Breast Cancer Implementation Science Study With Educational Intervention

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Decisional Conflict Scale (DCS) Score [Срок оценки: Baseline]
• Decisional Conflict Scale (DCS) Score [Срок оценки: Month 3]
• Decisional Conflict Scale (DCS) Score [Срок оценки: Month 6]
• Patient HER2-Targeted ADC Related Side Effect Pre-Test Score [Срок оценки: Baseline]
• Patient HER2-Targeted ADC Related Side Effect Post-Test Score [Срок оценки: Month 3]
• Patient HER2-Targeted ADC Related Side Effect Post-Test Score [Срок оценки: Month 6]
• Clinician HER2-Targeted ADC Related Side Effect Pre-Test Score [Срок оценки: Baseline]
• Clinician HER2-Targeted ADC Related Side Effect Post-Test Score [Срок оценки: Month 3]
• Clinician HER2-Targeted ADC Related Side Effect Post-Test Score [Срок оценки: Month 6]

Вторичные конечные точки (7)

• Self-Efficacy for Managing Chronic Disease Score [Срок оценки: Baseline]
• Self-Efficacy for Managing Chronic Disease Score [Срок оценки: Month 3]
• Self-Efficacy for Managing Chronic Disease Score [Срок оценки: Month 6]
• Patient Satisfaction Assessment Score [Срок оценки: Month 3]
• Patient Satisfaction Assessment Score [Срок оценки: Month 6]
• Clinician Satisfaction Assessment Score [Срок оценки: Month 3]
• Clinician Satisfaction Assessment Score [Срок оценки: Month 6]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06927895 · 24-00449

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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