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Peer Counseling Intervention for the Improvement of Parent Communication about Hereditary Breast Cancer
Trial Status: active
This clinical trial studies the impact of peer counseling on parent communication about hereditary breast cancer. Genetic counseling and testing for hereditary breast cancer may reveal that mothers, and possibly their blood relatives (including children, both male and female), are at increased risk for the disease across the lifespan. It is not yet known the best ways to educate mothers who have a risk gene (are BRCA positive [+]) about whether, when, and how to share genetic information with their children or manage their thoughts and feelings. The peer counseling may provide mothers with information and emotional support resources that are useful in making choices about talking to their children about hereditary breast cancer and also help them manage stress.
Inclusion Criteria
Participants are mothers self-identifying as primary caregivers to AYAs 13-24 years-old participating in genetic testing for hereditary breast-ovarian cancer. Although this will include screening women receiving single gene BRCA testing as well as those with panel genetic testing, only those ultimately receiving a positive result for a deleterious BRCA mutation (“BRCA+ mothers”) will be intervened upon and monitored for follow-up. The study sites are the MedStar Genetic Counseling Program led by Peshkin and the Fisher Center at the Lombardi Comprehensive Cancer Center (LCCC), the genetic counseling/testing services of Memorial Sloan Kettering Cancer Center (MSKCC) through its Clinical Genetics Service (Dr. Jada Hamilton, Site principal investigator [PI]), the Genetic Counseling Service of Inova Schar Cancer Institute (ISCI) (Ms. DeMarco, Site PI), and the Cancer Genetics and Prevention Clinic (Dr. Huma Rana, Site PI)
Maternal participants must be age 21+ and able to adequately understand, speak, and read English to benefit from participation and have access to a telephone and the Internet
Exclusion Criteria
All participants will be excluded if they do not meet these criteria and by lack of consent
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04258280.
I. To determine the impact of peer counseling (PC) versus (vs.) standard care (SC) on communication of maternal BRCA+ status to adolescent and young adult (AYA) children.
II. To evaluate the relative efficacy of PC vs. SC on informed decision making about disclosure, psychosocial distress, and parent-AYA child interaction.
III. To understand the mechanisms of intervention impact on these outcomes and changes.
IV. To identify mothers most likely to benefit from intervention to inform intervention targeting.
OUTLINE:
Participants complete 2 online surveys over 20-30 minutes each, and 1 month apart, regarding their knowledge, thoughts and feelings about hereditary breast cancer. Participants also undergo genetic testing and counseling at baseline per standard of care. Participants who are BRCA- proceed to end-of-study follow-up. Participants who are BRCA+ are randomized to 1 of 2 arms.
ARM I (INTERVENTION CONDITION): Participants attend up to 3 support coaching sessions, over 20-30 minutes each, via telephone, email, or text by a well-trained peer/lay parent expert. Participants also receive an educational workbook that provides basic information about talking to AYAs about hereditary breast cancer.
ARM II (CONTROL CONDITION): Participants receive an educational workbook that provides basic information about talking to AYAs about hereditary breast cancer.
After completion of study, participants are followed up at 1 and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMedStar Georgetown University Hospital
