Prehabilitation for Patients With Aggressive Gastrointestinal Cancers Undergoing Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Feasibility of Large-Scale Trial: Adherence & Contamination
研究概览
简要总结
This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of Band Together, a strength-training and walking program (intervention arm) vs. education on the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI) malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant therapy.
详细描述
A growing body of evidence suggests host resilience (lack of frailty, skeletal muscle reserve, etc.) may impact early healing, recovery following neoadjuvant therapy and surgery, and long-term cancer-free survival. It is well-recognized that resilience is enhanced in individuals with proper diet, sleep habits, and exercise. However, it is unknown whether such resilience can be enhanced by training programs initiated at the time of cancer diagnosis. Although exercise interventions may contribute to these improvements, it is unknown how willing and able these patients are to comply with an exercise regimen during the neoadjuvant therapy period. The aim of this study, therefore, is to evaluate compliance with and the efficacy of Band Together, an exercise program combining strength-training and aerobic exercise, in patients with aggressive GI malignancies undergoing neoadjuvant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 years or older
- •New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction.
- •Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation.
- •Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers.
- •The ability to speak and read English.
- •The ability to provide informed consent.
排除标准
- •Angina (stable or unstable)
- •Paraplegia or quadriplegia
- •Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands.
- •Patients who have already started neoadjuvant chemotherapy at other institutions.
- •Presence of metastatic disease.
- •Gastric or pancreatic histologies other than adenocarcinoma.
- •Pregnant women.
- •Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)
研究组 & 干预措施
Exercise Education
Distribution of exercise education materials
干预措施: Exercise Education (Other)
Band Together
A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy.
干预措施: Band Together (Behavioral)
结局指标
主要结局
Feasibility of Large-Scale Trial: Adherence & Contamination
时间窗: Throughout the course of neoadjuvant therapy (on average 10-12 weeks)
The mean adherence rates (percentage of prescribed sessions completed) in the intervention group will be determined based on weekly activity diaries. Activity diaries will be completed by the subject throughout their participation in the study and collected upon the end of participation. The mean contamination rates (completed exercise sessions) in the control group will also be determined based on weekly activity diaries.
次要结局
- Feasibility of a Large-Scale Trial: Eligibility & Willingness to Participate(Completion of neoadjuvant therapy (on average 10-12 weeks))
- Change in grip strength and upper body strength as a result of intervention(Enrollment in study and completion of neoadjuvant therapy (on average 10-12 weeks))
- Assessing the interaction between frailty and the Band Together program(Completion of neoadjuvant therapy (on average 10-12 weeks))
- Exercise Partner Benefits(Completion of neoadjuvant therapy (on average 10-12 weeks))
研究者
Amanda Cooper, MD
Staff Physician
Milton S. Hershey Medical Center