Breast CancerPCS IVNCT04258280
Improving Genetic Counseling for BRCA+ Mothers
A study testing Education and counseling and Education in people with Breast Cancer, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Education and counseling and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mothers/primary caregivers to adolescents/young adults ages 13-24 years-old.
- Participating in genetic testing for hereditary breast cancer.
- Adequately speak/read English.
Who cannot join
- Does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Principal Investigator
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Education and counseling, Education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and counselingBehavioural
Education includes a workbook, counseling includes peer support.
EducationBehavioural
Education includes a workbook.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Not described Receives: Behavioral: Education |
| Enhanced Care | Experimental | Not described Receives: Behavioral: Education and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication
Parent-child and family communication of hereditary cancer risk.
Measured: 1- and 6-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258280
- Sponsor's protocol ID
- 00001137
- Acronym
- PCS IV
- Status last verified
- Sep 2024
- First submitted
- 4 Feb 2020
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Communication Study IV: Improving Genetic Counseling for BRCA+ Mothers
- ClinicalTrials.gov ID
- NCT04258280
- Acronym / sponsor ID
- PCS IV / 00001137
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Education |
| Enhanced Care | Experimental | Behavioral: Education and counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mothers/primary caregivers to adolescents/young adults ages 13-24 years-old.
- Participating in genetic testing for hereditary breast cancer.
- Adequately speak/read English.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and counselingEducation includes a workbook, counseling includes peer support. | Behavioural | Enhanced Care |
| EducationEducation includes a workbook. | Behavioural | Usual Care |
Primary outcome
Communication
Time frame: 1- and 6-months post-treatment
Parent-child and family communication of hereditary cancer risk.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and counseling and Education in people with Breast Cancer, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Tercyak, PhD (202-687-0802, familycom@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication (time frame: 1- and 6-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.