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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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | June 27, 2007 | ||||
| Start Date ICMJE | April 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00201929 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Decision Aid for Women With Early Stage Breast Cancer | ||||
| Official Title ICMJE | Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer | ||||
| Brief Summary | To enhance information transfer and decision making for women with breast cancer. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | November 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Chemotherapy Group:
Surgery Group:
Exclusion Criteria: Chemotherapy Group:
Surgery Group:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00201929 | ||||
| Other Study ID Numbers ICMJE | SCCR-Unit-Decision Board, DAMD17-98-1-8100 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Ontario Clinical Oncology Group (OCOG) | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Ontario Clinical Oncology Group (OCOG) | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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