Yoga in Pediatric Cancer

May 31, 2023 updated by: Ozgun Kaya Kara, Akdeniz University

The Efficacy of Yoga in Pediatric Cancer Patients: A Randomized Controlled Study

Pediatric cancer patients and their families experience biopsychosocial difficulties as a result of the long and difficult treatment procedure, which have a severe impact on their quality of life. These difficulties might arise as a result of cancer and its treatment. Fatigue, pain, and an impaired motor skills are all common issues. These issues result in body structure and function deficits, as defined by the International Classification of Functioning-Child and Youth (ICF-CY), and have a negative impact on children's activity and participation levels. Yoga is a form of exercise that incorporates breathing methods, physical postures, and meditation. Yoga appears to relieve fatigue and improve quality of life in pediatric cancer patients, according to preliminary studies. However, no randomized controlled trial has been conducted in this population to determine the effectiveness of yoga. The purpose of this study is to assess children's quality of life, fatigue, pain, motor proficiency, participation, coping, and motivation; also to look at the effects of parents on quality of life, depression, fatigue, and care burden in a randomized controlled study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Childhood cancers are diseases that affect children and their families worldwide and occur in a variety of diagnostic groups. The focus has been on reducing mortality rates and long-term survival expectations in pediatric cancer patients, as well as reducing long-term side effects and improving quality of life, and it has become critical to develop interventions for problems that have long-term consequences. Within the framework of ICF-CY, biological problems such as exhaustion, pain, nausea, vomiting, and sleep difficulties, which are the most common symptoms in pediatric cancer patients, are included in body structure and function disorders. However, rather than cancer, the underlying cause of many difficulties is considered to be the treatment process itself. The symptoms experienced by pediatric cancer patients are moderate to high and are related to the stress level of the parents. As a result, improvements in pediatric cancer patients' symptoms may also lower the burden of care for their parents. Within the scope of the ICF-CY model, these biopsychosocial difficulties encountered by the child and family are interrelated and have an impact on the child's and family's quality of life. Limitations of normal joint movement, contractures, muscle weakness, diminished flexibility and functional mobility, balance and gait problems are among the physical and functional performance deficits reported by pediatric cancer patients as a result of the disease and therapy. Physical disabilities have a negative impact on children's participation in daily activities and their quality of life. As a result, specific therapy strategies aimed at improving children's physical limitations are required. In the current systematic review, it was stated that exercise applied to pediatric cancer patients had positive effects on fatigue, muscle strength, functional mobility, flexibility, sleep, physical activity level, and quality of life. No side effects were observed in the studies. In a meta-analysis, it was found that exercise, regardless of the type of exercise, lowers fatigue in pediatric cancer patients. Yoga is one of the promising approaches for children with cancer. Yoga improves stress and anxiety management, motor performance, concentration ability, and cardiovascular and musculoskeletal system functions in healthy children. Researchers reviewed yoga therapy in adult and pediatric cancer patients. Although yoga has been shown to improve psychological and physical functions in adults with cancer, the same cannot be said for children with cancer. In the literature, there are very few research on the impact of yoga on children with cancer. Children and their parents noted that after practicing yoga, sickness, the need for painkillers, and anxiety levels decreased, while sleep and mood improved. Yoga was useful in reducing stress and anxiety, according to the children and parents. In the existing literature, however, studies exploring the benefit of yoga in pediatric cancer patients are both quantitatively and qualitatively limited. In the literature, there is no randomized controlled trial that looks at the efficacy of yoga in children with cancer. The number of investigations in the literature is restricted to only eight pilot studies. This study is aimed to investigate the effects of yoga on quality of life, fatigue, pain, motor proficiency, and motivation in pediatric cancer patients in order to fill this gap in the literature.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of a hematological malignancy or a solid tumor
  • Age between 6 years and 12 years
  • Received chemotherapy for at least two weeks
  • Ability to stand and move without the use of an assistive device
  • To be able to read and speak Turkish

Exclusion Criteria:

  • Diagnosis of central nervous system tumor, genetic syndrome or neurological disorder
  • Surgery planned within the 8-week period planned to participate in yoga
  • Refused to participate the study

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Yoga Group
There will be a 45-minute yoga session 2 days a week for 8 weeks. Warm up with yoga-specific moves for 10 minutes (light stretching), yoga postures for 25 minutes and rest and meditate for the last ten minutes.
Other: Yoga training
There will be a 45-minute yoga session 2 days a week for 8 weeks. Warm up with yoga-specific moves for 10 minutes (light stretching), yoga postures for 25 minutes and rest and meditate for the last ten minutes.
Active Comparator: Control Group
The routine physiotherapy and rehabilitation program consists of strength, flexibility, balance, gait and coordination exercises 2 days a week for 8 weeks.
Other: Physiotherapy
The standard physiotherapy and rehabilitation program consists of strength, flexibility, balance, gait and coordination exercises 2 days a week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Pediatric Quality of Life Inventory (PedsQL) Cancer Module
Time Frame: change from baseline to end of the 8 weeks
The PedsQL-Cancer Module assesses the quality of life and symptoms of children diagnosed with pediatric cancer. Both the parent and child versions of the PedsQL-Cancer Module are available. The scale contains 26 items divided into eight domains: pain (2 items), nausea (5 items), operational anxiety (3 items), treatment anxiety (3 items), anxiety (3 items), cognitive issues (4 items), perceived physical appearance (3 items), and communication (3 items). It can be used on children with pediatric cancer aged 2-4, 5-7, and 8-12 years old. Minimum score is 0 and maximum score is 100.
change from baseline to end of the 8 weeks
Child Fatigue Scale-R 24-Hours
Time Frame: change from baseline to end of the 8 weeks
The Child Fatigue Scale-24 Hour (CFS-24 hours) is a scale that measures how tired children aged 7 to 12 were in the previous 24 hours. There are child and parent versions of CFS-24 hours. The CFS-24 child form contains 10 items. Each item is scored on a 5-point Likert scale. It is rated as 1 = not at all and 5 = very much. The scale total score is classified between 10 = no fatigue and 50 = high fatigue.
change from baseline to end of the 8 weeks
Pain Flexibility Scale for Children with Cancer
Time Frame: change from baseline to end of the 8 weeks
The scale assesses children's pain acceptance in chronic pain.It has a total of 20 questions divided into two sub-sections: valued activities and pain resistance. Pain resistance examines pain avoidance and control, whereas valued behaviors assesses involvement in meaningful activities despite pain. The scale is a seven-point Likert scale, with 0 indicating total disagreement (never true), and 6 indicating total agreement (Always true).
change from baseline to end of the 8 weeks
Bruininks-Oseretsky Test of Motor Proficiency Short Form -BOT-2 SF:
Time Frame: change from baseline to end of the 8 weeks
The Bruininks-Oseretsky Test of Motor Proficiency is a norm-referenced test. The Bruininks-Oseretsky Test of Motor Proficiency is a test that evaluates children's gross and fine motor skills between the ages of 4 and 21. It evaluates four different aspects of motor skills: fine manual control, manual coordination, body coordination, strength, and agility. Long and short versions are available. The short form comprises 14 items and contains some of the items from the long form. The results of the The Bruininks-Oseretsky Test of Motor Proficiency Short Form are given as standard scores or percentiles. In addition, outcomes may be classified as below average or above average in a descriptive category. Minimum point score is 0 and maximum point score is 88.
change from baseline to end of the 8 weeks
Pediatric Motivation Scale
Time Frame: change from baseline to end of the 8 weeks
PMOT assesses the motivation of children ages 8 to 18 to participate in a rehabilitation program. There are 21 items in total, divided into six categories: effort-importance, interest-enjoyment, competence, relatedness, autonomy, and value-usefulness. The first 19 questions are answered using a six-point smiley face scale (1 = not true at all, 6 = definitely true). The questions 20 and 21 are also open-ended. More motivation is indicated by higher scores.
change from baseline to end of the 8 weeks
Paediatric Cancer Coping Scale
Time Frame: change from baseline to end of the 8 weeks
For children aged 7-18 years, PCCS assesses children's notifications of cancer coping techniques. Cognitive coping, problem-focused coping, and defensive coping are the three subscales that comprise the PCCS. There are 33 items total. A likert scale with 0-3 points is used for scoring. From 0 to 99, the total rating is calculated. The higher the score, the better the coping ability.
change from baseline to end of the 8 weeks
Participation and Environment- Children and Youth (PEM-CY)
Time Frame: change from baseline to end of the 8 weeks
PEM-CY is a parent-report questionnaire to assess participation and environment factors in the home, at school and within community settings. The participation sections included 10 activities in the home setting, five activities in the school setting and 10 in the community setting. For each activity, parents are asked to determine the participation frequency (how frequently has the child participated with eight options: daily to never), participation involvement (how involved the child is while participating the activity rated on a five-point scale: very involved to minimally involved) and whether change is desired (do the parents want to see change in the child's participation in this type of activity: no or yes, with 5 different types of change)
change from baseline to end of the 8 weeks
The Child Fatigue Scale-Parent Form
Time Frame: change from baseline to end of the 8 weeks
The Child Fatigue Scale-Parent Form contains 17 items. It is scored on a 5-point Likert scale. The total score is classified between 17 = no fatigue and 85 = high fatigue.
change from baseline to end of the 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nottingham Health Profile
Time Frame: change from baseline to end of the 8 weeks
Nottingham Health Profile assess the physical, emotional and health problems perceived by a person. It consist of 6 different subcategories such as energy, pain, physical mobility, sleep, emotional reactions and social isolation with 38 items. Nottingham Health Profile examines that current state of health condition and the answers are dichotomous (yes/no). The overall value is calculated by multiplying the intensity of the questions by the positive answer to each one. The minimum score is 0, maximum score is 100.
change from baseline to end of the 8 weeks
Beck Depression Inventory (BDI)
Time Frame: change from baseline to end of the 8 weeks
The BDI assesses characteristic attitudes and depression symptoms with 21 self-reported items. It takes about 10 minutes to finish the assessment. It is intended for people aged 13 and up. BDI includes 21 questions. For each question, the lowest score is 0 and the maximum score is 3. The total score of all answers is evaluated as follows 0 to 9 points: "minimal depressive symptoms", 10 to 16 points: "mild depressive symptoms", 17 to 29 points: "moderate depressive symptoms", 20 to 63 points: "severe depressive symptoms".
change from baseline to end of the 8 weeks
Fatigue Impact Scale
Time Frame: change from baseline to end of the 8 weeks
It is a multidimensional scale that measures the physical, cognitive and social effects of fatigue. It consists of 40 items divided into 10 cognitive, 10 physical, and 20 social subscales. Each question is scored on a five-point Likert scale from 0 (no problem) to 4 (extreme problem). The maximum total point is 160.
change from baseline to end of the 8 weeks
The Fatigue Severity Scale
Time Frame: change from baseline to end of the 8 weeks
The fatigue severity scale is the one of the most used scale that assess fatigue. There are nine questions. Each question is scored on a seven-point Likert scale from one to seven. The mean of nine questions is the scale value. Higher scores indicating more severe fatigue. Although there is no recommendation, it is usually considered that fatigue above 4 points is significant.
change from baseline to end of the 8 weeks
Caregiving Burden Scale for Family Caregivers of Children with Cancer-CBSFC-CC
Time Frame: change from baseline to end of the 8 weeks
It assesses the burden of care of family members caregivers aged 0 to 18 who have been diagnosed with cancer. The measure assesses the burden of care in terms of physical, emotional, mental, socio-cultural, and economic factors over 36 items. The CBSFC-CC is measured on a 5-point Likert scale, with 1 indicating never and 5 indicating always.
change from baseline to end of the 8 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAEK-320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will be submitted to the journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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