Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy

Fatigue Clinical Trial

Official title:

A Feasibility Study of Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105389
• Other study ID #: Yoga Pilot
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: November 27, 2015
• Start date: January 2013

Study information

• Verified date: November 2015
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Behavioral:
• Individualized Yoga Intervention

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	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.	baseline	No
Secondary	Fatigue and Quality of Life outcomes	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.	Change from baseline to day 7, 14 and 21	No