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

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.

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Key information

Conditions

Breast Cancer Anxiety Disorders Breast Diseases Breast Neoplasms Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Comprehensive Breast Center

Springfield, Massachusetts, 01199, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physician Counseling

Behavioral

Sponsors and collaborators

Lead sponsor

Baystate Medical Center

Other

Registry information

Important dates

Study start: 2003
Study completion: 2006
First posted: Sep 28, 2006
Registry last updated: Sep 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed