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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381927
• Other study ID #: 03-159
• Status: Completed
• Phase: N/A
• First received: September 26, 2006
• Last updated: September 19, 2007
• Start date: August 2003
• Est. completion date: April 2006

Study information

• Verified date: September 2006
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Stress, Psychological

Intervention

Behavioral:
• Physician Counseling

Locations

Country	Name	City	State
United States	Comprehensive Breast Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States,