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)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Educational Intervention

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucia Greco; Phone Number: 718-687-8702; Email: lucia.greco@nyulangone.org
• Study Contact Backup: Name: Nadia Chowdhury; Phone Number: 347-327-4988; Email: nadia.chowdhury@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: Nancy Chan, MD
      • Contact: Lucia Greco; Phone Number: 718-687-8702; Email: lucia.greco@nyulangone.org
      • Contact: Nadia Chowdhury; Phone Number: 347-327-4988; Email: nadia.chowdhury@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult Patients with HER2+/HER2 Low Breast Cancer; Participants will receive the following educational interventions: Shared Decision Making (SDM) training video; Simulation case role play (patient-clinician interactions) training video; HER2-targeted ADC adverse effects and their management training video	Behavioral: Educational Intervention; The research-specific educational intervention is the enhancement of communications and SDM in AE management. To this end, interventions will include pre-recorded videos that address: SDM methodologies (~30 minutes); Simulated case role play interactions between a standardized patient actor and clinician participant (~60 minutes); In depth presentation on AEs associated with HER2-targeted ADC treatments, and the management of these AEs (~45 minutes) Clinician participant educational intervention videos and patient participant educational intervention videos will be slightly different, as they are each presented from their specific perspectives.
Experimental: Clinicians in the Oncology Breast Department; Participants will receive the following educational interventions: Shared Decision Making (SDM) training video; Simulation case role play (patient-clinician interactions) training video; HER2-targeted ADC adverse effects and their management training video	Behavioral: Educational Intervention; The research-specific educational intervention is the enhancement of communications and SDM in AE management. To this end, interventions will include pre-recorded videos that address: SDM methodologies (~30 minutes); Simulated case role play interactions between a standardized patient actor and clinician participant (~60 minutes); In depth presentation on AEs associated with HER2-targeted ADC treatments, and the management of these AEs (~45 minutes) Clinician participant educational intervention videos and patient participant educational intervention videos will be slightly different, as they are each presented from their specific perspectives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Conflict Scale (DCS) Score	16-item assessment of a person's uncertainty in making a healthcare choice. Each item is rated on a 5-point Likert scale from 0 (strongly agree) to 4 (strongly disagree). The total score is the sum of responses and ranges from 0-64; lower scores indicate less uncertainty. Assessed among patients only.	Baseline
Decisional Conflict Scale (DCS) Score	16-item assessment of a person's uncertainty in making a healthcare choice. Each item is rated on a 5-point Likert scale from 0 (strongly agree) to 4 (strongly disagree). The total score is the sum of responses and ranges from 0-64; lower scores indicate less uncertainty. Assessed among patients only.	Month 3
Decisional Conflict Scale (DCS) Score	16-item assessment of a person's uncertainty in making a healthcare choice. Each item is rated on a 5-point Likert scale from 0 (strongly agree) to 4 (strongly disagree). The total score is the sum of responses and ranges from 0-64; lower scores indicate less uncertainty. Assessed among patients only.	Month 6
Patient HER2-Targeted ADC Related Side Effect Pre-Test Score	6 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 4 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-4 and (b) responses to items 5-6. The total score ranges from 2-14; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.	Baseline
Patient HER2-Targeted ADC Related Side Effect Post-Test Score	6 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 4 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-4 and (b) responses to items 5-6. The total score ranges from 2-14; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.	Month 3
Patient HER2-Targeted ADC Related Side Effect Post-Test Score	6 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 4 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-4 and (b) responses to items 5-6. The total score ranges from 2-14; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.	Month 6
Clinician HER2-Targeted ADC Related Side Effect Pre-Test Score	7 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 5 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-5 and (b) responses to items 6-7. The total score ranges from 2-15; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.	Baseline
Clinician HER2-Targeted ADC Related Side Effect Post-Test Score	7 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 5 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-5 and (b) responses to items 6-7. The total score ranges from 2-15; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.	Month 3
Clinician HER2-Targeted ADC Related Side Effect Post-Test Score	7 questions assessing ability to recognize HER2-targeted ADC-related AEs and how they are managed. 5 items are multiple choice questions with (1) correct answer. The final 2 items are rated on a Likert scale from 5 (Always) to 1 (Never). The score is calculated as the sum of (a) total correct answers to items 1-5 and (b) responses to items 6-7. The total score ranges from 2-15; higher scores indicate greater ability to recognize HER2-targeted ADC-related AEs and how they are managed.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy for Managing Chronic Disease Score	6-item assessment of a person's confidence in performing different tasks with a chronic disease. Each item is rated on a Likert scale from 1 (not at all confident) to 10 (completely confident). The score is calculated as the average of responses; the total score ranges from 1-10; higher scores indicate greater self-efficacy in managing chronic disease. Assessed among patients only.	Baseline
Self-Efficacy for Managing Chronic Disease Score	6-item assessment of a person's confidence in performing different tasks with a chronic disease. Each item is rated on a Likert scale from 1 (not at all confident) to 10 (completely confident). The score is calculated as the average of responses; the total score ranges from 1-10; higher scores indicate greater self-efficacy in managing chronic disease. Assessed among patients only.	Month 3
Self-Efficacy for Managing Chronic Disease Score	6-item assessment of a person's confidence in performing different tasks with a chronic disease. Each item is rated on a Likert scale from 1 (not at all confident) to 10 (completely confident). The score is calculated as the average of responses; the total score ranges from 1-10; higher scores indicate greater self-efficacy in managing chronic disease. Assessed among patients only.	Month 6
Patient Satisfaction Assessment Score	4-item assessment of patient satisfaction with the program. Each item is rated on a scale from 0-100; the total score is the average of responses and ranges from 0-100; higher scores indicate greater patient satisfaction.	Month 3
Patient Satisfaction Assessment Score	4-item assessment of patient satisfaction with the program. Each item is rated on a scale from 0-100; the total score is the average of responses and ranges from 0-100; higher scores indicate greater patient satisfaction.	Month 6
Clinician Satisfaction Assessment Score	1-item assessment of clinician satisfaction with the program. The item is rated on a scale from 0-100; the total score is the item response and ranges from 0-100; higher scores indicate greater clinician satisfaction.	Month 3
Clinician Satisfaction Assessment Score	1-item assessment of clinician satisfaction with the program. The item is rated on a scale from 0-100; the total score is the item response and ranges from 0-100; higher scores indicate greater clinician satisfaction.	Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Daiichi Sankyo; Kaplan North America
• Investigators: Principal Investigator: Nancy Chan, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Early Intervention, Educational
• Other Study ID Numbers: 24-00449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not be sharing Individual Participant Data, deidentified or otherwise, with any other researchers. The study design includes only deidentified, aggregate reporting.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No