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

Assessing the Efficacy of a CDSS for Breast Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00473096
Acronym
H-6019
Enrollment
100
Registered
2007-05-14
Start date
2000-10-31
Completion date
2006-10-31
Last updated
2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Decision making, Patient Education, Indigency, Minority group

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.

Interventions

BEHAVIORALInformed breast cancer surgical treatment

Sponsors

U.S. Army Medical Research and Development Command
CollaboratorFED
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Satisfaction with decision at the pre-operation, 6 month and 1 year
Functional status at 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026