Self-Management Support for Lung Cancer Patients With Cachexia

February 15, 2023 updated by: Chang Li Chun, Changhua Christian Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Changhua, Taiwan, 51052
        • Recruiting
        • Yuanlin Christian Hospital
        • Contact:
        • Principal Investigator:
          • Tzu Fang Chen, Master
      • Taipei, Taiwan, 11219
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Tzu Fnag Chen, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before allocation and after intervention 8 and 12 weeks.
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.
Before allocation and after intervention 8 and 12 weeks.
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.
Before allocation and after intervention 8 and 12 weeks.
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.
Before allocation and after intervention 8 and 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 second arm curl test
Time Frame: 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.
Before allocation and after intervention 8 and 12 weeks.
30 second chair-stand test
Time Frame: 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.
Before allocation and after intervention 8 and 12 weeks.
Six-minute walking test
Time Frame: 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.
Before allocation and after intervention 8 and 12 weeks.
Functional Assessment of Cancer Therapy- Lung (FACT-L)
Time Frame: 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.
Before allocation and after intervention 12 weeks.
Cancer anorexia-cachexia syndrome nutrition knowledge scale
Time Frame: 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.
Before allocation and after intervention 12 weeks.
24 hours dietary recall
Time Frame: 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.
Before allocation and after intervention 8 and 12 weeks.
Change from amount of exercise at 12 weeks
Time Frame: 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.
Collect 1~8week and 8-12 week exercise record.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Investigators

  • Principal Investigator: Li Chun Chang, Master, Yuanlin Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

August 31, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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