A Community-based Educational Initiative to Raise Awareness of Melanoma and Other Skin Cancers.
1 other identifier
interventional
45
1 country
1
Brief Summary
This is a pilot study of a community- based melanoma educational intervention in Bensonhurst, Brooklyn conducted in-person by a community-health worker employed by the Perlmutter Cancer Center. Sample size will be around 35 participants. The participants will complete a pre-study survey and then take part in the educational session. There will be follow up study visits to assess the impact of the intervention on participant knowledge and skin self-examination behaviors at 3 weeks, 3 months, 6 months, and 12 months. At the 12-month mark, the participants will also complete a post-study survey.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 10, 2025
CompletedFirst Posted
Study publicly available on registry
September 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 27, 2026
September 17, 2025
September 1, 2025
1.1 years
September 10, 2025
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Melanoma Knowledge as Assessed by Questionnaire
Melanoma knowledge/awareness will be assessed using a study questionnaire. Each item is multiple choice with 1 correct answer: the total score is the percentage of correct responses and ranges from 0-100%.
Baseline, Immediately Post-Educational Session (Day 1)
Change in Melanoma Knowledge as Assessed by Questionnaire
Melanoma knowledge/awareness will be assessed using a study questionnaire. Each item is multiple choice with 1 correct answer: the total score is the percentage of correct responses and ranges from 0-100%.
Baseline, Week 3 Post-Intervention
Secondary Outcomes (4)
Change in Melanoma Knowledge as Assessed by Questionnaire
Month 3 Post-Intervention, Month 6 Post-Intervention
Change in Melanoma Knowledge as Assessed by Questionnaire
Month 3 Post-Intervention, Month 12 Post-Intervention
Change in Number of Self-Skin Examinations
Month 3 Post-Intervention, Month 6 Post-Intervention
Change in Number of Self-Skin Examinations
Month 3 Post-Intervention, Month 12 Post-Intervention
Study Arms (1)
Adults from Bensonhurst County in Brooklyn, New York
EXPERIMENTALParticipants will complete a pre-study survey and then take part in the educational session; follow-up visits to assess the impact of the intervention on participant knowledge and skin self-examination behaviors at will be held at 3 weeks, 3 months, 6 months, and 12 months. Participants will also complete a post-study survey at Month 12.
Interventions
Community based educational seminar led by a community health worker with follow-up questionnaires to assess knowledge retention and behavioral change.
Eligibility Criteria
You may qualify if:
- Above 18 years of age
- Individuals who understand and speak either English or Russian
- Willingness and ability to consent and participate in the study
You may not qualify if:
- Under 18 years of age
- Individuals who do not understand and speak either English or Russian
- Individuals who participated in the focus group portion of a related study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jewish Community House of Bensonhurst
Brooklyn, New York, 11214, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Polsky, MD, PhD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2025
First Posted
September 17, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
August 27, 2026
Study Completion (Estimated)
August 27, 2026
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to david.polsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: david.polsky@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.