Perioperative Telemonitoring to Optimize Cancer Care and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Patient Postoperative Complications Using the Comprehensive Complications Index (CCI)
研究概览
简要总结
This study aims to see whether an at-home monitoring program that collects health, symptoms, and quality of life data in real-time can be included as part of the care of surgery patients in order to provide better recovery. Patient-generated health data (weight, temperature, oxygen level, heart rate, blood pressure, daily steps, symptoms, quality of life) using at-home monitoring devices (thermometer, a pulse oximeter, a digital scale and a Vivofit 4 watch) and smart device applications are used more and more to measure value and quality in cancer care. However, measuring patient-generated health data is not currently part of standard care following cancer surgery. An at-home monitoring program may improve the care of patients after hospital discharge from surgery and may help reduce complications by identifying issues early.
详细描述
PRIMARY OBJECTIVE:
I. To conduct a pilot randomized trial of a remote, perioperative telemonitoring intervention to improve patient-centered outcomes, surgical outcomes, and healthcare resource use in English and Spanish-speaking patients scheduled to undergo major abdominal gastrointestinal (GI) cancer surgery.
Ia. Assess the feasibility, retention, and acceptability of the remote perioperative telemonitoring intervention as measured by the percentage of patients who a) agree to participate; b) complete >= 70% of the telemonitoring; and c) report satisfaction with the intervention through structured exit interviews.
Ib. Determine the preliminary efficacy of the remote perioperative telemonitoring intervention on surgical outcomes, healthcare utilization, patient-reported outcomes (PROs), and functional recovery.
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
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
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
- •Cancer patients scheduled to undergo major abdominal surgery for gastrointestinal (GI) malignancies. GI procedures include esophagectomy, gastrectomy, colectomy, abdominoperineal resection/low anterior resection, hepatectomy, pancreatectomy (distal or pancreaticoduodenectomy), and cytoreductive surgery for peritoneal carcinomatosis. We will include patients scheduled for an ostomy (colostomy or diverting ileostomy)
- •Age 18 years or older
- •Ability to read and understand English or Spanish
- •We are targeting patients across all stages of disease
- •Age criterion for this study is based on the National Institute of Health (NIH)'s age criteria, which defines an adult as individuals aged 18 years and over. There are no restrictions related to performance status or life expectancy
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
排除标准
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
结局指标
主要结局
Patient Postoperative Complications Using the Comprehensive Complications Index (CCI)
时间窗: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
Postoperative complications occurring within 30 days post-discharge after cancer surgery were measured using the Comprehensive Complications index (CCI), a validated tool that aggregates the Clavien grades of postoperative complications on a continuous scale ranging from 0 (no complication) to 100 (death).
Number of Participants Who Completed >= 70% of the Study
时间窗: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
Study completion was assessed based on the percentage of patients who completed at least 70% of the following during the study period: (a) daily step counts, (b) quality of life measures, and (c) patient-generated health data. These measures were assessed from baseline through 30 days post-discharge after cancer surgery.
Number of Participants Who Reported Intervention Acceptability
时间窗: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
Acceptability of telemonitoring was assessed using a patient satisfaction tool administered within 30 days post-discharge after cancer surgery. The tool evaluated ease of use, time burden of participation, and access to technology.
次要结局
- Participant Reported Quality of Life as Measured by the EQ-5D-5L.(Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.)
- Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission)(Up to day 30 post-discharge)
- Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)(Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.)