MySmartSkin Renewal

Overview

The goal of the iterative process of enhancing microsatellite stable (MSS) using stakeholder feedback and usability testing is to improve Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) outcomes, which will be assessed in Aims two and three. In Aim two, the investigator focus on effectiveness of the enhanced MSS, testing its effects on survivor-level outcomes including clinical outcomes (e.g., melanomas found). In Aim the, the investigators address the remaining RE-AIM outcomes. Additionally, to proactively identify barriers and facilitators to future scale-up and widespread dissemination and implementation of MSS, the investigators explore multilevel contextual factors identified by key stakeholders drawn from the Practical, Robust Implementation and Sustainability Model (PRISM) domains of the target population, external environment, intervention design, and sustainability infrastructure including costs. The investigators anticipate that incorporating PRISM/RE-AIM throughout the study aims will ensure that the enhanced intervention is responsive to key stakeholder preferences and "design for dissemination," recognizing potential barriers and facilitators to future scale-up and informing our next stage of developing dissemination and implementation strategies to maximize the public health impact of MSS.

Full Title of Study: “A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2027

Detailed Description

This is a type one hybrid effectiveness-implementation study consisting of three aims. Aim one (Months 1-15) focuses on MSS enhancement using stakeholder collaboration. Aim two (Months 16-60) involves the longitudinal randomized control trial (RCT) comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on Society for Scientific Exploration (SSE) as well as new recurrences/melanomas. Aim three (Months 16-60) is a mixed-methods study with multi-level stakeholders to assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation

Interventions

  • Other: MSS enhancement
    • Focuses on MSS enhancement using stakeholder collaboration
  • Other: Educational webpage on SSE
    • Longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas
  • Other: Assess implementation outcomes
    • A mixed-methods study with multi-level stakeholders to assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation.

Arms, Groups and Cohorts

  • Experimental: Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)
    • Enhancements of MSS to increase intervention effects – theory – based strategies (PHM), (BCT)
  • Experimental: Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)
    • RCT of enhanced MSS testing effectiveness (through SSE, sun protection behavior Involves the longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas
  • Active Comparator: Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)
    • Assessment of implementation outcomes and key contextual factors from the perspective of multi – level stakeholders

Clinical Trial Outcome Measures

Primary Measures

  • Body parts examined
    • Time Frame: 18 months
    • Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma – Three months to five years post-surgery – No current evidence of cancer – Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months) – ≥ 18 years old – Internet access – Able to speak/read English – Able to provide informed consent Exclusion Criteria:

  • Children

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sharon Manne, PhD, Associate Director for Cancer Prevention, Control and Population Science – Rutgers, The State University of New Jersey
  • Overall Official(s)
    • Sharon Manne, MD, Principal Investigator, Rutgers Cancer Institute of New Jersey
  • Overall Contact(s)
    • Sharon Manne, MD, 732-235-6759, mannesl@cinj.rutgers.edu

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