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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00473096
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : September 22, 2015
U.S. Army Medical Research and Materiel Command
Information provided by:
Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: Informed breast cancer surgical treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assessing the Efficacy of a CDSS for Breast Cancer
Study Start Date : October 2000
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Treatment decisions more consistent with preferences (utilities)at pre-operation
  2. Breast cancer treatment knowledge at 6 month and 1 year
  3. Certainty about treatment choice at pre-operation

Secondary Outcome Measures :
  1. Satisfaction with decision at the pre-operation, 6 month and 1 year
  2. Preferences for decision making at pre-operation
  3. Satisfaction with the decision making process at pre-operation, 6 month and 1 year
  4. Functional status at 6 month and 1 year

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00473096

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
U.S. Army Medical Research and Materiel Command
Principal Investigator: Maria L Jibaja Weiss, EdD Baylor College of Medicine