Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans
December 2, 2015 updated by: Case Comprehensive Cancer Center
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106-5065
- Case Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Self-identified African-Americans who are literate and fluent in English
Exclusion Criteria:
- Non-African-Americans
- English illiteracy
- non-fluency in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (educational brochure, online educational tutorial)
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.
|
Receive brochure with skin cancer education and preventative information
Other Names:
Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations
Other Names:
|
|
Active Comparator: Arm II (educational brochure)
Participants receive an educational brochure as in Arm I.
|
Receive brochure with skin cancer education and preventative information
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sunscreen use among African-American patients
Time Frame: Baseline to day 30
|
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
Time Frame: Baseline to day 30
|
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
Time Frame: Baseline to day 30
|
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
Time Frame: Baseline to day 30
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeremy Bordeaux, Case Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
April 13, 2015
First Submitted That Met QC Criteria
April 15, 2015
First Posted (Estimate)
April 16, 2015
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE1615 (Other Identifier: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH Grant/Contract)
- NCI-2015-00481 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.