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Patient-Centered Care-Improving the Patient Experience in the Management of Adverse Events (AEs) Associated With Antibody Drug Conjugates (ADCs)

NCT ID: NCT06927895Sponsor: NYU Langone HealthLast updated: 2026-03-30

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.

Arms & interventions

  • BehavioralEducational 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: 1. SDM methodologies (\~30 minutes) 2. Simulated case role play interactions between a standardized patient actor and clinician participant (\~60 minutes) 3. 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.

Outcome measures

Primary

  • 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Month 6

Secondary

  • Self-Efficacy for Managing Chronic Disease Score

    Time frame: Baseline

  • Self-Efficacy for Managing Chronic Disease Score

    Time frame: Month 3

  • Self-Efficacy for Managing Chronic Disease Score

    Time frame: Month 6

  • Patient Satisfaction Assessment Score

    Time frame: Month 3

  • Patient Satisfaction Assessment Score

    Time frame: Month 6

  • Clinician Satisfaction Assessment Score

    Time frame: Month 3

  • Clinician Satisfaction Assessment Score

    Time frame: Month 6

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

NYU Langone Health

New York, New York, 10016

Recruiting
Lucia Greco · Contact
718-687-8702Lucia.Greco@nyulangone.org
Nadia Chowdhury · Contact
347-327-4988Nadia.Chowdhury@nyulangone.org
Nancy Chan, MD · Principal Investigator