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肺癌恶病质患者的自我管理支持

2026年5月11日 更新者：Chang Li Chun、Changhua Christian Hospital

自我管理支持对癌症恶病质综合征肺癌患者营养状况的疗效：一项随机临床试验

这项随机临床试验的目的是测试基于自我管理支持的运动联合营养干预对患有癌症恶病质厌食综合征的肺癌患者的疗效。 它旨在回答的主要问题是：

• 运动结合营养干预会改善肺癌患者的营养状况吗？ 参与者将在自我管理支持基础教育后制定定制的运动计划并吃足够的蛋白质食物。

并且有一个对照组：研究人员将比较对照组，看看接受常规健康教育的营养状况。

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (估计的)

104

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 台湾
    • Changhua
      • Changhua、Changhua、台湾、51052
        • Changhua Christian Hospital
    • Taipei
      • Taipei、Taipei、台湾、11219
        • Taipei Veterans General Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 80年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 确诊肺癌（ICD-10 代码：C33-C34）
  2. 体重减轻：招募前2个月体重减轻2%或招募前6个月体重减轻5%。
  3. 经判断的医师可以在没有监督的情况下进行家庭锻炼。
  4. 拥有智能手机并同意使用与锻炼相关的应用程序。
  5. 只要可以，同意戴小米手环。
  6. 意识清晰和沟通。
  7. 东部肿瘤合作组 (ECOG) 0-1。

排除标准：

  1. 患有心血管疾病的参与者不能在没有监督者的情况下锻炼。
  2. 血糖控制不佳的糖尿病。
  3. 慢性阻塞性肺病伴有劳力性呼吸困难。
  4. 由于疾病或治疗导致血小板<50000mm3。
  5. 血红蛋白 <10mg/dl。
  6. 最近跌跌撞撞，剧烈疼痛，认知和行为发生改变。
  7. 怀疑或诊断出脑转移。
  8. 怀疑或诊断出骨转移。
  9. 接受鼻胃管喂养或肠外营养。
  10. 医生判断不能在家锻炼。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Combined Exercise and Nutrition Self-management Support Program
Participants receive a 12-week multimodal intervention. This includes personalized exercise prescriptions (aerobic, resistance, and flexibility training) guided by wearable technology and structured nutritional counseling focused on adequate protein intake (e.g., 1.2 g/kg/day). All activities are supported by a self-management behavioral framework to enhance adherence. In addition, both arms receive baseline cancer care from hospital case managers to ensure ethical standards of care are met.
行为的：Self-management support nutrition and exercise intervention
A structured 12-week multimodal support program. (1) Exercise: Personalized home-based aerobic, resistance, and flexibility training (at least 3 times/week, 30 min/session) monitored via Xiaomi smart bands. (2) Nutrition: Goal-oriented counseling focused on achieving a high-protein intake (e.g., 1.2-1.5 g/kg/day). (3) Self-management: Continuous support using a self-monitoring manual, wearable device feedback, and a dedicated Line@ social media platform for real-time interaction with researchers, providing counseling and symptom management support to enhance patient adherence.
无干预：Routine health education group
Participants will receive standard of care provided by cancer case managers, including education on medication adherence, symptom/side-effect management, and nutritional supplement trials as needed. To maintain study blinding, participants in this group will also wear Xiaomi smart bands and undergo the same assessment schedule (Baseline, Week 8, Week 12) without the additional self-management support program.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from baseline Mini Nutrition Assessment(MNA)
大体时间：baseline, Week 8, Week 12.
The MNA consists of 18 self-reported questions covering ingestion, weight loss, mobility, acute illness/stress, neuropsychological problems, BMI, living arrangements, polypharmacy, skin ulcers, meal frequency, food/fluid intake, and mode of feeding. The maximal score is 30. A score >23.5 means well-nourished, 17-23.5 means risk of malnutrition, and <17 means malnutrition. Higher scores indicate better nutritional status.
baseline, Week 8, Week 12.

