Clinical trial · Interventional
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)
NCT06927895CI-TRIAL-00106819recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adult Patients with HER2+/HER2 Low Breast Cancer
- description
- 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
- interventionNames
- Behavioral: Educational Intervention
- type
- EXPERIMENTAL
- label
- Clinicians in the Oncology Breast Department
- description
- 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
- interventionNames
- Behavioral: Educational Intervention
Primary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.