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Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children

16. mai 2017 oppdatert av: Georgetown University

Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children

RATIONALE: A study that evaluates the support of a decision guide used together with genetic counseling may improve communication between mothers undergoing BRCA1/2 testing and their minor-age children.

PURPOSE: This randomized phase III trial is studying standard genetic counseling given together with a decision guide to see how well it works compared with genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

Primary

  • To evaluate the efficacy of a decision support intervention delivered in conjunction with standard genetic counseling compared to standard genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.

Secondary

  • To understand the mechanisms by which decision support impacts on decision outcomes.
  • To identify mothers who are most and least likely to benefit from decision support.
  • To explore the potential impact of decision support on disclosure and parent-child psychosocial well-being.

OUTLINE: This is a multicenter study. Mothers are stratified according to their child's age (< 13 vs ≥ 13 years old), child's gender (female vs male), and trial site. Mothers are randomized to 1 of 2 arms.

  • Arm I (standard genetic counseling with communication aid): Mothers undergo standard pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers also receive a copy of "My Children, My Test Results," a detailed decision guide developed to promote quality and informed decision making and outcomes, and provide support to mothers regardless of whether or not they choose to communicate their BRCA1/2 test results to their children.
  • Arm II (standard genetic counseling alone): Mothers undergo standard pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers also receive a copy of "Genetic Testing for Breast and Ovarian Cancer Risk: It's Your Choice" containing information regarding family history of breast and ovarian cancer risks, BRCA1/2 genes, risks and benefits of genetic testing, medical management options for carriers, and considerations including family communication.

All mothers complete extensive family history assessments during their baseline interviews and disclose if they have been diagnosed with cancer, length and type of treatments, and the number of other relatives with a history of cancer. Mothers are assessed at baseline (pre-test genetic counseling), post-genetic counseling after learning test results, and at 1 and 6 months post-genetic counseling by a 30-45 minute multi-item and multi-scale self-report telephone survey. Genetic testing results are also submitted to this study. The frequency (number), intensity (length in minutes), and content of participant-initiated telephone contacts to genetic counselors to assess intervention reactivity; participants' self-reported use of educational guides; and their satisfaction with the intervention will be assessed.

Studietype

Intervensjonell

Registrering (Faktiske)

245

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • District of Columbia
      • Washington, D.C., District of Columbia, Forente stater, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år til 120 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

DISEASE CHARACTERISTICS:

  • Mothers self-identified as primary caregivers to minor-age children (ages 8-21 years-old)
  • Mothers must be undergoing genetic counseling and have provided a blood sample for analysis for BRCA1/2 mutations
  • Mothers must have resided in the same home as the child(ren) for the past 6 months and intend to continue to reside with the child(ren) for the next 6 months

PATIENT CHARACTERISTICS:

  • At least 21 years old (mothers)
  • No serious mental illness (e.g., cognitive and psychotic disorders) or developmental disability that would limit participation or preclude informed consent
  • Must be able to adequately understand, speak, and read English
  • Must have ready and consistent access to a telephone

PRIOR CONCURRENT THERAPY:

  • Not specified

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Self-reported outcomes at 1-and 6-months
Tidsramme: 6 months
6 months
Decision conflict, as assessed by the Decisional Conflict Scale
Tidsramme: 6 months
6 months
Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale
Tidsramme: 6 months
6 months
Decision quality
Tidsramme: 6 months
6 months
Disclosure of genetic testing results by parents
Tidsramme: 6 months
6 months
Child-rearing alliance between parents, as measured by the Parenting Alliance Measure at baseline, after learning test results, and at 1 and 6 months after genetic counseling
Tidsramme: 6 months
6 months
Parent-child communication, as assessed by the Parent-Adolescent Communication Scale at baseline, after learning test results, and at 1 and 6 months after genetic counseling
Tidsramme: 6 months
6 months
Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling
Tidsramme: 6 months
6 months
Children's stress and worry, as assessed by the Child Behavior Checklist at baseline, after learning test results, and at 1 and 6 months after genetic counseling
Tidsramme: 6 months
6 months
Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children
Tidsramme: 6 months
6 months
Parents' preferences and values regarding family communication of genetic test results
Tidsramme: 6 months
6 months
Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale
Tidsramme: 6 months
6 months
Cognitive appraisals
Tidsramme: 6 months
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Kenneth Tercyak, PhD, Lombardi Comprehensive Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2008

Primær fullføring (Faktiske)

1. februar 2013

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

24. mai 2008

Først innsendt som oppfylte QC-kriteriene

24. mai 2008

Først lagt ut (Anslag)

28. mai 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CDR0000592726
  • P30CA051008 (U.S. NIH-stipend/kontrakt)
  • R01HG002686 (U.S. NIH-stipend/kontrakt)
  • GUMC-2007-444

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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