Breast Cancer Implementation Science Study With Educational Intervention
Patient-Centered Care-Improving the Patient Experience in the Management of Adverse Events (AEs) Associated With Antibody Drug Conjugates (ADCs)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether education helps patients and care teams spot and manage treatment side effects, make decisions together, and communicate better. It is for people with HER2-positive or HER2-low breast cancer who take or will start certain HER2-targeted drugs, and the clinicians who care for them. HER2 is a protein that helps cancer cells grow.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients: Be at least 18 years old.
- Patients: Have confirmed HER2-positive or HER2-low breast cancer and take or plan to start a HER2-targeted antibody-drug conjugate, a drug that carries cancer medicine to targeted cells.
- Patients: Be able to give written consent and agree to 3 visits, surveys, and training. Some patients also join 2 interviews and a group discussion. These activities are virtual.
- Patients: Be able to read, speak, and understand English.
- Patients: Be able to use a computer or iPad to enter study information online and complete training.
- Clinicians: Be a doctor, nurse practitioner, physician assistant, nurse, or pharmacist who works with HER2-positive or HER2-low breast cancer patients.
- Clinicians: Give consent and agree to training, 3 interviews, 3 practice role-plays, and 3 study visits per patient. See your own patients at those visits.
- Clinicians: Agree to online training about making decisions with patients, practice cases, and managing side effects of HER2-targeted antibody-drug conjugates.
Who can't join
- Patients: Have a history of not following care or study requirements.
- Patients: Cannot attend required visits, either in person or online.
- Patients: Cannot take part in training.
- Patients: Cannot walk.
- Patients: Have other health conditions that limit participation, such as a mental health condition or serious trouble thinking or remembering.
- Patients: Are pregnant.
- Patients: Lack internet and computer access.
- Clinicians: Cannot complete required virtual visits, training, assessments, or other study tasks.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
NY
- NYU Langone Health · New York, NY 10016Lucia Greco · Study contact · 718-687-8702 · Lucia.Greco@nyulangone.orgNadia Chowdhury · Study contact · 347-327-4988 · Nadia.Chowdhury@nyulangone.orgNancy Chan, MD · Principal investigatorMore trials in New York