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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

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.

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 groups in NCT03318068
Study groupRoleWhat they receive
Yoga intervention armExperimentalThe 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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.

  8. 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.

  1. First posted23 Oct 2017
  2. Study start1 Apr 2017
  3. Primary completion13 Feb 2018
  4. Study completion13 Feb 2018

Resources

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)
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

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.

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