Clinical trial NCT07024849: Developing an Ecological and Tailored Nutritional Intervention to Improve Quality of Life in Esophageal Cancer Survivors
Official title: Developing an Ecological and Tailored Nutritional Intervention to Improve Quality of Life in Esophageal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Keywords: nutritional intervention
nutrition
survivors
esophageal cancer
care foods
health behavior
ecological intervention
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Survey Questionnaire on Health Behavior Change through an Intervention Program
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
Secondary outcomes:
measure: Change in body weight (kg)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in body composition (fat mass and fat-free mass)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in Body Mass Index (BMI) (kg/m²)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS) score
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in dumping syndrome assessed by clinical questionnaire
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal Cancer Module (EORTC QLQ-OES18) score
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in patient satisfaction assessed by satisfaction survey
timeFrame: End of intervention (post-enrollment 4 weeks)
measure: Service-experience assessed by qualitative interview
timeFrame: End of intervention (post-enrollment 4 weeks)
Other outcomes:
measure: Change in grip strength (kg)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in serum albumin (g/dL)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in prealbumin (mg/dL)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in Nutritional Risk Index (NRI) (score)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in Prognostic Nutritional Index (PNI) score
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in total protein measured by laboratory assay (g/dL)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in hemoglobin measured by laboratory assay (g/dL)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in white blood cell count (WBC) measured by laboratory assay (×10³/μL)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in absolute lymphocyte count (ALC) measured by laboratory assay (×10³/μL)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in absolute neutrophil count (ANC) measured by laboratory assay (×10³/μL)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
measure: Change in platelet count (PLT) measured by laboratory assay (×10³/μL)
timeFrame: Baseline, end of intervention (post-enrollment 4 weeks)
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Juhee Cho, PhD
role: PRINCIPAL_INVESTIGATOR
References: