NCT06927895 Breast Cancer Implementation Science Study With Educational Intervention
| NCT ID | NCT06927895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-07-03 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Nancy Chan, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06927895 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06927895 currently recruiting?
Yes, NCT06927895 is actively recruiting participants. Contact the research team at Lucia.Greco@nyulangone.org for enrollment information.
Where is the NCT06927895 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06927895 clinical trial?
NCT06927895 is sponsored by NYU Langone Health. The principal investigator is Nancy Chan, MD at NYU Langone Health. The trial plans to enroll 30 participants.
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