Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for Patients With Pancreatic and Periampullary Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in participants physical capacity, as represented by hand grip strength
研究概览
简要总结
Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms
详细描述
Frailty is independently associated with an increased risk of adverse outcomes after major surgery, including pancreatic resection. Prehabilitation aims to optimize modifiable risk factors to improve participants' baseline health prior to surgery. Multiple studies with participants undergoing pancreatic surgery have investigated the impact of prehabilitation on preoperative health metrics as well as postoperative outcomes. The majority of these studies focused only on exercise; if nutritional and/or psychological status were assessed, these dimensions were not intervened upon in prehabilitation regimens or reassessed postoperatively. This randomized controlled trial (RCT) is designed to assess the impact of physical and nutritional prehabilitation on participants' perioperative condition for those undergoing pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms.
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
- •Participants > 18 years old with ECOG performance status 0-2 and ASA score ≤3
- •Requiring pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms
- •Surgery scheduled at least 2 weeks after the initial surgical evaluation
- •Fluency in English
- •Willingness to answer questionnaires, complete daily exercise & nutrition log, as well as participate in follow-up telephone calls
- •Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)
- •PAR-Q+ assesses participants comorbidities and symptoms with current activities. If participants answer "yes" to any of the screening questions, they will need to complete additional questions regarding their chronic medical conditions including, but not limited to, heart disease, stroke, diabetes, depression/anxiety, and COPD/asthma, to determine their ability to participate in physical activity.
排除标准
- •Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)
- •Participants with concurrent medical conditions that prohibit exercise, such as those who indicate on the questionnaire that they experience chest pain, dizziness, or loss of consciousness with physical activity; those with chest pain at rest; or those with bone/joint/soft tissue conditions that could worsen with physical activity. Participants with specific comorbidities, such as coronary artery disease. congestive heart failure, or uncontrolled asthma/COPD, that may prevent participation will also be excluded.
- •Inability to provide own informed consent
- •Inability to read or verbally understand questionnaires in English
- •Impaired hearing that creates a barrier for telephone follow-up
- •Visual deficit that would cause exercise to be hazardous
- •Emergent or urgent surgeries
研究组 & 干预措施
Control Arm (Standard of Care)
Participants will receive the current standard preoperative education and counseling. Participants will receive information regarding exercise and nutrition from a member of the surgical team. Participants will meet with a behavioral medicine specialist for additional education regarding factors affecting postoperative stress and relaxation techniques. Participants who are actively smoking will be counseled regarding smoking cessation and offered a referral to smoking cessation resources.
干预措施: Behavioral Medicine (Behavioral)
Control Arm (Standard of Care)
Participants will receive the current standard preoperative education and counseling. Participants will receive information regarding exercise and nutrition from a member of the surgical team. Participants will meet with a behavioral medicine specialist for additional education regarding factors affecting postoperative stress and relaxation techniques. Participants who are actively smoking will be counseled regarding smoking cessation and offered a referral to smoking cessation resources.
干预措施: Smoking Cessation (Behavioral)
Intervention Arm (Prehabilitation)
Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens.
During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity.
干预措施: Exercise (Other)
Intervention Arm (Prehabilitation)
Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens.
During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity.
干预措施: Nutritional (Dietary Supplement)
Intervention Arm (Prehabilitation)
Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens.
During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity.
干预措施: Behavioral Medicine (Behavioral)
Intervention Arm (Prehabilitation)
Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens.
During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity.
干预措施: Smoking Cessation (Behavioral)
结局指标
主要结局
Change in participants physical capacity, as represented by hand grip strength
时间窗: 3 weeks after the surgery
Previous studies have demonstrated that grip strength is a predictor of surgical outcomes and mortality in cancer participants. Grip strength will be measured utilizing the Jamar Dynamometer.
次要结局
- Mortality Rate(Up to 90 days after the surgery)
- Morbidity rate(Up to 90 days after the surgery)
- Physical capacity as represented by 30s CST (Chair Stand Test )(3 weeks after the surgery)
- Physical capacity as represented by 6-Minute Walk Test(3 weeks after the surgery)