Yoga Fatigue Study

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02134782
• Other study ID #: Yoga RCT
• Status: Terminated
• Phase: N/A
• Start date: October 2, 2014
• Est. completion date: April 14, 2023

Study information

• Verified date: July 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia in Relapse
• Acute Myeloid Leukemia (AML)
• Burkitt Lymphoma
• Burkitt's Lymphoma Stage III
• Burkitt's Lymphoma Stage IV
• Fatigue
• Leukemia
• Leukemia, Myeloid, Acute
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Type 3 Diffuse Large B-Cell Lymphoma

Intervention

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.

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of systemic opioids	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.	Change from baseline to day 21
Other	Change in self-reported fatigue	Patient self-reported fatigue using the scales PedsQL MFS (Child and adolescent versions) and FS-Adolescent and FS-Child, are exploratory endpoints.	Change from baseline to day 10 and day 21
Other	Change in self-reported quality of life	Patient self-reported quality of life using the scale PedsQL Acute Cancer Module (child and adolescent version) is another exploratory endpoint.	Change from baseline to day 10 and day 21
Primary	Change in proxy-reported general fatigue (PedsQL MFS)	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.	Change from baseline to day 10 and day 21
Secondary	Change in proxy-reported other fatigue outcomes (PedsQL MFS)	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.	Change from baseline to day 10 and day 21
Secondary	Change in proxy-reported fatigue outcomes (FS-P)	One of the secondary outcomes is the Fatigue Scale Parent (FS-P) on days 10 and 21.	Change from baseline to day 10 and day 21
Secondary	Change in proxy-reported fatigue outcomes (PedsQL Acute Cancer Module)	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.	Change from baseline to day 10 and day 21