Cancer Genetics CD-ROM for Hispanics
Interactive CD-ROM on Cancer Genetics for Hispanics
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).
調査の概要
詳細な説明
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. Up to 414 women will take part in this study.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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El Paso、Texas、アメリカ、79905
- The Cancer and Chronic Disease Consortium (CCDC) of El Paso
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Houston、Texas、アメリカ、77030
- UT MD Anderson Cancer Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Group 1: Written Materials
One group asked to read educational materials.
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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.
他の名前：
|
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実験的：Group 2: Computer Program Only
Group 2 use an educational computer program to learn about breast cancer risk and genetic testing without guidance.
|
Focus group discussion lasting about 60 to 90 minutes.
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
他の名前：
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). |
|
実験的：Group 3: Computer Program + Promotora
Group 3 use the computer program with the guidance of a promotora.
|
Focus group discussion lasting about 60 to 90 minutes.
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
他の名前：
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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Data analysis of structured questionnaires
時間枠：3 Years
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3 Years
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Comparison of 3 Intervention Groups by Continuous Outcomes (knowledge, risk assessment, decisional conflict and quality of life)
時間枠：3 Years
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3 Years
|
協力者と研究者
捜査官
- 主任研究者：Susan Peterson, PhD、M.D. Anderson Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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