Outpatient Yoga Study for Adolescents Receiving Chemotherapy

NCT03318068 | Completed

• 1 other identifier: REB# 1000054681
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer; Quality of Life; Cancer, Treatment-Related; Psychological Distress; Yoga; Feasibility

Keywords

Cancer; Pediatric cancer; Yoga; Psychological distress; Outpatient chemotherapy

Outcome Measures

Primary Outcomes (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.

  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

  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

  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

  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

  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

  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.

Study Arms (1)

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.

Other: Yoga Intervention

Interventions

Yoga Intervention OTHER

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.

Yoga intervention arm

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Pediatric Oncology Group of Ontario: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 30712097 DERIVED

MeSH Terms

Conditions

Neoplasms; Neoplasms, Second Primary

Study Officials

• Lillian Sung, MD, PhD

  Pediatric Oncologist, Senior Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Oncologist

Model Details: This is a feasibility study to determine if a yoga intervention can be delivered via to outpatients receiving chemotherapy.

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: October 23, 2017
• Study Start: April 1, 2017
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)