Educational Interventions for Patients With DCIS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00148655|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 28, 2007
|Condition or disease||Intervention/treatment||Phase|
|DCIS||Device: Decision Board||Not Applicable|
- The decision board explains the risks and benefits of mastectomy, excision and radiation, excision, radiation, and tamoxifen, excision alone, and excision without radiation and tamoxifen for women with DCIS.
- Patients will receive a decision board to take home for review. Two fifteen-minute telephone interviews will be conducted, one approximately one week after enrollment and one 2 months after enrollment.
- In the phone interviews, patients will asked to complete a brief survey. This survey will ask abou DCIS in general, the patient's treatment decisions, their feelings, as well as their experience with the decision board.
- This study will take about 2 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
Device: Decision Board
- To determine the impact of an educational intervention on the decision-making in women with DCIS. [ Time Frame: 3 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148655
|United States, Massachusetts|
|Dana-Farber Cancer Center|
|Boston, Massachusetts, United States, 02115|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||Eric Winer, MD||Dana-Farber Cancer Institute|