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Oncology
Protocol
Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study
  1. Zhuohan Wu1,
  2. Brooke Nickel2,3,
  3. Farzaneh Boroumand4,
  4. David Elder5,
  5. Peter M Ferguson6,7,
  6. Richard A Scolyer4,
  7. Blake O'Brien8,
  8. Raymond Barnhill9,
  9. Adewole S Adamson10,11,
  10. Alexander C J van Akkooi6,
  11. Jon Emery12,
  12. Lisa Parker13,
  13. Donald Low14,
  14. Cynthia Low14,
  15. Elspeth Davies15,
  16. Sherrie Liu16,
  17. Stacey Lewis16,
  18. Bella Spongberg-Ross16,
  19. Katy JL Bell3,4
  1. 1 Wiser Healthcare collabration, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
  2. 2 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
  3. 3 Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia
  4. 4 The University of Sydney, Sydney, New South Wales, Australia
  5. 5 Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
  6. 6 Melanoma Institute Australia, North Sydney, New South Wales, Australia
  7. 7 Tissue Pathology and Diagnostic Oncology, Royal Prince Alfred Hospital and NSW Health Pathology, Sydney, New South Wales, Australia
  8. 8 Surgical Pathology, Sullivan Nicolaides Pathology, Brisbane, Queensland, Australia
  9. 9 Department of Translational Research, Paris Sciences and Lettres Research University, Paris, France
  10. 10 Department of Internal Medicine, Austin, Austin, Texas, USA
  11. 11 The University of Texas at Austin Dell Medical School, Austin, Texas, USA
  12. 12 General Practice and Primary Care Academic Centre, University of Melbourne, Carlton, Victoria, Australia
  13. 13 Evidence, Policy and Influence Collaborative (EPIC), Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia
  14. 14 Cancer Voices New South Wales, Sydney, New South Wales, Australia
  15. 15 Patient Researcher, Cambridge, Cambridge, UK
  16. 16 Health Consumers New South Wales, Sydney, New South Wales, Australia
  1. Correspondence to Dr Katy JL Bell; katy.bell{at}sydney.edu.au

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).

  • Dermatological tumours
  • Adverse events
  • Clinical Decision-Making
  • Surgical dermatology
  • Surgical pathology
  • Patient-Centered Care
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2024-089558

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • The randomised design enables robust comparison of diagnostic labels on decision-making and psychological outcomes.

    • The study has been co-designed with patients, members of the public and clinicians to ensure that labels and evidence are relevant to end-users.

    • The large online randomised study is representative of adults in the Australian community.

    • The study’s hypothetical nature limits its ability to capture real patients after an actual melanoma in situ diagnosis (or alternative label).

    • The study does not explore the potential for recalibration of diagnostic thresholds using existing labels, the impact of diagnostic labels on actual patient or clinician decisions or the impact of detailed risk information on diagnostic labels, all of which are areas for future research.

    Introduction

    Melanoma incidence and mortality trajectories in Australia and other countries show a classic epidemiological signature of overdiagnosis:1 steeply increasing incidence curves coupled with flat mortality trends.2–6 While ageing populations may lead to a small real increase in melanoma incidence,7 much of the increase is likely overdiagnosis.2–6 This appears to be largely driven by increased diagnosis of melanoma in situ,2 4 8 which in Australia is now diagnosed over twice as frequently as invasive melanoma.9 Similar findings have been found for melanoma in the USA (diagnosed at least as frequently as invasive melanoma)3 and Denmark (diagnosed over half as frequently as invasive melanoma).10

    Multiple evidence lines indicate that melanoma in situ is a risk factor for invasive melanoma rather than an obligate precursor.3 9 11 12 Overdiagnosis is partly driven by lowering the diagnostic threshold over the years, such that the same lesion that was called benign in the past would now be labelled melanoma in situ.12 Concerns about litigation may also be driving a tendency to interpret melanocytic lesions as a more severe diagnosis13 particularly in partial biopsies or where the lesion extends to the surgical margins. Harms stemming from melanoma overdiagnosis include physical, psychosocial and economic dimensions.14 Physical harms can include overtreatment, repeat skin biopsies,15 scarring,15 pain, infection and/or functional impairment. Psychological harms include anxiety and fear,16 17 with many patients perceiving that they have a high risk of dying from melanoma, when their actual risk is much lower (and risk all-cause mortality is actually lower than the population average).18 These psychological harms can manifest as anxiety about being outdoors, fear of cancer recurrence, or guilt for past ultraviolet (UV) radiation exposure causing melanoma.5 Social harms include impacts of the diagnosis on loved ones, and on patients’ social networks.15 Economic harms include treatment costs for the immediate diagnosis and for future long-term clinical surveillance. These incur substantial financial costs to both the health system and patient (as out-of-pocket costs), as well as opportunity costs for both clinician time and patient time. There is also a possible denial of life insurance as the person is now identified as a cancer survivor by many insurance companies.3

    One possible solution is to consider a new label for melanoma in situ without the word ‘melanoma’.12 This might help patients recognise the lower risk of this type of lesion18 and help to reduce the potential psychological harm. It may also pave the way for the de-escalation of treatment19 and surveillance.20–22 Evidence from other cancer contexts, including thyroid,23 breast24 and prostate25 lesions, suggests that new diagnostic labels may beneficially impact psychological outcomes and management decisions.26 We seek to build on these findings by investigating the potential impacts of new labels for melanoma in situ. To ensure relevance of our findings to end-users, we will test alternative labels for melanoma in situ that were chosen by our co-investigators representing clinicians, patients and the public. Alternative label(s) need to be acceptable to both patients and clinicians, and convey the low, but not zero, risk of future invasive melanoma. This study aims to explore whether using an alternative diagnostic label to communicate a hypothetical melanoma in situ diagnosis influences management choice and level of anxiety among Australian adults.

    Methods and analysis

    Study design

    An online randomised study of Australian community members will be run, with participants randomised to receive one of the three hypothetical scenarios about the diagnosis of a melanoma in situ. Each group will be presented with a different diagnostic label, and we will survey participants about their preferred choices of management for that diagnosis, their level of anxiety about that diagnosis and their level of anxiety about their management choices.

    This study is a between-subjects randomised online experiment. Following consent, eligible participants will be randomised 1:1:1 to ‘melanoma in situ’ (control), ‘low-risk melanocytic neoplasm’ (intervention label 1) and ‘low-risk melanocytic neoplasm, in situ’ (intervention label 2). The co-primary outcomes and secondary outcomes will be compared across randomised groups.

    There will be an equal probability of being assigned to each of the three groups, and we expect approximately equal numbers per group. We will use Qualtrics survey software to randomly allocate participants into groups, present the scenarios, survey questions and collect data on the outcomes.27 Our participants’ flow diagram presents a summary of the randomisation of participants into the allocated control and intervention arms (figure 1).

    Figure 1
    Figure 1

    Study Consolidated Standards of Reporting Trials flow diagram for participants. Participants’ selection inclusion criteria are age over 40 years, understanding written English and residing in Australia. Patients will be excluded if they have melanoma or do not provide consent.

    Eligibility criteria

    Participants will be eligible if they are 40 years or older, understand written English and reside in Australia. Participants will be excluded if they have a history of melanoma (invasive or in situ).

    Recruitment and data collection

    Participants will be recruited from the general Australian public through an independent social research company (Dynata), which has a panel of 600 000 participants whose demographic characteristics align closely with those of the national population. Dynata has a point system in which participants receive points after completing surveys. The points can then be used to redeem vouchers, cash or other rewards. Stratified sampling will be used, with quotas in place for gender (50% male, 50% female or other), age (25% for each of 40–29 years, 50–59 years, 60–69 years, 70 years or older, ±15% allowed for first three age groups and ±30% for oldest age group),28 education (50% high school or less, 50% more than high school, ±15% allowed) and State or Territory of residence (quotas proportionate to Australian population, ±5% allowed: New South Wales, 31.3%; Victoria, 25.6%; Queensland, 20.5%; South Australia, 6.9%; Western Australia, 10.9%; Tasmania, 2.1%; Northern Territory, 0.9%; and Australian Capital Territory 1.7%).29

