Clinical trial · Interventional
Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
A Randomized Study of Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
NCT00165152CI-TRIAL-00007801completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic Counseling | Procedure | — | UNRESOLVED |
| Informed Consent Counseling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Genetic Counseling
- interventionNames
- Procedure: Genetic Counseling
- type
- ACTIVE_COMPARATOR
- label
- Informed Consent Counseling
- interventionNames
- Procedure: Informed Consent Counseling
Primary outcomes (1)
- measure
- To determine if genetic counseling yields better psycho-social and medical care utilization outcomes, compared to a medical model of informed consent for genetic testing.
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process. * Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene * Documentation of key family member cancer diagnoses is required Exclusion Criteria: * Males, will be offered BRCA 1/2 testing through other protocols * Individuals unable to speak or write English * Already participated in a genetic counseling program for BRCA1 or BRCA2 testing * Life expectancy of less than 12 months.
References
Publications (0)
Data not yet available
No reference posted for this study.