Status:
COMPLETED
Educational Interventions for Patients With DCIS
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
DCIS
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether adding an educational intervention, in the form of a decision board, which outlines the risks and benefits of treatment options for DCIS, at the time ...
Detailed Description
* The decision board explains the risks and benefits of mastectomy, excision and radiation, excision, radiation, and tamoxifen, excision alone, and excision without radiation and tamoxifen for women w...
Eligibility Criteria
Inclusion
- Eligible patients will include women over the age of 25 with newly-diagnosed DCIS who are candidates for breast conserving therapy.
- Pathologic confirmation of DCIS without evidence of invasive breast cancer and mammograms showing a single suspicious focus without mammographic or clinical evidence of multicentricity.
- Patients that have not made a decision regarding management of DCIS
- Eligible for radiotherapy to breast
- Oral and written knowledge of English
Exclusion
- Patients that have undergone mastectomy
- History of prior radiotherapy to the breast, scleroderma or systemic lupus erythematosus
- Clinically palpable disease in the axilla or contralateral breast cancer
- Co-morbidities that would render them ineligible for general anesthesia
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00148655
Start Date
May 1 2003
End Date
August 1 2006
Last Update
December 28 2007
Active Locations (2)
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1
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
2
Faulkner Hospital
Boston, Massachusetts, United States, 02130