A Decision Aid for Women With Early Stage Breast Cancer

Ontario Clinical Oncology Group (OCOG)

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: Computer Decision Board; Procedure: Paper Decision Board; Procedure: Standard Decision Board

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00201929

DAMD17-98-1-8100

SCCR-Unit-Decision Board

Details and patient eligibility

About

To enhance information transfer and decision making for women with breast cancer.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

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