Status:
COMPLETED
A Decision Aid for Women With Early Stage Breast Cancer
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Supportive Cancer Care Research Unit
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
To enhance information transfer and decision making for women with breast cancer.
Detailed Description
Our specific objectives are: (i) to develop computer and paper based versions of the Decision Boards for (a) chemotherapy for early stage breast cancer (chemotherapy versus no treatment), (b) mastecto...
Eligibility Criteria
Inclusion
- Chemotherapy Group:
- 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
- Chemotherapy Group:
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00201929
Start Date
April 1 2002
End Date
November 1 2006
Last Update
June 29 2007
Active Locations (9)
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1
Denise Schnider
Brantford, Ontario, Canada, N3R 1G8
2
Ken Reed
Guelph, Ontario, Canada, N1E 6L9
3
Susan Reid
Hamilton, Ontario, Canada, L8N 3Z5
4
Barbara Heller
Hamilton, Ontario, Canada, L8P 3A9