What is this study about? Cancer often causes unwanted weight loss and loss of appetite, a condition called "cancer cachexia." This affects patients' strength, quality of life, and ability to tolerate cancer treatment. Proper nutrition is very important to help maintain weight and strength during cancer treatment. Currently, cancer patients receive nutritional counseling during hospital visits, which requires travel time and expense. With telemedicine (video calls on mobile phones), nutritional counseling can be provided from patients' homes. What is the purpose of this study? This study compares two ways of providing nutritional counseling to cancer patients who have experienced weight loss: Telemedicine group: Counseling through video calls (WhatsApp, Zoom, or Microsoft Teams) from home Standard care group: Counseling during in-person hospital visits Both groups receive the same nutritional advice every 2 weeks for 12 weeks. The only difference is how the counseling is delivered (video call vs. in-person). Who can participate? Adults (18 years or older) with cancer who have lost weight in recent months and have access to a smartphone with internet connection. What will participants do? Telemedicine group: Receive counseling through 20-30 minute video calls every 2 weeks (7 sessions total) Come to hospital only twice: at the beginning and end (Week 0 and Week 12) Standard care group: Come to hospital every 2 weeks for 30-45 minute counseling sessions (7 visits total) Both groups receive: Personalized dietary advice from registered dietitians Help with eating problems (poor appetite, nausea, taste changes) Pakistani meal plans that fit their preferences Free nutritional counseling throughout the study Reimbursement for travel or mobile data costs What will be measured? Body weight change over 12 weeks Food and protein intake Arm muscle measurements Nutritional status and quality of life Patient satisfaction with counseling method Costs of each method Why is this study important? This will be the first study in Pakistan and South Asia to test whether telemedicine nutritional counseling works as well as hospital visits for cancer patients. Results will help make nutritional care more accessible, especially for patients living far from hospitals. Study Location: King Edward Medical University/Mayo Hospital, Lahore, Pakistan Duration: 12 weeks per participant Total Participants Needed: 80 patients
BACKGROUND AND RATIONALE Cancer cachexia is a metabolic syndrome characterized by progressive involuntary weight loss, skeletal muscle depletion, systemic inflammation, and anorexia, affecting 50-80% of cancer patients and contributing to 30% of cancer-related deaths. International guidelines from ESPEN and ASCO recommend nutritional counselling as a cornerstone of multimodal cachexia management; however, high-quality randomized evidence remains limited, particularly in low-and-middle-income countries. In Pakistan, 31-97% of cancer patients experience malnutrition, compounded by geographic barriers, critical shortage of trained clinical nutritionists, and catastrophic out-of-pocket healthcare expenditure. No randomized controlled trial has evaluated telemedicine-delivered nutritional counselling for cancer cachexia anywhere in South Asia, representing a critical evidence gap. STUDY DESIGN Single-centre, parallel-group, pilot randomized controlled trial with 1:1 allocation. Randomization is computer-generated with variable block sizes (4-6), stratified by cancer type (gastrointestinal vs. non-gastrointestinal) using sequentially numbered sealed opaque envelopes. The trial uses a single-blind design: outcomes assessors, laboratory staff, and the statistician are blinded to group allocation; participants and dietitians cannot be blinded due to the nature of the intervention. INTERVENTION RATIONALE Both arms receive identical nutritional counselling content from the same registered dietitians following standardized ESPEN-based protocols (energy ≥25 kcal/kg/day; protein ≥1.0 g/kg/day), with culturally adapted Pakistani meal plans. Sessions are delivered bi-weekly at equal frequency (7 sessions over 12 weeks) so that delivery modality - not counselling dose - is the sole variable under study. The telemedicine arm uses WhatsApp Video Call as the primary platform (given its widespread use and low-bandwidth requirements in Pakistan), with Zoom or Microsoft Teams as alternatives. Patients participate from home; dietitians conduct sessions from a dedicated workspace at the Department of Medical Oncology, KEMU. NON-INFERIORITY RATIONALE Given that both groups receive equivalent counselling frequency and content, a non-inferiority design