Impact of Prehabilitation in Oncology Via Exercise- Esophageal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention
研究概览
简要总结
The goal of this study is to determine the feasibility of a prehabilitation exercise and nutrition program (exercise and nutrition before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise and nutrition program will include resistance and aerobic training and nutrition supplementation during the weeks before surgery. We will also assess pre-surgical care needs in adults with esophageal cancer. Researchers will compare the exercise and nutrition intervention to usual care- which is standard medical care and post-surgery surveillance/follow-up to understand the impact of exercise and nutrition before surgery. We will follow-up with participants before surgery, and after surgery at 2 weeks, 6 weeks, and 4-months at appointments that coincide with clinical follow-ups.
The main questions of this trials are:
- Is exercise and nutrition supplementation before surgery for esophageal cancer feasible and acceptable to patients?
- How does exercise and nutrition supplementation before surgery change physical function and psychosocial health?
- What are important pre-surgical needs for adults with esophageal cancer?
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
- •Men and women, age ≥ 18 years old
- •Diagnosed with esophageal cancer
- •Identified as esophagectomy surgery candidates at Hillman Cancer Center, UPMC Shadyside, or UPMC Passavant
- •≥ 2 weeks until scheduled esophagectomy
- •ECOG Performance Status Scale score of ≤ 2
- •Ability to provide written informed consent
- •Ability to understand, speak, and read English.
排除标准
- •Evidence in the medical record of an absolute contraindication for exercise (e.g., Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability)
- •Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
- •Receiving non-esophagectomy related chemotherapy and/or radiotherapy
- •Active infections, hemorrhages, and cytopenias that could place surgical patients at risk for further adverse events, deemed by the exercise interventionist, physician, and/or nurse
研究组 & 干预措施
Usual Care (CONT)
The CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.
干预措施: Usual Care Group (Behavioral)
Home-based prehabilitation exercise and nutrition (PRE)
Interventions will include:
- Up to 8 weeks of 3-5 times per week resistance training and 3-5 times per week of aerobic training.
- Ensure Complete nutrition supplement drinks: 2 per day starting on the same day the exercise begins, up until 5 days prior to surgery.
干预措施: Exercise and Nutrition (Behavioral)
结局指标
主要结局
Acceptability of Intervention
时间窗: From enrollment through surgical admission, up to 8 weeks
Acceptability is defined as the proportion of approached participants who agree to participate and complete the baseline assessments and be randomized.
Adherence to Intervention
时间窗: From enrollment through surgical admission, up to 8 weeks
Exercise adherence will be calculated as the proportion of completed exercise sessions over the number of prescribed sessions.
Feasibility of Intervention
时间窗: From enrollment through surgical admission, up to 8 weeks
The intervention will be considered feasible if 50% of participants complete approximately 70% of prescribed prehabilitation sessions prior to their surgical admission.
次要结局
- Six-minute walk test (6MWT)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Brief Pain Inventory (BPI)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- 30-second chair stand test (30CST)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Timed-Up-and-Go (TUG) test(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Handgrip assessment(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Short Physical Performance Battery (SPPB)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Actigraph accelerometry(Baseline, 2 Weeks post esophagectomy, and 4 Months post esophagectomy)
- SARC-F Sarcopenia scale(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Carbon Monoxide (CO) assessment(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Demographics(Baseline)
- Injury History Survey (EX Cohort only)(Time of Admission)
- EORTC QLQ-C30 Quality of Life (QoL)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Multidimensional Fatigue Inventory(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Godin Leisure Time Exercise(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- PROMIS Smoking Assessment(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- PROMIS Cognitive Function- Short Form(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- PG-SGA Nutrition Assessment- Short Form(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Healthcare utilization(Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Pre-Treatment Resources Assessment(Baseline)
- Six-minute walk test (6MWT)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- 2-Minute Step Test(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- 30-second chair stand test (30CST)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Timed-Up-and-Go (TUG) test(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Frail Scale(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Handgrip assessment(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Short Physical Performance Battery (SPPB)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Actigraph accelerometry(Baseline, 2 Weeks post esophagectomy, and 4 Months post esophagectomy)
- SARC-F Sarcopenia scale(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Carbon Monoxide (CO) assessment(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Edmonton Frail Scale (EDS)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Demographics(Baseline)
- Injury History Survey (EX Cohort only)(Time of Admission)
- EORTC QLQ-C30 Quality of Life (QoL)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Multidimensional Fatigue Inventory(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Godin Leisure Time Exercise(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- PROMIS Smoking Assessment(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- PROMIS Cognitive Function- Short Form(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- PG-SGA Nutrition Assessment- Short Form(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Healthcare utilization(Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
- Pre-Treatment Resources Assessment(Baseline)
- Brief Pain Inventory (BPI)(Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy)
研究者
Melanie Potiaumpai
Assistant Professor
University of Pittsburgh