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

Primary Purpose

Skin Carcinoma, Skin Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Educational Brochure
Online educational video
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Self-identified African-Americans who are literate and fluent in English

Exclusion Criteria:

  • Non-African-Americans
  • English illiteracy
  • non-fluency in English

Sites / Locations

  • Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (educational brochure, online educational tutorial)

Arm II (educational brochure)

Arm Description

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.

Participants receive an educational brochure as in Arm I.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 13, 2015
Last Updated
December 2, 2015
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02417948
Brief Title
Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans
Official Title
Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Carcinoma, Skin Melanoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (educational brochure, online educational tutorial)
Arm Type
Experimental
Arm Description
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 Title
Arm II (educational brochure)
Arm Type
Active Comparator
Arm Description
Participants receive an educational brochure as in Arm I.
Intervention Type
Other
Intervention Name(s)
Written Educational Brochure
Other Intervention Name(s)
Education for Intervention, Intervention, Educational
Intervention Description
Receive brochure with skin cancer education and preventative information
Intervention Type
Other
Intervention Name(s)
Online educational video
Other Intervention Name(s)
video intervention, X-Plain
Intervention Description
Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations
Primary Outcome Measure Information:
Title
Change in sunscreen use among African-American patients
Description
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.
Time Frame
Baseline to day 30
Title
Change in apparel use when exposed to sun among African-American patients
Description
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.
Time Frame
Baseline to day 30
Title
Change in frequency of tanning among African-American patients
Description
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.
Time Frame
Baseline to day 30
Secondary Outcome Measure Information:
Title
Change in skin self-examinations among African-American patients as measured by knowledge, behavior and anxiety
Description
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.
Time Frame
Baseline to day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Self-identified African-Americans who are literate and fluent in English Exclusion Criteria: Non-African-Americans English illiteracy non-fluency in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Bordeaux
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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

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