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A Digital Intervention to Improve Skin Self-Examination Among Melanoma Survivors.

Aim 1. To enhance MSS by collaborating with multi-level stakeholders. We will collaborate with stakeholders in enhancing MSS through qualitative interviews and usability testing of potential enhancements. Enhancements are based on empirically validated behavior change techniques (BCTs) and our prior study. We will utilize an iterative process that includes: (1) key informant interviews with survivors, providers, and professional organizations regarding proposed enhancements; (2) conversion to an enhanced mobile-based delivery platform; (3) usability testing, and; (4) iterative program refinements.

Aim 2. To evaluate the effects of enhanced MSS on thorough SSE in an RCT and examine its impact on the diagnosis of new/recurrent melanomas (N= 300). We will conduct a RCT comparing MSS and a non-interactive educational webpage with 300 survivors to test its effects on SSE. We propose that MSS participants will be more likely to perform thorough SSE over the 18-month follow-up. We will explore the impact of MSS on new/recurrent melanomas. We propose that there will be more earlier stage melanomas diagnosed in MSS as compared with UC.

Aim 3. To assess selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation. We will use mixed methods to assess implementation outcomes and explore perspectives from survivors, care providers, and professional organizations about how to best disseminate and implement MSS on a broad scale. The sub-aims are: 3a) To estimate program costs and assess cost-effectiveness of MSS relative to control. We hypothesize that MSS costs will be higher than UC. We expect that MSS will be a more cost-effective strategy, given its greater effectiveness to increase SSE and identify new or recurrent melanoma. If our findings support this as expected, exploratory cost-effectiveness analyses from the health care and societal perspectives will be conducted using simulation models of melanoma-related costs, disease progression, and survival over 5- and 10-year analysis horizons. 3b) To examine MSS reach, adoption, engagement, acceptability, appropriateness, feasibility, and maintenance. For reach, we predict that demographic variables will not differ from the general population of melanoma survivors. For adoption, we propose that the proportion of contacted/eligible survivors randomized to MSS who consent, complete the baseline, and log into MSS will be equal or greater than the efficacy trial. For engagement, we propose that 80% of MSS participants will log in. For acceptability, we predict MSS will be rated as highly acceptable. 3c) To identify and describe contextual factors from multilevel stakeholders as key to scale-up and widespread implementation of MSS, including consideration of potential delivery settings, timing of delivery, and needed resources to promote its implementation and sustainability.

Protocol Number: 132202
Phase: N/A
Applicable Disease Sites: Melanoma, Skin
Principal Investigator: Sharon Manne PhD
Scope: National
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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