Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study

Zhuohan Wu; Brooke Nickel; Farzaneh Boroumand; David Elder; Peter M Ferguson; Richard A Scolyer; Blake O'Brien; Raymond Barnhill; Adewole S Adamson; Alexander C J van Akkooi; Jon Emery; Lisa Parker; Donald Low; Cynthia Low; Elspeth Davies; Sherrie Liu; Stacey Lewis; Bella Spongberg-Ross; Katy Jl Bell

doi:10.1136/bmjopen-2024-089558

Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study

BMJ Open. 2024 Dec 20;14(12):e089558. doi: 10.1136/bmjopen-2024-089558.

Authors

Zhuohan Wu¹, Brooke Nickel^{2

3}, Farzaneh Boroumand⁴, David Elder⁵, Peter M Ferguson^{6

7}, Richard A Scolyer⁴, Blake O'Brien⁸, Raymond Barnhill⁹, Adewole S Adamson^{10

11}, Alexander C J van Akkooi⁶, Jon Emery¹², Lisa Parker¹³, Donald Low¹⁴, Cynthia Low¹⁴, Elspeth Davies¹⁵, Sherrie Liu¹⁶, Stacey Lewis¹⁶, Bella Spongberg-Ross¹⁶, Katy Jl Bell^{17

4}

Affiliations

¹ Wiser Healthcare collabration, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
² Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
³ Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia.
⁴ The University of Sydney, Sydney, New South Wales, Australia.
⁵ Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁶ Melanoma Institute Australia, North Sydney, New South Wales, Australia.
⁷ Tissue Pathology and Diagnostic Oncology, Royal Prince Alfred Hospital and NSW Health Pathology, Sydney, New South Wales, Australia.
⁸ Surgical Pathology, Sullivan Nicolaides Pathology, Brisbane, Queensland, Australia.
⁹ Department of Translational Research, Paris Sciences and Lettres Research University, Paris, France.
¹⁰ Department of Internal Medicine, Austin, Austin, Texas, USA.
¹¹ The University of Texas at Austin Dell Medical School, Austin, Texas, USA.
¹² General Practice and Primary Care Academic Centre, University of Melbourne, Carlton, Victoria, Australia.
¹³ Evidence, Policy and Influence Collaborative (EPIC), Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.
¹⁴ Cancer Voices New South Wales, Sydney, New South Wales, Australia.
¹⁵ Patient Researcher, Cambridge, Cambridge, UK.
¹⁶ Health Consumers New South Wales, Sydney, New South Wales, Australia.
¹⁷ Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia katy.bell@sydney.edu.au.

PMID: 39806624
DOI: 10.1136/bmjopen-2024-089558

Abstract

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).

Keywords: Adverse events; Clinical Decision-Making; Dermatological tumours; Patient-Centered Care; Surgical dermatology; Surgical pathology.

Publication types

Clinical Trial Protocol
Randomized Controlled Trial

MeSH terms

Anxiety*
Australia
Choice Behavior
Humans
Melanoma* / diagnosis
Melanoma* / pathology
Melanoma* / psychology
Melanoma* / therapy
Randomized Controlled Trials as Topic
Skin Neoplasms* / diagnosis
Skin Neoplasms* / pathology
Skin Neoplasms* / psychology
Skin Neoplasms* / therapy