Cancer Genetics CD-ROM for Hispanics

NCT00525980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2013-04-10

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525980 on ClinicalTrials.gov