Breast CancerCECityNCT02616133
HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program
An observational study of Breast Cancer, run by Duke University at 4 sites in United States.
Trial summary
Currently many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by a medical oncologist for neo-adjuvant treatment due to the current lack of care coordination between the surgeon/surgical oncologist and the medical oncologists. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- chart abstraction
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to 31 Mar 2017
- Phase
- Observational
- 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
Study population: Identified patient with breast cancer
Who may be able to join
- diagnosis of breast cancer
Who cannot join
- no diagnosis of breast cancer
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Augusta Health
Fishersville, Virginia
DLP Maria Parham Medical Center
Henderson, North Carolina, 27536
Marquette General Hospital
Marquette, Michigan, 49855
Lexington Medical Center
West Columbia, South Carolina, 29169
About this study
Currently many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by a medical oncologist for neo-adjuvant treatment due to the current lack of care coordination between the surgeon/surgical oncologist and the medical oncologists.
This project will evaluate the feasibility to enhance knowledge that drives adoption of evidence based care, and evaluate the improvement in care coordination between oncologists and surgeons for patients with HER2+ Breast Cancer in the Neo-Adjuvant setting.
Read the detailed description
The HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program will evaluate the feasibility, effectiveness, and adoption of evidence based medicine for patients with HER2+ breast cancer through a care coordination application hosted on CECity's MedConcert™ platform. The goal is to implement evidence into practice using existing patient data, and to improve care based on knowledge that will enable care coordination between medical oncologists and surgeons.
PHASE 1: Workflow Design The steering committee from Duke has created a workflow process related to the HER2+ Neo-Adjuvant Therapy Treatment. The goal of the workflow is to establish a coordinated approach to care and identifying key steps in the process. The workflow will identify if the patient had a timely engagement of the multidisciplinary team; if a pre-treatment assessment was performed; if neo-adjuvant therapy treatment was prescribed; if appropriate management and adherence to treatment as prescribed occurred; if surgery was performed and the identification of the type of surgery; and if any subsequent therapy was prescribed. Data collection will be performed at each of the steps in the workflow.
PHASE 2: Engagement Three sites were identified to participate in the project. Each is affiliated with the Duke Cancer Network and are free standing hospital systems and clinics. A coordinator will be designated at each site to guide the process, enter data and communicate patient progress to the sites multidisciplinary project team. Routine communication will be maintained between each site and the project team to ensure timely resolution of any issues or to answer questions.
PHASE 3: Feedback Performance measures have been identified for which data will be collected and aggregated. The data will be displayed in a performance monitor in the CECity MedConcert™ application to provide feedback to providers on their performance related to the measures. Providers will also be provided access to educational resources and improvement opportunities through the application.
PHASE 4: Assessment of Change and Dissemination of Findings Currently, many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by an oncologist for neo-adjuvant treatment because of a lack of coordinated care between surgeons and oncologists. This project will evaluate adopting evidence-based medicine for patients with HER2+ through the use of a coordinated care application. The goal is to facilitate greater coordination of care between oncologists and surgeons and to identify interventions for improved care. A final report will outline the results of the coordinated care approach. The results of this QI initiative will be developed into a manuscript for publication.
- Conditions
- Breast Cancer
- Being tested
- chart abstraction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chart abstractionOther
abstraction of breast cancer patients with de-identified data
What is being measured
The primary outcome is the main question the study is designed to answer.
Coordination of Care efforts evaluation score
Multiple measurements will be aggregated from across study sites to evaluate coordination of care efforts across different disciplines involved in the care of a breast cancer patient.This evaluation will result in the formation of a multidisciplinary approach to care for breast cancer subjects.
Measured: 6 months to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Sutton, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616133
- Sponsor's protocol ID
- Pro00064108
- Acronym
- CECity
- Status last verified
- Feb 2017
- First submitted
- 9 Nov 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program
- ClinicalTrials.gov ID
- NCT02616133
- Acronym / sponsor ID
- CECity / Pro00064108
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 26 Nov 2015 (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.
Currently many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by a medical oncologist for neo-adjuvant treatment due to the current lack of care coordination between the surgeon/surgical oncologist and the medical oncologists.
This project will evaluate the feasibility to enhance knowledge that drives adoption of evidence based care, and evaluate the improvement in care coordination between oncologists and surgeons for patients with HER2+ Breast Cancer in the Neo-Adjuvant setting.
Detailed description
The HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program will evaluate the feasibility, effectiveness, and adoption of evidence based medicine for patients with HER2+ breast cancer through a care coordination application hosted on CECity's MedConcert™ platform. The goal is to implement evidence into practice using existing patient data, and to improve care based on knowledge that will enable care coordination between medical oncologists and surgeons.
PHASE 1: Workflow Design The steering committee from Duke has created a workflow process related to the HER2+ Neo-Adjuvant Therapy Treatment. The goal of the workflow is to establish a coordinated approach to care and identifying key steps in the process. The workflow will identify if the patient had a timely engagement of the multidisciplinary team; if a pre-treatment assessment was performed; if neo-adjuvant therapy treatment was prescribed; if appropriate management and adherence to treatment as prescribed occurred; if surgery was performed and the identification of the type of surgery; and if any subsequent therapy was prescribed. Data collection will be performed at each of the steps in the workflow.
PHASE 2: Engagement Three sites were identified to participate in the project. Each is affiliated with the Duke Cancer Network and are free standing hospital systems and clinics. A coordinator will be designated at each site to guide the process, enter data and communicate patient progress to the sites multidisciplinary project team. Routine communication will be maintained between each site and the project team to ensure timely resolution of any issues or to answer questions.
PHASE 3: Feedback Performance measures have been identified for which data will be collected and aggregated. The data will be displayed in a performance monitor in the CECity MedConcert™ application to provide feedback to providers on their performance related to the measures. Providers will also be provided access to educational resources and improvement opportunities through the application.
PHASE 4: Assessment of Change and Dissemination of Findings Currently, many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by an oncologist for neo-adjuvant treatment because of a lack of coordinated care between surgeons and oncologists. This project will evaluate adopting evidence-based medicine for patients with HER2+ through the use of a coordinated care application. The goal is to facilitate greater coordination of care between oncologists and surgeons and to identify interventions for improved care. A final report will outline the results of the coordinated care approach. The results of this QI initiative will be developed into a manuscript for publication.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Identified patient with breast cancer
Key inclusion criteria (1 listed)
- diagnosis of breast cancer
Key exclusion criteria (1 listed)
- no diagnosis of breast cancer
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 |
|---|---|---|
| chart abstractionabstraction of breast cancer patients with de-identified data | Other | – |
Primary outcome
Coordination of Care efforts evaluation score
Time frame: 6 months to one year
Multiple measurements will be aggregated from across study sites to evaluate coordination of care efforts across different disciplines involved in the care of a breast cancer patient.This evaluation will result in the formation of a multidisciplinary approach to care for breast cancer subjects.
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 2 Jul 2017.
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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.
Linda Sutton, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Duke University at 4 sites 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 1 inclusion and 1 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Coordination of Care efforts evaluation score (time frame: 6 months to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.