Recruiting

HER2 Targeted TherapyBreast Cancer Implementation Science Study With Educational Intervention

Sponsor:

NYU Langone Health

Code:

NCT06927895

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Educational Intervention

Study Details

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 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.

Conditions

Breast Cancer

Study ID

NCT06927895

Start date

Jul 3, 2025

Status verified date

Mar, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

Educational Intervention

The research-specific educational intervention is the enhancement of communications and SDM in AE management.

To this end, interventions will include pre-recorded videos that address:

1. SDM methodologies (\~30 minutes)
2. Simulated case role play interactions between a standardized patient actor and clinician participant (\~60 minutes)
3. In depth presentation on AEs associated with HER2-targeted ADC treatments, and the management of these AEs (\~45 minutes)

Clinician participant educational intervention videos and patient participant educational intervention videos will be slightly different, as they are each presented from their specific perspectives.

Primary outcome measure

Decisional Conflict Scale (DCS) Score [ Time Frame: Baseline ]
Decisional Conflict Scale (DCS) Score [ Time Frame: Month 3 ]
Decisional Conflict Scale (DCS) Score [ Time Frame: Month 6 ]
Patient HER2-Targeted ADC Related Side Effect Pre-Test Score [ Time Frame: Baseline ]
Patient HER2-Targeted ADC Related Side Effect Post-Test Score [ Time Frame: Month 3 ]
Patient HER2-Targeted ADC Related Side Effect Post-Test Score [ Time Frame: Month 6 ]
Clinician HER2-Targeted ADC Related Side Effect Pre-Test Score [ Time Frame: Baseline ]
Clinician HER2-Targeted ADC Related Side Effect Post-Test Score [ Time Frame: Month 3 ]
Clinician HER2-Targeted ADC Related Side Effect Post-Test Score [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Lucia Greco

718-687-8702 Lucia.Greco@nyulangone.org

Nadia Chowdhury

347-327-4988 nadia.chowdhury@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Lucia Greco

718-687-8702 Lucia.Greco@nyulangone.org

Nadia Chowdhury

347-327-4988 Nadia.Chowdhury@nyulangone.org

Principal Investigator:

Nancy Chan, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-30.