    Participants who agree to participate in the study will complete an online Qualtrics survey managed by the research team. Only eligible participants will proceed to the randomisation step. The survey will capture baseline data and characteristics of participants including socio-demographic details including their age, location, health literacy, and personal and family history of any cancer, and participant responses on outcome measures. The survey questions are presented in the online supplemental file.

    Supplemental material

    All data will be collected via Qualtrics software and hosted on The University of Sydney secure server. Information will be de-identified, and we will not be able to link the survey back to participants. The non-identifiable data will be downloaded for analysis and stored within The University of Sydney’s Research Data Store.

    Determination of alternative labels to be tested

    We undertook a targeted literature search in September 2023 by retrieving forward and backward citation searches of four key papers on the topic.5 12 26 30 We used the automated tool ‘Spider Cite’31 to identify records and Covidence to screen title, abstract and full texts.32 Of 593 unique records retrieved, we screened the full text of 27 and included seven papers describing nine alternative labels (see box 1).

    Box 1

    Process to select alternative labels to melanoma in situ for testing

    • In the first-round surveys, clinician and patient/public co-investigators indicated their ranking the seven labels identified in the targeted literature search and two additional labels in order of preference. The potential alternative labels from the literature search were as follows: melanocytic neoplasm of low malignant potential (8, 24, 25), melanocytic neoplasm, atypical neoplasm (25), severe or high-grade melanocytic dysplasia, superficial atypical melanocytic proliferation of uncertain malignant significance (SAMPUS) (26–28), melanocytic tumour of uncertain malignant potential (MELTUMP) and melanocytoma (28). The two additional labels suggested by the research team were low-risk melanocytic neoplasm and low-risk melanocytic lesion.

    • In the second-round surveys, co-investigators indicated their preferred ranking of the top three choices from round 1 and two new labels suggested in round 1: low-risk melanocytic neoplasm, low-risk melanocytic lesion and melanocytic neoplasm of low malignant potential, melanocytic intraepithelial neoplasia and in situ melanocytic neoplasm.

    • In the third-round surveys, co-investigators indicated their preferred ranking of the top two choices from round 2 and three new labels suggested in round 2: in situ melanocytic neoplasm, low-risk melanocytic neoplasm, in situ melanocytic neoplasm, low risk, low-risk melanocytic neoplasm, in situ and dysplastic naevus.

    The two highest ranked labels, chosen as the alternative labels to test in the online experiment, were ‘low-risk melanocytic neoplasm’ and ‘low-risk melanocytic neoplasm, in-situ’.

    Using short online questionnaires implemented in Qualtrics,27 we then ran three rounds of surveys with the nine international clinician co-investigators (with expertise in dermatopathology, dermatology, surgical oncology, primary care and radiation oncology) and six patient/public co-investigators (two with lived experience of a melanoma diagnosis and four without a history of melanoma) to determine choice of alternative labels. This resulted in the final choice of two alternative labels that we will test in the online survey: low-risk melanocytic neoplasm and low-risk melanocytic neoplasm, in situ.

    Interventions

    Participants will be randomised using Qualtrics randomisation software to receive one of the three hypothetical scenarios. They will not be blinded. In each scenario, the participant will be told that the results of their recent skin surgery indicate a particular diagnosis. Group 1 (the control group) will be told they have a melanoma in situ. Group 2 will be told that they have a low-risk melanocytic neoplasm. Group 3 will be told that they have a low-risk melanocytic neoplasm, in situ. We will not provide further explanation of what low risk means.

