Efficacy of Self-Management Support on Nutritional Status in Lung Cancer Patients With Cancer Cachexia Syndrome: A Randomized Clinical Trail
Overview
- Phase
- N/A
- Intervention
- Self-management support nutrition and exercise intervention
- Conditions
- Cachexia-Anorexia Syndrome
- Sponsor
- Changhua Christian Hospital
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Change from muscle mass at 12weeks
- Status
- Enrolling by Invitation
- Last Updated
- last month
Overview
Brief Summary
The goal of this randomized clinical trial is to test the efficacy of self-management support based exercise combine nutrition intervention in lung cancer patient with cancer cachexia anorexia syndrome . The main question it aims to answer is:
• Would exercise combine nutrition intervention improve lung cancer patients' nutrition status? Participants will make custom exercise plan and eat enough protein food after self-management support based education.
And there is a comparison group: Researchers will compare comparison group to see nutrition status who receive routine health education.
Investigators
Chang Li Chun
Head of nurse practitioner
Changhua Christian Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Self-management support nutrition and exercise group
Educate how to plain regular exercise and eat enough protein diet with self-management support.
Intervention: Self-management support nutrition and exercise intervention
Routine health education group
Routine health education.
Outcomes
Primary Outcomes
Change from muscle mass at 12weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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.)