A Decision Aid for Women With Early Stage Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00201929
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Completion: 2006-11
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-27
• Last Update Posted: 2007-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient comprehension
Patient satisfaction with information transfer

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Ken Reed; 🇨🇦 Guelph, Ontario, Canada

Ken Sanders; 🇨🇦 Hamilton, Ontario, Canada

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Barbara Heller; 🇨🇦 Hamilton, Ontario, Canada

Nabih Mattar; 🇨🇦 Simcoe, Ontario, Canada

Anna Kobylecky; 🇨🇦 St. Catharines, Ontario, Canada

Susan Reid; 🇨🇦 Hamilton, Ontario, Canada

Denise Schnider; 🇨🇦 Brantford, Ontario, Canada

Peter Koziarz; 🇨🇦 Welland, Ontario, Canada