Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02105389|
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : November 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Behavioral: Individualized Yoga Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2013|
Experimental: 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.
Behavioral: Individualized Yoga Intervention
- Feasibility of recruitment [ Time Frame: 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.
- Fatigue and Quality of Life outcomes [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105389
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|