Multidisciplinary Prehabilitation and Postoperative Rehabilitation for Avoiding Complications in Patients Undergoing Resection of Colon Cancer: Rationale, Design, and Methodology of the ONCOFIT Study

Abstract

ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary Prehabilitation and Postoperative Program (PPP) on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care. Primary and secondary endpoints will be assessed at baseline, at preoperative conditions, at the end of the PPP intervention (after 12 weeks) and 1-year post-surgery, and will include: post-surgery complications (primary endpoint); prolonged hospital length of stay; readmissions and emergency department call within 1-year after surgery; functional capacity; patient reported outcome measures targeted; anthropometry and body composition; clinical/tumor parameters; physical activity levels and sedentariness; dietary habits; other unhealthy habits; sleep quality; and fecal microbiota diversity and composition. Considering the feasibility of the present intervention in a real-life scenario, ONCOFIT will contribute to the standardization of a cost-effective strategy for preventing and improving health-related consequences in patients undergoing resection of colon cancer with an important clinical and economic impact, not only in the scientific community, but also in clinical practice.

How much does it cost to be fit for operation? The economics of prehabilitation

“…Moreover, digitalization would help lower the impact of staff and facility shortage. There are ongoing trials aiming to prove the clinical-as well as the cost-effectiveness of such programs [24][25][26][27]. Community based prehabilitation has also been proven to reduce postoperative complications [28], the cost-effectiveness of this type of programs is to be analysed in further studies.…”

Multimodal prerehabilitation for elderly patients with sarcopenia in colorectal surgery

“…Present studies on prehabilitation in colorectal surgery are very heterogeneous in terms of the interventions and measured outcomes, hindering the standardization and adoption of this approach in clinical practice [ 44 ]. There are currently no standardized multimodal prehabilitation programs available, although efforts are being made to design and test formulated interventions through ongoing randomized controlled trials [ 66 , 67 ]. A multimodal program inevitably requires an orchestrated effort and mobilization of resources from various disciplines, including physicians, surgeons, therapists, and nutritionists, and the cost-effectiveness of such an approach will need to be further evaluated.…”

Nutritional interventions in prehabilitation for cancer surgery

“…Most regimes include some aspect of exercise or physical activity (of varying frequency, intensity, time and type) and nutritional supplementation/advice [1,20], delivered both with and without further interventions. These additional components include, for example, nurse-led phone support [21], psychological support [22][23][24][25][26][27][28][29], motivational support [30], alcohol (reduction) and smoking (cessation) interventions [23,30], 'medical optimization' [23,28,31,32], and relaxation techniques [33].…”

“…Even when considering just the nutritional components of these interventions, there remains a vast gulf in the degree to which patients are prehabilitated, with many studies offering only advice [21][22][23]29,34,35] whilst others provide routine supplementation [1,25,[30][31][32][33]. Beyond this, Bojesen et al [36], although arguably not undertaking prehabilitation in its purest sense, offered nutritional screening alone, leaving management of the screening results up to the clinical care team.…”

“…1 ). Clinical outcomes commonly include length-of-stay (LOS) [ 1 , 22 , 25 , 30 – 32 , 35 , 39 ], complications/morbidity [ 1 , 22 , 23 , 25 , 31 , 32 , 36 , 39 ], mortality [ 31 , 32 , 39 ], readmission [ 1 , 22 , 30 ] and unplanned ITU admissions [ 36 ]. Functional outcomes include walking parameters [ 25 , 32 , 35 , 40 ], strength [ 21 , 31 , 32 , 35 ], and cardiopulmonary exercise test (CPET)-derived parameters [ 31 ].…”