Efficacy Study of an Educational Program for Decision Support for Breast Cancer (H-6019)

Baylor College of Medicine

Status: Completed

Conditions: Breast Neoplasms

Treatments: Behavioral: Informed breast cancer surgical treatment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00473096

DAMD17-98-1-8022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)