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Идёт набор NCT07024849

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

Без фазы С лечением Esophageal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ecological nutritional intervention.
Кому может быть актуально
Состояния в реестре: Esophageal Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Пищевая добавка 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.

Первичные конечные точки

  • Survey Questionnaire on Health Behavior Change through an Intervention Program [Срок оценки: Baseline, end of intervention (post-enrollment 4 weeks)]
Вторичные конечные точки (11)
  • Change in body weight (kg) [Срок оценки: Baseline, end of intervention (post-enrollment 4 weeks)]
  • Change in body composition (fat mass and fat-free mass) [Срок оценки: Baseline, end of intervention (post-enrollment 4 weeks)]
  • Change in Body Mass Index (BMI) (kg/m²) [Срок оценки: Baseline, end of intervention (post-enrollment 4 weeks)]
  • Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score [Срок оценки: Baseline, end of intervention (post-enrollment 4 weeks)]
  • Change in Gastrointestinal Symptom Rating Scale (GSRS) score [Срок оценки: Baseline, end of intervention (post-enrollment 4 weeks)]
  • Change in dumping syndrome assessed by clinical questionnaire [Срок оценки: Baseline, end of intervention (post-enrollment 4 weeks)]
  • Change in EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, end of intervention (post-enrollment 4 weeks)]
  • Change in patient satisfaction assessed by satisfaction survey [Срок оценки: End of intervention (post-enrollment 4 weeks)]
  • Service-experience assessed by qualitative interview [Срок оценки: End of intervention (post-enrollment 4 weeks)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

South Korea · 1 центр
  • Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT07024849 · 2023-05-127 · RS-2023-CC139778

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