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.

Brief Title

Yoga Fatigue Study

Official Title

A Randomized Controlled Trial of Individualized Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy

Brief Summary

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

Detailed Description

Background: Fatigue or tiredness is a major problem in children, adolescents and adults
receiving intensive chemotherapy for cancer and in those undergoing hematopoietic stem cell
transplantation (HSCT). While exercise is good for reducing fatigue, these patients are often
too sick to participate in regular exercise sessions. A unique, potentially effective type of
exercise is individualized yoga. Yoga is particularly good since it can be tailored to be
more or less intensive depending on how the child is feeling. The investigators have
previously performed a feasibility study of yoga in children admitted to the hospital
receiving very intensive chemotherapy or HSCT and found that our program of yoga is doable.
The investigators also found children and their parents like the program.

Preliminary Data: The investigators' team completed a feasibility study of yoga in 11
children with cancer or HSCT recipients meeting similar eligibility criteria as the proposed
study. In short, these results demonstrated the feasibility of individualized yoga and
suggested several design changes to enhance compliance with outcome ascertainment. The
investigators found that the mean ± standard deviation for the baseline and day 21
proxy-report PedsQL MFS general fatigue scores were 46.4±26.8 and 55.6±15.5. These scores are
much lower compared to fatigue scores observed in two studies of healthy children in which
scores of 88.8±12.3 and 89.3±13.3 were described. This data suggest that fatigue is expected
to be very severe in our patient population.

Objectives: Primary: To determine if a 3 week program of individualized yoga for hospitalized
children receiving intensive chemotherapy is associated with lower general fatigue or
tiredness compared to the control intervention of iPad games, music, movies or books.
Secondary: To determine if a 3 week program of yoga is associated with better quality of life
and less pain medication use when compared to an iPad activity control program.

Methods: This is a multi-center, randomized trial of individualized yoga for fatigue.
Participants are children 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 individualized yoga or to the iPad activity control program. The intervention
is an individualized yoga program in which intensity level may change with each session. The
control program consists of visits in which games, music, movies or books on a study-supplied
iPad will be offered. Yoga sessions will be offered five times a week over 3 weeks and will
be led by a trained yoga teacher. In the control arm, the yoga teacher will visit once a day
and will offer children games, music, movies or books on an iPad. Fatigue and quality of life
will be measured by the parent at baseline, on day 10 and on day 21. For subjects who remain
hospitalized on day 21, they will be offered the alternate arm for one week to promote
retention.

The investigators intend to record 20% of yoga and iPad sessions using the iPad to ensure
quality control and monitoring of sessions. Recorded files will be downloaded to a secure
File Transfer Protocol (FTP) site. Any deviations from the protocol will result in feedback
to the site within 1 week of the session and ideally, within 2 days. The research team will
also routinely audit the data submitted to ensure completeness of the data submissions.

The investigators plan to enroll 210 subjects at 2 centres in Canada and 1 centre in the
United States over 4 years.

Significance: 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 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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.