Clinical trial · Interventional
Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results
- 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 non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Internet DA | Behavioral | — | UNRESOLVED |
| Enhanced Print DA | Behavioral | — | UNRESOLVED |
| Inconclusive Results DA | Behavioral | — | UNRESOLVED |
| Internet DA | Behavioral | — | UNRESOLVED |
| Print DA | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Mutation Carrier: Enhanced Internet DA
- description
- BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
- interventionNames
- Behavioral: Enhanced Internet DA
- type
- EXPERIMENTAL
- label
- Mutation Carrier: Internet DA
- description
- BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.
- interventionNames
- Behavioral: Internet DA
- type
- ACTIVE_COMPARATOR
- label
- Mutation Carrier: Enhanced Print DA
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Undergo BRCA1/2 genetic counseling and testing at one of four study sites * Receive positive or uninformative test results * English speaking Exclusion Criteria: * Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment * Previous bilateral mastectomy
References
Publications (0)
Data not yet available