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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2006-04-30

Brief Summary

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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

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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

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Breast Cancer

Keywords

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Breast Cancer Risk Counseling Prevention Anxiety BRCA1 mutation BRCA2 mutation Tamoxifen

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Physician Counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Wilson C Mertens, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Regional Cancer Program/Baystate Medical Center

Locations

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Comprehensive Breast Center

Springfield, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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03-159

Identifier Type: -

Identifier Source: org_study_id