Effects of Health Informatics for Symptom Management and Resistance Exercise Strategies on Quality of Life and Sarcopenia in Post-Esophagectomy Patients With Esophageal Cancer: A Mixed-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Quality of Life (EORTC QLQ-C30 score)
研究概览
简要总结
Participants are invited to take part in a research study. In accordance with the requirements of the health authorities, participants must be informed of the purpose of the study and its potential risks. Participation is voluntary, and each participant is free to decide whether or not to enroll. The study may be discussed with trusted individuals, and sufficient time may be taken to consider the decision. If any part of this consent form is unclear, questions may be directed to the principal investigator or the research team, who will provide an explanation.
If a participant chooses not to participate, appropriate treatment will still be provided. Even if a participant agrees to participate initially, withdrawal is allowed at any time without affecting medical rights or the care that should be received.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 years or older
- •Diagnosed with esophageal cancer and having undergone esophagectomy
- •Postoperative pathological report confirms R0 resection (complete tumor removal)
- •Able to be discharged after surgery
- •With or without adjuvant chemoradiotherapy
- •Clear consciousness and able to communicate in Mandarin or Taiwanese
排除标准
- •Presence of severe cardiovascular disease or psychiatric disorders
- •Inability to communicate in Mandarin Chinese or Taiwanese
- •Disease progression during the intervention period that prevents continuation of participation.
研究组 & 干预措施
Usual Care Group
Participants receive standard postoperative nursing care and education as routinely provided by the clinical team. No additional interventions will be given.
干预措施: Usual Care Group (Behavioral)
Symptom Management Health Informatics plus Resistance Exercise Group
Participants receive access to a symptom management health informatics program and a structured resistance band exercise training program.
干预措施: symptom management health informatics plus Resistance band exercise training (Behavioral)
结局指标
主要结局
Quality of Life (EORTC QLQ-C30 score)
时间窗: Baseline, 1 month, 3 months, 6 months after intervention
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a validated and widely used instrument for assessing quality of life in patients with cancer. It includes five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/quality of life scale, and several single-item symptom measures (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores are linearly transformed to a 0-100 scale; higher scores on functional and global health scales indicate better functioning/quality of life, whereas higher scores on symptom scales indicate greater symptom burden.
次要结局
- Esophageal Cancer-related Symptoms (EORTC QLQ-OES18 score)(1 month, 3 months, 6 months after intervention)
- Sarcopenia Status (e.g., SARC-F or handgrip strength, muscle mass index)(Baseline, 1 month, 3 months, 6 months after intervention)
- Body Mass Index (BMI)(Baseline, 1 month, 3 months, 6 months after intervention)
研究者
Yu-Ling Chang
Assistant Professor
Chang Gung University