Cancer Genetics CD-ROM for Hispanics
Interactive CD-ROM on Cancer Genetics for Hispanics
1 other identifier
interventional
37
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Feb 2007
Longer than P75 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 4, 2007
CompletedFirst Posted
Study publicly available on registry
September 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 10, 2013
April 1, 2013
6.1 years
September 4, 2007
April 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Data analysis of structured questionnaires
3 Years
Secondary Outcomes (1)
Comparison of 3 Intervention Groups by Continuous Outcomes (knowledge, risk assessment, decisional conflict and quality of life)
3 Years
Study Arms (3)
Group 1: Written Materials
EXPERIMENTALOne group asked to read educational materials.
Group 2: Computer Program Only
EXPERIMENTALGroup 2 use an educational computer program to learn about breast cancer risk and genetic testing without guidance.
Group 3: Computer Program + Promotora
EXPERIMENTALGroup 3 use the computer program with the guidance of a promotora.
Interventions
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 discussion lasting about 60 to 90 minutes.
Printed materials will be given. The CD-ROM will be offered at the end of the study.
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Eligibility Criteria
You may qualify if:
- Residing in the El Paso metropolitan area and self-identifying as Hispanic
- 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
You may not qualify if:
- Having a primary language other than English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Human Genome Research Institute (NHGRI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (2)
The Cancer and Chronic Disease Consortium (CCDC) of El Paso
El Paso, Texas, 79905, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Peterson, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2007
First Posted
September 6, 2007
Study Start
February 1, 2007
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 10, 2013
Record last verified: 2013-04