Breast Cancer Implementation Science Study With Educational Intervention

NYU Langone Health

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Educational Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06927895

24-00449

Details and patient eligibility

About

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 adverse effects for HER2+/HER2 low breast cancer patients on or about to start on HER2 targeted antibody drug conjugates (fam-trastuzumab deruxtecan-nxki or ado-trastuzumab emtansine) and shared decision-making methodologies to improve adverse event (AE) management and patient-clinician communications.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Adult Patients with HER2+/HER2 Low Breast Cancer

Experimental group

Description:

Participants will receive the following educational interventions: 1. Shared Decision Making (SDM) training video 2. Simulation case role play (patient-clinician interactions) training video 3. HER2-targeted ADC adverse effects and their management training video

Treatment:

Behavioral: Educational Intervention

Clinicians in the Oncology Breast Department

Experimental group

Description:

Participants will receive the following educational interventions: 1. Shared Decision Making (SDM) training video 2. Simulation case role play (patient-clinician interactions) training video 3. HER2-targeted ADC adverse effects and their management training video

Treatment:

Behavioral: Educational Intervention