Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy

Not Applicable

Completed

• Conditions: Fatigue
• Interventions: Behavioral: Individualized Yoga Intervention

• Registration Number: NCT02105389
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving treatment for cancer, and intensively treated patients may be at higher risk. While exercise is an effective intervention for CRF, patients receiving the most intensive chemotherapy may frequently be too ill to participate in a standardized exercise program. A unique intervention that combines exercise and relaxation is yoga. This pilot study will evaluate the feasibility of three times weekly yoga sessions administered by a trained yoga instructor for a three week duration and will enroll between 10 and 20 children. If feasible, the intervention will be tested in a randomized controlled trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-10
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Diagnosed with any acute myeloid leukemia (AML), relapsed acute lymphoblastic leukemia, stage 3 or 4 Burkitt's lymphoma/leukemia or about to receive autologous or allogeneic haematopoietic stem cell transplantation (HSCT)
• Expected to be an inpatient for at least three weeks after initiation of chemotherapy or conditioning
• Ages 7 to 18 years of age at enrollment

Exclusion Criteria

• Features present to an extent that would preclude compliance with yoga (as assessed by the attending physician): a) motor disability, b) cognitive disability, c) cardiopulmonary symptoms, or d) known compression fracture resulting in disability
• Parent or patient cannot understand English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Individualized Yoga Intervention	Individualized Yoga Intervention	Individualized Yoga Intervention sessions will be administered by a trained yoga instructor three times weekly (or up to a maximum of five times per week) for three consecutive weeks. There will be a common structure for all sessions that will include relaxation and breathing exercises as well as a series of poses focused on strengthening, flexibility, and balance. There will be low, moderate and high intensity regimens prescribed depending on the wishes and abilities of the child and parent and the judgment of the yoga instructor.

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment	baseline	To determine feasibility of a 3 times weekly, 3 week yoga intervention for hospitalized children receiving intensive chemotherapy ± radiation by determining the number of children who can complete at least 60% of scheduled yoga sessions for consenting individuals.; We will consider the ability to administer 60% of planned yoga sessions over a 3 week period as feasible (in other words, a minimum of 6 of 9 planned sessions) and anticipate that at least 70% of participants should be able to achieve this level of adherence.; We planned to enroll a minimum of 10 and a maximum of 20 patients and believe the final sample size (11 participants) provides sufficient information to know whether the intervention and measurements are appropriate.

Secondary Outcome Measures

Name	Time	Method
Fatigue and Quality of Life outcomes	Change from baseline to day 7, 14 and 21	To describe changes over the intervention period according to: 1) Parent/guardian proxy-report fatigue using the FS-P (Fatigue Scale-Parent) and PedsQL MFM (PedsQL Multidimensional Fatigue Module) and child self-report fatigue using the FS-C/FS-A (Fatigue Scale-Child/Adolescent) and PedsQL MFM; 2) Child QoL using the PedsQL Acute Cancer Module; 3) Parent QoL using the SF-36 (Short Form 36); 4) Acceptability of the yoga intervention according to parents and children; 5) Qualitatively, any aspects of the intervention or measurement that can be improved. We have chosen to focus on a small number of key endpoints to preserve the feasibility of the pilot and future RCT as incorporation of a large number of endpoints would likely result in greater non-compliance in outcome ascertainment. The secondary analyses will all be descriptive. Variability and change in outcome measures in this study will be used to assess the sample size required in the design of a future efficacy trial.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada