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| ID | Type | Description | Link |
|---|---|---|---|
| RS-2023-CC139778 | Other Grant/Funding Number | Korean Cancer Survivor Healthcare R&D Project (National Cancer Center, funded by the Ministry of Health & Welfare) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition Intervention group | Experimental | This is a single-arm study, with all participants in the intervention arm. Patients in the intervention arm will receive a 4-week nutrition management program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecological nutritional intervention | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survey Questionnaire on Health Behavior Change through an Intervention Program | Adherence to nutritional guidelines including food intake | Baseline, end of intervention (post-enrollment 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight (kg) | Change in body weight measured in kilograms from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in body composition (fat mass and fat-free mass) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in grip strength (kg) | Change in hand grip strength measured in kilograms from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in serum albumin (g/dL) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juhee Cho, PhD | Contact | +8234101448 | alfadur2j@gmail.com | |
| genehee lee, PhD | Contact | +82 3410 1062 | genehee@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juhee Cho, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Change in body composition assessed by bioimpedance analysis or DXA scan from baseline to end of intervention.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | End of intervention (post-enrollment 4 weeks) |
| Service-experience assessed by qualitative interview | Qualitative assessment of service experience through interview at end of intervention. | End of intervention (post-enrollment 4 weeks) |
Change in serum albumin level from baseline to end of intervention.
| Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in prealbumin (mg/dL) | Change in prealbumin level from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in Nutritional Risk Index (NRI) (score) | Change in Nutritional Risk Index score calculated from serum albumin and body weight from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in Prognostic Nutritional Index (PNI) score | Change in Prognostic Nutritional Index score calculated from serum albumin and total lymphocyte count from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in total protein measured by laboratory assay (g/dL) | Change in total protein level measured by laboratory assay from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in hemoglobin measured by laboratory assay (g/dL) | Change in hemoglobin level measured by laboratory assay from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in white blood cell count (WBC) measured by laboratory assay (×10³/μL) | Change in white blood cell count measured by laboratory assay from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in absolute lymphocyte count (ALC) measured by laboratory assay (×10³/μL) | Change in absolute lymphocyte count measured by laboratory assay from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in absolute neutrophil count (ANC) measured by laboratory assay (×10³/μL) | Change in absolute neutrophil count measured by laboratory assay from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| Change in platelet count (PLT) measured by laboratory assay (×10³/μL) | Change in platelet count measured by laboratory assay from baseline to end of intervention. | Baseline, end of intervention (post-enrollment 4 weeks) |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D001519 | Behavior |