    Primary and secondary outcomes

    Primary and secondary outcomes are described in table 1. The co-primary outcomes are (1) participant’s choice of surgical management option: no further surgery versus further surgery (to achieve pathology margins greater than 5 mm) and (2) follow-up management option: patient-led surveillance (self-skin examination with patient-initiated clinic visits) versus clinician-led surveillance (6 monthly routinely scheduled clinic visits).

    View this table:
    Table 1

    Participant characteristics and outcome measures

    The first co-primary outcome on surgical management choice reflects recent retrospective analyses that have found that narrower margins are likely to be as safe as margins currently recommended in guidelines in small melanoma in situ.33 Indeed, very narrow histological clearance (≥1 mm) appears to be safe for melanoma in situ of the trunk and limbs.34 The new MPATH-Dx V2.0 melanocytic lesion classification scheme recommends that provided margins are not involved, and clinicians may consider not re-excising class II lesions—which includes melanoma in situ.35 The second co-primary outcome on follow-up management choice centres around patient-led surveillance (also called patient-initiated follow-up) as an alternative model of follow-up for cancer survivors to routinely schedule clinic appointments.36 Among people diagnosed and treated for early stage melanoma, patient-led surveillance is being evaluated in the MELanoma SELF surveillance (MEL-SELF) randomised controlled trial. Here, this model of care includes training in self-skin examination, digital technologies to record and take images of concerning lesions (using a mobile dermatoscope), online system for submitting images for remote review by a dermatologist and advice on whether urgent clinical review may be needed (teledermatology).37

    Secondary outcomes are as follows: diagnosis anxiety, perceived lifetime risk of invasive melanoma, perceived lifetime risk of dying from melanoma, management choice anxiety and open-text explanation of management choices (free text input).

    Sample size

    We estimated a sample size of 1668 participants with 556 participants per group in the study, which would provide 80% power (1 - β) to detect a pairwise difference in the proportion of choosing no further surgery and 89% power to detect a pairwise difference in the proportion in choosing patient-led surveillance as small as 10%.

    The assumptions are 50% would choose no further surgery (most conservative assumption) and 35%22 would choose patient-led surveillance in the control label condition, a 5% dropout rate, α=0.05, the normal approximation to the binomial distribution and the standard formula for comparing proportions in independent equal-sized groups.

    Analysis

    The analysis will focus on assessing the impact of different diagnostic labels for melanoma in situ on participants’ psychological responses and healthcare decisions. Data analysts will be blinded to intervention assignment. For both co-primary outcomes, we will compare the proportion chosen for each management option. For first four secondary outcomes, we will compare summary statistical measures (means or medians) across randomised groups. For the last outcome, we will use thematic framework methods of qualitative data.

    The analysis will adhere to the intention-to-treat principle, and participant data will be analysed according to their randomly assigned diagnostic label group, regardless of adherence to the study protocol. The number of participant responses included in each analysis will be presented for each outcome. We will summarise categorical data for the randomised groups using counts and percentages, and continuous data using the minimum and maximum, mean and SD or median and IQR.

    Statistical analyses will be conducted within a superiority framework to make pairwise comparisons across the three diagnostic label groups. Binary outcomes will be analysed using logistic regression. Continuous outcomes will be analysed using linear regression. For the cancer worry outcome, we will compare changes in worry across randomised groups by including baseline scores as a covariate in the regression model. Effect estimates for all primary and secondary outcomes will be presented with associated 95% CI. All hypothesis tests will be two-sided with a significance level (α) of 5%. The potential for participants’ health literacy to act as an effect modifier of intervention effects will be explored.

    We will estimate unadjusted and adjusted effects using the relevant regression model. These will include variables used in sampling strata: age, education and geographic location (by state/territory). Prognostic factors will be measured through the baseline questionnaire and include baseline anxiety levels, sun exposure behaviour, prior diagnosis of melanoma and diagnosis of melanoma in a family member. The effects of participants’ health literacy on intervention effects will also be explored as a potential confounder.

    Planned start and end dates for the study

    The anticipated date of first participant enrolment was 01 July 2024, and the anticipated date of last data collection completion was 01 August 2024 (see Australian New Zealand Clinical Trials Registry, ID: ACTRN12624000740594).

