Breast NeoplasmsH-6019NCT00473096
Efficacy Study of an Educational Program for Decision Support for Breast Cancer
A study testing Informed breast cancer surgical treatment in people with Breast Neoplasms, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Informed breast cancer surgical treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female
- Breast cancer diagnosis in stages I, IIA, IIB, or IIIA
- Candidates for surgery
- Speak English or Spanish
Who cannot join
- Breast cancer diagnosis in stages 0, IIIB, or IV
- Recurrent breast cancer or inflammatory breast carcinoma
- Not eligible for lumpectomy with radiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Efficacy of a CDSS for Breast Cancer
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Informed breast cancer surgical treatment
- Keywords
- Decision making, Patient Education, Indigency, Minority group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed breast cancer surgical treatmentBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startOct 2000
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Maria Jibaja Weiss, Baylor College of Medicine
- Investigators
- Maria L Jibaja Weiss, EdD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473096
- Sponsor's protocol ID
- DAMD17-98-1-8022
- Acronym
- H-6019
- Status last verified
- Feb 2020
- First submitted
- 11 May 2007
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16911136Jibaja-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.
PubMed 17371175
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of a CDSS for Breast Cancer
- ClinicalTrials.gov ID
- NCT00473096
- Acronym / sponsor ID
- H-6019 / DAMD17-98-1-8022
- Conditions
- Breast Neoplasms
- Keywords
- Decision making, Patient Education, Indigency, Minority group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Oct 2000
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 14 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Breast cancer diagnosis in stages I, IIA, IIB, or IIIA
- Candidates for surgery
- Speak English or Spanish
Key exclusion criteria (3 listed)
- Breast cancer diagnosis in stages 0, IIIB, or IV
- Recurrent breast cancer or inflammatory breast carcinoma
- Not eligible for lumpectomy with radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informed breast cancer surgical treatment | Behavioural | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Results publication: PubMed 16911136Jibaja-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 publication: PubMed 17371175Jibaja-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria L Jibaja Weiss, EdD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informed breast cancer surgical treatment in people with Breast Neoplasms, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment decisions more consistent with preferences (utilities)at pre-operation. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00473096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.