Efficacy Study of an Educational Program for Decision Support for Breast Cancer
H-6019
Assessing the Efficacy of a CDSS for Breast Cancer
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 11, 2007
CompletedFirst Posted
Study publicly available on registry
May 14, 2007
CompletedFebruary 28, 2020
February 1, 2020
6 years
May 11, 2007
February 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- Female
- Breast cancer diagnosis in stages I, IIA, IIB, or IIIA
- Candidates for surgery
- Speak English or Spanish
You may not qualify if:
- Breast cancer diagnosis in stages 0, IIIB, or IV
- Recurrent breast cancer or inflammatory breast carcinoma
- Not eligible for lumpectomy with radiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 16911136RESULTJibaja-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.
PMID: 17371175RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria L Jibaja Weiss, EdD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Duncan Cancer Center
Study Record Dates
First Submitted
May 11, 2007
First Posted
May 14, 2007
Study Start
October 1, 2000
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
February 28, 2020
Record last verified: 2020-02