This study aims to apply and assess the clinical feasibility of a health behavior theory-based ecological nutrition intervention program, providing nutrition care tailored to the unmet needs of esophageal cancer survivors after surgery. Esophageal cancer survivors will receive a 4-week nutrition intervention program tailored to their individual nutritional needs. The program includes providing nutritional guidelines, customized care food, encouraging walking through a wearable device, and weekly telephone counseling. The evaluation of the program will assess food intake, adherence to dietary guidelines, activity level, nutritional indicators (such as PNI and NRI), weight change, fatigue, symptoms, quality of life, and satisfaction with meals and services. Additionally, interviews will be conducted after the intervention to evaluate the patient's experience.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Patients in the intervention arm will receive a 4-week nutrition management program(1 week for patients more than 4 months post-surgery), which includes providing nutritional guidelines, home delivery of personalized care foods, encouragement of physical activity using a wearable device, and weekly phone calls to check on nutritional goals and symptoms. Management services are also available through the mobile application.
Samsung Medical Center
Seoul, Seoul, South Korea
RECRUITINGSurvey Questionnaire on Health Behavior Change through an Intervention Program
Adherence to nutritional guidelines including food intake
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in body weight (kg)
Change in body weight measured in kilograms from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in body composition (fat mass and fat-free mass)
Change in body composition assessed by bioimpedance analysis or DXA scan from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Body Mass Index (BMI) (kg/m²)
Change in BMI calculated from weight and height from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score
Change in nutritional status assessed by the Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) questionnaire (score range: 0-35, higher score indicates worse nutritional status) from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Gastrointestinal Symptom Rating Scale (GSRS) score
Change in gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (score range: 1-7, higher score indicates more severe symptoms) from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in dumping syndrome assessed by clinical questionnaire
Change in presence or severity of dumping syndrome assessed by clinical questionnaire or evaluation from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score
Change in quality of life assessed by the EQ-5D-5L questionnaire (score range: 0-1, higher score indicates better quality of life) from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
Change in quality of life assessed by the EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) questionnaire (score range varies by domain; higher score in function scales indicates better function, higher score in symptom scales indicates worse symptoms) from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal Cancer Module (EORTC QLQ-OES18) score
Change in quality of life specific to esophageal cancer assessed by the EORTC QLQ-OES18 (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagus 18) questionnaire (score range varies by domain; higher score in function scales indicates better function, higher score in symptom scales indicates worse symptoms) from baseline to end of intervention.
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in patient satisfaction assessed by satisfaction survey
Change in patient satisfaction assessed by satisfaction survey (score range: specify, e.g., 1-5, higher score indicates higher satisfaction) from baseline to end of intervention.
Time frame: End of intervention (post-enrollment 4 weeks)
Service-experience assessed by qualitative interview
Qualitative assessment of service experience through interview at end of intervention.
Time frame: End of intervention (post-enrollment 4 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.