Efficacy Study of an Educational Program for Decision Support for Breast Cancer (H-6019)
The purpose of this study is to develop and test an informative computer-based program to help women in making good choices among options for treating early stage breast cancer. Women who are exposed to the computerized program will, when compared to women who receive standard of care offered at the hospital: (a) be more knowledgeable about treatment options,(b) be more satisfied with their treatment decision, and (c) be more assured about their treatment choice.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Assessing the Efficacy of a CDSS for Breast Cancer|
- Treatment decisions more consistent with preferences (utilities)at pre-operation [ Designated as safety issue: No ]
- Breast cancer treatment knowledge at 6 month and 1 year [ Designated as safety issue: No ]
- Certainty about treatment choice at pre-operation [ Designated as safety issue: No ]
- Satisfaction with decision at the pre-operation, 6 month and 1 year [ Designated as safety issue: No ]
- Preferences for decision making at pre-operation [ Designated as safety issue: No ]
- Satisfaction with the decision making process at pre-operation, 6 month and 1 year [ Designated as safety issue: No ]
- Functional status at 6 month and 1 year [ Designated as safety issue: No ]
|Study Start Date:||October 2000|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
The purpose of this project is to develop and test a computer-based decision support system on breast cancer for low-income women who speak English or Spanish. This project is designed to respond to the under utilization of breast conserving surgery by women with early stage breast cancer, as indicated by both national and local data on treatment choices. The literature suggests that underuse of BCS by women for whom it is the recommended therapy may relate to inadequacies in efforts to educate them about treatment options. The program was designed to convey information to women with varying levels of reading ability. This was done through multimedia approaches which include voice-over narrative in simple English or Spanish, and use of photo novella and/or "soap opera" presentation of situational material that allows women to explore possible consequences associated with different decisions.
Comparison(s): Women exposed to the computer-based decision support program on breast cancer treatment, receiving standard care and education offered at two public hospitals, compared to women exposed to standard care and education at the same public hospitals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473096
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Maria L Jibaja Weiss, EdD||Baylor College of Medicine|