Efficacy Study of an Educational Program for Decision Support for Breast Cancer

Not Applicable

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00473096
• Lead Sponsor: Baylor College of Medicine

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 options,(b) 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 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.

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2007-05-11
• Study First Submitted QC: 2007-05-11
• Study First Posted: 2007-05-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female
• Breast cancer diagnosis in stages I, IIA, IIB, or IIIA
• Candidates for surgery
• Speak English or Spanish

Exclusion Criteria

• Breast cancer diagnosis in stages 0, IIIB, or IV
• Recurrent breast cancer or inflammatory breast carcinoma
• Not eligible for lumpectomy with radiation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment decisions more consistent with preferences (utilities)at pre-operation
Breast cancer treatment knowledge at 6 month and 1 year
Certainty about treatment choice at pre-operation

Secondary Outcome Measures

Name	Time	Method
Preferences for decision making at pre-operation
Satisfaction with the decision making process at pre-operation, 6 month and 1 year
Functional status at 6 month and 1 year
Satisfaction with decision at the pre-operation, 6 month and 1 year

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States