NCT00381927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2006

First QC Date

September 26, 2006

Last Update Submit

September 19, 2007

Conditions

Breast Cancer

Keywords

Breast Cancer RiskCounselingPreventionAnxietyBRCA1 mutationBRCA2 mutationTamoxifen

Interventions

Physician CounselingBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Attendance at High-risk Clinic
  • Ability to complete BSI-18 and risk perception questionnaire

You may not qualify if:

  • Diagnosis of invasive breast cancer
  • Diagnosis of ductal carcinoma in situ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Breast Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Study Officials

  • Wilson C Mertens, MD

    Baystate Regional Cancer Program/Baystate Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 28, 2006

Study Start

August 1, 2003

Study Completion

April 1, 2006

Last Updated

September 20, 2007

Record last verified: 2006-09

Locations

US(1)