Re-Defining Frailty and Improving Outcomes Through Prehabilitation (RIOT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Morbidity
研究概览
简要总结
This trial studies how well a prehabilitation program works to improve patient outcomes after surgery compared to the normal standard of care prehabilitation in frail patients undergoing surgery for pancreatic, liver, or gastric cancer. Frailty is defined as the pathophysiology of aging or through the accumulation of physiologic and functional deficits. Prehabilitation programs seek to optimize the medical and physical state of patients prior to undergoing surgery with the goal of improving outcomes following surgery. Despite evidence for its importance in health outcomes for frail patients, prehabilitation programs have not been well studied in cancer surgery populations. This trial may provide researchers with more information on how to improve patient outcomes after cancer surgery through the use of prehabilitation programs.
详细描述
PRIMARY OBJECTIVES:
I. To develop a novel, multi-dimensional index of physiologic reserve and resilience specific to surgical cancer patients.
II. To implement and assess a novel comprehensive multidimensional prehabilitation program on frail cancer surgery patients.
OUTLINE: All patients enrolled (both frail and non-frail) will be randomized (1:1) at the time of enrollment to receive pre-operative exercise or non-preoperative exercises. Randomization will be stratified by frailty status.
ARM I: Enrolled patients undergo a physical therapy consultation and complete home exercises 3 days per week, in addition to standard guidelines.
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
- 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
- •Scheduled for any abdominal (e.g., pancreatic, liver or gastric) cancer surgery or established in the GI surgical oncology clinics or
- •Scheduled for neoadjuvant therapy prior with the plan to be scheduled for surgery
排除标准
- •Non-English speaking
- •Prisoners
- •Persons unable to provide informed consent
结局指标
主要结局
Morbidity
时间窗: Baseline
Will be assessed using standardized case report forms.
Frailty assessment
时间窗: Baseline
A rapid assessment for frailty using the widely used 5-item fatigue, resistance, ambulation, illness, \& loss of weight (FRAIL) questionnaire will be performed. Patients are identified as frail by scoring 2 or more points on the FRAIL questionnaire. The frailty assessment will be aimed at identifying factors related to the 6 characteristics of frailty: physical performance, gait speed, mobility, nutritional status, mental health and cognition.
Health-related quality of life (composite measure)
时间窗: Baseline, 2 weeks, 3, 6, 12 months
Will be recorded by administration of the Patient Reported Outcomes Measurement Information System (PROMIS) health-related quality of life questionnaire. PROMIS is a validated set of patient-centered measures that evaluates and monitors life domains (physical, mental, social health) and provide standardized patient reported outcome resources for use in clinical research and practice.
Complication burden
时间窗: Baseline
Will be calculated using the Comprehensive Complication Index (CCI). This method is more powerful than standard binary measures of morbidity (presence/absence of individual events) as it presents a quantitative score based on an aggregate weighted total ranging from 0 (no complications) to 100 (death).
次要结局
未报告次要终点
研究者
Mark Rubinstein
Principal Investigator
Ohio State University Comprehensive Cancer Center