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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
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.
NYU Langone Health
New York, New York, United States
RECRUITINGDecisional Conflict Scale (DCS) Score
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.
Time frame: Baseline
Decisional Conflict Scale (DCS) Score
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.
Time frame: Month 3
Decisional Conflict Scale (DCS) Score
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.
Time frame: Month 6
Patient HER2-Targeted ADC Related Side Effect Pre-Test Score
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.
Time frame: Baseline
Patient HER2-Targeted ADC Related Side Effect Post-Test Score
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.
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Time frame: Month 3
Patient HER2-Targeted ADC Related Side Effect Post-Test Score
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.
Time frame: Month 6
Clinician HER2-Targeted ADC Related Side Effect Pre-Test Score
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.
Time frame: Baseline
Clinician HER2-Targeted ADC Related Side Effect Post-Test Score
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.
Time frame: Month 3
Clinician HER2-Targeted ADC Related Side Effect Post-Test Score
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.
Time frame: Month 6
Self-Efficacy for Managing Chronic Disease Score
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.
Time frame: Baseline
Self-Efficacy for Managing Chronic Disease Score
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.
Time frame: Month 3
Self-Efficacy for Managing Chronic Disease Score
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.
Time frame: Month 6
Patient Satisfaction Assessment Score
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.
Time frame: Month 3
Patient Satisfaction Assessment Score
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.
Time frame: Month 6
Clinician Satisfaction Assessment Score
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.
Time frame: Month 3
Clinician Satisfaction Assessment Score
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.
Time frame: Month 6