Developing an Ecological and Tailored Nutritional Intervention to Improve Quality of Life in Esophageal Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ecological nutritional intervention.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Ecological nutritional intervention
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.
Primary outcome measures
- Survey Questionnaire on Health Behavior Change through an Intervention Program [Time frame: Baseline, end of intervention (post-enrollment 4 weeks)]
Secondary outcome measures (11)
- Change in body weight (kg) [Time frame: Baseline, end of intervention (post-enrollment 4 weeks)]
- Change in body composition (fat mass and fat-free mass) [Time frame: Baseline, end of intervention (post-enrollment 4 weeks)]
- Change in Body Mass Index (BMI) (kg/m²) [Time frame: Baseline, end of intervention (post-enrollment 4 weeks)]
- Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score [Time frame: Baseline, end of intervention (post-enrollment 4 weeks)]
- Change in Gastrointestinal Symptom Rating Scale (GSRS) score [Time frame: Baseline, end of intervention (post-enrollment 4 weeks)]
- Change in dumping syndrome assessed by clinical questionnaire [Time frame: Baseline, end of intervention (post-enrollment 4 weeks)]
- Change in EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score [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 [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 [Time frame: Baseline, end of intervention (post-enrollment 4 weeks)]
- Change in patient satisfaction assessed by satisfaction survey [Time frame: End of intervention (post-enrollment 4 weeks)]
- Service-experience assessed by qualitative interview [Time frame: End of intervention (post-enrollment 4 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07024849 · 2023-05-127 · RS-2023-CC139778