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Patient-Centered Care-Improving the Patient Experience in the Management of Adverse Events (AEs) Associated With Antibody Drug Conjugates (ADCs)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

• 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

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Lucia Greco
Lucia.Greco@nyulangone.org
718-687-8702
Backup
Nadia Chowdhury
nadia.chowdhury@nyulangone.org
347-327-4988
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 30
Treatments
Experimental: Adult Patients with HER2+/HER2 Low Breast Cancer
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
Experimental: Clinicians in the Oncology Breast Department
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
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: Kaplan North America, Daiichi Sankyo

This content was sourced from clinicaltrials.gov