Breast Cancer Implementation Science Study With Educational Intervention

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06927895
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Educational Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 3, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Adult Patients with HER2+/HER2 Low Breast Cancer
    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
  • Experimental: Clinicians in the Oncology Breast Department
    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

Primary Outcome Measure

Decisional Conflict Scale (DCS) Score [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Lucia Greco
[email protected]
718-687-8702
Nadia Chowdhury
[email protected]
347-327-4988
Nancy Chan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
NYU Langone Health· New York, NY

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