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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Notify MeKey information
Conditions
Sex eligibility
Female
Study type
Interventional
Phase
Phase 3
Primary location
Denise Schnider, Brantford, Ontario, Canada
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
Computer Decision Board
ProcedurePaper Decision Board
ProcedurePrimary outcomes
-
Patient comprehension
-
Patient satisfaction with information transfer
Secondary outcomes
-
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
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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