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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
| Kaplan North America | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Patients with HER2+/HER2 Low Breast Cancer | Experimental | Participants will receive the following educational interventions:
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| Clinicians in the Oncology Breast Department | Experimental | Participants will receive the following educational interventions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | 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:
Clinician participant educational intervention videos and patient participant educational intervention videos will be slightly different, as they are each presented from their specific perspectives. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria, PATIENT participant group:
Inclusion Criteria, CLINICIAN participant group:
Exclusion Criteria, PATIENT participant group:
Exclusion Criteria, CLINICIAN participant group:
• Inability to participate in required virtual visits, training, assessments, and other protocol requirements.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Greco | Contact | 718-687-8702 | Lucia.Greco@nyulangone.org | |
| Nadia Chowdhury | Contact | 347-327-4988 | nadia.chowdhury@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Nancy Chan, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
We will not be sharing Individual Participant Data, deidentified or otherwise, with any other researchers. The study design includes only deidentified, aggregate reporting.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| 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. | 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. | 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. | 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. | Month 6 |
| 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. | 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. | 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. | 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. | 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. | 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. | Month 6 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011314 | Preventive Health Services |