Standard Decision Board and Computer Decision Board and Paper Decision Board in Breast Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

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 Type

Interventional

Enrollment

300

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Brantford, Ontario, Canada, N3R 1G8
    - Denise Schnider
  - Guelph, Ontario, Canada, N1E 6L9
    - Ken Reed
  - Hamilton, Ontario, Canada, L8V 5C2
    - Juravinski Cancer Centre
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Susan Reid
  - Hamilton, Ontario, Canada, L8P 3A9
    - Barbara Heller
  - Hamilton, Ontario, Canada, L8V 4T9
    - Ken Sanders
  - Simcoe, Ontario, Canada, N3Y 1T4
    - Nabih Mattar
  - St. Catharines, Ontario, Canada, L2S 3P1
    - Anna Kobylecky
  - Welland, Ontario, Canada, L3B 5X9
    - Peter Koziarz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient comprehension
Patient satisfaction with information transfer

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

U.S. Army Medical Research and Development Command

Supportive Cancer Care Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria