Clinical trial NCT06927895: Breast Cancer Implementation Science Study With Educational Intervention
Official title: Patient-Centered Care-Improving the Patient Experience in the Management of Adverse Events (AEs) Associated With Antibody Drug Conjugates (ADCs)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
name: Kaplan North America
First posted: 2025-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Primary outcomes:
measure: Decisional Conflict Scale (DCS) Score
timeFrame: Baseline
measure: Decisional Conflict Scale (DCS) Score
timeFrame: Month 3
measure: Decisional Conflict Scale (DCS) Score
timeFrame: Month 6
measure: Patient HER2-Targeted ADC Related Side Effect Pre-Test Score
timeFrame: Baseline
measure: Patient HER2-Targeted ADC Related Side Effect Post-Test Score
timeFrame: Month 3
measure: Patient HER2-Targeted ADC Related Side Effect Post-Test Score
timeFrame: Month 6
measure: Clinician HER2-Targeted ADC Related Side Effect Pre-Test Score
timeFrame: Baseline
measure: Clinician HER2-Targeted ADC Related Side Effect Post-Test Score
timeFrame: Month 3
measure: Clinician HER2-Targeted ADC Related Side Effect Post-Test Score
timeFrame: Month 6
Secondary outcomes:
measure: Self-Efficacy for Managing Chronic Disease Score
timeFrame: Baseline
measure: Self-Efficacy for Managing Chronic Disease Score
timeFrame: Month 3
measure: Self-Efficacy for Managing Chronic Disease Score
timeFrame: Month 6
measure: Patient Satisfaction Assessment Score
timeFrame: Month 3
measure: Patient Satisfaction Assessment Score
timeFrame: Month 6
measure: Clinician Satisfaction Assessment Score
timeFrame: Month 3
measure: Clinician Satisfaction Assessment Score
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nancy Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: