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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
Sponsor:
Information provided by (Responsible Party):
Lillian Sung, 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.

Condition or disease Intervention/treatment Phase
Fatigue Behavioral: Individualized Yoga Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lillian Sung, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02105389     History of Changes
Other Study ID Numbers: Yoga Pilot
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015
Keywords provided by Lillian Sung, The Hospital for Sick Children:
fatigue
quality of life
chemotherapy
haematopoietic stem cell transplantation
children
pilot
yoga
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms