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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
Melanoma
MSS enhancement - Other
Eligibility
18+
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 18 months

18 months
Body parts examined

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Aim 3: Assess implementation outcomes, identify factors relevant for future scal...
1 of 3
Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)
1 of 3
Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (M...
1 of 3
Active Control
Experimental Treatment

385 Total Participants · 3 Treatment Groups

Primary Treatment: Enhance MSS using multi-level stakeholder collaboration (Mo.1-15) · No Placebo Group · N/A

Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)
Other
Experimental Group · 1 Intervention: MSS enhancement · Intervention Types: Other
Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)
Other
Experimental Group · 1 Intervention: Educational webpage on SSE · Intervention Types: Other
Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)
Other
ActiveComparator Group · 1 Intervention: Assess implementation outcomes · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Trial Background

Sharon Manne, PhD
Principal Investigator
Rutgers, The State University of New Jersey
Closest Location: Rutgers Cancer Institute of New Jersey · New Brunswick, NJ
2013First Recorded Clinical Trial
33 TrialsResearching Melanoma
158 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The patient has a diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma.
You have a minimum life expectancy of at least three months to five years post-surgery.
You are not adherent to thorough SSE.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.