Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans

Study Overview
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Brief Summary
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This randomized clinical trial uses an educational brochure and online tutorial program to assess sun-protective behavior and skin self-examination among African Americans. Skin cancer is very common among African Americans, with a disproportionately high mortality rate. Providing a brochure and an online educational program about sun-protective behaviors may encourage African Americans to take preventative measures against skin cancer, help improve early skin cancer detection, determine how far the disease has spread, and plan the best treatment.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess whether an educational brochure and online program will increase sun-protective behaviors among African-American patients who present at the general dermatology clinic. SECONDARY OBJECTIVES: I. To assess whether the educational brochure and online program will improve skills for skin self-examinations among African-American patients who present at the general dermatology clinic. OUTLINE: Participants are assigned to 1 of 2 arms. ARM I: Participants receive a skin cancer educational and preventive brochure distributed by the National Cancer Institute and watch a 30-minute online tutorial video called X-Plain about skin cancer, preventative behaviors, and skin self-examinations. ARM II: Participants receive an educational brochure as in Arm I. After completion of study, participants are followed up at 30 days.

Official Title
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Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans

Conditions
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Skin Carcinoma, Skin Melanoma

Intervention / Treatment
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* Other: Written Educational Brochure
* Other: Online educational video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identified African-Americans who are literate and fluent in English Exclusion Criteria: Non-African-Americans English illiteracy non-fluency in English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (educational brochure, online educational tutorial)<br>Participants receive a skin cancer educational and preventive brochure distributed by the National Cancer Institute and watch a 30-minute online tutorial video called X-Plain about skin cancer, preventative behaviors, and skin self-examinations. | Other: Written Educational Brochure<br>* Receive brochure with skin cancer education and preventative information<br>* Other names: Intervention, Educational;Other: Online educational video<br>* Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations<br>* Other names: X-Plain;|
| Active Comparator: Arm II (educational brochure)<br>Participants receive an educational brochure as in Arm I. | Other: Written Educational Brochure<br>* Receive brochure with skin cancer education and preventative information<br>* Other names: Intervention, Educational;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sunscreen use among African-American patients | Change in sun-protective behaviors among African-American patients. Measured by sunscreen use. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups. | Baseline to day 30 | 
| Change in apparel use when exposed to sun among African-American patients | Change in sun-protective behaviors among African-American patients. Measured by apparel use when exposed to sun. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups. | Baseline to day 30 | 
| Change in frequency of tanning among African-American patients | Change in sun-protective behaviors among African-American patients. Measured by frequency of tanning. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups. | Baseline to day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skin self-examinations among African-American patients as measured by knowledge, behavior and anxiety | Analyzed by looking at increase or decrease in skin self-examinations the patients report from pre-intervention to post-intervention. Performance of skin self-examination is measured by knowledge, behavior, and anxiety. Most responses for questions about skin self-examinations are on a 5-point Likert scale, while some are yes/no or true/false. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. T-tests will be used to compare mean scores for skin self-examinations between groups. | Baseline to day 30 |