This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00685256
First received: May 24, 2008
Last updated: May 16, 2017
Last verified: February 2017
May 24, 2008
May 16, 2017
March 2008
February 2013   (Final data collection date for primary outcome measure)
  • Self-reported outcomes at 1-and 6-months [ Time Frame: 6 months ]
  • Decision conflict, as assessed by the Decisional Conflict Scale [ Time Frame: 6 months ]
  • Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale [ Time Frame: 6 months ]
  • Decision quality [ Time Frame: 6 months ]
  • Disclosure of genetic testing results by parents [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
  • Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children [ Time Frame: 6 months ]
  • Parents' preferences and values regarding family communication of genetic test results [ Time Frame: 6 months ]
  • Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale [ Time Frame: 6 months ]
  • Cognitive appraisals [ Time Frame: 6 months ]
  • Self-reported outcomes at 1-and 6-months
  • Decision conflict, as assessed by the Decisional Conflict Scale
  • Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale
  • Decision quality
  • Disclosure of genetic testing results by parents
  • 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
  • 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
  • Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling
  • 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
  • Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children
  • Parents' preferences and values regarding family communication of genetic test results
  • Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale
  • Cognitive appraisals
Complete list of historical versions of study NCT00685256 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
  • Breast Cancer
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
December 2015
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
8 Years to 120 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00685256
CDR0000592726
R01HG002686 ( U.S. NIH Grant/Contract )
P30CA051008 ( U.S. NIH Grant/Contract )
GUMC-2007-444
No
Not Provided
Not Provided
Georgetown University
Georgetown University
  • National Cancer Institute (NCI)
  • National Human Genome Research Institute (NHGRI)
Principal Investigator: Kenneth Tercyak, PhD Lombardi Comprehensive Cancer Center
Georgetown University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP