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Clinical Trials/NCT04258280
NCT04258280RecruitingNot Applicable

Parent Communication Study IV: Improving Genetic Counseling for BRCA+ Mothers

Georgetown University1 site in 1 country200 target enrollmentStarted: July 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
Communication

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Usual Care

Active Comparator

Intervention: Education (Behavioral)

Enhanced Care

Experimental

Intervention: Education and counseling (Behavioral)

Outcomes

Primary Outcomes

Communication

Time Frame: 1- and 6-months post-treatment

Parent-child and family communication of hereditary cancer risk.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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