MEL-SELF dataset: a randomised controlled trial of patient-led surveillance compared to clinician-led surveillance in people treated for localised melanoma
The University of SydneyDataset description
The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma. Stage 0/I/II melanoma patients (n=500) from dermatology, surgical, or general practice clinics in Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n=250) or control (usual care, n=250). The primary outcome, measured at 12-months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma diagnosed at an unscheduled clinic visit. Clinical secondary outcomes include time from randomisation to diagnosis of any skin cancer (melanoma or keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), number of lesions surgically evaluated, and number of clinic visits attended. Patient-reported outcomes collected at baseline, 6 and 12 months, include thoroughness, confidence, beliefs, and knowledge of skin self-examination, adherence with recommended clinician SSE practice guidelines, fear of new or recurrent melanoma severity and general anxiety, stress, and depression. A nested qualitative study will include interviews with patients and clinicians, and a costing study will compare costs from a societal perspective. The data will be available in CSV format.
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12621000176864
Funding
Government body, National Health and Medical Research Council (NHMRC)
Scientific enquiries
Katy Bell
Brief Summary
This study tests patient-led surveillance which is a new way of following up people who have had an early melanoma (in situ melanoma or stage I or II invasive melanoma). Patient-led surveillance combines skin self-examination and teledermatology, which involves taking pictures of skin lesions on your body with a device attached to your smartphone and uploading these images for a dermatologist to review remotely. This study will investigate if this type of follow-up can diagnose new or recurrent .... Read more
Key Inclusion Criteria
Patients who: • Have been treated for stage 0/I/II melanoma, and are attending regular melanoma follow-up as indicated by at least one scheduled visit within next 12 months at a recruiting clinic • Are able to self-examine • Have a suitable study partner (spouse, partner, family member, friend) to help with self-examination • Own a compatible smartphone (and have access to Internet / email / SMS text messaging) • Are having no more frequent than 6 monthly scheduled clinics at treatment centres • .... Read more
Key Exclusion Criteria
Patients who: • Have ever had stage III/IV melanoma • Have a known past or current diagnosis of cognitive impairment. • Were participants in the MEL-SELF pilot trial
Can healthy volunteers participate?
No
Population
Sample Size 504
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Melanoma , Keratinocyte skin cancer
Condition code Cancer
Intervention
Intervention code Early detection / Screening
Before randomisation, all potential participants undergo an active run-in phase. In the active run-in phase participants will be asked to: • complete an online Baseline Questionnaire measuring demographics, knowledge, attitudes and confidence on self-examination and smartphone applications, and their baseline level of fear of new or recurrent melanoma (using a melanoma specific version of the Fear of Cancer Recurrence Index) • log-in to the web-based ASICA skin checker platform, view instruction .... Read more
Comparison
Control group Active
The control arm will receive clinician-led surveillance (usual care) which involves: • An educational booklet ‘Your guide to early melanoma’ (freely available at https://www.melanoma.org.au/melanoma/assets/File/Stage%20I%20and%20II%20(Early%20Stage)%20Melanoma%20Information%20Packs_FINAL.pdf) • Routinely scheduled visits as per treating clinician. • Unscheduled visits if needed.
Outcomes
Outcome: Proportion of participants who are diagnosed with a new primary or recurrent melanoma (any stage) at an unscheduled visit at the treatment centre during the 12 months follow-up of the trial. All new melanoma diagnoses will be identified through patient medical records, and through data linkage to the NSW cancer registry. The slides for all new melanoma diagnoses will be reviewed by the trial dermatopathologist, masked to randomised arm of the participant to confirm or r .... Read more
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
Data will be made available on a case by case basis at the discretion of the Coordinating Principal Investigator, Associate Professor Katy Bell.
Are there any conditions for requesting access to individual participant data?
-
What individual participant data might be shared?
Individual participant data not covered above
All non-identifiable participant data will be made available to other researchers to maximise the benefits that can be derived from the data. A data dictionary and code book will be available. It will be made available in Excel format either .csv or .xlsx format.
What types of analyses could be done with individual participant data?
Data will be made available on a case by case basis at the discretion of the Coordinating Principal Investigator, Associate Professor Katy Bell.
Are there extra considerations when requesting access to individual participant data?
No
When can request for individual data be made (start and end dates)?
From: Data will be available from within 12 Months of final publication of all study results until 15 years after trial completion.
To: -