Rutgers, The State University of New Jersey
Sharon Manne, PhD
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.
Melanoma
MySmartSkin enhancement
Educational webpage on Skin Self-Examination
Assess implementation outcomes
Not Applicable
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.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 385 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Screening |
| Official Title : | A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors |
| Actual Study Start Date : | March 6, 2023 |
| Estimated Primary Completion Date : | December 31, 2026 |
| Estimated Study Completion Date : | March 31, 2027 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Enhance MSS using multi-level stakeholder collaboration (Mo.1-15) Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT) |
Other: MySmartSkin enhancement |
|
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 |
Other: Educational webpage on Skin Self-Examination |
|
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 |
Other: Assess implementation outcomes |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901