Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381927
Status:
COMPLETED
Last Update Posted:
2007-09-20
First Post:
2006-09-26
Brief Title:
Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development
Sponsor:
Baystate Medical Center
Organization:
Baystate Medical Center
Study Overview
Official Title:
Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 BRCA12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None