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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00381927
Enrollment
80
Registered
2006-09-28
Start date
2003-08-31
Completion date
2006-04-30
Last updated
2007-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer Risk, Counseling, Prevention, Anxiety, BRCA1 mutation, BRCA2 mutation, Tamoxifen

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.

Interventions

Sponsors

Baystate Medical Center
Lead SponsorOTHER

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026