Efficacy of Self-Management Support on Nutritional Status in Lung Cancer Patients With Cancer Cachexia Syndrome: A Randomized Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Change from muscle mass at 12weeks
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the efficacy of a self-management support program combining exercise and nutrition intervention for lung cancer patients with cancer cachexia anorexia syndrome.
This study is conducted in two stages. In the first stage (Pilot Phase), the researchers aim to assess the feasibility of the intervention and its potential impact on nutritional status in 20 participants. Based on these preliminary results, the intervention protocol or supervision model may be refined for the subsequent full-scale trial.
The main questions it aims to answer are:
Is the combined exercise and nutrition self-management support program feasible for lung cancer patients with cachexia?
Can this integrated intervention improve the nutritional status of these patients compared to routine care?
Participants in the intervention group will receive self-management support-based education to develop personalized exercise plans and ensure adequate protein intake. The researchers will compare this group to a control group receiving routine health education to evaluate differences in nutritional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
To maintain blinding, all participants are provided with wearable devices and undergo identical assessment protocols. They are informed that personalized health education will be delivered at varying intervals based on clinical results, which prevents them from distinguishing between the experimental and control intervention models．
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed lung cancer(ICD-10 code: C33-C34)
- •Body weight loss: body weight loss 2% before recruitment 2 months or body weight loss 5% before recruitment 6months.
- •Physician judged may do home exercise without supervisor.
- •Has smart phone and agree to use exercise associated application.
- •Agree to wear Xioami smart band as long as passible.
- •Conscious clear and communication.
- •Eastern Cooperative Oncology Group (ECOG) 0-1.
排除标准
- •Participants with cardiovascular disease can't exercise without supervisor.
- •Diabetes Mellitus with blood sugar poor control.
- •Chronic obstructive pulmonary disease with dyspnea on exertion.
- •Platelets < 50000mm3 due to disease or treatment.
- •Hemoglobin <10mg/dl.
- •Recently stumble, severe pain, cognitive and behavior change.
- •Suspect or diagnosed brain metastasis.
- •Suspect or diagnosed bone metastasis.
- •Receive Nasogastric tube feeding or parenteral nutrition.
- •Physician judged can't do home exercise.
研究组 & 干预措施
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.
结局指标
主要结局
Change from muscle mass at 12weeks
时间窗: Before allocation and after intervention 8 and 12 weeks.
The muscle mass will be detected by OMRON HBF-375. Data record with percentage and after the first decimal place.
Change from body fat mass at 12weeks
时间窗: Before allocation and after intervention 8 and 12 weeks.
The body fat mass will be detected by OMRON HBF-375. Data record with percentage and after the first decimal place.
Change form Minimal Nutrition Assessment(MNA) at 12 weeks
时间窗: Before allocation and after intervention 8 and 12 weeks.
The MNA consists of 18 self- reported questions. Each question has different score and marked near the answer. The first part of MNA is six questions about ingestion, weight loss, current mobility, an acute illness or major stress, a neuropsychological problem, and a decrease in body mass index. The second part evaluates living arrangements, the presence of polypharmacy or pressure ulcers, the number of full meals eaten daily, the amount and frequency of specific foods and fluids, and the mode of feeding. The patient reports nutritional and health status, and the practitioner determines weight and height (to calculate BMI), and mid-arm and mid-calf circumferences. The maximal score is 30, score \>23.5 means well-nourished, 17\~23.5 means risk of malnutrition, \< 17 means malnutrition.
Change from body weight at 12weeks
时间窗: Before allocation and after intervention 8 and 12 weeks.
The body wight will be detected by OMRON HBF-375. Data record in kilograms and after the first decimal place.
次要结局
- 24 hours dietary recall(Before allocation and after intervention 8 and 12 weeks.)
- Change from amount of exercise at 12 weeks(Collect 1~8week and 8-12 week exercise record.)
- 30 second arm curl test(Before allocation and after intervention 8 and 12 weeks.)
- Six-minute walking test(Before allocation and after intervention 8 and 12 weeks.)
- Functional Assessment of Cancer Therapy- Lung (FACT-L)(Before allocation and after intervention 12 weeks.)
- 30 second chair-stand test(Before allocation and after intervention 8 and 12 weeks.)
- Cancer anorexia-cachexia syndrome nutrition knowledge scale(Before allocation and after intervention 12 weeks.)
研究者
Chang Li Chun
Head of nurse practitioner
Changhua Christian Hospital