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

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00473096
First received: May 11, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 Intervention
Breast Neoplasms
Behavioral: Informed breast cancer surgical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Assessing the Efficacy of a CDSS for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 100
Study Start Date: October 2000
Estimated Study Completion Date: September 2004
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473096

Locations
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
Investigators
Principal Investigator: Maria L Jibaja Weiss, EdD Baylor College of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00473096     History of Changes
Other Study ID Numbers: DAMD17-98-1-8022
Study First Received: May 11, 2007
Last Updated: May 11, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Decision making
Patient Education
Indigency
Minority group

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014