Clinical trial · Interventional
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study
The caRe Study: Clinical Application of Refined Risk Estimates
- 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)
This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation. BRCA1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer. Due to the high risk of cancer, mutation carriers are provided guidelines on more intensive screening and preventative surgeries such as bilateral mastectomy and bilateral salpingo-oophorectomy. Doctors want to learn if a more personalized risk assessment impacts the patients' risk perceptions and comfort with decision-making around cancer prevention behaviors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Counseling | Other | — | UNRESOLVED |
| Discussion | Procedure | — | UNRESOLVED |
| Genotyping | Procedure | — | UNRESOLVED |
| Molecular Risk Assessment | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (enhanced risk assessment)
- description
- Patients undergo collection of blood or mouthwash samples. Patients undergo genotyping with enhanced risk assessment on study. 4 to 8 weeks later, patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Counseling
- Procedure: Discussion
- Procedure: Genotyping
- Procedure: Molecular Risk Assessment
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard)
- description
- Patients undergo collection of blood or mouthwash samples. 4-8 weeks later, patients receive a standard follow-up phone call.
- interventionNames
- Other: Best Practice
- Procedure: Biospecimen Collection
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have had genetic counseling and testing for mutations in BRCA1 and/or BRCA2 through a Clinical Laboratory Improvement Act (CLIA)-certified laboratory * Were found to have a known pathogenic mutation upon testing * Are within 3 weeks of results disclosure * Have available medical records for ascertainment of clinical information * Are able to provide a source of deoxyribonucleic acid (DNA) (blood or mouthwash) for study * Have access to a telephone and a computer or other internet-ready device * Have not yet had a bilateral prophylactic mastectomy or bilateral Salpingo oophorectomy
References
Publications (0)
Data not yet available