Patient-Centered Care-Improving the Patient Experience in the Management of Adverse Events (AEs) Associated With Antibody Drug Conjugates (ADCs)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Decisional Conflict Scale (DCS) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •, 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
排除标准
- •, 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.
研究组 & 干预措施
Adult Patients with HER2+/HER2 Low Breast Cancer
Participants will receive the following educational interventions:
- Shared Decision Making (SDM) training video
- Simulation case role play (patient-clinician interactions) training video
- HER2-targeted ADC adverse effects and their management training video
干预措施: Educational Intervention (Behavioral)
Clinicians in the Oncology Breast Department
Participants will receive the following educational interventions:
- Shared Decision Making (SDM) training video
- Simulation case role play (patient-clinician interactions) training video
- HER2-targeted ADC adverse effects and their management training video
干预措施: Educational Intervention (Behavioral)
结局指标
主要结局
Decisional Conflict Scale (DCS) Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Decisional Conflict Scale (DCS) Score
时间窗: Baseline
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.
Decisional Conflict Scale (DCS) Score
时间窗: Month 3
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 Post-Test Score
时间窗: Month 3
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 Post-Test Score
时间窗: Month 3
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.
次要结局
- Self-Efficacy for Managing Chronic Disease Score(Month 6)
- Patient Satisfaction Assessment Score(Month 6)
- Clinician Satisfaction Assessment Score(Month 6)
- Self-Efficacy for Managing Chronic Disease Score(Baseline)
- Self-Efficacy for Managing Chronic Disease Score(Month 3)
- Patient Satisfaction Assessment Score(Month 3)
- Clinician Satisfaction Assessment Score(Month 3)