Breast Cancer Implementation Science Study With Educational Intervention

NCT ID: NCT06927895

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2025-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: 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.

Interventions

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:

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥ 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

• 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

• 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

• Inability to participate in required virtual visits, training, assessments, and other protocol requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Kaplan North America

UNKNOWN

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Chan, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Central Contacts

Lucia Greco

Role: CONTACT

Lucia.Greco@nyulangone.org

718-687-8702

Nadia Chowdhury

Role: CONTACT

nadia.chowdhury@nyulangone.org

347-327-4988

Facility Contacts

Lucia Greco

Role: primary

Lucia.Greco@nyulangone.org

718-687-8702

Nadia Chowdhury

Role: backup

Nadia.Chowdhury@nyulangone.org

347-327-4988

Other Identifiers

24-00449

Identifier Type: -

Identifier Source: org_study_id