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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Georgetown University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00685256
First received: May 24, 2008
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Hereditary Breast/Ovarian Cancer (brca1, brca2)
Other: counseling intervention
Other: educational intervention
Other: survey administration
Behavioral: psychosocial assessment and care
Behavioral: supportive care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Self-reported outcomes at 1-and 6-months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Decision conflict, as assessed by the Decisional Conflict Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Decision quality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Disclosure of genetic testing results by parents [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Parents' preferences and values regarding family communication of genetic test results [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cognitive appraisals [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: counseling intervention
    subjects and parents will receive genetic counseling
    Other: educational intervention
    subjects and parents will receive education re: genetic testing
    Other: survey administration
    surveys will be administered to subjects and parents
    Behavioral: psychosocial assessment and care
    psychosocial assessment and counseling will be provided
    Behavioral: supportive care
    parents and children will be provided with supportive care
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685256

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center    202-444-0381      
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andrea Farkas Patenaude, PhD    617-632-3314    andrea_patenaude@dfci.harvard.edu   
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Kenneth Tercyak, PhD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00685256     History of Changes
Other Study ID Numbers: CDR0000592726, R01HG002686, P30CA051008, GUMC-2007-444
Study First Received: May 24, 2008
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
breast cancer
hereditary breast/ovarian cancer (BRCA1, BRCA2)

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014