Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Yoga Fatigue Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134782
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Lillian Sung, The Hospital for Sick Children

Brief Summary:
Fatigue is a major problem in children, adolescents and adults receiving intensive chemotherapy for cancer and in patients undergoing hematopoietic stem cell transplantation (HSCT). Guidelines from the National Comprehensive Cancer Network suggest that all patients, including children as young as 5 years of age, should be routinely screened for fatigue at the initial visit and at regular intervals throughout and following anti-cancer treatment. These guidelines also suggest that fatigue should be managed according to clinical practice guidelines. However, evidence demonstrating effective interventions for fatigue in children with cancer is scarce. Exercise is an effective intervention for cancer-related fatigue in patients of all ages. However, patients receiving the most intensive treatments may be too ill to participate in a standardized exercise program. A unique and potentially effective intervention that combines exercise and relaxation is yoga. This randomized controlled trial (RCT) will determine whether a 3 week program of individualized yoga is associated with less fatigue, better quality of life (QoL) and less systemic opioid use compared to the control program of an Apple tablet (iPad) games, music, movies or books. This is a multi-center, parallel-group, randomized trial of individualized yoga for fatigue. Subjects are inpatients 8-18 years of age receiving intensive chemotherapy for cancer or undergoing HSCT who are expected to remain in hospital for 3 weeks. Participants will be randomized to the individualized yoga program or to the iPad activity control program. For those who remain hospitalized on day 21, the alternate intervention will be offered for 1 week and the preferred strategy will be determined. Yoga has the potential to significantly reduce fatigue, a prevalent and distressing symptom, in children with cancer and HSCT. The investigators have assembled the optimal team with the expertise and track record to accomplish this important trial. This trial is an incremental and critically important step in a program of research designed to improve health for children at the highest risk for poor quality of life. Results may have broad applicability to other hospitalized pediatric populations and has the potential to change in-hospital care for these patients.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Acute Lymphocytic Leukemia in Relapse Burkitt's Lymphoma Stage III Burkitt's Lymphoma Stage IV Type 3 Diffuse Large B-Cell Lymphoma Behavioral: Individualized Yoga Intervention Group Other: iPad Activity Control Group Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Individualized Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
Study Start Date : October 2014
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023


Arm Intervention/treatment
Experimental: Individualized Yoga Intervention Group
Yoga will be administered individually by a trained yoga instructor, and offered daily for 21 days (5 days per week or 15 days in total). There will be a common structure for all sessions that will include relaxation and breathing exercises. Additional poses focused on strength, flexibility, and balance will be incorporated at low, moderate or high intensity levels based upon the wishes and abilities of the child and parent and the judgment of the yoga instructor. The target intensity will be documented and may change with each yoga session. Each yoga session will vary in duration between 15 and 45 minutes. Modifications will be made to accommodate devices such as central venous lines, particularly if accessed. For children who are in isolation, the research team will follow hospital policies and procedures.
Behavioral: Individualized Yoga Intervention Group
These children will not receive a study-supplied iPad. Use of child or hospital supplied iPad games, music, movies or books will be permitted without any modification, encouragement or discouragement of these activities. There will be no restrictions on concomitant medications. Standardized sleep hygiene recommendations will be provided.

Active Comparator: iPad Activity Control Group
For those randomized to the control group, visits by the same yoga instructors will occur at the same schedule as the yoga intervention. Contact will be offered daily (5 days per week) for 21 days. The yoga instructor will offer games, music, movies or books on a study-supplied iPad. The instructor will offer to interact with the child (for example, read to, or play games with the child) for a maximum of 45 minutes (the maximum length of yoga sessions). This approach will allow us to control for contact frequency and the individual providing contact, and consequently, to better measure the independent effect of yoga. These children will not receive yoga during the 3 week iPad activity period; instructors will receive specific training to ensure that no yoga occurs during this time frame. Use of child or hospital supplied iPad activities will be permitted instead of the study-supplied iPad activities.
Other: iPad Activity Control Group
These children will not receive yoga during the 3 week iPad activity period; instructors will receive specific training to ensure that no yoga occurs during this time frame. Use of child or hospital supplied iPad activities will be permitted instead of the study-supplied iPad activities. There will be no restrictions on concomitant medications. Standardized sleep hygiene recommendations will be provided.




Primary Outcome Measures :
  1. Change in proxy-reported general fatigue (PedsQL MFS) [ Time Frame: Change from baseline to day 10 and day 21 ]
    The primary outcome is parent/guardian proxy-reported general fatigue using the pediatric population validated questionnaire PedsQL Multidimensional Fatigue Scale (MFS) measured at day 21. PedsQL MFS assesses general fatigue, sleep/rest fatigue and cognitive fatigue. The investigators have chosen this fatigue measure as the primary outcome as in our experience, it is sensitive to change and it is easy to administer and complete.


Secondary Outcome Measures :
  1. Change in proxy-reported other fatigue outcomes (PedsQL MFS) [ Time Frame: Change from baseline to day 10 and day 21 ]
    One of the secondary outcomes is the other fatigue outcomes for proxy-reported PedsQL MFS (sleep/rest fatigue and cognitive fatigue) on days 10 and 21.

  2. Change in proxy-reported fatigue outcomes (FS-P) [ Time Frame: Change from baseline to day 10 and day 21 ]
    One of the secondary outcomes is the Fatigue Scale Parent (FS-P) on days 10 and 21.

  3. Change in proxy-reported fatigue outcomes (PedsQL Acute Cancer Module) [ Time Frame: Change from baseline to day 10 and day 21 ]
    One of the secondary outcomes is the fatigue outcomes for proxy-reported PedsQL Acute Cancer Module (pain, nausea and anxiety) on days 10 and 21.


Other Outcome Measures:
  1. Use of systemic opioids [ Time Frame: Change from baseline to day 21 ]
    All systemic opioid administrations between randomization and date off study will be tabulated and will be expressed as the cumulative amount in morphine equivalents/kg/day on study. Systemic opioid administration will be obtained from patient's chart review. Systemic opioid intake is o potential co-variates the could affect fatigue.

  2. Change in self-reported fatigue [ Time Frame: Change from baseline to day 10 and day 21 ]
    Patient self-reported fatigue using the scales PedsQL MFS (Child and adolescent versions) and FS-Adolescent and FS-Child, are exploratory endpoints.

  3. Change in self-reported quality of life [ Time Frame: Change from baseline to day 10 and day 21 ]
    Patient self-reported quality of life using the scale PedsQL Acute Cancer Module (child and adolescent version) is another exploratory endpoint.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child diagnosed with any AML, relapsed ALL, stage 3 or 4 Burkitt's or diffuse B large cell lymphoma/leukemia OR about to receive autologous or allogeneic HSCT for any indication
  • Child expected to be an inpatient for at least 3 weeks after initiation of chemotherapy or conditioning
  • Child aged 8 to 18 years at enrollment. Conditioning regimen may be myeloablative or reduced intensity

Exclusion Criteria:

  • Following 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 verbal English
  • For HSCT patients, planned non-myeloablative conditioning regimen.

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): NCT02134782


Contacts
Layout table for location contacts
Contact: Lillian Sung, MD 416-813-5287 lillian.sung@sickkids.ca

Locations
Layout table for location information
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Andrea Orsey, MD, MSCE       Aorsey@connecticutchildrens.org   
Principal Investigator: Andrea Orsey, MD, MSCE         
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4V8
Contact: Nicole Culos-Reed, PhD    4032207540    nculosre@ucalgary.ca   
Principal Investigator: Nicole Culos-Reed, PhD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Layout table for investigator information
Principal Investigator: Lillian Sung, MD The Hospital for Sick Children
Layout table for additonal information
Responsible Party: Lillian Sung, Pediatric Oncologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02134782    
Other Study ID Numbers: Yoga RCT
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Keywords provided by Lillian Sung, The Hospital for Sick Children:
Randomized Controlled Trial, yoga, children, chemotherapy, haematopoietic stem cell transplantation, fatigue, quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Burkitt Lymphoma
Lymphoma
Leukemia
Leukemia, Myeloid, Acute
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Fatigue
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections