Does the label given to low-risk melanoma influence patient management choice?
Not Applicable
- Conditions
- MelanomaFear of cancerCancer - Malignant melanoma
- Registration Number
- ACTRN12624000740594
- Lead Sponsor
- The University of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1688
Inclusion Criteria
To be included in the trial, participants will be eligible if they are:
•40 years or older.
•Understand written English.
•Reside in Australia.
Exclusion Criteria
Has a prior history of melanoma (invasive or in-situ).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Choice of further surgery:<br>•No further surgery <br>•Further surgery to ensure clear margins >0.5mm [Binary choices between two options in an online questionnaire designed for this study Immediately after intervention.];Choice of follow-up:<br>• Patient-led surveillance: self-monitoring with patient-initiated clinic visits as needed. <br>• Clinician-led surveillance: six monthly routinely scheduled clinic visits (current standard care after diagnosis of melanoma in situ).<br>[Binary choices between two options in an online questionnaire designed for this study Immediately after intervention.]
- Secondary Outcome Measures
Name Time Method Diagnosis of anxiety[10-point single-question Visual Analogue Scale, with anchored endpoints of 1 = not anxious at all and 10 = extremely anxious in an online questionnaire designed for this study Immediately after intervention.];Treatment choice anxiety[10-point single-question Visual Analogue Scale, with anchored endpoints of 1 = not anxious at all and 10 = extremely anxious in an online questionnaire designed for this study Immediately after intervention.];Rationale for Decisions[Open-text explanation of management choices in an online questionnaire designed for this study Immediately after intervention.];perceived lifetime risk of invasive melanoma[Single-question Visual Analogue Scale (0-100) in an online questionnaire designed for this study Immediately after intervention];perceived risk of dying from melanoma[Single-question Visual Analogue Scale (0-100) in an online survey designed for this study Immediately after intervention]