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Recruiting NCT05373823

MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

No phase Interventional Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MySmartSkin enhancement, Educational webpage on Skin Self-Examination, Assess implementation outcomes.
Who it may be relevant to
Registry conditions: Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors

Overview

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.

Interventions

  • Other MySmartSkin enhancement
    Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input
  • Other 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
  • Other 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 measures

  • 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]
Secondary outcome measures (12)
  • Melanoma Diagnosis [Time frame: 6 months]
  • Melanoma Diagnosis [Time frame: 12 months]
  • Melanoma Diagnosis [Time frame: 18 months]
  • Melanoma Stage [Time frame: 3 months]
  • Melanoma Stage [Time frame: 6 months]
  • Melanoma Stage [Time frame: 12 months]
  • Melanoma Stage [Time frame: 18 months]
  • Melanoma Diagnosis Date [Time frame: 3 months]
  • Melanoma Diagnosis Date [Time frame: 6 months]
  • Melanoma Diagnosis Date [Time frame: 12 months]
  • Melanoma Diagnosis Date [Time frame: 18 months]
  • Melanoma Diagnosis [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Rutgers Cancer Institute of New Jersey — New Brunswick

Identifiers

NCT: NCT05373823 · CINJ132202 · R01CA264548 · Pro2022000948

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