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MySmartSkin Renewal

Primary Purpose

Melanoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MSS enhancement
Educational webpage on SSE
Assess implementation outcomes
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Melanoma focused on measuring Self-Examination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)
  • โ‰ฅ 18 years old
  • Internet access
  • Able to speak/read English
  • Able to provide informed consent

Exclusion Criteria:

  • Children

Sites / Locations

  • Rutgers Cancer Institute of New JerseyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

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

Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)

Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)

Arm Description

Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT)

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

Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 28, 2022
Last Updated
August 30, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05373823
Brief Title
MySmartSkin Renewal
Official Title
A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Self-Examination

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
385 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)
Arm Type
Experimental
Arm Description
Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT)
Arm Title
Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)
Arm Type
Experimental
Arm Description
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
Arm Title
Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)
Arm Type
Active Comparator
Arm Description
Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders
Intervention Type
Other
Intervention Name(s)
MSS enhancement
Intervention Description
Focuses on MSS enhancement using stakeholder collaboration
Intervention Type
Other
Intervention Name(s)
Educational webpage on SSE
Intervention Description
Longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas
Intervention Type
Other
Intervention Name(s)
Assess implementation outcomes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body parts examined
Description
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).
Time Frame
Baseline
Title
Body parts examined
Description
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).
Time Frame
3 months
Title
Body parts examined
Description
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).
Time Frame
6 months
Title
Body parts examined
Description
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).
Time Frame
12 months
Title
Body parts examined
Description
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).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Melanoma Diagnosis
Description
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.
Time Frame
6 months
Title
Melanoma Diagnosis
Description
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.
Time Frame
12 months
Title
Melanoma Diagnosis
Description
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.
Time Frame
18 months
Title
Melanoma Stage
Description
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.
Time Frame
3 months
Title
Melanoma Stage
Description
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.
Time Frame
6 months
Title
Melanoma Stage
Description
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.
Time Frame
12 months
Title
Melanoma Stage
Description
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.
Time Frame
18 months
Title
Melanoma Thickness
Description
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.
Time Frame
3 months
Title
Melanoma Thickness
Description
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.
Time Frame
6 months
Title
Melanoma Thickness
Description
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.
Time Frame
12 months
Title
Melanoma Thickness
Description
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.
Time Frame
18 months
Title
Melanoma Diagnosis Date
Description
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.
Time Frame
3 months
Title
Melanoma Diagnosis Date
Description
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.
Time Frame
6 months
Title
Melanoma Diagnosis Date
Description
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.
Time Frame
12 months
Title
Melanoma Diagnosis Date
Description
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.
Time Frame
18 months
Title
Melanoma Diagnosis
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Age
Description
This will be assessed by asking the participant his/her age in the baseline survey.
Time Frame
Baseline
Title
Sex
Description
This will be assessed by asking the participant his/her sex in the baseline survey.
Time Frame
Baseline
Title
Race/Ethnicity
Description
This will be assessed by asking the participant his/her race and ethnicity in the baseline survey.
Time Frame
Baseline
Title
Education
Description
This will be assessed by asking the participant his/her education level in the baseline survey.
Time Frame
Baseline
Title
Marital Status
Description
This will be assessed by asking the participant his/her marital status in the baseline survey.
Time Frame
Baseline
Title
State Residing In
Description
This will be assessed by asking the participant what state he/she resides in the baseline survey.
Time Frame
Baseline
Title
Employment
Description
This will be assessed by asking the participant his/her employment status in the baseline survey.
Time Frame
Baseline
Title
Income
Description
This will be assessed by asking the participant his/her income level in the baseline survey.
Time Frame
Baseline
Title
Health Insurance
Description
This will be assessed by asking the participant if he/she has health insurance coverage in the baseline survey.
Time Frame
Baseline
Title
Date of Diagnosis
Description
This will be assessed by asking the participant in the baseline survey the date that he/she was diagnosed with skin cancer.
Time Frame
Baseline
Title
Stage
Description
This will be assessed by asking the participant in the baseline survey the stage of cancer he/she was diagnosed with.
Time Frame
Baseline
Title
Treatment Received
Description
This will be assessed by asking the participant in the baseline survey what treatment he/she received.
Time Frame
Baseline
Title
Eye Color
Description
This will be assessed by asking the participant in the baseline survey what color eyes he/she has. Eye color is an important covariate as certain eye colors pose as a risk factor for melanoma.
Time Frame
Baseline
Title
Natural Hair Color
Description
This will be assessed by asking the participant in the baseline survey what color hair he/she has. Hair color is an important covariate as certain hair colors pose as a risk factor for melanoma.
Time Frame
Baseline
Title
Natural Skin Color
Description
This will be assessed by asking the participant in the baseline survey what skin color he/she has. Skin color is an important covariate as certain skin colors pose as a risk factor for melanoma.
Time Frame
Baseline
Title
Skin Reactivity to the Sun
Description
This will be assessed by asking the participant in the baseline survey how reactive his/her skin is to the sun. Skin reactivity is an important covariate as certain skin reactivity levels pose as a risk factor for melanoma.
Time Frame
Baseline
Title
Freckling
Description
This will be assessed by asking the participant in the baseline survey how many freckles are present on his/her skin. Freckling is an important covariate because it can pose as a risk factor for melanoma.
Time Frame
Baseline
Title
Moles
Description
This will be assessed by asking the participant in the baseline survey how many moles are present on his/her skin. Number of moles is an important covariate because it can pose as a risk factor for melanoma.
Time Frame
Baseline
Title
Sunburn History
Description
This will be assessed by asking the participant in the baseline survey about his/her sunburn history. Sunburn history is an important covariate because it can pose as a risk factor for melanoma.
Time Frame
Baseline
Title
Indoor UV Tanning
Description
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.
Time Frame
Baseline
Title
Family History of Melanoma
Description
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.
Time Frame
Baseline
Title
Month of Assessment
Description
This will be assessed by asking participant in the baseline survey in what month he/she is completing the survey
Time Frame
Baseline
Title
Month of Assessment
Description
This will be assessed by asking participant in the first follow-up survey in what month he/she is completing the survey
Time Frame
3 months
Title
Month of Assessment
Description
This will be assessed by asking participant in the second follow-up survey in what month he/she is completing the survey
Time Frame
6 months
Title
Month of Assessment
Description
This will be assessed by asking participant in the third follow-up survey in what month he/she is completing the survey
Time Frame
12 months
Title
Month of Assessment
Description
This will be assessed by asking participant in the fourth follow-up survey in what month he/she is completing the survey
Time Frame
18 months
Title
Location of Assessment
Description
This will be assessed by asking participant in the baseline survey in what location he/she is completing the survey
Time Frame
Baseline
Title
Location of Assessment
Description
This will be assessed by asking participant in the first follow-up survey in what location he/she is completing the survey
Time Frame
3 months
Title
Location of Assessment
Description
This will be assessed by asking participant in the second follow-up survey in what location he/she is completing the survey
Time Frame
6 months
Title
Location of Assessment
Description
This will be assessed by asking participant in the third follow-up survey in what location he/she is completing the survey
Time Frame
12 months
Title
Location of Assessment
Description
This will be assessed by asking participant in the fourth follow-up survey in what location he/she is completing the survey
Time Frame
18 months
Title
Average UV Index
Description
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.
Time Frame
Baseline
Title
Average UV Index
Description
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.
Time Frame
3 months
Title
Average UV Index
Description
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.
Time Frame
6 months
Title
Average UV Index
Description
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.
Time Frame
12 months
Title
Average UV Index
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) โ‰ฅ 18 years old Internet access Able to speak/read English Able to provide informed consent Exclusion Criteria: Children
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Manne, MD
Phone
732-235-6759
Email
mannesl@cinj.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Manne, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Manne, MD
Phone
732-235-6759
Email
Sharon.Manne@rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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