Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 12, 2023
Open Peer Review Period: Sep 12, 2023 - Oct 26, 2023
Date Accepted: Oct 26, 2023
(closed for review but you can still tweet)
A digital intervention to improve skin self-examination among melanoma survivors: Protocol for a type 1 hybrid effectiveness-implementation randomized trial
ABSTRACT
Background:
Although melanoma survival rates have improved in recent years, survivors remain at risk for recurrence, second primary cancers, and keratinocyte carcinomas. The National Comprehensive Cancer Network recommends skin exams by a physician every 3-12 months. Regular thorough skin self-examinations (SSE) are recommended for melanoma survivors to promote the detection of earlier stage, thinner melanomas, which are associated with improved survival and lower treatment costs. Despite the importance, less than a quarter of melanoma survivors engage in SSEs.
Objective:
Previously, our team developed and evaluated an online, fully automated intervention, called mySmartSkin (MSS), that successfully improved SSE among melanoma survivors. Enhancements were proposed to improve engagement with and outcomes from MSS. The purpose of this paper is to describe the rationale and methodology for a type 1 hybrid effectiveness-implementation randomized trial evaluating the enhanced MSS versus control and exploring implementation outcomes and contextual factors.
Methods:
: This study will recruit from state cancer registries and social media 300 individuals diagnosed with cutaneous malignant melanoma between 3 months to five years post-surgery who are currently cancer-free. Participants will be randomly assigned to either enhanced MSS or a non-interactive educational webpage. Surveys will be collected from both arms at baseline, 3 months, 6 months, 12 months, and 18 months to assess measures of intervention engagement, barriers, self-efficacy, habit, and SSE. The primary outcome is thorough SSE. Secondary outcomes are the diagnosis of new/recurrent melanomas and sun protection practices.
Results:
Multi-level modeling will be used to examine whether there are significant differences in survivor outcomes between MSS versus the non-interactive web page over time. Mixed methods will evaluate reach, adoption, implementation (including costs), and potential for maintenance of MSS, as well as contextual factors relevant to those outcomes and future scale-up.
Conclusions:
This trial has the potential to improve outcomes among melanoma survivors. If MSS is effective, results could guide its implementation in oncology care and non-profit organizations focused on skin cancers. Clinical Trial: Registry: ClinicalTrials.gov Brief Tite: mySmartSkin Renewal Protocol ID: CINJ132202 ClinicalTrials.gov ID: NCT05373823
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.