A Decision Aid for Women With Early Stage Breast Cancer

Phase 3CompletedNCT00201929

Ontario Clinical Oncology Group (OCOG)300 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

300

Conditions

Breast Cancer

Interventions

Standard Decision BoardPROCEDURE

Computer Decision BoardPROCEDURE

Paper Decision BoardPROCEDURE

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (9)

Denise Schnider

Brantford, Ontario, Canada

Ken Reed

Guelph, Ontario, Canada

Susan Reid

Hamilton, Ontario, Canada

Barbara Heller

Hamilton, Ontario, Canada

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

Data from ClinicalTrials.gov

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