Pediatric CancerNCT03318068
Outpatient Yoga Study for Adolescents Receiving Chemotherapy
A study testing Yoga Intervention in people with Pediatric Cancer and Quality of Life, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
LAY SUMMARY: The diagnosis and treatment of pediatric cancer is a significant stressor for adolescents and their families . Although most adolescents cope well with their cancer diagnosis, many experience emotional distress. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pediatric Cancer, Quality of Life, Cancer, Treatment-Related
- What is being tested?
- Yoga Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2017to 13 Feb 2018
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10 to 18
- Receiving active cancer therapy within 21 days of enrollment and for the 10 weeks of the study
- Able to perform yoga at home (the yoga is modified at home so that it low impact exercises and fit the capabilities of the patient)
- Planned to be outpatients for more than 75 % of study
Who cannot join
- Sarcoma patients with future planned surgical interventions (can be enrolled after surgery)
- Planned HSCT during the 10 week study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study Examining the Impact of Out-patient Yoga on Children Receiving Chemotherapy
LAY SUMMARY:
The diagnosis and treatment of pediatric cancer is a significant stressor for adolescents and their families . Although most adolescents cope well with their cancer diagnosis, many experience emotional distress. A small proportion of those diagnosed with cancer will experience more intense mental distress, such as depression, anxiety, or anger. The practice of yoga may be a possible way of treating the negative emotional symptoms experienced by these adolescents. Previous studies suggest that yoga may improve anxiety, mood and psychological distress in adults with cancer. The results of two recent pediatric pilot studies show that yoga programs improved quality of life for adolescents receiving cancer treatment. Given this, we wish to examine the feasibility of offering a 10-week yoga program for adolescents who are receiving outpatient chemotherapy. This program includes both one-on-one in-person sessions and home-based sessions offered using SkypeTM. To assess this program, we will monitor patients' attendance, ask their opinions of the program and evaluate whether yoga improved their mental well-being. This study represents an important step toward identifying possible treatments to improve patients' quality of life and emotional health.
Read the detailed description
Background: The diagnosis and treatment of pediatric cancer is often a distressing time for patients and families. Moreover, a subset of patients experience significant negative psychological symptoms at time of diagnosis. Often times, these symptoms persist throughout treatment, and, possibly, for years after their diagnosis. Available evidence suggests that early identification and intervention for these psychological symptoms may reduce their short-term and long-term impact. Yoga has emerged as a potential therapeutic intervention to improve psychosocial wellness with promising preliminary results in adult cancer populations.
Objective: To determine the feasibility of a 10-week, weekly yoga intervention for adolescents with cancer currently receiving cancer therapy.
Methods: This pilot study will consist of 45-minute yoga sessions administered weekly for 10 (+/- 2) consecutive weeks. Three sessions will take place in-person, timed in conjunction with participants' clinic appointments, with the remainder of sessions administered at home, through SkypeTM. Each session will be one-to-one and conducted by a yoga instructor. Participants will also complete home exercises in between these weekly sessions. Adolescents ages 10 to 18 with any cancer diagnosis will be eligible for this study. Feasibility, the primary objective, will be determined by 1) the number of patients who are recruited for this study, and 2) the number of patients who in attend at least 60% of administered sessions. The feasibility, acceptability and utility of measuring participants' emotional distress and quality of life will be examined as secondary outcomes. These outcomes will be measured at baseline, mid-way and at the end of the intervention. The Patient Reported Outcomes Measurement Information System measures for anxiety, depression and anger will be used to measure emotional distress. Patient's fatigue and quality of life will be determined using the Pediatric Quality of Life Inventory Fatigue and Acute Cancer Modules. Study enrollment is planned at 10 participants, as this sample size will enable to assess if our intervention and measurements tool are appropriate.
Significance: This study represents an important first step in determining if yoga programs can be offered at home, and if such programs influence patient well-being. If feasible, outpatient yoga programs may offer a practical and cost-effective tool to provide enhanced psychosocial wellbeing among adolescents undergoing cancer therapy.
