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OpenTrials
Completed

NCT Number: NCT00201929

A Decision Aid for Women With Early Stage Breast Cancer

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

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Denise Schnider, Brantford, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Decision Board

Procedure

Computer Decision Board

Procedure

Paper Decision Board

Procedure

Primary outcomes

  1. Patient comprehension

  2. Patient satisfaction with information transfer

Secondary outcomes

  1. Patient satisfaction with decision making

  2. Physician satisfaction with information transfer

  3. Physician satisfaction with decision making

  4. Time required for administration of the instrument

  5. Patient preference for decision making

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Supportive Cancer Care Research Unit
  • U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Jun 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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