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Web-Based Genetic Education for BRCA Mutation Carriers

N/A
Waitlist Available
Led By Marc D Schwartz, PhD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1- and 6-months post-randomization
Awards & highlights

Study Summary

This trial is testing a web-based intervention to educate people from cancer families about genetic testing. The goal is to see if this is better than standard care at helping them make decisions about testing.

Who is the study for?
This trial is for men and women who have a close relative with a BRCA1 or BRCA2 mutation, indicating they might be at risk for hereditary cancer. They should not have metastatic cancer themselves, no prior genetic testing for these mutations, and must understand English to give informed consent.Check my eligibility
What is being tested?
The study compares standard care with a web-based educational tool followed by streamlined telephone counseling about genetic testing. Participants will complete surveys before the study starts and again at 1-month and 6-month intervals to measure outcomes like test uptake and quality of life.See study design
What are the potential side effects?
Since this trial involves education and counseling rather than medication, traditional physical side effects are not expected. However, participants may experience emotional or psychological responses upon learning about their genetic risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1- and 6-months post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1- and 6-months post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Uptake of genetic counseling and testing
Secondary outcome measures
Decisional Conflict Scale
Multidimensional Impact of Cancer Risk Scale - Uncertainty Scale
Patient Reported Outcomes Measurement Information System -- Anxiety
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Proactive Outreach + Web CounselingExperimental Treatment1 Intervention
Web + Streamlined Telephone Genetic Counseling
Group II: Usual CareActive Control1 Intervention
Participants in the usual care arm will not be provided with access to the web-based intervention nor will they have access to streamlined genetic counseling. They can pursue clinical genetic counseling on their own.

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,076 Total Patients Enrolled
George Washington UniversityOTHER
243 Previous Clinical Trials
453,348 Total Patients Enrolled
Marc D Schwartz, PhDPrincipal InvestigatorGeorgetown University
1 Previous Clinical Trials
369 Total Patients Enrolled

Media Library

Web + Streamlined Telephone Genetic Counseling Clinical Trial Eligibility Overview. Trial Name: NCT03544983 — N/A
BRCA1 Research Study Groups: Proactive Outreach + Web Counseling, Usual Care
BRCA1 Clinical Trial 2023: Web + Streamlined Telephone Genetic Counseling Highlights & Side Effects. Trial Name: NCT03544983 — N/A
Web + Streamlined Telephone Genetic Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT03544983 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential participants meet to qualify for this clinical trial?

"This trial is looking for 426 individuals aged 21-75 with the brca1 gene. Notably, they must be a first or second degree biological relative of someone who recently had their BRCA1 or BRCA2 mutation identified."

Answered by AI

Is enrollment into this clinical experiment open at present?

"Based on the information found clinicaltrials.gov, this specific medical trial is no longer seeking participants; its initial posting date was May 1st 2020 and it was last updated June 11th 2021. Nevertheless, 16 other trials are actively accepting patients at present."

Answered by AI

Does this research involve minors?

"According to the parameters of this trial, individuals must be at least 21 years old and no older than 75 in order to qualify for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Genetic Education in BRCA Families
Marc D Schwartz 2020. "Genetic Education in BRCA Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03544983.
~62 spots leftby Dec 2024
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