A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Enrollment Rate (Feasibility)
研究概览
简要总结
The goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer.
详细描述
This research study is to test whether a novel, 4-week surgical multimodal prehabilitation protocol is feasible in at-risk older adult patients who have previously undergone neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal cancer.
Research study procedures include screening for eligibility, clinic visits, questionnaires, blood tests, and Computed Tomography (CT) scans.
Participation in this research study is expected to last 7 months.
It is expected about 30 patients will participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age and over
- •Adult male or non-pregnant female volunteers
- •Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer
- •At least four weeks to esophageal cancer surgery
- •Without skin conditions that preclude wearing sensors
- •Able to speak English and consent
排除标准
- •Participants in any other interventional study that may bias results or limit study adherence during our study
- •Dietary restrictions that prevent consumption of nutritional supplements
- •Women who are pregnant, nursing, or at risk of becoming pregnant
- •Profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.
研究组 & 干预措施
Prehabilitation Program
30 participants will be enrolled and will complete study procedures as follows:
- Enrollment at least 4 weeks prior to esophageal cancer surgery.
- In-person clinic visit with dietitian and physical therapist for assessments, and completion of baseline questionnaires with study coordinator.
- Adherence to daily physical function, dietary, and sleep recommendations and consumption of 5-day immunonutrition supplement.
- Regular electronic/phone-call check-ins with study staff.
- Telehealth appointment with physical therapist and dietitian prior to surgery.
- After surgery and during hospital admission, final visit with dietitian and physical therapist for assessments, and completion of questionnaires.
- 6-month follow-up period.
干预措施: Prehabilitation Program (Behavioral)
结局指标
主要结局
Enrollment Rate (Feasibility)
时间窗: At screening
Number of eligible patients who enroll in study
Completion Rate (Feasibility)
时间窗: 30 days
Defined as the number of patients who complete study procedures.
次要结局
- Sleep Health Compliance Rate (Feasibility)(30 days)
- Nutrition Compliance Rate (Feasibility)(5 days)
- Physical Function Compliance Rate (Feasibility)(30 days)
- Actigraphy Compliance Rate (Feasibility)(30 days)
研究者
Hassan Dashti
Principal Investigator
Massachusetts General Hospital