Clinical trial · Interventional
Genetic Education in BRCA Families
A Randomized Trial of Proactive Outreach and Streamlined Genetic Education in BRCA Families
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary goal of this research is to test a web-based genetic education intervention that is designed to educate men and women from hereditary cancer families about the personal relevance of genetic testing in order to help them male decisions about whether to pursue genetic testing. We will test this intervention against standard care for men and women from hereditary cancer families. The web-based educational intervention includes all of the information typically covered during genetic counseling. As a result, after completing the education intervention, participants can proceed directly to a brief telephone call with a genetic counselor followed by testing if they choose. A baseline survey will be administered prior to randomization and then follow-up surveys will be administered at 1-month and 6-months post-randomization. Primary outcomes will be completion of genetic counseling, uptake of genetic testing, genetic test results and quality of life.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Web + Streamlined Telephone Genetic Information | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proactive Outreach + Web Counseling
- description
- Web + Streamlined Telephone Genetic Information
- interventionNames
- Behavioral: Web + Streamlined Telephone Genetic Information
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- 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.
Primary outcomes (1)
- measure
- Uptake of genetic counseling and testing
- timeFrame
- 6-months post randomization
- description
- The proportion of participants who complete genetic counseling and testing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * A first- (sibling, adult offspring) or second-degree (aunt/uncle, niece/nephew if at-risk parent is deceased) biological relative of an individual with a recently identified BRCA1 or BRCA2 mutation Exclusion Criteria: * Personal diagnosis of metastatic cancer * Prior genetic testing for hereditary breast/ovarian cancer * Have one or more children who have tested positive for a BRCA1 or BRCA2 mutation * Cannot participate in or understand English * Cannot provide meaningful informed consent
References
Publications (0)
Data not yet available