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A Decision Aid for Women With Early Stage Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00201929
First Posted: September 20, 2005
Last Update Posted: June 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
U.S. Army Medical Research and Materiel Command
Supportive Cancer Care Research Unit
Information provided by:
Ontario Clinical Oncology Group (OCOG)
September 13, 2005
September 20, 2005
June 29, 2007
April 2002
Not Provided
  • Patient comprehension
  • Patient satisfaction with information transfer
  • - patient comprehension
  • - patient satisfaction with information transfer
Complete list of historical versions of study NCT00201929 on ClinicalTrials.gov Archive Site
  • 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
  • - 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
Not Provided
Not Provided
 
A Decision Aid for Women With Early Stage Breast Cancer
Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Breast Cancer
  • Procedure: Standard Decision Board
  • Procedure: Computer Decision Board
  • Procedure: Paper Decision Board
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
November 2006
Not Provided

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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00201929
SCCR-Unit-Decision Board
DAMD17-98-1-8100
Not Provided
Not Provided
Not Provided
Not Provided
Ontario Clinical Oncology Group (OCOG)
  • U.S. Army Medical Research and Materiel Command
  • Supportive Cancer Care Research Unit
Study Chair: Timothy Whelan, MD Juravinski Cancer Centre
Ontario Clinical Oncology Group (OCOG)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP