Self-Management Support for Lung Cancer Patients With Cachexia

Not Applicable

Recruiting

• Conditions: Cachexia-Anorexia Syndrome
• Interventions: Behavioral: Self-management support nutrition and exercise intervention

• Registration Number: NCT05731076
• Lead Sponsor: Changhua Christian Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-20
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Diagnosed lung cancer(ICD-10 code: C33-C34)
2. Body weight loss: body weight loss 2% before recruitment 2 months or body weight loss 5% before recruitment 6months.
3. Physician judged may do home exercise without supervisor.
4. Has smart phone and agree to use exercise associated application.
5. Agree to wear Xioami smart band as long as passible.
6. Conscious clear and communication.
7. Eastern Cooperative Oncology Group (ECOG) 0-1.

Exclusion Criteria

1. Participants with cardiovascular disease can't exercise without supervisor.
2. Diabetes Mellitus with blood sugar poor control.
3. Chronic obstructive pulmonary disease with dyspnea on exertion.
4. Platelets < 50000mm3 due to disease or treatment.
5. Hemoglobin <10mg/dl.
6. Recently stumble, severe pain, cognitive and behavior change.
7. Suspect or diagnosed brain metastasis.
8. Suspect or diagnosed bone metastasis.
9. Receive Nasogastric tube feeding or parenteral nutrition.
10. Physician judged can't do home exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management support nutrition and exercise group	Self-management support nutrition and exercise intervention	Educate how to plain regular exercise and eat enough protein diet with self-management support.

Primary Outcome Measures

Name	Time	Method
Change from muscle mass at 12weeks	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	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	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	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 Outcome Measures

Name	Time	Method
24 hours dietary recall	Before allocation and after intervention 8 and 12 weeks.	To understand participants' nutrition intake before and after intervention. Let participants recall their last 24 hours diet by interview, include dish name, amount, cooking method, and nutrition supply. Collected data will be translated to calories, protein, fat, and carbohydrate by a nutritionist, and then it will be continues variable for analysis.
Change from amount of exercise at 12 weeks	Collect 1~8week and 8-12 week exercise record.	Measure amount of exercise by Xioami smart band. It is a wearable device, can record exercise, include time, duration, and heart rate...etc. Let the participant wear the smart band all day if passible. Collect walking distance, exercise date, exercise mode, duration by latest Xioami published application. Collected data will be continuous variable and analyzed.
30 second arm curl test	Before allocation and after intervention 8 and 12 weeks.	Used to test muscle endurance of upper extremities. Let the participant sit on a chair and holding the dumbbell(female 5 pound; male 8 pound), then repeated curl his/her elbow. Count how many times can the participant curl their elbow in 30 seconds. More curl times means better upper endurance.
Six-minute walking test	Before allocation and after intervention 8 and 12 weeks.	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.
Functional Assessment of Cancer Therapy- Lung (FACT-L)	Before allocation and after intervention 12 weeks.	FACT-L could determine quality of life in lung cancer patients. It content 5 dimensions, physical well-being 7items, social/family well-being 7items, emotional well-being 6items, functional well-being 7 items, and Lung cancer sub-scale 9 items. It used Likert 5 point and the score ranged from 0 to 144. The higher score means better quality of life.
30 second chair-stand test	Before allocation and after intervention 8 and 12 weeks.	To test muscle endurance of lower extremities. Let the participant sit on a chair, then repeated stand up and sit. Count how many times can he/she curl his/ her elbow in 30 seconds. The more frequency the better lower limb endurance.
Cancer anorexia-cachexia syndrome nutrition knowledge scale	Before allocation and after intervention 12 weeks.	Cancer anorexia-cachexia syndrome nutrition knowledge scale was developed to test cancer patients' cachexia nutrition knowledge. It content the knowing of cancer anorexia-cachexia syndrome(7 items), the technology on choose food(15 items), and anorexia management(7 items). The items are multiple choice but only one correct answer. The score ranged from 0 to 29, the higher score means the participant has better nutrition knowledge to against cancer anorexia-cachexia syndrome.

Trial Locations

Locations (2)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Yuanlin Christian Hospital; 🇨🇳 Changhua, Taiwan