Yoga in Pediatric Cancer

NCT05434871 | Unknown

• 1 other identifier: KAEK-320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Pediatric Cancer

Keywords

Pediatric Cancer; Yoga; Physiotherapy; Quality of Life; Fatigue; Pain; Motor Proficiency

Outcome Measures

Primary Outcomes (8)

• The Pediatric Quality of Life Inventory (PedsQL) Cancer Module

  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

  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

  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:

  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

  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

  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)

  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

  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 Outcomes (5)

• Nottingham Health Profile

  change from baseline to end of the 8 weeks

• Beck Depression Inventory (BDI)

  change from baseline to end of the 8 weeks

• Fatigue Impact Scale

  change from baseline to end of the 8 weeks

• The Fatigue Severity Scale

  change from baseline to end of the 8 weeks

• Caregiving Burden Scale for Family Caregivers of Children with Cancer-CBSFC-CC

  change from baseline to end of the 8 weeks

Study Arms (2)

Yoga Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

The routine physiotherapy and rehabilitation program consists of strength, flexibility, balance, gait and coordination exercises 2 days a week for 8 weeks.

Other: Physiotherapy

Interventions

Yoga training OTHER

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.

Yoga Group

Physiotherapy OTHER

The standard physiotherapy and rehabilitation program consists of strength, flexibility, balance, gait and coordination exercises 2 days a week for 8 weeks.

Control Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

RECRUITING

Related Publications (15)

• Tanner L, Keppner K, Lesmeister D, Lyons K, Rock K, Sparrow J. Cancer Rehabilitation in the Pediatric and Adolescent/Young Adult Population. Semin Oncol Nurs. 2020 Feb;36(1):150984. doi: 10.1016/j.soncn.2019.150984. Epub 2020 Jan 24.

  PMID: 31983485 RESULT

• Hooke MC, Linder LA. Symptoms in Children Receiving Treatment for Cancer-Part I: Fatigue, Sleep Disturbance, and Nausea/Vomiting. J Pediatr Oncol Nurs. 2019 Jul/Aug;36(4):244-261. doi: 10.1177/1043454219849576.

  PMID: 31307321 RESULT

• Linder LA, Hooke MC. Symptoms in Children Receiving Treatment for Cancer-Part II: Pain, Sadness, and Symptom Clusters. J Pediatr Oncol Nurs. 2019 Jul/Aug;36(4):262-279. doi: 10.1177/1043454219849578.

  PMID: 31307323 RESULT

• Olagunju AT, Sarimiye FO, Olagunju TO, Habeebu MY, Aina OF. Child's symptom burden and depressive symptoms among caregivers of children with cancers: an argument for early integration of pediatric palliative care. Ann Palliat Med. 2016 Jul;5(3):157-65. doi: 10.21037/apm.2016.04.03. Epub 2016 May 9.

  PMID: 27199271 RESULT

• Svavarsdottir EK, Tryggvadottir GB. Predictors of quality of life for families of children and adolescents with severe physical illnesses who are receiving hospital-based care. Scand J Caring Sci. 2019 Sep;33(3):698-705. doi: 10.1111/scs.12665. Epub 2019 May 6.

  PMID: 31058346 RESULT

• Gotte M, Kesting SV, Winter CC, Rosenbaum D, Boos J. Motor performance in children and adolescents with cancer at the end of acute treatment phase. Eur J Pediatr. 2015 Jun;174(6):791-9. doi: 10.1007/s00431-014-2460-x. Epub 2014 Nov 28.

  PMID: 25428233 RESULT

• Sontgerath R, Eckert K. Impairments of Lower Extremity Muscle Strength and Balance in Childhood Cancer Patients and Survivors: A Systematic Review. Pediatr Hematol Oncol. 2015;32(8):585-612. doi: 10.3109/08880018.2015.1079756. Epub 2015 Nov 11.

  PMID: 26558954 RESULT

• Baumann FT, Bloch W, Beulertz J. Clinical exercise interventions in pediatric oncology: a systematic review. Pediatr Res. 2013 Oct;74(4):366-74. doi: 10.1038/pr.2013.123. Epub 2013 Jul 15.

  PMID: 23857296 RESULT

• Nanthakumar C. The benefits of yoga in children. J Integr Med. 2018 Jan;16(1):14-19. doi: 10.1016/j.joim.2017.12.008. Epub 2017 Dec 14.

  PMID: 29397087 RESULT

• Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208.

  PMID: 18300936 RESULT

• Danhauer SC, Addington EL, Sohl SJ, Chaoul A, Cohen L. Review of yoga therapy during cancer treatment. Support Care Cancer. 2017 Apr;25(4):1357-1372. doi: 10.1007/s00520-016-3556-9. Epub 2017 Jan 7.

  PMID: 28064385 RESULT

• Tomlinson D, Diorio C, Beyene J, Sung L. Effect of exercise on cancer-related fatigue: a meta-analysis. Am J Phys Med Rehabil. 2014 Aug;93(8):675-86. doi: 10.1097/PHM.0000000000000083.

  PMID: 24743466 RESULT

• Wurz A, Chamorro-Vina C, Guilcher GM, Schulte F, Culos-Reed SN. The feasibility and benefits of a 12-week yoga intervention for pediatric cancer out-patients. Pediatr Blood Cancer. 2014 Oct;61(10):1828-34. doi: 10.1002/pbc.25096. Epub 2014 Jun 17.

  PMID: 24938424 RESULT

• Stein E, Rayar M, Krishnadev U, Gupta A, Hyslop S, Plenert E, Schechter-Finkelstein T, Sung L. A feasibility study examining the impact of yoga on psychosocial health and symptoms in pediatric outpatients receiving chemotherapy. Support Care Cancer. 2019 Oct;27(10):3769-3776. doi: 10.1007/s00520-019-04673-9. Epub 2019 Feb 2.

  PMID: 30712097 RESULT

• Fukuhara JS, O'Haver J, Proudfoot JA, Spies JM, Kuo DJ. Yoga as a Complementary and Alternative Therapy in Children with Hematologic and Oncologic Disease. J Pediatr Oncol Nurs. 2020 Jul/Aug;37(4):278-283. doi: 10.1177/1043454220909787. Epub 2020 Mar 13.

  PMID: 32167404 RESULT

MeSH Terms

Conditions

Neoplasms; Fatigue; Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Arda Tasatargil, Prof. Dr.

CONTACT

+902422496954; etik@akdeniz.edu.tr

Ozgun Kaya Kara, Assoc. Prof.

CONTACT

ozgunkara@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PhD

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 28, 2022
• Study Start: August 30, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 30, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)