- Conditions
- Pediatric Cancer, Quality of Life, Cancer, Treatment-Related, Psychological Distress, Yoga, Feasibility
- Being tested
- Yoga Intervention
- Keywords
- Cancer, Pediatric cancer, Yoga, Psychological distress, Outpatient chemotherapy
- Medical subject headings
- Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionOther
The yoga intervention will consist of a combination of yoga postures, gentle stretches, breathing techniques and relaxation. The sessions will be delivered one-on-one and will be adapted to accommodate the patients each day.
| Study group | Role | What they receive |
|---|---|---|
| Yoga intervention arm | Experimental | The group will receive a weekly yoga session for the duration of 10 weeks. The yoga sessions will be delivered in person for 3 weeks during the intervention, coordinated with existing clinic visits. The other 7 sessions will be delivered via skype. The participant will be asked to fill out questionnaires during each of the three in-person yoga visits asking about psychological symptoms and quality of life. Receives: Other: Yoga Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of delivering weekly yoga sessions to outpatients receiving chemotherapy.
Will be determined by both the number of patients who are recruited for this study, and the number of patients who attend at least 60% of administered sessions. We will aim to enroll 10 participants at SickKids over one year. Compliance will be defined as the number of participants who complete 6 (60%) of the scheduled yoga sessions. Feasibility will be met if at least 80% (8) of participants meet this threshold of participation.
Measured: Intervention runs for 10 weeks, and is administered one-on-one; study will be enrolling for 1 year with a goal to enroll 10 participants on this study. We will determine feasibility once all 10 participants have completed the study after 1 year.
Secondary outcomes (8)
Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale Acute Version, Version 3.0
Measures self-reported fatigue; 5-point likert scale ranging from 0(almost never) to 4 (almost always), with higher scores indicating higher problems; there is no weighting of items. Scores are transformed on a scale from 0 to 100.Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Mean score is calculated= Sum of the items over the number of items answered.
Total Score is used and calculated by: Sum of all the items over the number of items answered on all the Scales. Higher scores indicate lower problems.
Measured: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in fatigue from week 1- 10.
Pediatric Quality of Life (Peds QL) Cancer Module Acute Version
Measures self-reported symptoms related to cancer treatment, capturing physical, psychological and cognitive health. 5-point likert scale ranging from 0(almost never) to 4 (almost always); there is no weighting of items. Scores are transformed on a scale from 0 to 100. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Mean score is calculated= Sum of the items over the number of items answered.
Total Score is used and calculated by: Sum of all the items over the number of items answered on all the Scales. Higher scores indicate lower problems.
Measured: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in symptoms from week 1- 10.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8b
The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). 5-point Likert scale ranging from 1 (never) to 5 (almost always); there are 8 questions in this measure. First a raw total score is calculated by added up the values to each question, ranging from 5-40. The total raw score is then converted into a T-score using the conversion table. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 1. A higher PROMIS T-score represents more of the concept being measured, in this case, anxiety symptoms.
Measured: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in anxiety from week 1- 10.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anger - Fixed Form
The PROMIS Anger instruments measure self-reported angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. This measure includes 5 questions. 5-point Likert scale ranging from 1 (never) to 5 (almost always) First a raw total score is calculated by added up the values to each question, ranging from 5-25. The total raw score is then converted into a T-score using the conversion table. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 1. A higher PROMIS T-score represents more of the concept being measured, in this case, anger.
Measured: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in anger from week 1- 10.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depressive Symptoms- Short Form 8a
The PROMIS Depression instruments assess self-reported negative mood (sadness, guilt), views of self (selfcriticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms (changes in appetite, sleeping patterns) are not included. The Depression short form is universal rather than disease-specific. This measure includes 8 questions. 5-point Likert scale ranging from 1 (never) to 5 (almost always). It assesses depression over the past seven days. First a raw total score is calculated by added up the values to each question, ranging from 5-40. The total raw score is then converted into a T-score using the conversion table. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 1. A higher PROMIS T-score represents more of the concept being measured, in this case, depression symptoms.
Measured: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in mood from week 1- 10.
Symptom Screening in Pediatrics (SSPedi)
Self-reported symptom screening questionnaire asking pediatric patients (age 8-18) how bothered they are by 15 identified symptoms and side effects of cancer treatment. This 5-point Likert scale score from 0 (not bothered at all) to 4 (extremely bothered), and has a total score ranging from 0-60, with a higher number indicating more bother cancer-related symptoms. Likert scores will be summed for a total score that ranges from 0 (none) to 60 (worst possible).
