NCT00201929
Completed
Phase 3
Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer
Ontario Clinical Oncology Group (OCOG)9 sites in 1 country300 target enrollmentApril 2002
ConditionsBreast Cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
- Enrollment
- 300
- Locations
- 9
- Primary Endpoint
- Patient comprehension
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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) mastectomy versus lumpectomy plus radiation and (ii) to compare the relative effectiveness of the computer and paper based versions with the standard Decision Board for patients with early breast cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chemotherapy Group:
- •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:
- •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
- •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
- •Clinical suspicion of bilateral breast cancer
Outcomes
Primary Outcomes
Patient comprehension
Patient satisfaction with information transfer
Secondary Outcomes
- Patient satisfaction with decision making
- Physician satisfaction with information transfer
- Physician satisfaction with decision making
- Time required for administration of the instrument
- Patient preference for decision making
Study Sites (9)
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