Developing an Ecological and Tailored Nutritional Intervention to Improve Quality of Life in Esophageal Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Survey Questionnaire on Health Behavior Change through an Intervention Program
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nutrition Intervention group
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.
干预措施: Ecological nutritional intervention (Dietary Supplement)
结局指标
主要结局
Survey Questionnaire on Health Behavior Change through an Intervention Program
时间窗: Baseline, end of intervention (post-enrollment 4 weeks)
Adherence to nutritional guidelines including food intake
次要结局
- Change in body weight (kg)(Baseline, end of intervention (post-enrollment 4 weeks))
- Change in body composition (fat mass and fat-free mass)(Baseline, end of intervention (post-enrollment 4 weeks))
- Change in Body Mass Index (BMI) (kg/m²)(Baseline, end of intervention (post-enrollment 4 weeks))
- Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score(Baseline, end of intervention (post-enrollment 4 weeks))
- Change in Gastrointestinal Symptom Rating Scale (GSRS) score(Baseline, end of intervention (post-enrollment 4 weeks))
- Change in dumping syndrome assessed by clinical questionnaire(Baseline, end of intervention (post-enrollment 4 weeks))
- Change in EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score(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(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(Baseline, end of intervention (post-enrollment 4 weeks))
- Change in patient satisfaction assessed by satisfaction survey(End of intervention (post-enrollment 4 weeks))
- Service-experience assessed by qualitative interview(End of intervention (post-enrollment 4 weeks))
研究者
Juhee Cho
Director of Cancer Education Center
Samsung Medical Center