Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study
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 me...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/12/e089558.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Brooke Nickel |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-38e048f575a54a8ea55dc5f6bdbc9fc0 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-38e048f575a54a8ea55dc5f6bdbc9fc02025-01-14T10:15:09ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-089558Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised studyBrooke Nickel0Lisa Parker1Jon Emery2Richard A Scolyer3Raymond Barnhill4David Elder5Katy JL Bell6Elspeth Davies7Blake O'Brien8Adewole S Adamson9Alexander C J van Akkooi10Farzaneh Boroumand11Zhuohan Wu12Peter M Ferguson13Donald Low14Cynthia Low15Sherrie Liu16Stacey Lewis17Bella Spongberg-Ross183 Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia13 Evidence, Policy and Influence Collaborative (EPIC), Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia12 General Practice and Primary Care Academic Centre, University of Melbourne, Carlton, Victoria, Australia4 The University of Sydney, Sydney, New South Wales, Australia9 Department of Translational Research, Paris Sciences and Lettres Research University, Paris, France5 Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA3 Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia15 Patient Researcher, Cambridge, Cambridge, UK8 Surgical Pathology, Sullivan Nicolaides Pathology, Brisbane, Queensland, Australia10 Department of Internal Medicine, Austin, Austin, Texas, USA6 Melanoma Institute Australia, North Sydney, New South Wales, Australia4 The University of Sydney, Sydney, New South Wales, Australia1 Wiser Healthcare collabration, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia6 Melanoma Institute Australia, North Sydney, New South Wales, Australia14 Cancer Voices New South Wales, Sydney, New South Wales, Australia14 Cancer Voices New South Wales, Sydney, New South Wales, Australia16 Health Consumers New South Wales, Sydney, New South Wales, Australia16 Health Consumers New South Wales, Sydney, New South Wales, Australia16 Health Consumers New South Wales, Sydney, New South Wales, AustraliaIntroduction 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).https://bmjopen.bmj.com/content/14/12/e089558.full |
| spellingShingle | 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 Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study BMJ Open |
| title | Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study |
| title_full | Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study |
| title_fullStr | Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study |
| title_full_unstemmed | Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study |
| title_short | Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study |
| title_sort | impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes protocol for an online randomised study |
| url | https://bmjopen.bmj.com/content/14/12/e089558.full |
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