is appropriate. The non-inferiority margin of -1.0 kg for body weight change at 12 weeks was selected based on clinical judgment and published cachexia literature, representing the maximum weight difference that would still be considered clinically acceptable for telemedicine to be adopted as a delivery alternative. Telemedicine will be declared non-inferior if the lower limit of the 95% confidence interval for mean weight difference (telemedicine minus standard care) exceeds -1.0 kg. SAMPLE SIZE Using G\*Power for an independent samples t-test: Cohen's d = 0.75, α = 0.05 (two-sided), power = 85%, yields 29 participants per group. Adjusted for 20% anticipated dropout in cancer cachexia trials, the final sample is 40 per group (80 total), with an expected evaluable sample of 64 participants. STATISTICAL ANALYSIS Primary analysis is intention-to-treat. The primary outcome (body weight change, baseline to Week 12) will be analysed using an independent samples t-test or Mann-Whitney U test as appropriate, with ANCOVA adjusting for baseline weight, cancer type, ECOG performance status, and treatment changes during the study. Missing data will be handled by multiple imputation using chained equations (20 imputations) for \<20% missingness, with complete case analysis as a sensitivity check. Per-protocol analysis (participants completing ≥75% of sessions) will be conducted as a secondary analysis. Exploratory subgroup analyses are planned by cancer type, baseline cachexia severity, sex, and urban versus rural residence. SIGNIFICANCE This is the first RCT of telemedicine nutritional counselling for cancer cachexia in South Asia. The design isolates the effect of delivery modality by equalizing counselling frequency across arms. Results will provide effect size estimates to power a larger multi-centre trial, cost-effectiveness data for health policy decisions, and a scalable evidence-based model for nutritional care delivery in resource-constrained settings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Bi-weekly video consultation-based nutritional counseling delivered remotely via WhatsApp Video Call (primary platform), Zoom, or Microsoft Teams. Individual one-on-one sessions lasting 20-30 minutes conducted by registered dietitians from the hospital while patients participate from their homes.
Bi-weekly in-person hospital-based nutritional counseling delivered at the hospital nutrition clinic. Individual face-to-face sessions lasting 30-45 minutes conducted by registered dietitians at the Department of Medical Oncology, King Edward Medical University/Mayo Hospital.
Department of Radiotherapy and Medical Oncology, Mayo Hospital Lahore, 54000, Lahore, Pakistan.
Lahore, Punjab Province, Pakistan
Change in Body Weight From Baseline to 12 Weeks
Mean change in body weight (measured in kilograms) from baseline (Week 0) to end of intervention (Week 12). Body weight is measured using a calibrated digital scale (±0.1 kg precision) with standardized protocol: patient wearing light clothing without shoes, with empty bladder, measured at consistent time of day. Higher positive values indicate weight gain; negative values indicate weight loss. The primary objective is to assess non-inferiority of telemedicine-delivered nutritional counseling compared to standard in-person counseling, with a non-inferiority margin of -1.0 kg. Body weight is a validated, objective, clinically meaningful outcome for cancer cachexia interventions and recommended by international guidelines (ESPEN, ASCO) as a key endpoint for nutritional intervention trials in oncology.
Time frame: Baseline (Week 0) and Week 12 (end of 12-week intervention period). Measurements also collected at Week 6 (mid-point) for trajectory analysis.
Proportion of Participants Achieving Adequate Daily Energy Intake at 12 Weeks
Proportion (percentage) of participants achieving adequate daily energy intake, operationally defined as ≥25 kilocalories per kilogram of actual or adjusted body weight per day, consistent with European Society for Clinical Nutrition and Metabolism (ESPEN) clinical practice guidelines for cancer patients. Energy intake assessed via two non-consecutive 24-hour dietary recalls (one weekday and one weekend day) conducted by trained dietitians using the validated USDA 5-step multiple-pass method. Dietary data analyzed using the Pakistani Food Composition Database from the National Institute of Health, Islamabad. Higher proportions indicate better nutritional adequacy. This outcome reflects the effectiveness of nutritional counseling interventions in improving actual dietary intake behaviors.
Time frame: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.
