MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05373823
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MySmartSkin enhancement — OTHER
    Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input
  • Educational webpage on Skin Self-Examination — OTHER
    Longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas
  • Assess implementation outcomes — OTHER
    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.

Study Details

This project, mySmartSkin (MSS), includes an innovative Type 1 hybrid effectiveness-implementation trial designed to enhance the effects of MSS and simultaneously assess key implementation outcomes (e.g., cost, adoption) as well as contextual factors important for scale-up in community and health care settings where melanoma survivors receive follow-up care. A type 1 hybrid effectiveness-implementation design allows us to engage multilevel stakeholders throughout this process, evaluate the effectiveness of the enhanced MSS, and identify critical factors for wide-scale implementation. Aim 1 will focus on enhancing the previous version of MSS by collaborating with multi-level stakeholders in qualitative interviews and usability testing. Aim 2 will evaluate the effects of enhanced MSS on thorough skin-self examinations (SSE) in a randomized-control trial (RCT) and examine its impact on the diagnosis of new/recurrent melanomas. Aim 3 will focus on assessing selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation.

Key Dates

Start date
Mar 6, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
385 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

Arms

  • 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 (thorough 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

Primary Outcome Measure

Body parts examined [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Sharon Manne, PhD
732-235-6759

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