Self-Management Support for Lung Cancer Patients With Cachexia

Sponsor

Changhua Christian Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05731076

Collaborator

(none)

104

Enrollment

Locations

Arms

19.4

Anticipated Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cachexia-Anorexia Syndrome	Behavioral: Self-management support nutrition and exercise intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy of Self-Management Support on Nutritional Status in Lung Cancer Patients With Cancer Cachexia Syndrome: A Randomized Clinical Trail

Actual Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-management support nutrition and exercise group Educate how to plain regular exercise and eat enough protein diet with self-management support.	Behavioral: Self-management support nutrition and exercise intervention Provide information about different home exercise type(walking, strength training, flexibility training), nutrition knowledge to maintain or improve cancer cachexia syndrome.
No Intervention: Routine health education group Routine health education.

Arm

Intervention/Treatment

Experimental: Self-management support nutrition and exercise group

Educate how to plain regular exercise and eat enough protein diet with self-management support.

Behavioral: Self-management support nutrition and exercise intervention

Provide information about different home exercise type(walking, strength training, flexibility training), nutrition knowledge to maintain or improve cancer cachexia syndrome.

No Intervention: Routine health education group

Routine health education.

Outcome Measures

Primary Outcome Measures

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.
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 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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.