Breast Cancer
Conditions
Keywords
breast cancer, decision aid, Decision Board, information transfer
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.
Interventions
PROCEDUREStandard Decision Board
PROCEDUREComputer Decision Board
PROCEDUREPaper Decision Board
Sponsors
U.S. Army Medical Research and Development Command
Supportive Cancer Care Research Unit
Ontario Clinical Oncology Group (OCOG)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
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 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient comprehension | — |
| Patient satisfaction with information transfer | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed