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Cancer Genetics CD-ROM for Hispanics

8 avril 2013 mis à jour par: M.D. Anderson Cancer Center

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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

37

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • El Paso, Texas, États-Unis, 79905
        • The Cancer and Chronic Disease Consortium (CCDC) of El Paso
      • Houston, Texas, États-Unis, 77030
        • UT MD Anderson Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Group 1: Written Materials
One group asked to read educational materials.
Comportemental: Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Autre: Written Materials
Printed materials will be given. The CD-ROM will be offered at the end of the study.
Comportemental: Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Autres noms:
  • Enquête
Expérimental: Group 2: Computer Program Only
Group 2 use an educational computer program to learn about breast cancer risk and genetic testing without guidance.
Comportemental: Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Comportemental: Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Autres noms:
  • Enquête
Comportemental: 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).
Expérimental: Group 3: Computer Program + Promotora
Group 3 use the computer program with the guidance of a promotora.
Comportemental: Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Comportemental: Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Autres noms:
  • Enquête
Comportemental: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Data analysis of structured questionnaires
Délai: 3 Years
3 Years

Mesures de résultats secondaires

Mesure des résultats
Délai
Comparison of 3 Intervention Groups by Continuous Outcomes (knowledge, risk assessment, decisional conflict and quality of life)
Délai: 3 Years
3 Years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

M.D. Anderson Cancer Center

Collaborateurs

National Institutes of Health (NIH)
National Human Genome Research Institute (NHGRI)

Les enquêteurs

  • Chercheur principal: Susan Peterson, PhD, M.D. Anderson Cancer Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2007

Achèvement primaire (Réel)

1 mars 2013

Achèvement de l'étude (Réel)

1 mars 2013

Dates d'inscription aux études

Première soumission

4 septembre 2007

Première soumission répondant aux critères de contrôle qualité

5 septembre 2007

Première publication (Estimation)

6 septembre 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

10 avril 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 avril 2013

Dernière vérification

1 avril 2013

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2006-0339

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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