Measured: Intervention runs for 10 weeks; Measure will be completed at three timepoints throughout the study: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study)
Acceptability of the yoga program
Acceptability of the yoga program will be measured using a 5-point Likert scale at week 10. At each assessment point (week 1, week4, 5, or 6 and week 10), participants will be interviewed using open-ended questions to assess their views of the program. Likert items score from 1(strongly agree) to 5(strongly disagree) a higher score indicating greater acceptability of the yoga program.
Measured: At the final assessement timepoint, at week 10 for each participant.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Fatigue- Short Form
The PROMIS Fatigue instruments evaluate a range of self-reported symptoms. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The Fatigue short form is universal rather than disease-specific. It assesses fatigue over the past seven days This measure includes 10 questions. 5-point Likert scale ranging from 1 (never) to 5 (almost always).First a raw total score is calculated by added up the values to each question, ranging from 5-50. The total raw score is then converted into a T-score using the conversion table. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 1. A higher PROMIS T-score represents more of the concept being measured, in this case, depression symptoms.
Measured: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in fatigue from week 1- 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Apr 2017
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility study to determine if a yoga intervention can be delivered via to outpatients receiving chemotherapy.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Oncology Group of Ontario
- Responsible party
- Principal investigator, Lillian Sung, The Hospital for Sick Children
- Investigators
- Lillian Sung, MD, PhD, Principal investigator, Pediatric Oncologist, Senior Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318068
- Sponsor's protocol ID
- REB# 1000054681
- Status last verified
- Mar 2018
- First submitted
- 11 Apr 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30712097
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Examining the Impact of Out-patient Yoga on Children Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT03318068
- Acronym / sponsor ID
- REB# 1000054681
- Conditions
- Pediatric Cancer, Quality of Life, Cancer, Treatment-Related, Psychological Distress, Yoga, Feasibility
- Keywords
- Cancer, Pediatric cancer, Yoga, Psychological distress, Outpatient chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Pediatric Oncology Group of Ontario
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 23 Oct 2017 (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.
LAY SUMMARY:
The diagnosis and treatment of pediatric cancer is a significant stressor for adolescents and their families . Although most adolescents cope well with their cancer diagnosis, many experience emotional distress. A small proportion of those diagnosed with cancer will experience more intense mental distress, such as depression, anxiety, or anger. The practice of yoga may be a possible way of treating the negative emotional symptoms experienced by these adolescents. Previous studies suggest that yoga may improve anxiety, mood and psychological distress in adults with cancer. The results of two recent pediatric pilot studies show that yoga programs improved quality of life for adolescents receiving cancer treatment. Given this, we wish to examine the feasibility of offering a 10-week yoga program for adolescents who are receiving outpatient chemotherapy. This program includes both one-on-one in-person sessions and home-based sessions offered using SkypeTM. To assess this program, we will monitor patients' attendance, ask their opinions of the program and evaluate whether yoga improved their mental well-being. This study represents an important step toward identifying possible treatments to improve patients' quality of life and emotional health.
Detailed description
Background: The diagnosis and treatment of pediatric cancer is often a distressing time for patients and families. Moreover, a subset of patients experience significant negative psychological symptoms at time of diagnosis. Often times, these symptoms persist throughout treatment, and, possibly, for years after their diagnosis. Available evidence suggests that early identification and intervention for these psychological symptoms may reduce their short-term and long-term impact. Yoga has emerged as a potential therapeutic intervention to improve psychosocial wellness with promising preliminary results in adult cancer populations.
Objective: To determine the feasibility of a 10-week, weekly yoga intervention for adolescents with cancer currently receiving cancer therapy.
Methods: This pilot study will consist of 45-minute yoga sessions administered weekly for 10 (+/- 2) consecutive weeks. Three sessions will take place in-person, timed in conjunction with participants' clinic appointments, with the remainder of sessions administered at home, through SkypeTM. Each session will be one-to-one and conducted by a yoga instructor. Participants will also complete home exercises in between these weekly sessions. Adolescents ages 10 to 18 with any cancer diagnosis will be eligible for this study. Feasibility, the primary objective, will be determined by 1) the number of patients who are recruited for this study, and 2) the number of patients who in attend at least 60% of administered sessions. The feasibility, acceptability and utility of measuring participants' emotional distress and quality of life will be examined as secondary outcomes. These outcomes will be measured at baseline, mid-way and at the end of the intervention. The Patient Reported Outcomes Measurement Information System measures for anxiety, depression and anger will be used to measure emotional distress. Patient's fatigue and quality of life will be determined using the Pediatric Quality of Life Inventory Fatigue and Acute Cancer Modules. Study enrollment is planned at 10 participants, as this sample size will enable to assess if our intervention and measurements tool are appropriate.
