Muscle Wasting in Children and Adolescents With Cancer

National Taiwan University

Status: Unknown

Conditions: Adolescent Development; Child Development; Cachexia; Cancer; Muscle Wasting

Treatments: Behavioral: Multidisciplinary care with a personalized care

Study type: Interventional

Funder types: Other

Identifiers

NCT04353063

202001023RINA

Details and patient eligibility

About

The series of the 3-year study aims to explore parents' experience of caring for a child's weight change among parents of children and adolescents with cancer, examine the associations and trends among muscle wasting and health-related variables, and then implement and assess effectiveness of a multidisciplinary approach with a personalized physical activity (walking) training intervention on improving muscle mass and other health-related variables.

Full description

Specific aims, year by year

1. The aim for Year 1 is as follows:

   Aim 1: To explore parents' experience of caring for promoting a child's exercise among parents of children and adolescents with cancer.

2. The aims for Year 2 are as follows:

   Aim 2-1: To examine the associations between the degree of muscle wasting and health-related variables (fatigue level, symptom distress level, physical activity involvement, dietary intake, and QoL) among children and adolescents with cancer.

   Aim 2-2: To examine the trends of changes in muscle wasting and health-related variables (fatigue level, symptom distress level, physical activity involvement, dietary intake, and QoL) during the first 6 months of cancer treatment among children and adolescents with cancer.

3. The aim for Year 3 is as follows:

Aim 3: To examine the effectiveness of a multidisciplinary approach with a personalized walking exercise program on changes in body composition and health-related variables (fatigue level, symptom distress level, subjective physical activity involvement, objective physical activity measurement, dietary intake, and QoL) among children and adolescents with cancer.

Enrollment: 440 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aim 1:(1) parents of children diagnosed with malignancies at 3-18 years old, (2) whose children have received cancer treatment for at least 6 months, (3) who are the main caregivers, and (4) who are willing to participate in the study.
• Aim 2-1:(1) children and adolescents diagnosed with malignancies at 3-18 years old, (2) who are previously or currently treated for cancer, and (3) who are willing to participate in the study. Two hundred patients will be recruited.
• Aim 2-2:(1) children and adolescents diagnosed with malignancies at 3-18 years old, (2) newly diagnosed with cancer within the past 1 month, and (3) willing to participate in the study. One hundred participants will be recruited.
• Aim 3:(1) children and adolescents aged 3-18 years old and are undergoing treatment, and (2) who are willing to participate in the study.

Exclusion criteria

-Aim 1-3: Children and adolescents are under poor physical or cognitive conditions.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

control group

No Intervention group

Description:

The patients in the control group will not receive any walking exercise education until the 4-week intervention ends. They will then receive the same education material ("How walking is beneficial to your health") and will be told about the benefits of walking.

experimental group

Experimental group

Description:

Participants in the experimental group will also be educated on the general use of the ActiGraph through verbal and written information and will be asked to wear the ActiGraph during week 0 for 3 consecutive days. The collected physical activity parameters will be the baseline data.Afterward, participants in the experimental group will be educated with the educational materials "How walking is beneficial to muscle mass and your health." And then the ActiGraph will be collected by the research assistant in order to analyze the physical activity parameters, including time spent walking and walking steps. A final assessment will be conducted at week 4. The participant will be reminded that the ActiGraph and the post-test questionnaires will be picked up at the end of week 4.

Treatment:

Behavioral: Multidisciplinary care with a personalized care