Short-Term Nutritional Enhancement Combined With Health Education in Postoperative Colorectal Cancer Patients: A Randomized Controlled Trial

Longitudinal assessment of nutritional status using the mPG-SGA, a validated tool composed of five sections (weight loss history, dietary intake, symptoms, function/activity, and age). Total scores range from 0 to ≥7 points, with higher scores indicating worse nutritional status. Patients will be classified as:

0-2 = Normal

3-6 = Mild malnutrition

≥7 = Moderate to severe malnutrition.

Assessment of patients' perceived overall health status using the global health subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores range from 0 to 100, with higher scores indicating better global quality of life.

Assessment of symptom burden including fatigue, pain, nausea/vomiting, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulty using symptom subscales of the EORTC QLQ-C30. Each symptom is scored separately from 0 to 100, with higher scores indicating worse symptom severity.

Overall survival is defined as the time from the date of enrollment to the date of death from any cause. Patients still alive at the last follow-up will be censored. Kaplan-Meier survival analysis and Cox proportional hazards regression will be used to estimate survival and explore associations with baseline and longitudinal nutritional status.

Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first. Patients without progression at the time of last follow-up will be censored. PFS will be analyzed using Kaplan-Meier estimates and Cox regression models, stratified by nutritional status.

Longitudinal evaluation of nutritional risk using the NRS-2002, which considers disease severity, nutritional impairment, and age. Total score ranges from 0 to ≥7 points. A score of ≥3 indicates nutritional risk and warrants intervention; <3 indicates no immediate risk.

Serum total protein concentration (g/L), used to evaluate protein-energy nutritional status. Measured using standard biochemical assays.

Serum albumin concentration (g/L), used to assess visceral protein status and systemic inflammation.

Serum prealbumin level (mg/L), an indicator of short-term changes in protein-energy nutritional status.

Serum transferrin concentration (g/L), a marker of protein status and iron metabolism.

Serum CRP (mg/L), a marker of systemic inflammation and acute-phase response.

Fasting blood glucose (mmol/L), measured to assess metabolic function and risk of hyperglycemia.

AST concentration (U/L), used as a liver function test and hepatotoxicity marker.

ALT level (U/L), a liver enzyme measured to monitor hepatic injury.

IL-1 concentration (pg/mL), a pro-inflammatory cytokine indicative of immune and inflammatory activity.

Tumor Necrosis Factor-alpha (TNF-α) level (pg/mL) measured to assess systemic inflammation and cancer-related cachexia.

Serum creatinine (μmol/L), measured to evaluate kidney function and treatment-related nephrotoxicity.

Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.

Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.

Total cholesterol level (mmol/L), measured to assess lipid metabolism and nutritional status.

Serum triglyceride level (mmol/L), used to evaluate energy reserves and lipid metabolism.

HDL-C (mmol/L), assessed as a marker of cardiovascular health and lipid status.

LDL-C (mmol/L), measured as a risk factor for cardiovascular disease and lipid status.

IL-6 level (pg/mL), a pro-inflammatory cytokine measured to monitor systemic inflammation and cachexia.

Hemoglobin concentration (*10⁹/L), used to assess anemia and oxygen-carrying capacity.

Total white blood cell count (*10⁹/L), measured to monitor immune status and detect infection or myelosuppression.

Absolute neutrophil count (*10⁹/L), used to assess infection risk and bone marrow suppression.

Lymphocyte count (*10⁹/L), measured to evaluate immune competence.

Red blood cell count (*10¹²/L), used to assess erythropoiesis and anemia.

Platelet count (*10⁹/L), measured to evaluate coagulation status and myelosuppression.

Standing height (cm) measured using a stadiometer with 0.5 cm precision. Values adjusted for presence of ascites, edema, or large tumors.ascites, systemic edema, and huge tumors.

Body weight (kg) measured using a calibrated scale with 0.2 kg precision. Values adjusted if ascites or edema are present.

BMI calculated as weight (kg) divided by height squared (m²), recorded to one decimal place.

Assessment of anxiety using the HADS-A subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Results will be analyzed in relation to nutritional status (normal, mild, moderate malnutrition).

Assessment of depressive symptoms using the HADS-D subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe depression. Results will be analyzed in relation to nutritional status (normal, mild, moderate malnutrition).

Functional performance will be evaluated using the Karnofsky Performance Status (KPS) scale, which ranges from 0 to 100. Higher scores indicate better functional ability and independence in daily activities. Longitudinal KPS changes will be assessed in relation to changes in nutritional status over time.

Sleep quality and disturbances will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a standardized questionnaire assessing seven components of sleep. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. PSQI scores will be analyzed in relation to nutritional risk categories and treatment phases.

Assessment of leisure-time physical activity levels (mild, moderate, vigorous) and their relationship with nutritional status and cancer treatment response.

Patients' dietary knowledge, attitudes, and practices will be assessed using a validated Nutrition KAP (Knowledge, Attitude, and Practice) questionnaire. The total score ranges from 0 to 104, with higher scores indicating better nutritional knowledge, more positive attitudes, and healthier dietary behaviors. Longitudinal changes in KAP scores will be evaluated in relation to treatment outcomes.

Evaluation of healthcare utilization related to nutritional care, including total number of hospitalization days, number of ICU admissions, and direct costs associated with enteral and parenteral nutrition support. Metrics will be analyzed in relation to malnutrition risk at baseline and during treatment.

Tracking of serious adverse events potentially related to nutritional support or treatment, including infections, allergic reactions, gastrointestinal distress, and metabolic complications.

Evaluation of whether baseline nutritional indicators-including mPG-SGA scores and laboratory biomarkers such as albumin, prealbumin, and CRP-predict 30-day clinical outcomes, including mortality, ICU admission, and significant unintentional weight loss (>5%). Logistic regression will be used for model construction and discrimination.

Identification of distinct nutritional change trajectories over time using latent class growth analysis (LCGA) and hierarchical clustering based on serial measurements of mPG-SGA and anthropometric data. Trajectories will be used to classify patients into nutritional risk subgroups.

Assessment of the diagnostic agreement, sensitivity, and specificity of two nutritional screening tools-modified Patient-Generated Subjective Global Assessment (mPG-SGA) and Nutritional Risk Screening 2002 (NRS-2002)-in detecting malnutrition risk. Agreement will be evaluated using Cohen's kappa and ROC curve analysis.

Analysis of sociodemographic factors-including income level, education, employment status, and rural vs. urban residence-in predicting baseline malnutrition and nutritional deterioration over time. Multivariable models will be used to explore independent associations.

Evaluation of patient-reported adherence to prescribed oral nutritional supplements or enteral/parenteral support regimens after hospital discharge. Adherence data will be collected via structured interviews and compared with clinical outcomes and readmission rates.