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 — OTHERFocuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input
- Educational webpage on Skin Self-Examination — OTHERLongitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas
- Assess implementation outcomes — OTHERA 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
- Sharon Manne, PhD732-235-6759
- Carolyn Heckman, PhD732-266-9514
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 |
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