- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04258280
Improving Genetic Counseling for BRCA+ Mothers (PCS IV)
February 22, 2023 updated by: Georgetown University
Parent Communication Study IV: Improving Genetic Counseling for BRCA+ Mothers
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kenneth Tercyak, PhD
- Phone Number: 202-687-0802
- Email: familycom@georgetown.edu
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Recruiting
- MedStar Georgetown University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care
|
Education includes a workbook.
|
Experimental: Enhanced Care
|
Education includes a workbook, counseling includes peer support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Communication
Time Frame: 1- and 6-months post-treatment
|
Parent-child and family communication of hereditary cancer risk.
|
1- and 6-months post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
February 4, 2020
First Submitted That Met QC Criteria
February 4, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 22, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 00001137
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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