Improving Genetic Counseling for BRCA+ Mothers

NCT04258280 | Recruiting

• 1 other identifier: 00001137
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Genetic counseling and testing for hereditary breast cancer may reveal that you, and possibly your blood relatives, are at increased risk for the disease across the lifespan. This includes biological children, both male and female. We do not yet know the best ways to educate mothers who have a risk gene (are BRCA+) about whether, when, and how to share genetic information with their children or manage their thoughts and feelings. The purpose of this study is to help mothers make more informed choices about talking with children about hereditary breast cancer, provide them with age-and gender-appropriate information and emotional support, and improve their psychological well-being.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Communication

  Parent-child and family communication of hereditary cancer risk.

  1- and 6-months post-treatment

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Behavioral: Education

Enhanced Care

EXPERIMENTAL

Behavioral: Education and counseling

Interventions

Education and counseling BEHAVIORAL

Education includes a workbook, counseling includes peer support.

Enhanced Care

Education BEHAVIORAL

Education includes a workbook.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers/primary caregivers to adolescents/young adults ages 13-24 years-old.
• Participating in genetic testing for hereditary breast cancer.
• Adequately speak/read English.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Educational Status; Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Kenneth Tercyak, PhD

CONTACT

202-687-0802; familycom@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

US (1)