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

  • United States
    • 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.
Other: Written Educational Brochure
Receive brochure with skin cancer education and preventative information
Other Names:
  • Education for Intervention
  • Intervention, Educational
Other: Online educational video
Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations
Other Names:
  • video intervention
  • X-Plain
Active Comparator: Arm II (educational brochure)
Participants receive an educational brochure as in Arm I.
Other: Written Educational Brochure
Receive brochure with skin cancer education and preventative information
Other Names:
  • Education for Intervention
  • Intervention, Educational

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

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

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.

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