ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary prehabilitation + postoperative program 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.
Nowadays, colon cancer is one of the most common types of tumors worldwide being surgical resection the elective therapy for its curation. However, a surgery is a stressful procedure that may involve several postoperative complications. Risk factors for such undesirable events are closely related to lifestyle issues including decreased physical activity levels or dietary unhealthy habits. Recent studies have suggested that the implementation of multidisciplinary prehabilitation and postoperative interventions based on lifestyle habits may be a potential strategy for accelerate post-surgical recovery. To the best of our knowledge, the combined effect of a Prehabilitation + Postoperative Programs (PPP) on post-surgery complications and functional capacity of patients undergoing resection of colon cancer remains unclear. ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary 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 and 1-year post-surgery, including: post-surgery complications, prolonged hospital length of stay, readmissions and emergency department call, functional capacity, patient' reported outcome measures targeted, anthropometry and body composition, clinical markers, physical activity levels and sedentariness, dietary habits, others 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 the clinical practice.
Study Type
INTERVENTIONAL
Allocation
This intervention will include 3 complementary modules: (i) supervised physical exercise: aerobic and strength High Intensity Interval Training (HIIT), 3 times per week (ii) dietary behavior change: nutritional talk + an informative brochure + a video summary, a session per week and (iii) psychological support: psychoeducation, written and verbal emotional expression, promotion of coping strategies, progressive muscle relaxation training, problem-solving and social skills, and self-efficacy enhancing, among others. This psychological component will also include counseling regarding smoking and alcohol cessation and sleep hygiene.
This intervention will include 3 complementary modules: (i) supervised physical exercise: aerobic and strength High Intensity Interval Training (HIIT), 3 times per week (ii) dietary behavior change: nutritional talk + an informative brochure + a video summary, a session per week and (iii) psychological support: psychoeducation, written and verbal emotional expression, promotion of coping strategies, progressive muscle relaxation training, problem-solving and social skills, and self-efficacy enhancing, among others. This psychological component will also include counseling regarding smoking and alcohol cessation and sleep hygiene. NOTE: Both preoperative and postoperative programs will be administer to the participants assigned to the intervention group.
Department of Medical Physiology, Faculty of Medicine, University of Granada
Granada, Andalusia, Spain
Post-surgery complications
Post-surgery complications determined by the Comprehensive Complication Index (CCI). Minimum value: 0 // Maximum value: 100. Higher scores mean a worse outcome.
Time frame: 30-days and 3-months post-surgery
Post-surgery complications
Post-surgery complications determined by the Comprehensive Complication Index (CCI). Minimum value: 0 // Maximum value: 100. Higher scores mean a worse outcome.
Time frame: 1-year post-surgery (i.e., week 57)
Additional surgery-derived events
Electronic medical records will be used to register data regarding primary and total prolonged hospital length of stay.
Time frame: 1-year post-surgery (i.e., week 57).
Post-surgery complications
Post-surgery complications determined by the number of patients experiencing complications.
Time frame: 30-days, 3-months and 1-year post-surgery
Additional surgery-derived events
Electronic medical records will be used to register data regarding readmissions.
Time frame: 30-days, 3-months and 1-year post-surgery
Additional surgery-derived events
Electronic medical records will be used to register data regarding emergency department appointments.
Time frame: 30-days, 3-months and 1-year post-surgery
Additional surgery outcomes
Quality of Recovery Short-form questionnaire (QOR-15). Minimum value: 0// Maximum value: 150. Higher scores mean a better outcome. Visual Analogue Scale for abdominal pain. Minimum value: 0 // Maximum value: 100. Higher score mean a worse outcome
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RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Usual care group will follow the usual institutional pre-surgery care: (i) medication management, (ii) assessment of the surgery-derived risks, (iii) smoking cessation and peri-operative blood management. A trained nutritionist will evaluate the nutritional status of all patients at the baseline providing oral protein/vitamin supplementation, when necessary. Patients allocated to the control group will receive basic expert' advice on lifestyle changes.
Time frame: 24 hours, 48 hours and 72 hours after the surgical procedure.
Cardiorespiratory fitness
Cardiorespiratory fitness measured by the 6-minute walking test (6MWT) distance, expresed in total m.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Upper Limb muscular strength
Muscular strength assessed by handgrip strength. Handgrip strength will be determined using a digital hand dynamometer and expressed as total kg.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Lower limb muscular strength
Muscular strength assessed by the 30 seconds sit-to-stand test.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Lower limb muscular strenght
Muscular strength assessed by the 5 times sit-to-stand test, assessing the time needed to rise 5 times from a seated position without using arms.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Gait speed
The 4-meter usual walking speed test will be used to assess the Gait Speed
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Health-related quality of life
The European Organisation for Research and Treatment of Cancer quality of life questionnaire for patients with colorectal cancer (EORT-QLQ-CR29).