Significance: This study represents an important first step in determining if yoga programs can be offered at home, and if such programs influence patient well-being. If feasible, outpatient yoga programs may offer a practical and cost-effective tool to provide enhanced psychosocial wellbeing among adolescents undergoing cancer therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasibility study to determine if a yoga intervention can be delivered via to outpatients receiving chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Yoga intervention arm | Experimental | Other: Yoga InterventionThe group will receive a weekly yoga session for the duration of 10 weeks. The yoga sessions will be delivered in person for 3 weeks during the intervention, coordinated with existing clinic visits. The other 7 sessions will be delivered via skype. The participant will be asked to fill out questionnaires during each of the three in-person yoga visits asking about psychological symptoms and quality of life. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 10 to 18
- Receiving active cancer therapy within 21 days of enrollment and for the 10 weeks of the study
- Able to perform yoga at home (the yoga is modified at home so that it low impact exercises and fit the capabilities of the patient)
- Planned to be outpatients for more than 75 % of study
Key exclusion criteria (2 listed)
- Sarcoma patients with future planned surgical interventions (can be enrolled after surgery)
- Planned HSCT during the 10 week study period
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 InterventionThe yoga intervention will consist of a combination of yoga postures, gentle stretches, breathing techniques and relaxation. The sessions will be delivered one-on-one and will be adapted to accommodate the patients each day. | Other | Yoga intervention arm |
Primary outcome
Feasibility of delivering weekly yoga sessions to outpatients receiving chemotherapy.
Time frame: Intervention runs for 10 weeks, and is administered one-on-one; study will be enrolling for 1 year with a goal to enroll 10 participants on this study. We will determine feasibility once all 10 participants have completed the study after 1 year.
Will be determined by both the number of patients who are recruited for this study, and the number of patients who attend at least 60% of administered sessions. We will aim to enroll 10 participants at SickKids over one year. Compliance will be defined as the number of participants who complete 6 (60%) of the scheduled yoga sessions. Feasibility will be met if at least 80% (8) of participants meet this threshold of participation.
8 secondary outcomes
Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale Acute Version, Version 3.0
Time frame: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in fatigue from week 1- 10.
Pediatric Quality of Life (Peds QL) Cancer Module Acute Version
Time frame: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in symptoms from week 1- 10.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8b
Time frame: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in anxiety from week 1- 10.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anger - Fixed Form
Time frame: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in anger from week 1- 10.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depressive Symptoms- Short Form 8a
Time frame: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in mood from week 1- 10.
Symptom Screening in Pediatrics (SSPedi)
Time frame: Intervention runs for 10 weeks; Measure will be completed at three timepoints throughout the study: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study)
Acceptability of the yoga program
Time frame: At the final assessement timepoint, at week 10 for each participant.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Fatigue- Short Form
Time frame: Measure will be completed at three timepoints: 1) week 1, 2) week 4, 5 or 6 (coordinated with their medical clinic appointments), and 3) at week 10 (upon completion of the study). A change score will be used to assess changes in fatigue from week 1- 10.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Derived from this study: PubMed 30712097Stein 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.
- Individual participant dataSharing planned: No
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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.
Lillian Sung, MD, PhD principal investigator
Pediatric Oncologist, Senior Scientist
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 Intervention in people with Pediatric Cancer and Quality of Life, run by The Hospital for Sick Children at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 22 Mar 2018. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of delivering weekly yoga sessions to outpatients receiving chemotherapy. (time frame: Intervention runs for 10 weeks, and is administered one-on-one; study will be enrolling for 1 year with a goal to enroll 10 participants on this study. We will determine feasibility once all 10 participants have completed the study after 1 year.). 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 NCT03318068, which also lists 1 linked publication.
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 22 Mar 2018.