandt Brodersen
10 Centre of General Practice, Department of Public Health & Research Unit for General Practice, Region Zealand, University of Copenhagen, Copenhagen, Denmark
James Bullen
1 School of Public Health, University of Sydney, Sydney, New South Wales, Australia
Farzaneh Boroumand
1 School of Public Health, University of Sydney, Sydney, New South Wales, Australia
Andrew Warden
3 Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia
Lawrence Diller
3 Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia
Larry Billington
17 Health Consumers New South Wales, Sydney, New South Wales, Australia
Christo van Rensburg
17 Health Consumers New South Wales, Sydney, New South Wales, Australia
Introduction Many 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 analysis We 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 dissemination Ethics 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 numbers Australian New Zealand Clinical Trials Registry (ID 386701 and 386889).
