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Cancer Genetics CD-ROM for Hispanics

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, March 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Human Genome Research Institute (NHGRI)
National Institutes of Health (NIH)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00525980
  Purpose

This project will build upon prior, successful research on the effectiveness of an interactive 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 BRCA1/2 mutation.

We 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, we 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, we will evaluate the program as a first-line educational method among women with a personal or family history of breast cancer. We 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).


Condition Intervention
Breast Cancer
Behavioral: Computer Program
Behavioral: Focus Group
Other: Written Materials

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Interactive CD-ROM on Cancer Genetics for Hispanics

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this research study is to try to find an effective way to provide information to Hispanic women about breast cancer risk and genetic testing for inherited cancer risk. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Researchers want to see which of 3 methods is most effective at improving women's knowledge and understanding about breast cancer risk and genetic testing for inherited cancer risk. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:   499
Study Start Date:   February 2007
Estimated Primary Completion Date:   February 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Written Materials
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.
2: Experimental
Computer Program Only
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.
Behavioral: Focus Group
Focus group discussion lasting about 60 to 90 minutes.
3: Experimental
Computer Program + Promotora
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.
Behavioral: Focus Group
Focus group discussion lasting about 60 to 90 minutes.

Detailed Description:

This study will test ways to help improve Hispanic women's knowledge and understanding about breast cancer risk and genetic testing for inherited cancer risk. These methods include providing printed educational materials, using an educational computer program, and using the computer program with the assistance of a lay health worker (a promotora).

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. There is no cost to you for taking part in this study. Up to 414 women will take part in this study.

Focus Groups and/or Semi-Structured Interviews:

If you agree to take part in this study, you will be asked to take part in a small group discussion (a focus group), or you will have a one-on-one, in-person interview. You may be asked to look at or use an educational computer program on breast cancer risk and genetic testing. You may be shown other pictures, a video, or text about breast cancer risk or genetic testing that are similar to the computer program.

You will be asked for your thoughts, feelings, and opinions about the computer program and other materials. You will be asked for some demographic information, such your age or marital status. Researchers will ask for permission to audiotape the focus group or interview. The focus group or interview will take about 60 to 90 minutes to complete.

Your answers to the questions in the focus group or interview and your personal information will be kept strictly confidential. Based on what is learned in this study, researchers will revise the computer program to make it more appealing to Hispanic women.

This is an investigational study. There is no cost to you for taking part in this study. Up to 85 women will take part in this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Having a primary language other than English or Spanish
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525980

Contacts
Contact: Susan Peterson, PhD     713-792-8267    

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Susan Peterson, PhD            
Recruiting
      El Paso, Texas, United States

Sponsors and Collaborators

Investigators
Principal Investigator:     Susan Peterson, PhD     U.T.M.D. Anderson Cancer Center    
  More Information


Responsible Party:   U.T.M.D. Anderson Cancer Center ( Susan Peterson, PhD/Assistant Professor )
Study ID Numbers:   2006-0339
First Received:   September 4, 2007
Last Updated:   March 6, 2008
ClinicalTrials.gov Identifier:   NCT00525980
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer  
Cancer Risk  
CD-ROM  
Focus Group  
Cancer Genetics  

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 22, 2008




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