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

Breast Neoplasms Clinical Trial

— H-6019  

Official title:

Assessing the Efficacy of a CDSS for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473096
• Other study ID #: DAMD17-98-1-8022
• Status: Completed
• Phase: N/A
• Start date: October 2000
• Est. completion date: October 2006

Study information

• Verified date: February 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• Informed breast cancer surgical treatment

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

References & Publications (2)

Jibaja-Weiss ML, Volk RJ, Friedman LC, Granchi TS, Neff NE, Spann SJ, Robinson EK, Aoki N, Robert Beck J. Preliminary testing of a just-in-time, user-defined values clarification exercise to aid lower literate women in making informed breast cancer treatm — View Citation

Jibaja-Weiss ML, Volk RJ, Granch TS, Nefe NE, Spann SJ, Aoki N, Robinson EK, Freidman LC, Beck JR. Entertainment education for informed breast cancer treatment decisions in low-literate women: development and initial evaluation of a patient decision aid. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment decisions more consistent with preferences (utilities)at pre-operation
Primary	Breast cancer treatment knowledge at 6 month and 1 year
Primary	Certainty about treatment choice at pre-operation
Secondary	Satisfaction with decision at the pre-operation, 6 month and 1 year
Secondary	Preferences for decision making at pre-operation
Secondary	Satisfaction with the decision making process at pre-operation, 6 month and 1 year
Secondary	Functional status at 6 month and 1 year