Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 17
- 主要终点
- Assess the impact of prehabilitation on severe postoperative complications among high-risk patients undergoing oncological surgery
研究概览
简要总结
The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients.
The multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.
详细描述
The standard treatment for most solid cancer includes surgery and concurrent medical therapies, both of which have been shown to significantly improve prognosis. However, cancer treatments impose impactful physiological stress and have detrimental effects on acute and long-term health outcomes.
Physical, nutritional, and mental status can influence surgical outcomes, functional recovery and quality of life throughout the course of the disease.
The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period provides a unique opportunity to address comorbidities and modifiable risk factors. In addition, the metabolic stress induced by neoadjuvant therapy has been documented to frequently result in muscle atrophy and diminished functional capacity. The recognition that selected risk factors of poor postoperative outcome can be modified has prompted clinicians to identify proactive interventions to facilitate the recovery process. In this context, prehabilitation, aimed at enhancing the patients' functional capacity to enable them to withstand the physiological stress of surgery, has emerged as a promising approach. Although the term prehabilitation is not novel, the concept of optimizing patients before acute stressor or treatment has gained attention over the last decade. Nonetheless, quantifiable evidence of its effectiveness has yet to be fully demonstrated.
This study is a multicenter randomized controlled trial to assess the efficacy of personalized procedure-specific prehabilitation programs on patient-centered surgical outcomes. A total of 400 patients will be recruited by systematic screening of patients scheduled for elective surgical procedures. All patients undergoing elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery undergoing major cancer surgery will be screened for eligibility and those who meet the inclusion/exclusion criteria will be approached for consent. Research personnel will use a web-based randomization system to assign patients (1:1 ratio) to either the prehabilitation or control arm. Study personnel will also collect data on recruitment rates, with reasons for non-enrolment.
Eligible patients will be randomly assigned to 1 of 2 treatments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Adult patient (age > 18 years);
- •Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
- •Signed informed consent.
排除标准
- •A) Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:
- •Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);
- •Severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 <50% pred, end-stage kidney or liver disease);
- •American Society of Anesthesiologists (ASA) physical status classes 4-5;
- •Disabling orthopedic and neuromuscular disease;
- •Psychosis, dementia;
- •Symptomatic anemia with a hemoglobin value < 7 gr/dl.
- •B) Patients with both optimal functional capacity (a Duke activity status index [DASI] score > 45) and optimal nutritional status (NRS-nutrition screening tool-score < 2).
研究组 & 干预措施
Prehabilitation
The prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline. This will be on top of Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery).
干预措施: Multimodal prehabilitation Program (Behavioral)
Control group
Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery)
结局指标
主要结局
Assess the impact of prehabilitation on severe postoperative complications among high-risk patients undergoing oncological surgery
时间窗: 30 days after surgery
The proportion of patients experiencing severe postoperative complications within 30 days after surgery defined as grade 3a or greater according to the Clavien-Dindo classification
次要结局
- Time to Functional Recovery (TFR)(30 days after surgery)
- Lenght of hospital stay (LOS)(30 days after surgery)
- Days at home up to 30 days after surgery (DAH-30)(30 days after surgery)
- Complication severity(30 days after surgery)
- Proportion of patients returning to preoperative functional walking capacity(30 days after surgery)
- Self-reported activity status and generic health related quality of life(30 days after surgery)
研究者
Marina Pieri
Doctor
Università Vita-Salute San Raffaele