    Patient and public involvement

    Two authors have lived experience of a melanoma diagnosis (one had MIS and one had a thin stage I invasive melanoma), and four authors are members of the public. Two authors are affiliated with Cancer Voices New South Wales (NSW), one author is a patient researcher from Cambridge UK, and three authors are affiliated with Health Consumers NSW.

    Ethics and dissemination

    Ethics approval of this project was provided by The University of Sydney on 06 May 2024 (No. 2024/HE000019). The study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000740594). Updates to the protocol will be uploaded to the registry and identified by version number.

    As this study is an online randomised experiment which includes a hypothetical scenario, we do not anticipate significant adverse events because of the trial interventions or conduct. Participants are reminded at several points before and after the study as part of the participant information, consent and debrief processes that the nature of the study is hypothetical, that none of the information relates to their actual health or well-being and that researchers do not have access to their actual medical histories or information. The debriefing content also includes links to relevant resources for participants who wish to find out more.

    Data availability statement

    The research team will have access to the final dataset. Access may be granted to other researchers on reasonable request. No contractual agreements limit the disclosure of data to other investigators. The findings of the study will be published in a peer-reviewed medical journal. A lay summary of the findings will be published via permanent link at the Wiser Healthcare publications page.

    Ethics statements

    Patient consent for publication

    References

    1. ↵
      2. Welch HG ,
      3. Kramer BS ,
      4. Black WC
      . Epidemiologic Signatures in Cancer. N Engl J Med 2019;381:1378–86. doi:10.1056/NEJMsr1905447
      OpenUrlCrossRef
    2. ↵
      2. Glasziou PP ,
      3. Jones MA ,
      4. Pathirana T , et al
      . Estimating the magnitude of cancer overdiagnosis in Australia. Med J Aust 2020;212:163–8. doi:10.5694/mja2.50455
      OpenUrlCrossRefPubMed
    3. ↵
      2. Welch HG ,
      3. Mazer BL ,
      4. Adamson AS
      . The Rapid Rise in Cutaneous Melanoma Diagnoses. N Engl J Med 2021;384:72–9. doi:10.1056/NEJMsb2019760
      OpenUrlCrossRefPubMed
    4. ↵
      2. Adamson AS ,
      3. Naik G ,
      4. Jones MA , et al
      . Ecological study estimating melanoma overdiagnosis in the USA using the lifetime risk method. BMJ EBM 2024;29:156–61. doi:10.1136/bmjebm-2023-112460
      OpenUrl
    5. ↵
      2. Adamson AS ,
      3. Suarez EA ,
      4. Welch HG
      . Estimating Overdiagnosis of Melanoma Using Trends Among Black and White Patients in the US. JAMA Dermatol 2022;158:426–31. doi:10.1001/jamadermatol.2022.0139
      OpenUrl
    6. ↵
      2. Bjørch MF ,
      3. Gram EG ,
      4. Brodersen JB
      . Overdiagnosis in malignant melanoma: a scoping review. BMJ EBM 2024;29:17–28. doi:10.1136/bmjebm-2023-112341
      OpenUrl
    7. ↵
      2. Long GV ,
      3. Swetter SM ,
      4. Menzies AM , et al
      . Cutaneous melanoma. The Lancet 2023;402:485–502. doi:10.1016/S0140-6736(23)00821-8
      OpenUrl
    8. ↵
      2. Whiteman DC ,
      3. Olsen CM ,
      4. MacGregor S , et al
      . The effect of screening on melanoma incidence and biopsy rates. Br J Dermatol 2022;187:515–22. doi:10.1111/bjd.21649
      OpenUrl
    9. ↵
      2. Olsen CM ,
      3. Pandeya N ,
      4. Rosenberg PS , et al
      . Incidence of in Situ vs Invasive Melanoma: Testing the “Obligate Precursor” Hypothesis. J Natl Cancer Inst 2022;114:1364–70. doi:10.1093/jnci/djac138
      OpenUrl
    10. ↵
      2. Nielsen JB ,
      3. Kristiansen IS ,
      4. Thapa S
      . Increasing melanoma incidence with unchanged mortality: more sunshine, better treatment, increased diagnostic activity, overdiagnosis or lowered diagnostic threshold? Br J Dermatol 2024;191:365–74. doi:10.1093/bjd/ljae175
      OpenUrl
    11. ↵
      2. Elder DE
      . Obligate and Potential Precursors of Melanoma. JNCI 2022;114:1320–2. doi:10.1093/jnci/djac139
      OpenUrl
    12. ↵
      2. Semsarian CR ,
      3. Ma T ,
      4. Nickel B , et al
      . Do we need to rethink the diagnoses melanoma in situ and severely dysplastic naevus? Br J Dermatol 2022;186:1030–2. doi:10.1111/bjd.21010
      OpenUrl
    13. ↵
      2. Titus LJ ,
      3. Reisch LM ,
      4. Tosteson ANA , et al
      . Malpractice Concerns, Defensive Medicine, and the Histopathology Diagnosis of Melanocytic Skin Lesions. Am J Clin Pathol 2018;150:338–45. doi:10.1093/ajcp/aqy057
      OpenUrl
    14. ↵
      2. Bell KJL ,
      3. Nijsten T
      . Melanoma overdiagnosis: why it matters and what can be done about it. Br J Dermatol 2022;187:459–60. doi:10.1111/bjd.21750
      OpenUrl
    15. ↵
      2. Davies E
      . Informed by research, transformed by research. BMJ EBM 2024;29:62–3. doi:10.1136/bmjebm-2023-112646
      OpenUrl
    16. ↵
      2. Bell KJL ,
      3. Mehta Y ,
      4. Turner RM , et al
      . Fear of new or recurrent melanoma after treatment for localised melanoma. Psychooncology 2017;26:1784–91. doi:10.1002/pon.4366
      OpenUrl
    17. ↵
      2. Mahama AN ,
      3. Haller CN ,
      4. Labrada J , et al
      . Lived Experiences and Fear of Cancer Recurrence Among Survivors of Localized Cutaneous Melanoma. JAMA Dermatol 2024;160:495–501. doi:10.1001/jamadermatol.2023.6158
      OpenUrl
    18. ↵
      2. Patel VR ,
      3. Roberson ML ,
      4. Pignone MP , et al
      . Risk of Mortality After a Diagnosis of Melanoma In Situ. JAMA Dermatol 2023;159:703–10. doi:10.1001/jamadermatol.2023.1494
      OpenUrl
    19. ↵
      2. Zijlker LP ,
      3. Eggermont AMM ,
      4. van Akkooi ACJ
      . The end of wide local excision (WLE) margins for melanoma? Eur J Cancer 2023;178:82–7. doi:10.1016/j.ejca.2022.10.028
      OpenUrl
    20. ↵
      2. Moncrieff MD ,
      3. Bastiaannet E ,
      4. Underwood B , et al
      . Follow-up Schedule for Patients With Sentinel Node-negative Cutaneous Melanoma (The MELFO Study): An International Phase III Randomized Clinical Trial. Ann Surg 2022;276:e208–16. doi:10.1097/SLA.0000000000005621
      OpenUrl
    21. ↵
      2. Lim W-Y ,
      3. Morton RL ,
      4. Turner RM , et al
      . Patient Preferences for Follow-up After Recent Excision of a Localized Melanoma. JAMA Dermatol 2018;154:420–7. doi:10.1001/jamadermatol.2018.0021
      OpenUrl
    22. ↵
      2. Drabarek D ,
      3. Ackermann D ,
      4. Medcalf E , et al
      . Acceptability of a Hypothetical Reduction in Routinely Scheduled Clinic Visits Among Patients With History of a Localized Melanoma (MEL-SELF): Pilot Randomized Clinical Trial. JMIR Dermatol 2023;6:e45865. doi:10.2196/45865
    23. ↵
      2. Nickel B ,
      3. Barratt A ,
      4. McGeechan K , et al
      . Effect of a Change in Papillary Thyroid Cancer Terminology on Anxiety Levels and Treatment Preferences: A Randomized Crossover Trial. JAMA Otolaryngol Head Neck Surg 2018;144:867–74. doi:10.1001/jamaoto.2018.1272
      OpenUrl
    24. ↵
      2. McCaffery K ,
      3. Nickel B ,
      4. Moynihan R , et al
      . How different terminology for ductal carcinoma in situ impacts women’s concern and treatment preferences: a randomised comparison within a national community survey. BMJ Open 2015;5:e008094. doi:10.1136/bmjopen-2015-008094
    25. ↵
      2. Berlin A ,
      3. Ramotar M ,
      4. Santiago AT , et al
      . The influence of the “cancer” label on perceptions and management decisions for low-grade prostate cancer. J Natl Cancer Inst 2023;115:1364–73. doi:10.1093/jnci/djad108
      OpenUrl
    26. ↵
      2. Nickel B ,
      3. Moynihan R ,
      4. Barratt A , et al
      . Renaming low risk conditions labelled as cancer. BMJ 2018;362:k3322. doi:10.1136/bmj.k3322
    27. ↵
      1. Qualtrics
      . Qualtrics. 2024. Available: https://www.qualtrics.com/
    28. ↵
      1. Australian Bureau of Statistics (ABS)