次要结果测量

结果测量
措施说明
大体时间
Feasibility of the self-management support program
大体时间：Week 12
Assessed by recruitment rate (percentage of eligible patients enrolled), retention rate (percentage of participants completing the 12-week study), and adherence to the wearable device and Line@ interaction.
Week 12
Change from balseline in Body Mass Index(BMI)
大体时间：Baseline, Week 8, Week 12
BMI is calculated as weight in kilograms divided by the square of height in meters (kg/m^2), measured using Bioelectrical Impedance Analysis (BIA) with the InBodyDial H20 device. Data are recorded and rounded to one decimal place.
Baseline, Week 8, Week 12
Change from baseline in skeletal muscle mass
大体时间：Baseline, Week 8, Week 12
Measured using Bioelectrical Impedance Analysis (BIA) with the InBodyDial H20 device. Data are recorded in percentage (%) and rounded to one decimal place.
Baseline, Week 8, Week 12
Change from basleline body fat mass at 12weeks
大体时间：Baseline, Week 8, Week 12
The body fat mass will be detected by InBodyDial H20. Data record with percentage and after the first decimal place.
Baseline, Week 8, Week 12
Change from Baseline in Upper Body Muscle Endurance (30-Second Arm Curl Test)
大体时间：Baseline, Week 8, Week 12
Used to evaluate upper body muscle endurance. The participant sits on a chair with back supported and performs as many bicep curls as possible in 30 seconds using a dumbbell (5 lbs for females; 8 lbs for males). The total number of completed curls is recorded. Higher scores (more repetitions) indicate better upper body muscle endurance.
Baseline, Week 8, Week 12
Change from Baseline in Lower Body Muscle Strength (30-Second Chair-Stand Test)
大体时间：Baseline, Week 8, Week 12
Used to evaluate lower body muscle strength. The participant sits in the middle of a chair with back straight and feet flat on the floor, then stands up completely and sits down repeatedly for 30 seconds. The total number of completed stands is recorded. Higher scores (more repetitions) indicate better lower body muscle strength.
Baseline, Week 8, Week 12
Change from Baseline in cardiopulmonary function (6-Minute Walk Test)
大体时间：Baseline, Week 8, Week 12
Examine cardiopulmonary function in this study. Let the participant sit and rest 10 minutes before test. Check vital signs and oxygen situation for patient safety. Position the participant at the starting line, and walking back and forth along the mark on the floor. When the participant starts to walk, starts the times. Don't walk nor talk with him/ her, and count the laps attentively. Participant can walk longer distance means better cardiopulmonary function.
Baseline, Week 8, Week 12
Change from basline in quality of life (FACT-L)
大体时间：Baseline, Week 12
The Functional Assessment of Cancer Therapy-Lung (FACT-L) is used to determine quality of life in lung cancer patients. It contains 5 dimensions: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and lung cancer subscale (9 items). Items are rated on a 5-point Likert scale with total scores ranging from 0 to 144. Higher scores indicate better quality of life."
Baseline, Week 12
Change from Baseline in Cancer anorexia-cachexia syndrome nutrition knowledge (CACSNKQ)
大体时间：Baseline, Week 12
The CACSNKQ is designed to assess patients' knowledge regarding cancer anorexia-cachexia syndrome. All items are multiple-choice with one correct answer. The total score ranges from 0 to 21, with higher scores indicating better nutritional knowledge and self-management ability against the syndrome.
Baseline, Week 12
Change from baseline in dietary intake (24 hours dietary recall)
大体时间：Baseline, Week 8, Week12
To assess participants' nutritional intake. A 24-hour dietary recall interview is conducted to record all food and beverage consumption (including dish names, portion sizes, and preparation methods). Data are converted into total calories (kcal) and macronutrients (protein, fat, and carbohydrates in grams) by a registered dietitian using nutritional analysis software.
Baseline, Week 8, Week12
Change from Baseline in amount of exercise
大体时间：Baseline to Week 8, and Week 8 to Week 12
Measured using the Xiaomi Smart Band and a self-management support manual. The Xiaomi Smart Band is worn daily by participants to record continuous physical activity data, including daily step count, exercise duration, walking distance, and heart rate. Additionally, participants use the self-management support manual to log the specific duration and frequency of resistance training and stretching exercises.
Baseline to Week 8, and Week 8 to Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Changhua Christian Hospital

合作者

National Taipei University of Nursing and Health Sciences
Taipei Veterans General Hospital, Taiwan

调查人员

  • 首席研究员：Li Chun Chang, Master、Changhua Christian Hospital
  • 研究主任：Tsae Jyy Wang, PhD、National Taipei University of Nursing and Health Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年1月20日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2023年1月23日

首先提交符合 QC 标准的

2023年2月15日

首次发布 (实际的)

2023年2月16日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月11日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 220582

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

由于伦理限制和知情同意书的条款规定，个人参与者数据将不会与第三方共享。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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