RecruitingNot Applicable

MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

United States385 participantsStarted 2023-03-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Body parts examined

Timeframe: Baseline

Body parts examined

Timeframe: 3 months

Body parts examined

Timeframe: 6 months

Body parts examined

Timeframe: 12 months

Body parts examined

Timeframe: 18 months

Trial details

NCT IDNCT05373823

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Sharon Manne, PhD

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

View on ClinicalTrials.gov More Melanoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.