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

Plain English Summary

Breast Cancer Implementation Science Study With Educational Intervention is a Not Applicable clinical trial sponsored by NYU Langone Health studying Breast Cancer. This study tests a new educational program for doctors and patients to better manage side effects from certain breast cancer drugs. It is for patients with HER2-positive or HER2-low breast cancer who are starting or are on specific targeted therapies. Patients will attend virtual visits, complete surveys, and may participate in interviews. Doctors will also receive training and participate in study activities. Alternatives include standard care and discussing side effect management with your doctor without this specific educational intervention. The trial aims to enroll 30 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients must be 18 or older with HER2+ or HER2-low breast cancer, starting or on specific targeted drugs. Patients need to be able to understand English, use a computer/tablet for surveys and training, and attend virtual visits. Patients with a history of noncompliance, significant cognitive impairment, or certain limiting health conditions may not be eligible. Doctors treating these patients are also invited to participate in the educational program. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study measures how well patients understand and feel confident making decisions about their treatment and managing side effects after receiving the educational intervention. The specific primary outcome measures are: Decisional Conflict Scale (DCS) Score (Baseline); Decisional Conflict Scale (DCS) Score (Month 3); Decisional Conflict Scale (DCS) Score (Month 6); Patient HER2-Targeted ADC Related Side Effect Pre-Test Score (Baseline); Patient HER2-Targeted ADC Related Side Effect Post-Test Score (Month 3). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to improve how doctors and patients communicate about and manage side effects from advanced breast cancer treatments, filling a gap in patient-centered care during complex therapy. This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This study focuses on improving patient experience with a specific class of cancer drugs, indicating a need for better supportive care in a growing oncology market.

Is This Trial Right for Me?

Ask your doctor if this study is right for you and what participation involves. Be prepared to attend virtual visits and complete online surveys and training modules. Understand that some patients may be asked to participate in interviews or focus groups. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 30 participants

Interventions

• 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: 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

Primary Outcomes

• Decisional Conflict Scale (DCS) Score (Baseline)
• Decisional Conflict Scale (DCS) Score (Month 3)
• Decisional Conflict Scale (DCS) Score (Month 6)
• Patient HER2-Targeted ADC Related Side Effect Pre-Test Score (Baseline)
• Patient HER2-Targeted ADC Related Side Effect Post-Test Score (Month 3)

Secondary Outcomes

• Self-Efficacy for Managing Chronic Disease Score (Baseline)
• Self-Efficacy for Managing Chronic Disease Score (Month 3)
• Self-Efficacy for Managing Chronic Disease Score (Month 6)
• Patient Satisfaction Assessment Score (Month 3)
• Patient Satisfaction Assessment Score (Month 6)

Full 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.

Trial Locations

• NYU Langone Health, New York, New York, United States

Frequently Asked Questions

Related Conditions

• Breast Cancer
• HER2-positive Breast Cancer
• HER2-low Breast Cancer
• Metastatic Breast Cancer
• Oncology
• Cancer Treatment
• Adverse Event Management
• Patient Education
• Shared Decision-Making
• Targeted Therapy

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