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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing the Efficacy of a CDSS for Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Behavioral: Informed breast cancer surgical treatment


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Informed breast cancer surgical treatment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision making, Patient Education, Indigency, Minority group