Educational Interventions for Patients With DCIS
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions|
- 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 ]
- 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 ]
|Study Start Date:||May 2003|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Device: Decision Board
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|