Recruiting

MySmartSkin

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05373823

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MySmartSkin enhancement

Educational webpage on Skin Self-Examination

Assess implementation outcomes

Study Details

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.

Conditions

Melanoma

Study ID

NCT05373823

Start date

Mar 6, 2023

Status verified date

Jul, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

385 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Screening

Interventions and Outcome Measures

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

Interventions

MySmartSkin enhancement

Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input

Educational webpage on Skin Self-Examination

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

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.

Primary outcome measure

  • Body parts examined [ Time Frame: Baseline ]
  • Body parts examined [ Time Frame: 3 months ]
  • Body parts examined [ Time Frame: 6 months ]
  • Body parts examined [ Time Frame: 12 months ]
  • Body parts examined [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Sharon Manne, PhD

732-235-6759mannesl@cinj.rutgers.edu

Carolyn Heckman, PhD

732-266-9514ch842@cinj.rutgers.edu

Locations

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Sharon Manne, PhD

732-235-6759Sharon.Manne@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Self-Examination

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-07-28.