A Decision Aid for Women With Early Stage Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Supportive Cancer Care Research Unit
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00201929
First received: September 13, 2005
Last updated: June 27, 2007
Last verified: June 2007
  Purpose

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


Condition Intervention Phase
Breast Cancer
Procedure: Standard Decision Board
Procedure: Computer Decision Board
Procedure: Paper Decision Board
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • Patient comprehension
  • Patient satisfaction with information transfer

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: April 2002
Study Completion Date: November 2006
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201929

Locations
Canada, Ontario
Denise Schnider
Brantford, Ontario, Canada, N3R 1G8
Ken Reed
Guelph, Ontario, Canada, N1E 6L9
Ken Sanders
Hamilton, Ontario, Canada, L8V 4T9
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Susan Reid
Hamilton, Ontario, Canada, L8N 3Z5
Barbara Heller
Hamilton, Ontario, Canada, L8P 3A9
Nabih Mattar
Simcoe, Ontario, Canada, N3Y 1T4
Anna Kobylecky
St. Catharines, Ontario, Canada, L2S 3P1
Peter Koziarz
Welland, Ontario, Canada, L3B 5X9
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
U.S. Army Medical Research and Materiel Command
Supportive Cancer Care Research Unit
Investigators
Study Chair: Timothy Whelan, MD Juravinski Cancer Centre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00201929     History of Changes
Other Study ID Numbers: SCCR-Unit-Decision Board, DAMD17-98-1-8100
Study First Received: September 13, 2005
Last Updated: June 27, 2007
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
breast cancer
decision aid
Decision Board
information transfer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014