Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00381927
• Lead Sponsor: Baystate Medical Center

Brief 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.

Study Timeline

• Study Start: 2003-08
• Study Completion: 2006-04
• Status Verified: 2006-09
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-28
• Last Update Submitted: 2007-09-19
• Last Update Posted: 2007-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Attendance at High-risk Clinic
• Ability to complete BSI-18 and risk perception questionnaire

Exclusion Criteria

• Diagnosis of invasive breast cancer
• Diagnosis of ductal carcinoma in situ.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Comprehensive Breast Center; 🇺🇸 Springfield, Massachusetts, United States