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Self-scored depression inventory
The Beck Depression Inventory-II questionnaire. Minimum value: 0 // Maximum value: 63. Higher scores mean a worse outcome.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Trait and state anxiety
The State-Trait Anxiety Inventory (STAI). Minimum value: 20 // Maximum value: 80. Higher scores mean a worse outcome.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Anxiety and Depression Levels
The Hospital Anxiety and Depression Scale (HADS). Minimum value: 0 // Maximum value: 21. Higher scores mean a better outcome.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Mental Adjustment to Cancer
The Mini-Mental Adjustment to Cancer. Five sub-scales are measured by this questionnaire: hopeless, anxious preoccupation, fighting spirit, fatalism and cognitive avoidance.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Weight
Weight measured with a scale (kg).
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Height
Height measured with a stadiometer (cm).
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Neck, waist and hip circumferences
Neck, waist and hip circumferences will be assessed with an anthropometric tape measure (cm).
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Bone mineral density
Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Bone mineral density in g/cm2.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Lean mass
Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Lean mass in kg.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Fat mass
Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Fat mass in kg.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Visceral adipose tissue
Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Visceral adipose tissue in kg.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Glycemic profile
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the glycemic profile. We will obtain plasma glucose (mg/dL) and insulin (mg/dL) levels.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Lipid profile
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the lipid profile.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Hepatic transaminases
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the hepatic transaminases levels.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Red cells
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the red cells levels.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Immunological blood profiles
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the immunological blood profiles. The following parameters will be obtained: Leukocytes (10\*3 uL), Neutrophils (10\*3 uL), Lymphocytes (10\*3 uL), Monocytes (10\*3 uL), Eosinophils (10\*3 uL), Basophils (10\*3 uL) and LUC cells (10\*3 uL).
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Inflammatory factors
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the inflammatory factors levels (PCR, leptin, adiponectin, resistin, IL 6, IL 10 and PAI 1; all of them expressed as pg/mL)
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Renal function parameters
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the renal function parameters (creatinine and urea; both will be expressed in mg/dL)
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Tumour markers
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the tumour markers levels (CA 19-9, CA 242, CA 72-4, TPA and TPS; all will be expressed as pg/mL))
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Hormones
Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the hormones levels (T3, T4, testosterone, cortisol, estrogens and DHEAs; all will be expressed as pg/mL))
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Blood pressure
The investigators will also asses systolic and diastolic blood pressure in the right arm at rest.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
HOMA index
The investigators will calculate the homeostatic model assessment of insulin resistance index (HOMA). HOMA index was calculated as follows: (fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
FLI index
The investigators will calculate the fatty liver index (FLI) as a validated surrogate marker of non-alcoholic fatty liver disease.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Cardiometabolic risk
The investigators will calculate a cardiometabolic risk score based on the International Diabetes Federation (IDF) criteria. The cardiometabolic risk score is a continuous variable with a mean of 0 and a standard deviation of 1 by definition, with lower scores denoting a more favorable profile.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Physical activity and sedentariness
The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey validity and reliability studies have been conducted in Turkey by Ozturk. The survey consists of 27 questions and 5 parts. Minimum value = 0 min/day of physical activity // Maximum value = 1440 min/day of physical activity. Higher scores imply a more physically active pattern. Objectively physical activity will be assessed by accelerometry
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Dietary habits
A food frequency questionnaire (FFQ) conducted by a trained nutritionist. Based on dietary data from the FFQ, the investigators will calculate the Mediterranean Diet Score. Minimum value: 0 // Maximum value: 14. Higher scores mean a better outcome. PREDIMED adherence to the Mediterranean diet questionnaire will also be conducted by a trained nutritionist.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Others unhealthy habits
A seven-day self-reported tobacco and alcohol consumption logs will be used to determine smoking and alcohol intake registering total number of cigarettes and alcoholic units/day, time and situation in which both are consumed and cigarette type of alcoholic drink.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Nicotine dependence
The Fagerström Test for Nicotine Dependence will be used to measure patients' nicotine dependence. Minimum value: 0 // Maximum value: 10. Higher scores mean a worse outcome.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Sleep quality
Sleep quality will be determined by the Pittsburgh Sleep Quality Index (PSQI) scale. PSQI global score ranges from 0 to 21, with a score higher than 5 indicating poor sleep quality Objectively sleep quality will be assessed by accelerometry
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Fecal microbiota analysis
A fecal sample (50-60 g) will be obtained and analyzed.
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Molecular Characterization of Colon Tumor Tissue
Colon tumor tissue samples will be collected during surgical resection and analyzed using molecular techniques (e.g., gene expression profiling) to assess markers associated with tumor progression.
Time frame: Day of surgery
Cost-effectiveness analysis
We will calculate the ratio of incremental costs and incremental clinical benefits as the additional expenditure required to generate an additional unit of benefit, expressed as cost per quality-adjusted life-year (QALY) added, and calculated as CE = (Cost2-Cost1)/(QALY2-QALY1). EuroQol 5-dimension 5-level (EQ-5D-5L) will be used for QALY estimation. With regard to the cost measurements, we will follow the WHO recommendations for estimating costs contemplated in its CEA guidelines such as the cost of providing the intervention and costs of accessing the intervention.
Time frame: At the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Heart rate variability
Participants will be lying in a supine position on a stretcher while the R-R signal will be assessed for 15 min (after 10 min of acclimation) using the Polar Ignite 2
Time frame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).