Viewing Study NCT00473096



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Last Modification Date: 2024-10-26 @ 9:32 AM
Study NCT ID: NCT00473096
Status: COMPLETED
Last Update Posted: 2020-02-28
First Post: 2007-05-11

Brief Title: Efficacy Study of an Educational Program for Decision Support for Breast Cancer
Sponsor: Baylor College of Medicine
Organization: Baylor College of Medicine

Study Overview

Official Title: Assessing the Efficacy of a CDSS for Breast Cancer
Status: COMPLETED
Status Verified Date: 2020-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: H-6019
Brief Summary: 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 optionsb be more satisfied with their treatment decision and c be more assured about their treatment choice
Detailed Description: 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 andor soap opera presentation of situational material that allows women to explore possible consequences associated with different decisions

Comparisons 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None