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A Decision Aid for Women With Early Stage Breast Cancer
This study has been completed.
Sponsor:
Ontario Clinical Oncology Group (OCOG)
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
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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 Intervention Model: Parallel Assignment Masking: None (Open Label) |
| Official Title: | Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
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 |
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes 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
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 | |
| Susan Reid | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Barbara Heller | |
| Hamilton, Ontario, Canada, L8P 3A9 | |
| Ken Sanders | |
| Hamilton, Ontario, Canada, L8V 4T9 | |
| Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| 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
| 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 |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
breast cancer decision aid Decision Board information transfer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on August 18, 2017