Breast Cancer Implementation Science Study With Educational Intervention

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06927895
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Decisional Conflict Scale (DCS) Score	Month 6	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.
Patient HER2-Targeted ADC Related Side Effect Pre-Test Score	Baseline	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.
Patient HER2-Targeted ADC Related Side Effect Post-Test Score	Month 6	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.
Clinician HER2-Targeted ADC Related Side Effect Pre-Test Score	Baseline	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.
Clinician HER2-Targeted ADC Related Side Effect Post-Test Score	Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Self-Efficacy for Managing Chronic Disease Score	Month 6	6-item assessment of a person's confidence in performing different tasks with a chronic disease. Each item is rated on a Likert scale from 1 (not at all confident) to 10 (completely confident). The score is calculated as the average of responses; the total score ranges from 1-10; higher scores indicate greater self-efficacy in managing chronic disease. Assessed among patients only.
Patient Satisfaction Assessment Score	Month 6	4-item assessment of patient satisfaction with the program. Each item is rated on a scale from 0-100; the total score is the average of responses and ranges from 0-100; higher scores indicate greater patient satisfaction.
Clinician Satisfaction Assessment Score	Month 6	1-item assessment of clinician satisfaction with the program. The item is rated on a scale from 0-100; the total score is the item response and ranges from 0-100; higher scores indicate greater clinician satisfaction.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States