MySmartSkin Renewal

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Melanoma

Intervention / Treatment
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* Other: MSS enhancement
* Other: Educational webpage on SSE
* Other: Assess implementation outcomes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Type one hybrid effectiveness-implementation study consisting of three aims. Aim 1 (Months 1-15) focuses on MSS enhancement using stakeholder collaboration. Aim 2 (Months 16-60) involves the longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas. Aim 3 (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. The figure below illustrates the integration of the PHM and implementation science frameworks with the study's aims.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)<br>Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT) | Other: MSS enhancement<br>* Focuses on MSS enhancement using stakeholder collaboration<br>|
| Experimental: Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)<br>RCT of enhanced MSS testing effectiveness (through 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 SSE<br>* Longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas<br>|
| Active Comparator: Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)<br>Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders | Other: Assess implementation outcomes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body parts examined | Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM). | Baseline | 
| Body parts examined | Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM). | 3 months | 
| Body parts examined | Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM). | 6 months | 
| Body parts examined | Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM). | 12 months | 
| Body parts examined | Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM). | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melanoma Diagnosis | This will be assessed by asking the participant at the second follow-up if a melanoma was diagnosed and confirmed by provider via medical records. | 6 months | 
| Melanoma Diagnosis | This will be assessed by asking the participant at the third follow-up if a melanoma was diagnosed and confirmed by provider via medical records. | 12 months | 
| Melanoma Diagnosis | This will be assessed by asking the participant at the fourth follow-up if a melanoma was diagnosed and confirmed by provider via medical records. | 18 months | 
| Melanoma Stage | This will be assessed by asking the participant at the first follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records. | 3 months | 
| Melanoma Stage | This will be assessed by asking the participant at the second follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records. | 6 months | 
| Melanoma Stage | This will be assessed by asking the participant at the third follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records. | 12 months | 
| Melanoma Stage | This will be assessed by asking the participant at the fourth follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records. | 18 months | 
| Melanoma Thickness | This will be assessed by asking the participant at the first follow-up the thickness of his/her melanoma, if diagnosed. Response will be confirmed by provider via medical records. | 3 months | 
| Melanoma Thickness | This will be assessed by asking the participant at the second follow-up the thickness of his/her melanoma, if diagnosed. Response will be confirmed by provider via medical records. | 6 months | 
| Melanoma Thickness | This will be assessed by asking the participant at the third follow-up the thickness of his/her melanoma, if diagnosed. Response will be confirmed by provider via medical records. | 12 months | 
| Melanoma Thickness | This will be assessed by asking the participant at the fourth follow-up the thickness of his/her melanoma, if diagnosed. Response will be confirmed by provider via medical records. | 18 months | 
| Melanoma Diagnosis Date | This will be assessed by asking the participant at the first follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records. | 3 months | 
| Melanoma Diagnosis Date | This will be assessed by asking the participant at the second follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records. | 6 months | 
| Melanoma Diagnosis Date | This will be assessed by asking the participant at the third follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records. | 12 months | 
| Melanoma Diagnosis Date | This will be assessed by asking the participant at the fourth follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records. | 18 months | 
| Melanoma Diagnosis | This will be assessed by asking the participant at the first follow-up if a melanoma was diagnosed and confirmed by provider via medical records. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-Examination