Status:
NOT_YET_RECRUITING
Breast Cancer Implementation Science Study With Educational Intervention
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Daiichi Sankyo
Kaplan North America
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A study uniquely focused on system-based practice change, measuring the impact of educational interventions on both patients and clinicians for the recognition and management of treatment-related adve...
Eligibility Criteria
Inclusion
- Inclusion Criteria, PATIENT participant group:
- ≥ 18 years of age
- Confirmed diagnosis of HER2+ or HER2 low breast cancer who are receiving or are about to receive HER2-targeted antibody drug conjugates (ADCs)
- Patient must be able to sign informed consent and be willing to participate in and comply with protocol requirements (3 visits \[can be virtual\], entry of survey information, access training, subset: 2 interviews and focus group) \[All Virtual\]
- Patient must be able to read, speak, and understand English
- Access to or ability to 1) enter information on computer or iPad into HIPAA-compliant Intelligent Dashboard online database; and 2) access training on computer or iPad
- Inclusion Criteria, CLINICIAN participant group:
- Clinician agrees to see their own patients at study visits (baseline, interim time point, and end of study) in order to reduce inter-clinician variability that can affect result findings (observe effect of clinician's education on their patients' learning.)
- Clinician is a physician, NP, physician assistant, nurse, or pharmacist who works with patients with HER2-positive or HER2-low breast cancer.
- Clinician must be willing to participate in and comply with protocol requirements and provide informed consent (per IRB requirements), including availability for interviews (3), case role plays (3), patient visits (3/patient), and training
- Clinician agrees to access virtual online training videos: SDM, simulation case role play, management of adverse events for patients receiving HER2-targeted ADCs for HER2-positive or HER2-low breast cancer
- Exclusion Criteria, PATIENT participant group:
- History of noncompliance
- Inability to make required "office visits" (in-person or virtual)
- Inability to participate in training
- Non-ambulatory
- Limiting comorbidities (eg. psychiatric diagnosis; significant cognitive impairment limiting ability to fulfill protocol requirements)
- Pregnant patients
- No internet and computer access
- Exclusion Criteria, CLINICIAN participant group:
- • Inability to participate in required virtual visits, training, assessments, and other protocol requirements.
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06927895
Start Date
April 1 2025
End Date
December 1 2025
Last Update
April 15 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016