A Decision Aid for Women With Early Stage Breast Cancer
NCT ID: NCT00201929
Last Updated: 2007-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2002-04-30
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Interventions
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Standard Decision Board
Computer Decision Board
Paper Decision Board
Eligibility Criteria
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Inclusion Criteria
* Female
* Histologically documented invasive carcinoma of the breast treated with modified radical mastectomy or lumpectomy
* Axillary node dissection
* Chemotherapy alone or in addition to tamoxifen as an appropriate treatment option
Surgery Group:
* Female
* Newly diagnosed carcinoma of the breast diagnosed either by cytology or pathological examination, OR if no biopsy, a strong clinical suspicion of malignancy
* Clinical stage I or II disease
* Candidate for breast conserving surgery
Exclusion Criteria
* Candidate for CEF chemotherapy
* Clinical evidence of metastatic disease
* Serious comorbidity that would preclude receiving chemotherapy treatment
* Unable to speak or read English fluently (including visual impairment)
* Mentally incompetent including any psychiatric or addictive disorders that would preclude shared decision-making
Surgery Group:
* Previous surgery for breast cancer
* Previous breast irradiation
* Pregnant
* Clinical suspicion of bilateral breast cancer
* Serious comorbidity that would preclude definitive surgery
* Unable to speak or read English fluently (including visual impairment)
* Mentally incompetent including any psychiatric or addictive disorder that would preclude shared decision making
FEMALE
No
Sponsors
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U.S. Army Medical Research and Development Command
FED
Supportive Cancer Care Research Unit
UNKNOWN
Ontario Clinical Oncology Group (OCOG)
OTHER
Principal Investigators
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Timothy Whelan, MD
Role: STUDY_CHAIR
Juravinski Cancer Centre
Locations
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Denise Schnider
Brantford, Ontario, Canada
Ken Reed
Guelph, Ontario, Canada
Susan Reid
Hamilton, Ontario, Canada
Barbara Heller
Hamilton, Ontario, Canada
Ken Sanders
Hamilton, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Nabih Mattar
Simcoe, Ontario, Canada
Anna Kobylecky
St. Catharines, Ontario, Canada
Peter Koziarz
Welland, Ontario, Canada
Countries
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Other Identifiers
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DAMD17-98-1-8100
Identifier Type: -
Identifier Source: secondary_id
SCCR-Unit-Decision Board
Identifier Type: -
Identifier Source: org_study_id