Yoga in Pediatric Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434871
• Other study ID #: KAEK-320
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2023
• Source: Akdeniz University
• Contact: Arda Tasatargil, Prof. Dr.
• Phone: +902422496954
• Email: etik[@]akdeniz.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pediatric Cancer

Intervention

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

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. do — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Nottingham Health Profile	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
Secondary	Beck Depression Inventory (BDI)	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
Secondary	Fatigue Impact Scale	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
Secondary	The Fatigue Severity Scale	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
Secondary	Caregiving Burden Scale for Family Caregivers of Children with Cancer-CBSFC-CC	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