CancerNCT05434871
Yoga in Pediatric Cancer
A study testing Yoga training and Physiotherapy in people with Cancer and Pediatric Cancer, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cancer, Pediatric Cancer
- What is being tested?
- Yoga training and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ozgun Kaya Kara, Assoc. Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University
Antalya
Ozgun KAYA KARA, Assoc. Prof., ozgunkara@akdeniz.edu.tr
About this study
Official title: 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.
Read the 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
- Being tested
- Yoga training, Physiotherapy
- Keywords
- Pediatric Cancer, Yoga, Physiotherapy, Quality of Life, Fatigue, Pain, Motor Proficiency
- Medical subject headings
- Neoplasms, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga trainingOther
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.
PhysiotherapyOther
The standard physiotherapy and rehabilitation program consists of strength, flexibility, balance, gait and coordination exercises 2 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: change from baseline to end of the 8 weeks
Secondary outcomes (5)
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.
Measured: change from baseline to end of the 8 weeks
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".
Measured: change from baseline to end of the 8 weeks
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.
Measured: change from baseline to end of the 8 weeks
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.
Measured: change from baseline to end of the 8 weeks
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.
Measured: change from baseline to end of the 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start30 Aug 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434871
- Sponsor's protocol ID
- KAEK-320
- Status last verified
- May 2023
- First submitted
- 14 Jun 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be submitted to the journal.
Publications
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.
PubMed 31983485Hooke 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.
PubMed 31307321Linder 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.
PubMed 31307323Olagunju 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.
PubMed 27199271Svavarsdottir 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.
PubMed 31058346Gotte 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.
PubMed 25428233Sontgerath 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.
PubMed 26558954Baumann 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.
PubMed 23857296Nanthakumar 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.
PubMed 29397087Galantino 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.
PubMed 18300936Danhauer 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.
PubMed 28064385Tomlinson 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.
PubMed 24743466Wurz 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.
PubMed 24938424Stein 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.
PubMed 30712097Fukuhara 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.
PubMed 32167404
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Yoga in Pediatric Cancer Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05434871
- Acronym / sponsor ID
- KAEK-320
- Conditions
- Cancer, Pediatric Cancer
- Keywords
- Pediatric Cancer, Yoga, Physiotherapy, Quality of Life, Fatigue, Pain, Motor Proficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Other: Yoga trainingThere 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 | Active comparator | Other: PhysiotherapyThe routine physiotherapy and rehabilitation program consists of strength, flexibility, balance, gait and coordination exercises 2 days a week for 8 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga trainingThere 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 Group |
| PhysiotherapyThe standard physiotherapy and rehabilitation program consists of strength, flexibility, balance, gait and coordination exercises 2 days a week for 8 weeks. | Other | Control Group |
Primary outcome
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.
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.
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).
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.
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.
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.
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)
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.
5 secondary outcomes
Nottingham Health Profile
Time frame: change from baseline to end of the 8 weeks
Beck Depression Inventory (BDI)
Time frame: change from baseline to end of the 8 weeks
Fatigue Impact Scale
Time frame: change from baseline to end of the 8 weeks
The Fatigue Severity Scale
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Results publication: PubMed 31983485Tanner 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.
- Results publication: PubMed 31307321Hooke 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.
- Results publication: PubMed 31307323Linder 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.
- Results publication: PubMed 27199271Olagunju 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.
- Results publication: PubMed 31058346Svavarsdottir 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.
- Results publication: PubMed 25428233Gotte 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.
- Results publication: PubMed 26558954Sontgerath 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.
- Results publication: PubMed 23857296Baumann 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.
- Results publication: PubMed 29397087Nanthakumar 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.
- Results publication: PubMed 18300936Galantino 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.
- Results publication: PubMed 28064385Danhauer 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.
- Results publication: PubMed 24743466Tomlinson 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.
- Individual participant dataSharing planned: No. Results will be submitted to the journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozgun Kaya Kara, Assoc. Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga training and Physiotherapy in people with Cancer and Pediatric Cancer, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arda Tasatargil, Prof. Dr. (+902422496954, etik@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pediatric Quality of Life Inventory (PedsQL) Cancer Module (time frame: change from baseline to end of the 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05434871, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.