Multimodal Prehabilitation in Cancer Surgery

About This Study

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.

What's Involved

Conditions Studied

Study Locations

Eligibility

Inclusion Criteria:

* Adult patient (age \> 18 years);
* Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
* Signed informed consent.

Exclusion Criteria:

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).