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Study Summary
No. 2006-0339:.......Breast; Ovary......Susan Peterson......Behavioral Science
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Study Summary Title
Study Summary
Number:
2006-0339
Study Title:Interactive CD-ROM on Cancer Genetics for Hispanics
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Physician New Patient Referral
Name:Susan PetersonPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8267
Contact us about clinical trials
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General Information
Disease Group:Breast
Ovary
Supported By:N/A
Phase of Study:N/AReturn
Visit:
Not applicable
Treatment
Agents:
NoneHome Care:Not applicable
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
Not applicable
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
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).
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Study Status Information
Study Activation / Registration Date:02/12/2007
IRB Review and Approval Date:05/25/2006
Study Type:Behavioral
Recruitment Status:Closed
Projected Accrual:499
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Residing in the El Paso metropolitan area and self-identifying as Hispanic

2) Being 18 years of age or older

3) 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)

4) Able to provide informed consent

Exclusion Criteria:1) Having a primary language other than English or Spanish

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Links
Registration Number: NCT00525980
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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