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Clinical Trials/NCT00473096
NCT00473096
Completed
Not Applicable

Assessing the Efficacy of a CDSS for Breast Cancer

Baylor College of Medicine1 site in 1 country100 target enrollmentOctober 2000

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Baylor College of Medicine
Enrollment
100
Locations
1
Primary Endpoint
Treatment decisions more consistent with preferences (utilities)at pre-operation
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2000
End Date
October 2006
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Jibaja Weiss

Associate Professor, Duncan Cancer Center

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Satisfaction with decision at the pre-operation, 6 month and 1 year
  • 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

Study Sites (1)

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