Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2007-02-28
2013-03-31
Brief Summary
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Researchers now propose to expand the use of the interactive CD-ROM in two innovative ways. The overall goal of this proposal is to evaluate the program as a first-line educational approach for Hispanic women on the Texas-Mexico border, where educational resources about cancer genetics are limited. First, researchers will modify and adapt the program for a primarily Hispanic population, in order to make it culturally and linguistically appropriate to the needs of that audience.
Second, researchers will evaluate the program as a first-line educational method among women with a personal or family history of breast cancer. Researchers will compare the effectiveness of the CD-ROM when implemented with and without the guidance of a trained promotora, and in comparison with standard educational materials (usual care condition).
The specific aims of this study include:
Aim 1: To modify the interactive CD-ROM to: a) make it culturally and linguistically appropriate for Hispanic women residing along the Texas-Mexico border; b) reflect current knowledge about breast cancer genetics; c) add a module to help women prepare to discuss their family history and cancer risk with a health care provider (n=50 participants).
Aim 2: To conduct a randomized, controlled evaluation that compares the efficacy of the modified CD-ROM when used alone vs. when used with a promotora-assisted approach vs. standard written materials (n=414 participants).
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Detailed Description
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If you agree to take part in this study, you will complete a questionnaire that will ask about your personal health as well as your knowledge and attitudes toward cancer and genetic testing. After the questionnaire is completed, you will be randomly assigned (as in the roll of dice) to 1 of 3 study groups. One group will be asked to read educational materials. Another group will use an educational computer program to learn about breast cancer risk and genetic testing without guidance. Another group will use the computer program with the guidance of a promotora.
Each of the 3 study groups should take between 30 and 60 minutes to complete.
Immediately after participating in your assigned group, you will be asked to complete another questionnaire that will ask about your knowledge and attitudes toward cancer and genetic testing. You will also be contacted later by telephone to complete similar questionnaires at about 1 month and 6 months after your study visit. Some women will be asked to complete an additional questionnaire by telephone 1 week after reading the educational materials or the computer program, and researchers will ask for permission to audiotape this interview. It will take about 20 minutes to complete each of the questionnaires used in this study.
This is an investigational study. Up to 414 women will take part in this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: Written Materials
One group asked to read educational materials.
Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Written Materials
Printed materials will be given. The CD-ROM will be offered at the end of the study.
Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Group 2: Computer Program Only
Group 2 use an educational computer program to learn about breast cancer risk and genetic testing without guidance.
Computer Program
Participants will be given a program to learn about breast cancer risk and genetic testing.
Arm 3 Only = Participants will use the program with the assistance of a promotora (female "promoter," community health worker, sometimes known as a lay health advisor).
Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Group 3: Computer Program + Promotora
Group 3 use the computer program with the guidance of a promotora.
Computer Program
Participants will be given a program to learn about breast cancer risk and genetic testing.
Arm 3 Only = Participants will use the program with the assistance of a promotora (female "promoter," community health worker, sometimes known as a lay health advisor).
Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Interventions
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Computer Program
Participants will be given a program to learn about breast cancer risk and genetic testing.
Arm 3 Only = Participants will use the program with the assistance of a promotora (female "promoter," community health worker, sometimes known as a lay health advisor).
Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Written Materials
Printed materials will be given. The CD-ROM will be offered at the end of the study.
Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Being 18 years of age or older
* Women who have a personal history of breast cancer or have a first-degree relative with breast cancer OR lay health workers (male or female)
* Able to provide informed consent
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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National Human Genome Research Institute (NHGRI)
NIH
National Institutes of Health (NIH)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Susan Peterson, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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The Cancer and Chronic Disease Consortium (CCDC) of El Paso
El Paso, Texas, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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2006-0339
Identifier Type: -
Identifier Source: org_study_id
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