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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informed breast cancer surgical treatment
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Neoplasms focused on measuring Decision making, Patient Education, Indigency, Minority group

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Baylor College of Medicine

Outcomes

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

Full Information

First Posted
May 11, 2007
Last Updated
February 26, 2020
Sponsor
Baylor College of Medicine
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT00473096
Brief Title
Efficacy Study of an Educational Program for Decision Support for Breast Cancer
Acronym
H-6019
Official Title
Assessing the Efficacy of a CDSS for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Decision making, Patient Education, Indigency, Minority group

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Informed breast cancer surgical treatment
Primary Outcome Measure Information:
Title
Treatment decisions more consistent with preferences (utilities)at pre-operation
Title
Breast cancer treatment knowledge at 6 month and 1 year
Title
Certainty about treatment choice at pre-operation
Secondary Outcome Measure Information:
Title
Satisfaction with decision at the pre-operation, 6 month and 1 year
Title
Preferences for decision making at pre-operation
Title
Satisfaction with the decision making process at pre-operation, 6 month and 1 year
Title
Functional status at 6 month and 1 year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria L Jibaja Weiss, EdD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16911136
Citation
Jibaja-Weiss ML, Volk RJ, Friedman LC, Granchi TS, Neff NE, Spann SJ, Robinson EK, Aoki N, Robert Beck J. Preliminary testing of a just-in-time, user-defined values clarification exercise to aid lower literate women in making informed breast cancer treatment decisions. Health Expect. 2006 Sep;9(3):218-31. doi: 10.1111/j.1369-7625.2006.00386.x.
Results Reference
result
PubMed Identifier
17371175
Citation
Jibaja-Weiss ML, Volk RJ, Granch TS, Nefe NE, Spann SJ, Aoki N, Robinson EK, Freidman LC, Beck JR. Entertainment education for informed breast cancer treatment decisions in low-literate women: development and initial evaluation of a patient decision aid. J Cancer Educ. 2006 Fall;21(3):133-9. doi: 10.1207/s15430154jce2103_8.
Results Reference
result

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

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