Educational Interventions for Patients With DCIS
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborator:
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00148655
First received: September 7, 2005
Last updated: December 22, 2007
Last verified: December 2007
| Tracking Information | |||||
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| First Received Date ICMJE | September 7, 2005 | ||||
| Last Updated Date | December 22, 2007 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine the impact of an educational intervention on the decision-making in women with DCIS. [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To determine the impact of an educational intervention on the decision-making in women with DCIS. | ||||
| Change History | Complete list of historical versions of study NCT00148655 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To assess the effect of an intervention on 1)satisfaction with decision-making, 2)knowledge of treatment options, 3)risk assessment, 4)treatment choice, 5)factors motivating treatment choice and 6)anxiety related to diagnosis. [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
To assess the effect of an intervention on 1)satisfaction with decision-making, 2)knowledge of treatment options, 3)risk assessment, 4)treatment choice, 5)factors motivating treatment choice and 6)anxiety related to diagnosis. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Educational Interventions for Patients With DCIS | ||||
| Official Title ICMJE | A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions | ||||
| Brief Summary | The purpose of this study is to determine whether adding an educational intervention, in the form of a decision board, which outlines the risks and benefits of treatment options for DCIS, at the time of the first surgical consultation will improve decision making for women with DCIS. |
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| Detailed Description |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | DCIS | ||||
| Intervention ICMJE | Device: Decision Board
Decision board that explains the risks and benefits of treatment options |
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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 | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Completion Date | August 2006 | ||||
| Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 25 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00148655 | ||||
| Other Study ID Numbers ICMJE | 02-331 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Eric Winer, MD, Dana-Farber Cancer Institute | ||||
| Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
| Collaborators ICMJE | Brigham and Women's Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Dana-Farber Cancer Institute | ||||
| Verification Date | December 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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