There Is No Place Like Home- A Pragmatic Effectiveness Trial of Technology-Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Rate of acute care visits
研究概览
简要总结
This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.
详细描述
PRIMARY OBJECTIVE:
I. Determine the efficacy of remote patient monitoring (RPM) on improving clinical outcomes.
SECONDARY OBJECTIVE:
I. Evaluate the following patient-centered outcomes: treatment delays, health-related quality-of-life (HRQOL), patient activation, and family caregiver-experience.
OUTLINE: Patients are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Adults (≥ 18 years)
- •English- and Spanish-fluent participants with thoracic and/or gastrointestinal cancers who are scheduled to initiate or continue outpatient chemotherapy at either MDACC (Texas Medical Center campus and any Houston-area location) or MDACC oncology clinic at Lyndon B Johnson (LBJ) hospital
- •Their adult (≥18 years) patient-identified or self-identified primary caregivers (MDACC only)
- •Participants on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion.
- •Participants may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers of MDACC participants may participate only if the participant consents.
排除标准
- •Participants who are receiving investigational new drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements.
- •Participants with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison, nursing homes), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded.
研究组 & 干预措施
Arm I (standard of care)
Patients receive standard of care consisting of oncology care provided via telemedicine.
干预措施: Best Practice (Other)
Arm I (standard of care)
Patients receive standard of care consisting of oncology care provided via telemedicine.
干预措施: Questionnaire Administration (Other)
Arm II (standard of care, remote monitoring)
Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
干预措施: Best Practice (Other)
Arm II (standard of care, remote monitoring)
Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
干预措施: Patient Monitoring (Procedure)
Arm II (standard of care, remote monitoring)
Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
干预措施: Questionnaire Administration (Other)
Arm III (standard of care, remote monitoring, biometrics)
Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.
干预措施: Best Practice (Other)
Arm III (standard of care, remote monitoring, biometrics)
Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.
干预措施: Patient Monitoring (Procedure)
Arm III (standard of care, remote monitoring, biometrics)
Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Rate of acute care visits
时间窗: Up to 3 months
Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period.
次要结局
- Change in health-related quality of life (HRQOL)(Baseline to 6 months)
- Change in patient engagement(Baseline to 6 months)
- Change in symptom management(Baseline to 6 months)