CompletedPhase 3

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

United States245 participantsStarted 2008-03

Plain-language summary

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.

Who can participate

Age range8 Years – 120 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Self-reported outcomes at 1-and 6-months

Timeframe: 6 months

Decision conflict, as assessed by the Decisional Conflict Scale

Timeframe: 6 months

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

Timeframe: 6 months

Decision quality

Timeframe: 6 months

Disclosure of genetic testing results by parents

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT00685256

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-02

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range8 Years – 120 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Self-reported outcomes at 1-and 6-months

Timeframe: 6 months

Decision conflict, as assessed by the Decisional Conflict Scale

Timeframe: 6 months

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

Timeframe: 6 months

Decision quality

Timeframe: 6 months

Disclosure of genetic testing results by parents

Timeframe: 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

Timeframe: 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

Timeframe: 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