Trials / Completed
CompletedNCT00381927
Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (planned)
- Sponsor
- Baystate Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate 1) the extent of patient overestimation of breast cancer development risk in subjects referred to a physician-based high-risk breast clinic; 2) the ability of physician counseling to improve patient risk perception and reduce psychological distress; 3) to identify factors relevant in clinical practice associated with increased distress and risk perception.
Detailed description
Patients referred to the Baystate Comprehensive Breast Center High-Risk Clinic wil, after giving consent, complete an intake evaluation of breast cancer risk, the patient's perceptions of breast cancer development risk, and the Brief Symptom Inventory-18. Physician history, physical and counseling then takes place, with sharing of risk estimates based on modified Gail model and Myriad tables regarding breast cancer risk and probability of BRCA1/2 mutation. After counseling, patients complete another assessment of risk perception and BSI-18, and again 2 months and 1 year post counseling. Recommendations for hormonal management and referral for formal genetic evaluation and testing will be tracked.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Physician Counseling |
Timeline
- Start date
- 2003-08-01
- Completion
- 2006-04-01
- First posted
- 2006-09-28
- Last updated
- 2007-09-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00381927. Inclusion in this directory is not an endorsement.