Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study
Brooke Nickel,
Lisa Parker,
Jon Emery,
Richard A Scolyer,
Raymond Barnhill,
David Elder,
Katy JL Bell,
Elspeth Davies,
Blake O'Brien,
Adewole S Adamson,
Alexander C J van Akkooi,
Farzaneh Boroumand,
Zhuohan Wu,
Peter M Ferguson,
Donald Low,
Cynthia Low,
Sherrie Liu,
Stacey Lewis,
Bella Spongberg-Ross
Affiliations
Brooke Nickel
3 Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia
Lisa Parker
13 Evidence, Policy and Influence Collaborative (EPIC), Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia
Jon Emery
12 General Practice and Primary Care Academic Centre, University of Melbourne, Carlton, Victoria, Australia
Richard A Scolyer
4 The University of Sydney, Sydney, New South Wales, Australia
Raymond Barnhill
9 Department of Translational Research, Paris Sciences and Lettres Research University, Paris, France
David Elder
5 Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
Katy JL Bell
3 Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia
Elspeth Davies
15 Patient Researcher, Cambridge, Cambridge, UK
Blake O'Brien
8 Surgical Pathology, Sullivan Nicolaides Pathology, Brisbane, Queensland, Australia
Adewole S Adamson
10 Department of Internal Medicine, Austin, Austin, Texas, USA
Alexander C J van Akkooi
6 Melanoma Institute Australia, North Sydney, New South Wales, Australia
Farzaneh Boroumand
4 The University of Sydney, Sydney, New South Wales, Australia
Zhuohan Wu
1 Wiser Healthcare collabration, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Peter M Ferguson
6 Melanoma Institute Australia, North Sydney, New South Wales, Australia
Donald Low
14 Cancer Voices New South Wales, Sydney, New South Wales, Australia
Cynthia Low
14 Cancer Voices New South Wales, Sydney, New South Wales, Australia
Sherrie Liu
16 Health Consumers New South Wales, Sydney, New South Wales, Australia
Stacey Lewis
16 Health Consumers New South Wales, Sydney, New South Wales, Australia
Bella Spongberg-Ross
16 Health Consumers New South Wales, Sydney, New South Wales, Australia
Introduction A diagnosis of melanoma in situ presents negligible risk to a person’s lifespan or physical well-being, but existing terminology makes it difficult for patients to distinguish these from higher risk invasive melanomas. This study aims to explore whether using an alternative label for melanoma in situ may influence patients’ management choices and anxiety levels.Methods and analysis This study is a between-subjects randomised online experiment, using hypothetical scenarios. Following consent, eligible participants will be randomised 1:1:1 to three labels: ‘melanoma in situ’ (control), ‘low-risk melanocytic neoplasm’ (intervention 1) and ‘low-risk melanocytic neoplasm, in situ’ (intervention 2). The required sample size is 1668 people. The co-primary outcomes are (1) choice between no further surgery or further surgery to ensure clear histological margins greater than 5 mm and (2) choice between patient-initiated clinical follow-up when needed (patient-led surveillance) and regular routinely scheduled clinical follow-up (clinician-led surveillance). Secondary outcomes include diagnosis anxiety, perceived risk of invasive melanoma and of dying from melanoma and management choice anxiety (after surgery choice and follow-up choice). We will make pairwise comparisons across the three diagnostic label groups using regression models (univariable and multivariable).Ethics and dissemination The study has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000740594). Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2024/HE000019). 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 publication page (https://www.wiserhealthcare.org.au/category/publications/).Trial registration number Australian New Zealand Clinical Trials Registry (ID 386943).
