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Cancer Genetics CD-ROM for Hispanics

8 april 2013 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

37

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group 1: Written Materials
One group asked to read educational materials.
Gedragsmatig: Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Ander: Written Materials
Printed materials will be given. The CD-ROM will be offered at the end of the study.
Gedragsmatig: Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Andere namen:
  • Vragenlijst
Experimenteel: Group 2: Computer Program Only
Group 2 use an educational computer program to learn about breast cancer risk and genetic testing without guidance.
Gedragsmatig: Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Gedragsmatig: Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Andere namen:
  • Vragenlijst
Gedragsmatig: 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).
Experimenteel: Group 3: Computer Program + Promotora
Group 3 use the computer program with the guidance of a promotora.
Gedragsmatig: Focus Group
Focus group discussion lasting about 60 to 90 minutes.
Gedragsmatig: Questionnaires
Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
Andere namen:
  • Vragenlijst
Gedragsmatig: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Data analysis of structured questionnaires
Tijdsspanne: 3 Years
3 Years

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Comparison of 3 Intervention Groups by Continuous Outcomes (knowledge, risk assessment, decisional conflict and quality of life)
Tijdsspanne: 3 Years
3 Years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

M.D. Anderson Cancer Center

Medewerkers

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

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2007

Primaire voltooiing (Werkelijk)

1 maart 2013

Studie voltooiing (Werkelijk)

1 maart 2013

Studieregistratiedata

Eerst ingediend

4 september 2007

Eerst ingediend dat voldeed aan de QC-criteria

5 september 2007

Eerst geplaatst (Schatting)

6 september 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

10 april 2013

Laatste update ingediend die voldeed aan QC-criteria

8 april 2013

Laatst geverifieerd

1 april 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2006-0339

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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