Melanoma Clinical Trial

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Summary

The goal of the iterative process of enhancing microsatellite stable (MSS) using stakeholder feedback and usability testing is to improve Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) outcomes, which will be assessed in Aims two and three. In Aim two, the investigator focus on effectiveness of the enhanced MSS, testing its effects on survivor-level outcomes including clinical outcomes (e.g., melanomas found). In Aim the, the investigators address the remaining RE-AIM outcomes. Additionally, to proactively identify barriers and facilitators to future scale-up and widespread dissemination and implementation of MSS, the investigators explore multilevel contextual factors identified by key stakeholders drawn from the Practical, Robust Implementation and Sustainability Model (PRISM) domains of the target population, external environment, intervention design, and sustainability infrastructure including costs. The investigators anticipate that incorporating PRISM/RE-AIM throughout the study aims will ensure that the enhanced intervention is responsive to key stakeholder preferences and "design for dissemination," recognizing potential barriers and facilitators to future scale-up and informing our next stage of developing dissemination and implementation strategies to maximize the public health impact of MSS.

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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 on Society for Scientific Exploration (SSE) as well as new recurrences/melanomas. Aim three (Months 16-60) is 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

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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

Study is for people with:

Melanoma

Estimated Enrollment:

385

Study ID:

NCT05373823

Recruitment Status:

Not yet recruiting

Sponsor:

Rutgers, The State University of New Jersey

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There is 1 Location for this study

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Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States More Info
Sharon Manne, MD
Contact
732-235-6759
[email protected]

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Study is for people with:

Melanoma

Estimated Enrollment:

385

Study ID:

NCT05373823

Recruitment Status:

Not yet recruiting

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

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