Proportion of Participants Achieving Adequate Daily Protein Intake at 12 Weeks
Proportion (percentage) of participants achieving adequate daily protein intake, operationally defined as ≥1.0 gram per kilogram of actual or adjusted body weight per day, consistent with ESPEN clinical practice guidelines for cancer patients. Protein intake assessed via two non-consecutive 24-hour dietary recalls (one weekday and one weekend day) conducted using the validated USDA 5-step multiple-pass method and analyzed using the Pakistani Food Composition Database. Higher proportions indicate better protein adequacy. Adequate protein intake is critical for preventing muscle wasting and supporting immune function during cancer treatment. This outcome measures the effectiveness of counseling in achieving evidence-based protein intake targets.
Time frame: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.
Change in Mid-Upper Arm Circumference (MUAC) From Baseline to 12 Weeks
Mean change in mid-upper arm circumference (MUAC) measured in centimeters as a proxy anthropometric measure for skeletal muscle mass. MUAC is measured on the non-dominant arm at the midpoint between the acromion process (shoulder) and olecranon process (elbow) using a non-stretchable measuring tape with the arm relaxed at the side, recorded to the nearest 0.1 cm by trained personnel following standardized protocol. MUAC \<23 cm indicates malnutrition; decreases indicate muscle wasting (sarcopenia); increases indicate muscle gain. Higher positive change scores indicate muscle mass preservation or gain. MUAC is a validated, simple, low-cost anthropometric assessment tool recommended by WHO and FAO for nutritional surveillance in clinical populations and has been validated as a muscle mass surrogate in cancer cachexia research.
Time frame: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
Change in Patient-Generated Subjective Global Assessment (PG-SGA) Score From Baseline to 12 Weeks
Mean change in Patient-Generated Subjective Global Assessment (PG-SGA) total score from baseline to Week 12. The PG-SGA is the gold standard validated nutritional assessment instrument specifically developed and validated for cancer patients. The tool comprises a patient-completed section (weight history, food intake, nutrition impact symptoms, activities and function) and a professional-completed section (disease and metabolic stress, physical examination). Total score ranges from 0 to 35 points, with higher scores indicating greater malnutrition risk and severity. Score categories: well-nourished (0-1), moderately malnourished (2-8), severely malnourished (≥9). Negative change scores indicate nutritional improvement; positive change scores indicate deterioration. The PG-SGA has demonstrated reliability, validity, and sensitivity to change in multiple international studies and is recommended by the Oncology Nutrition Dietetic Practice Group of the Academy of Nutrition and Dietetics.
Time frame: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
Change in Global Health Status/Quality of Life Score (EORTC QLQ-C30) From Baseline to 12 Weeks
Mean change in the Global Health Status/Quality of Life (QoL) scale from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to Week 12. The EORTC QLQ-C30 is a validated, cancer-specific, multidimensional health-related quality of life instrument comprising 30 items organized into functional scales (physical, role, emotional, cognitive, social functioning), symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and a global health status/QoL scale. The global health status/QoL scale (items 29-30) is scored and linearly transformed to a 0-100 scale, where higher scores represent better quality of life. The validated Urdu version will be used. Positive change scores indicate QoL improvement. The EORTC QLQ-C30 has been extensively validated internationally including in Pakistani cancer populations and is recommended by EORTC for cancer
Time frame: Measured at baseline (Week 0) and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
Nutritional Counseling Session Adherence Rate Over 12 Weeks
Session adherence rate calculated as the percentage of scheduled nutritional counseling sessions actually completed by the participant over the 12-week intervention period. Calculated as: (number of sessions attended ÷ number of sessions scheduled) × 100%. Total of 7 sessions are scheduled per participant at Weeks 0, 2, 4, 6, 8, 10, and 12. For the telemedicine group, a session is considered "attended" if the participant successfully joins the video call and completes the counseling session. For the standard care group, a session is considered "attended" if the participant presents for the in-person hospital visit and completes the session. Adherence ≥70% (completing ≥5 out of 7 sessions) is defined as good adherence based on behavioral intervention literature. Higher adherence rates indicate better intervention engagement and may predict better outcomes. Adherence is a key implementation outcome for assessing intervention feasibility and acceptability.
Time frame: Assessed continuously throughout the 12-week intervention period. Final adherence rate calculated at Week 12 (end of intervention).
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