- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00201929
A Decision Aid for Women With Early Stage Breast Cancer
June 27, 2007 updated by: Ontario Clinical Oncology Group (OCOG)
Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer
To enhance information transfer and decision making for women with breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Brantford, Ontario, Canada, N3R 1G8
- Denise Schnider
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Guelph, Ontario, Canada, N1E 6L9
- Ken Reed
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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Hamilton, Ontario, Canada, L8N 3Z5
- Susan Reid
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Hamilton, Ontario, Canada, L8P 3A9
- Barbara Heller
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Hamilton, Ontario, Canada, L8V 4T9
- Ken Sanders
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Simcoe, Ontario, Canada, N3Y 1T4
- Nabih Mattar
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St. Catharines, Ontario, Canada, L2S 3P1
- Anna Kobylecky
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Welland, Ontario, Canada, L3B 5X9
- Peter Koziarz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Patient comprehension
|
Patient satisfaction with information transfer
|
Secondary Outcome Measures
Outcome Measure |
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
June 29, 2007
Last Update Submitted That Met QC Criteria
June 27, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCCR-Unit-Decision Board
- DAMD17-98-1-8100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
Clinical Trials on Standard Decision Board
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Dana-Farber Cancer InstituteBrigham and Women's HospitalCompleted
-
University of California, San FranciscoTranslational Genomics Research InstituteCompletedDiffuse Intrinsic Pontine Glioma (DIPG)United States
-
Geisinger ClinicCompletedRadiation Exposure to OperatorUnited States
-
University of California, San FranciscoTranslational Genomics Research Institute; The Ben & Catherine Ivy FoundationCompletedAdult GlioblastomaUnited States
-
Children's Hospital of PhiladelphiaVanguard Strong Start for Kids ProgramCompleted
-
University of PennsylvaniaCompleted
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Christiana Care Health ServicesUniversity of Michigan; NorthShore University HealthSystem; Virtua HealthCompleted
-
Mario Negri Institute for Pharmacological ResearchCompleted
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingChronic Kidney Diseases | CKDUnited States
-
Thomas Jefferson UniversityPatient-Centered Outcomes Research Institute; Fox Chase Cancer Center; Lehigh...CompletedColorectal CancerUnited States