Recruiting

Genetic Counseling

Sponsor:

Georgetown University

Code:

NCT04258280

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Education and counseling

Education

Study Details

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

Study ID

NCT04258280

Start date

Jul 1, 2020

Status verified date

Sep, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

- Does not meet inclusion criteria.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Usual Care

experimental: Enhanced Care

Interventions

Education and counseling

Education includes a workbook, counseling includes peer support.

Education

Education includes a workbook.

Primary outcome measure

  • Communication [ Time Frame: 1- and 6-months post-treatment ]

Central Contacts and Locations

Central contacts

Locations

MedStar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

More Information

Sponsor

Georgetown University

Last update posted

Sep 27, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2024-09-27.