MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

Not Applicable

Recruiting

• Conditions: Melanoma
• Interventions: Other: Assess implementation outcomes; Other: MySmartSkin enhancement; Other: Educational webpage on Skin Self-Examination

• Registration Number: NCT05373823
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

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. Aim three (Months 16-60) will assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation.

Study Timeline

• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-13
• Study Start: 2023-03-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)	Assess implementation outcomes	Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders
Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)	MySmartSkin enhancement	Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT)
Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)	Educational webpage on Skin Self-Examination	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

Primary Outcome Measures

Name	Time	Method
Body parts examined	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).

Secondary Outcome Measures

Name	Time	Method
Melanoma Diagnosis	3 months	This will be assessed by asking the participant at the first follow-up if a melanoma was diagnosed and confirmed by provider via medical records.
Melanoma Diagnosis Date	18 months	This will be assessed by asking the participant at the fourth follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records.
Melanoma Stage	18 months	This will be assessed by asking the participant at the fourth follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records.

Trial Locations

Locations (1)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States