Educational Interventions for Patients With DCIS
A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions
1 other identifier
interventional
120
1 country
2
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 of the first surgical consultation will improve decision making for women with DCIS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2003
Longer than P75 for not_applicable
2 active sites
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
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedDecember 28, 2007
December 1, 2007
3.3 years
September 7, 2005
December 22, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the impact of an educational intervention on the decision-making in women with DCIS.
3 years
Secondary Outcomes (1)
To assess the effect of an intervention on 1)satisfaction with decision-making, 2)knowledge of treatment options, 3)risk assessment, 4)treatment choice, 5)factors motivating treatment choice and 6)anxiety related to diagnosis.
3 years
Interventions
Decision board that explains the risks and benefits of treatment options
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
Study Sites (2)
Dana-Farber Cancer Center
Boston, Massachusetts, 02115, United States
Faulkner Hospital
Boston, Massachusetts, 02130, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Winer, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 8, 2005
Study Start
May 1, 2003
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
December 28, 2007
Record last verified: 2007-12