Developing an Ecological and Tailored Nutritional Intervention to Improve Quality of Life in Esophageal Cancer Survivors

Not Applicable

Recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT07024849
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-03
• Study First Submitted: 2025-05-12
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with clinical stage 1-3 primary esophageal cancer at diagnosis who have planned or received treatment, including esophageal resection and reconstruction, with curative intent, and their families*.
• You are at least 18 years of age
• Have a native-level understanding of Korean
• Who consented to this study

Exclusion Criteria

• Concurrent multiple cancers at the time of diagnosis or a history of diagnosed and treated other organ cancers within the past year at the time of diagnosis
• Have had esophageal resection and reconstruction surgery for other reasons before being diagnosed with esophageal cancer
• Persons with limited cognitive and communication abilities
• The patient has had problems progressing to oral feeding after surgery, requiring a concurrent ileostomy, or the investigator determines that an interventional study is not appropriate.
• Individuals with reduced renal function for whom protein intake is not recommended (estimated GFR <60 mL/min/1.73 m2)
• People who are unable to walk due to joint problems, paralysis, etc.
• Those who do not use smartphones

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survey Questionnaire on Health Behavior Change through an Intervention Program	Baseline, end of intervention (post-enrollment 4 weeks)	Adherence to nutritional guidelines including food intake

Secondary Outcome Measures

Name	Time	Method
Change in body weight (kg)	Baseline, end of intervention (post-enrollment 4 weeks)	Change in body weight measured in kilograms from baseline to end of intervention.
Change in body composition (fat mass and fat-free mass)	Baseline, end of intervention (post-enrollment 4 weeks)	Change in body composition assessed by bioimpedance analysis or DXA scan from baseline to end of intervention.
Change in Body Mass Index (BMI) (kg/m²)	Baseline, end of intervention (post-enrollment 4 weeks)	Change in BMI calculated from weight and height from baseline to end of intervention.
Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score	Baseline, end of intervention (post-enrollment 4 weeks)	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.
Change in Gastrointestinal Symptom Rating Scale (GSRS) score	Baseline, end of intervention (post-enrollment 4 weeks)	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.
Change in dumping syndrome assessed by clinical questionnaire	Baseline, end of intervention (post-enrollment 4 weeks)	Change in presence or severity of dumping syndrome assessed by clinical questionnaire or evaluation from baseline to end of intervention.
Change in EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score	Baseline, end of intervention (post-enrollment 4 weeks)	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.
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score	Baseline, end of intervention (post-enrollment 4 weeks)	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.
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal Cancer Module (EORTC QLQ-OES18) score	Baseline, end of intervention (post-enrollment 4 weeks)	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.
Change in patient satisfaction assessed by satisfaction survey	End of intervention (post-enrollment 4 weeks)	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.
Service-experience assessed by qualitative interview	End of intervention (post-enrollment 4 weeks)	Qualitative assessment of service experience through interview at end of intervention.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of