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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 de maio de 2017 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

245

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

8 anos a 120 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Self-reported outcomes at 1-and 6-months
Prazo: 6 months
6 months
Decision conflict, as assessed by the Decisional Conflict Scale
Prazo: 6 months
6 months
Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale
Prazo: 6 months
6 months
Decision quality
Prazo: 6 months
6 months
Disclosure of genetic testing results by parents
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 6 months
6 months
Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children
Prazo: 6 months
6 months
Parents' preferences and values regarding family communication of genetic test results
Prazo: 6 months
6 months
Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale
Prazo: 6 months
6 months
Cognitive appraisals
Prazo: 6 months
6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Kenneth Tercyak, PhD, Lombardi Comprehensive Cancer Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2008

Conclusão Primária (Real)

1 de fevereiro de 2013

Conclusão do estudo (Real)

1 de dezembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

24 de maio de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de maio de 2008

Primeira postagem (Estimativa)

28 de maio de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de maio de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de maio de 2017

Última verificação

1 de fevereiro de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • CDR0000592726
  • P30CA051008 (Concessão/Contrato do NIH dos EUA)
  • R01HG002686 (Concessão/Contrato do NIH dos EUA)
  • GUMC-2007-444

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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