MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373823
• Other study ID #: CINJ132202
• Secondary ID: R01CA264548
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: February 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Sharon Manne, PhD
• Phone: 732-235-6759
• Email: mannesl[@]cinj.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 385
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• MySmartSkin enhancement
Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input
• 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
• 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.

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	This will be assessed by asking the participant his/her age in the baseline survey.	Baseline
Other	Sex	This will be assessed by asking the participant his/her sex in the baseline survey.	Baseline
Other	Race/Ethnicity	This will be assessed by asking the participant his/her race and ethnicity in the baseline survey.	Baseline
Other	Education	This will be assessed by asking the participant his/her education level in the baseline survey.	Baseline
Other	Marital Status	This will be assessed by asking the participant his/her marital status in the baseline survey.	Baseline
Other	State Residing In	This will be assessed by asking the participant what state he/she resides in the baseline survey.	Baseline
Other	Employment	This will be assessed by asking the participant his/her employment status in the baseline survey.	Baseline
Other	Income	This will be assessed by asking the participant his/her income level in the baseline survey.	Baseline
Other	Health Insurance	This will be assessed by asking the participant if he/she has health insurance coverage in the baseline survey.	Baseline
Other	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
Other	Stage	This will be assessed by asking the participant in the baseline survey the stage of cancer he/she was diagnosed with.	Baseline
Other	Treatment Received	This will be assessed by asking the participant in the baseline survey what treatment he/she received.	Baseline
Other	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
Other	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
Other	Month of Assessment	This will be assessed by asking participant in the baseline survey in what month he/she is completing the survey	Baseline
Other	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
Other	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
Other	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
Other	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
Other	Location of Assessment	This will be assessed by asking participant in the baseline survey in what location he/she is completing the survey	Baseline
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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