A Decision Aid for Women With Early Stage Breast Cancer

NCT00201929 | Completed Phase 3

• 2 other identifiers: SCCR-Unit-Decision BoardDAMD17-98-1-8100
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Breast Cancer

Keywords

breast cancer; decision aid; Decision Board; information transfer

Outcome Measures

Primary Outcomes (2)

• Patient comprehension

• Patient satisfaction with information transfer

Secondary Outcomes (5)

• 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

Interventions

Standard Decision Board PROCEDURE

Computer Decision Board PROCEDURE

Paper Decision Board PROCEDURE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• U.S. Army Medical Research and Development Command: collaborator
• Supportive Cancer Care Research Unit: collaborator

Study Sites (9)

Denise Schnider

Brantford, Ontario, N3R 1G8, Canada

Location

Ken Reed

Guelph, Ontario, N1E 6L9, Canada

Location

Susan Reid

Hamilton, Ontario, L8N 3Z5, Canada

Location

Barbara Heller

Hamilton, Ontario, L8P 3A9, Canada

Location

Ken Sanders

Hamilton, Ontario, L8V 4T9, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Nabih Mattar

Simcoe, Ontario, N3Y 1T4, Canada

Location

Anna Kobylecky

St. Catharines, Ontario, L2S 3P1, Canada

Location

Peter Koziarz

Welland, Ontario, L3B 5X9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Timothy Whelan, MD

  Juravinski Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2002
• Study Completion: November 1, 2006
• Last Updated: June 29, 2007

Record last verified: 2007-06

Locations

CA (9)