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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults from Bensonhurst County in Brooklyn, New York | Experimental | Participants 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education Sessions to Improve Melanoma Knowledge and Awareness | Behavioral | Community based educational seminar led by a community health worker with follow-up questionnaires to assess knowledge retention and behavioral change. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Month 3 Post-Intervention, Month 6 Post-Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Polsky, MD, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish Community House of Bensonhurst | Brooklyn | New York | 11214 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D008545 | Melanoma |
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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%. |
| Month 3 Post-Intervention, Month 12 Post-Intervention |
| Change in Number of Self-Skin Examinations | Assessed via survey. | Month 3 Post-Intervention, Month 6 Post-Intervention |
| Change in Number of Self-Skin Examinations | Assessed via survey. | Month 3 Post-Intervention, Month 12 Post-Intervention |
| D018358 |
| Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |