Clinical trial NCT03318068: Outpatient Yoga Study for Adolescents Receiving Chemotherapy
Official title: A Feasibility Study Examining the Impact of Out-patient Yoga on Children Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Quality of Life
Cancer, Treatment-Related
Psychological Distress
Yoga
Feasibility
Keywords: Cancer
Pediatric cancer
Yoga
Psychological distress
Outpatient chemotherapy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Pediatric Oncology Group of Ontario
First posted: 2017-10-23
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a feasibility study to determine if a yoga intervention can be delivered via to outpatients receiving chemotherapy.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Sarcoma patients with future planned surgical interventions (can be enrolled after surgery)
* Planned HSCT during the 10 week study period

Primary outcomes:
measure: Feasibility of delivering weekly yoga sessions to outpatients receiving chemotherapy.
timeFrame: 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:
measure: Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale Acute Version, Version 3.0
timeFrame: 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.
measure: Pediatric Quality of Life (Peds QL) Cancer Module Acute Version
timeFrame: 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.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8b
timeFrame: 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.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anger - Fixed Form
timeFrame: 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.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depressive Symptoms- Short Form 8a
timeFrame: 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.
measure: Symptom Screening in Pediatrics (SSPedi)
timeFrame: 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)
measure: Acceptability of the yoga program
timeFrame: At the final assessement timepoint, at week 10 for each participant.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Fatigue- Short Form
timeFrame: 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.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Pediatric Oncologist, Senior Scientist
name: Lillian Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein E, Rayar M, Krishnadev U, Gupta A, Hyslop S, Plenert E, Schechter-Finkelstein T, Sung L. A feasibility study examining the impact of yoga on psychosocial health and symptoms in pediatric outpatients receiving chemotherapy. Support Care Cancer. 2019 Oct;27(10):3769-3776. doi: 10.1007/s00520-019-04673-9. Epub 2019 Feb 2.