A Decision Aid for Women With Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201929
• Other study ID #: SCCR-Unit-Decision Board
• Secondary ID: DAMD17-98-1-8100
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 27, 2007
• Start date: April 2002
• Est. completion date: November 2006

Study information

• Verified date: June 2007
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Standard Decision Board

• Computer Decision Board

• Paper Decision Board

Locations

Country	Name	City	State
Canada	Denise Schnider	Brantford	Ontario
Canada	Ken Reed	Guelph	Ontario
Canada	Barbara Heller	Hamilton	Ontario
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Ken Sanders	Hamilton	Ontario
Canada	Susan Reid	Hamilton	Ontario
Canada	Nabih Mattar	Simcoe	Ontario
Canada	Anna Kobylecky	St. Catharines	Ontario
Canada	Peter Koziarz	Welland	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Supportive Cancer Care Research Unit, U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient comprehension
Primary	Patient satisfaction with information transfer
Secondary	Patient satisfaction with decision making
Secondary	Physician satisfaction with information transfer
Secondary	Physician satisfaction with decision making
Secondary	Time required for administration of the instrument
Secondary	Patient preference for decision making