      . Regional population by age and sex 2023. 2023. Available: https://www.abs.gov.au/statistics/people/population/regional-population-age-and-sex/latest-release [Accessed 15 Oct 2024].
    29. ↵
      1. Australian Bureau of Statistics (ABS)
      . National, state and territory population. 2023. Available: https://www.abs.gov.au/statistics/people/population/national-state-and-territory-population/dec-2023 [Accessed 15 Oct 2024].
    30. ↵
      2. Elmore JG ,
      3. Barnhill RL ,
      4. Elder DE , et al
      . Pathologists’ diagnosis of invasive melanoma and melanocytic proliferations: observer accuracy and reproducibility study. BMJ 2017;357:j2813. doi:10.1136/bmj.j2813
    31. ↵
      2. Clark J ,
      3. Glasziou P ,
      4. Del Mar C , et al
      . A full systematic review was completed in 2 weeks using automation tools: a case study. J Clin Epidemiol 2020;121:81–90. doi:10.1016/j.jclinepi.2020.01.008
      OpenUrlCrossRefPubMed
    32. ↵
      1. Veritas Health Innovation
      . Covidence systematic review software. n.d. Available: www.covidence.org
    33. ↵
      2. Sun C ,
      3. Lim A ,
      4. De’Ambrosis B , et al
      . Recurrence Rate of Small Melanoma In Situ on Low-Risk Sites Excised With 5-mm Excisional Margin. JAMA Dermatol 2024;160:874–7. doi:10.1001/jamadermatol.2024.1878
      OpenUrl
    34. ↵
      2. Smith H ,
      3. Hussain W
      . Is it time we changed the way we manage melanoma in situ of the trunk and limbs? Br J Dermatol 2023;188:685–7. doi:10.1093/bjd/ljad031
      OpenUrl
    35. ↵
      2. Barnhill RL ,
      3. Elder DE ,
      4. Piepkorn MW , et al
      . Revision of the Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis Classification Schema for Melanocytic Lesions: A Consensus Statement. JAMA Netw Open 2023;6:e2250613. doi:10.1001/jamanetworkopen.2022.50613
    36. ↵
      2. Dretzke J ,
      3. Chaudri T ,
      4. Balaji R , et al
      . A systematic review of the effectiveness of patient-initiated follow-up after cancer. Cancer Med 2023;12:19057–71. doi:10.1002/cam4.6462
      OpenUrl
    37. ↵
      2. Ackermann DM ,
      3. Dieng M ,
      4. Medcalf E , et al
      . Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical Trial. JAMA Dermatol 2022;158:33–42. doi:10.1001/jamadermatol.2021.4704
      OpenUrl
      2. Vuong K ,
      3. Armstrong BK ,
      4. Weiderpass E , et al
      . Development and External Validation of a Melanoma Risk Prediction Model Based on Self-assessed Risk Factors. JAMA Dermatol 2016;152:889–96. doi:10.1001/jamadermatol.2016.0939
      OpenUrl
      1. World Health Organization
      . Wellbeing measures in primary health care/the depcare project: report on a WHO meeting: Stockholm, Sweden, 12–13 February 1998. Regional Office for Europe; 1998.
      2. Scherer LD ,
      3. Zikmund-Fisher BJ
      . Eliciting Medical Maximizing-Minimizing Preferences with a Single Question: Development and Validation of the MM1. Med Decis Making 2020;40:545–50. doi:10.1177/0272989X20927700
      OpenUrlCrossRef
      2. Morris NS ,
      3. MacLean CD ,
      4. Chew LD , et al
      . The Single Item Literacy Screener: evaluation of a brief instrument to identify limited reading ability. BMC Fam Pract 2006;7:1–7. doi:10.1186/1471-2296-7-21
      OpenUrlCrossRefPubMed
      2. Schwarzer R ,
      3. Jerusalem M
      . Generalized self-efficacy scale. In: Weinman J , Wright S , Johnston M , eds. Measures in health psychology: A user’s portfolio Causal and control beliefs, 35. 1995: 37.
      2. Davey HM ,
      3. Barratt AL ,
      4. Butow PN , et al
      . A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. J Clin Epidemiol 2007;60:356–60. doi:10.1016/j.jclinepi.2006.07.015
      OpenUrlCrossRefPubMedWeb of Science
      2. Dillard AJ ,
      3. Ferrer RA ,
      4. Welch JD
      . Associations between narrative transportation, risk perception and behaviour intentions following narrative messages about skin cancer. Psychol Health 2018;33:573–93. doi:10.1080/08870446.2017.1380811
      OpenUrl

