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


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Development and Evaluation of Different Versions of the Decision Board for Early 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Patient comprehension

Principal Investigator

Timothy Whelan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Juravinski Cancer Centre

Authority:

Canada: Health Canada

Study ID:

SCCR-Unit-Decision Board

NCT ID:

NCT00201929

Start Date:

April 2002

Completion Date:

November 2006

Related Keywords:

  • Breast Cancer
  • breast cancer
  • decision aid
  • Decision Board
  • information transfer
  • Breast Neoplasms

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