Yoga in Pediatric Cancer

NCT ID: NCT05434871

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2023-09-30

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.

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.

Conditions

Cancer; Pediatric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Yoga training

Intervention Type: 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.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Physiotherapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Ozgun Kaya Kara

Assoc. Prof. PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Arda Tasatargil, Prof. Dr.

Role: CONTACT

etik@akdeniz.edu.tr

+902422496954

Ozgun Kaya Kara, Assoc. Prof.

Role: CONTACT

ozgunkara@akdeniz.edu.tr

Facility Contacts

Ozgun KAYA KARA, Assoc. Prof.

Role: primary

ozgunkara@akdeniz.edu.tr

References

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.

Reference Type: RESULT

PMID: 31983485 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31307321 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31307323 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27199271 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31058346 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25428233 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26558954 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23857296 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29397087 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18300936 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28064385 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24743466 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24938424 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30712097 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32167404 (View on PubMed)

Other Identifiers

KAEK-320

Identifier Type: -

Identifier Source: org_study_id