    Footnotes

    • X @@ProfRScolyerMIA, @adeadamson, @KatyJLBell

    • Contributors ZW co-led drafting of the manuscript, led drafting of the study questionnaire and application to the Human Research Ethics Committee and assisted with the targeted literature review (full-text screening and data extraction). BN and KB conceptualised the research and provided methodological expertise. KB, who is the guarantor, led the targeted literature review and the Clinician and Consumer Investigator survey to decide the choice of alternative labels and co-led drafting of the manuscript. FB calculated the sample size. BN, FB, DE, PMF, RAS, BO'B, RB, ACJvA, ASA, JE, LP, DL, CL, ED, SLi, SLe, BS-R and KB revised the manuscript. All authors read, contributed to and approved the final manuscript.

    • Funding National Health and Medical Research Council of Australia (NHMRC) Centre for Research Excellence Grant (2021/GNT2006545). Brooke Nickel: NHMRC Investigator Grant (2020/GNT1113532). Richard A Scolyer: NHMRC Investigator Grant (2022/GNT2018514). Katy JL Bell: NHMRC Investigator Grant (2019/GNT1174523).

    • Competing interests RAS has received fees for professional services from SkylineDx BV, IO Biotech ApS, MetaOptima Technology Inc., F. Hoffmann-La Roche Ltd, Evaxion, Provectus Biopharmaceuticals Australia, Qbiotics, Novartis, Merck Sharp & Dohme, NeraCare, AMGEN Inc., Bristol-Myers Squibb, Myriad Genetics and GlaxoSmithKline. ACJvA received Advisory Board/Consultancy Honoraria from 4SC AG, Amgen, Bristol-Myers Squibb, Merck Serono-Pfizer, MSD-Merck, Neracare, Novartis, Pierre Fabre, Sanofi, Sirius Medical and SkylineDX and Research Grants from Amgen, Merck Serono-Pfizer and SkylineDX. All other authors have no conflicts of interest to declare.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.