Education to improve side-effect recognition and management for people on HER2-targeted antibody–drug conjugates
Patient-Centered Care-Improving the Patient Experience in the Management of Adverse Events (AEs) Associated With Antibody Drug Conjugates (ADCs)
This program will test an educational intervention for adults with HER2+ or HER2-low breast cancer and their clinicians to help spot and manage side effects while on HER2-targeted antibody–drug conjugates.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06927895 on ClinicalTrials.gov |
What this trial studies
The project delivers structured educational interventions to both patients and clinicians aimed at improving recognition and management of treatment-related adverse effects for people with HER2+ or HER2-low breast cancer who are starting or receiving HER2-targeted ADCs. Interventions include patient training, clinician education in shared decision-making, and use of a HIPAA-compliant Intelligent Dashboard for survey entry and monitoring, with most activities conducted virtually. Outcomes are measured across three visits (which can be virtual) using patient surveys, clinician-reported data, and for a subset, interviews and a focus group to capture implementation barriers and facilitators. Clinicians agree to follow their own patients through the protocol to reduce inter-clinician variability and better observe the effects of the educational program.
Who should consider this trial
Good fit: Adults (≥18) with confirmed HER2+ or HER2-low breast cancer who are receiving or about to receive HER2-targeted ADCs, can read and speak English, have internet access and a device to enter survey data and complete training, and are willing to complete three visits and study surveys.
Not a fit: Patients not receiving HER2-targeted ADCs, those who cannot read or interact in English, lack internet access or a device, or are unable to consent or participate in virtual visits are unlikely to receive benefit from this program.
Why it matters
Potential benefit: If successful, the intervention could help patients and clinicians spot side effects earlier, improve communication, and reduce preventable complications from HER2-targeted ADCs.
How similar studies have performed: Previous educational and implementation studies in oncology have improved adverse-event recognition and patient–clinician communication, but few have specifically targeted HER2-directed ADCs or combined patient and clinician training in this way.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Nancy Chan, MD — NYU Langone Health
- Study coordinator: Lucia Greco
- Email: Lucia.Greco@nyulangone.org
- Phone: 718-687-8702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.