HER2+ Breast Cancer Neo-Adjuvant Coordination of Care Program
NCT ID: NCT02616133
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
30 participants
OBSERVATIONAL
2016-01-31
2017-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma
NCT02156648
Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery
NCT03188393
(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer
NCT02627703
Evaluation of the DCIS Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
NCT02766881
Implementation of a Web-based Decision Aid for Breast Cancer Surgery
NCT03304002
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
chart abstraction
abstraction of breast cancer patients with de-identified data
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Linda Sutton, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marquette General Hospital
Marquette, Michigan, United States
DLP Maria Parham Medical Center
Henderson, North Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Augusta Health
Fishersville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00064108
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.