MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Melanoma

Treatments: Other: MySmartSkin enhancement; Other: Assess implementation outcomes; Other: Educational webpage on Skin Self-Examination

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05373823

CINJ132202

R01CA264548 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 385 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

385 participants in 3 patient groups

Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)

Experimental group

Description:

Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT)

Treatment:

Other: MySmartSkin enhancement

Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)

Experimental group

Description:

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

Treatment:

Other: Educational webpage on Skin Self-Examination

Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)

Active Comparator group

Description:

Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders

Treatment:

Other: Assess implementation outcomes