Cancer Genetics CD-ROM for Hispanics
NCT00525980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2013-04-10
Summary
This project will build upon prior, successful research on the effectiveness of an interactive computer disk with readable only memory (CD-ROM) for educating women about breast cancer and genetic risk. Prior studies found that an interactive CD-ROM for educating women about breast cancer risk and genetic testing was effective. The program was well received by lay persons and professionals. In a randomized controlled trial conducted at multiple sites, the CD-ROM intervention was highly effective in increasing knowledge, especially among women at low risk of carrying a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation.
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).
Conditions
Interventions
- BEHAVIORAL
-
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).
- BEHAVIORAL
-
Focus Group
Focus group discussion lasting about 60 to 90 minutes.
- OTHER
-
Written Materials
Printed materials will be given. The CD-ROM will be offered at the end of the study.
- BEHAVIORAL
-
Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Sponsors & Collaborators
-
National Human Genome Research Institute (NHGRI)
collaborator NIH -
National Institutes of Health (NIH)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Susan Peterson, PhD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-02-28
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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