Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALPhysician 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.