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Completed

NCT Number: NCT00685256

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

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hereditary Breast and Ovarian Cancer Syndrome Hereditary Breast/Ovarian Cancer (brca1, brca2) Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

8 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

counseling intervention

Other

subjects and parents will receive genetic counseling

Educational Intervention

Other

subjects and parents will receive education re: genetic testing

Survey Administration

Other

surveys will be administered to subjects and parents

psychosocial assessment and care

Behavioral

psychosocial assessment and counseling will be provided

Supportive Care

Behavioral

parents and children will be provided with supportive care

Primary outcomes

  1. Self-reported outcomes at 1-and 6-months

    Time frame: 6 months

  2. Decision conflict, as assessed by the Decisional Conflict Scale

    Time frame: 6 months

  3. Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale

    Time frame: 6 months

  4. Decision quality

    Time frame: 6 months

  5. Disclosure of genetic testing results by parents

    Time frame: 6 months

  6. 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

  7. 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

  8. 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

  9. 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

  10. Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children

    Time frame: 6 months

  11. Parents' preferences and values regarding family communication of genetic test results

    Time frame: 6 months

  12. Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale

    Time frame: 6 months

  13. Cognitive appraisals

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2015
First posted
May 28, 2008
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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