MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Other: Assess implementation outcomes; Other: MySmartSkin enhancement; Other: Educational webpage on Skin Self-Examination

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.

• Study Type: Interventional
• Enrollment (Estimated): 385
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharon Manne, PhD; Phone Number: 732-235-6759; Email: mannesl@cinj.rutgers.edu
• Study Contact Backup: Name: Carolyn Heckman, PhD; Phone Number: 732-266-9514; Email: ch842@cinj.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Sharon Manne, PhD; Phone Number: 732-235-6759; Email: Sharon.Manne@rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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; Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input
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; 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.
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; Longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas

What is the study measuring?

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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	This will be assessed by asking the participant his/her age in the baseline survey.	Baseline
Sex	This will be assessed by asking the participant his/her sex in the baseline survey.	Baseline
Race/Ethnicity	This will be assessed by asking the participant his/her race and ethnicity in the baseline survey.	Baseline
Education	This will be assessed by asking the participant his/her education level in the baseline survey.	Baseline
Marital Status	This will be assessed by asking the participant his/her marital status in the baseline survey.	Baseline
State Residing In	This will be assessed by asking the participant what state he/she resides in the baseline survey.	Baseline
Employment	This will be assessed by asking the participant his/her employment status in the baseline survey.	Baseline
Income	This will be assessed by asking the participant his/her income level in the baseline survey.	Baseline
Health Insurance	This will be assessed by asking the participant if he/she has health insurance coverage in the baseline survey.	Baseline
Date of Diagnosis	This will be assessed by asking the participant in the baseline survey the date that he/she was diagnosed with skin cancer.	Baseline
Stage	This will be assessed by asking the participant in the baseline survey the stage of cancer he/she was diagnosed with.	Baseline
Treatment Received	This will be assessed by asking the participant in the baseline survey what treatment he/she received.	Baseline
Family History of Melanoma	This will be assessed by asking the participant in the baseline survey about his/her family history of melanoma. Family history is an important covariate because it can pose as a risk factor for melanoma.	Baseline
Month of Assessment	This will be assessed by asking participant in the baseline survey in what month he/she is completing the survey	Baseline
Month of Assessment	This will be assessed by asking participant in the first follow-up survey in what month he/she is completing the survey	3 months
Month of Assessment	This will be assessed by asking participant in the second follow-up survey in what month he/she is completing the survey	6 months
Month of Assessment	This will be assessed by asking participant in the third follow-up survey in what month he/she is completing the survey	12 months
Month of Assessment	This will be assessed by asking participant in the fourth follow-up survey in what month he/she is completing the survey	18 months
Location of Assessment	This will be assessed by asking participant in the baseline survey in what location he/she is completing the survey	Baseline
Location of Assessment	This will be assessed by asking participant in the first follow-up survey in what location he/she is completing the survey	3 months
Location of Assessment	This will be assessed by asking participant in the second follow-up survey in what location he/she is completing the survey	6 months
Location of Assessment	This will be assessed by asking participant in the third follow-up survey in what location he/she is completing the survey	12 months
Location of Assessment	This will be assessed by asking participant in the fourth follow-up survey in what location he/she is completing the survey	18 months
Average UV Index	Assessing the average UV index at solar noon over the 3 months prior to baseline survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the baseline survey.	Baseline
Average UV Index	Assessing the average UV index at solar noon over the 3 months prior to the first follow-up survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the first follow-up survey.	3 months
Average UV Index	Assessing the average UV index at solar noon over the 3 months prior to the second follow-up survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the second follow-up survey.	6 months
Average UV Index	Assessing the average UV index at solar noon over the 3 months prior to the third follow-up survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the third follow-up survey.	12 months
Average UV Index	Assessing the average UV index at solar noon over the 3 months prior to the fourth follow-up survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the fourth follow-up survey.	18 months
Indoor UV Tanning	This will be assessed by asking the participant in the baseline survey about his/her indoor UV tanning behaviors. Indoor UV tanning is an important covariate because it can pose as a risk factor for melanoma.	12 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sharon Manne, PhD, Rutgers Cancer Institute of New Jersey; Principal Investigator: Carolyn Heckman, PhD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Self-Examination
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Behavior; Skin and Connective Tissue Diseases; Health Behavior; Melanoma; Self-Examination
• Other Study ID Numbers: CINJ132202; R01CA264548 (U.S. NIH Grant/Contract); Pro2022000948 (Other Identifier: Rutgers IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No