Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

12. oktober 2022 opdateret af: Georgetown University

Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results

This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

369

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Georgetown University Medical Center/Lombardi Comprehensive Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Undergo BRCA1/2 genetic counseling and testing at one of four study sites
  • Receive positive or uninformative test results
  • English speaking

Exclusion Criteria:

  • Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
  • Previous bilateral mastectomy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mutation Carrier: Enhanced Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
Adfærdsmæssigt: Enhanced Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
Eksperimentel: Mutation Carrier: Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.
Adfærdsmæssigt: Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options.
Aktiv komparator: Mutation Carrier: Enhanced Print DA
BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.
Adfærdsmæssigt: Enhanced Print DA
BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
Aktiv komparator: Mutation Carrier: Print DA
BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.
Adfærdsmæssigt: Print DA
BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
Eksperimentel: Inconclusive Results: DA
Participants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making
Adfærdsmæssigt: Inconclusive Results DA
Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
Ingen indgriben: Inconclusive Results: Usual care
Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knowledge
Tidsramme: 1-month post randomization
Knowledge of risk management options.
1-month post randomization
Decision Conflict
Tidsramme: 1-month post-randomization
Decisional Conflict Scale
1-month post-randomization
Decision Satisfaction
Tidsramme: 12-months post-randomization
Satisfaction with Decision Scale
12-months post-randomization
Psychological Distress
Tidsramme: 1-month post randomization
1-month post randomization
Health Related Quality of Life
Tidsramme: 12-months post randomization
SF-12
12-months post randomization
Utilization of breast and ovarian cancer risk management options
Tidsramme: 12-months post-randomization

We will assess uptake of the following risk management strategies:

  1. Risk reducing surgery (mastectomy and oophorectomy)
  2. Chemoprevention
  3. Breast and ovarian cancer screening
12-months post-randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knowledge
Tidsramme: 3-months post randomization
Knowledge of risk management options
3-months post randomization
Psychological Distress
Tidsramme: 3-months post-randomization
3-months post-randomization
Decisional Conflict
Tidsramme: 3-months post-randomization
Decisional Conflict Scale
3-months post-randomization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Georgetown University

Samarbejdspartnere

National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)

Efterforskere

  • Ledende efterforsker: Marc D Schwartz, PhD, Georgetown University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. juli 2022

Studieafslutning (Faktiske)

1. juli 2022

Datoer for studieregistrering

Først indsendt

9. april 2014

Først indsendt, der opfyldte QC-kriterier

6. maj 2014

Først opslået (Skøn)

8. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. oktober 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010-611
  • R01CA135179-01 (U.S. NIH-bevilling/kontrakt)
  • R01HG005055 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystkræft

Kliniske forsøg med Enhanced Internet DA

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Türkiye

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner