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Individualized Yoga Intervention Group for Acute Myeloid Leukemia

N/A

Waitlist Available

Led By Lillian Sung, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to day 10 and day 21

Awards & highlights

Study Summary

This trial is testing whether yoga can help reduce fatigue in children with cancer or undergoing stem cell transplantation, compared to using an iPad for games, music, movies or books.

Eligible Conditions

Acute Myeloid Leukemia
Acute Lymphocytic Leukemia
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to day 10 and day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to day 10 and day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to day 10 and day 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fatigue

Secondary outcome measures

Change in proxy-reported fatigue outcomes (FS-P)

Change in proxy-reported fatigue outcomes (PedsQL Acute Cancer Module)

Fatigue

Other outcome measures

Change in self-reported fatigue

Change in self-reported quality of life

Use of systemic opioids

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Individualized Yoga Intervention GroupExperimental Treatment1 Intervention

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.

Group II: iPad Activity Control GroupActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

686 Previous Clinical Trials

6,944,668 Total Patients Enrolled

Lillian Sung, MDPrincipal Investigator - The Hospital for Sick Children

The Hospital for Sick Children

3 Previous Clinical Trials

384 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor accept participants above 25 years of age?

"This experiment is inviting individuals aged 8 and up, but below 18 years old to participate."

Answered by AI

What is the maximum number of participants that can join this trial?

"Indeed, clinicaltrials.gov reflects that this medical study is still actively looking for enrollees. The original posting date was October 1st 2014 and the most current update occurred on November 9th 2022. 210 participants must be recruited from 3 distinct centres for this trial to commence."

Answered by AI

May I be considered a participant in this investigation?

"This clinical trial seeks 210 children aged 8 to 18, with a diagnosis of acute myeloid leukemia (AML), relapsed ALL, stage 3 or 4 Burkitt's lymphoma/leukemia, about to receive an autologous or allogeneic hematopoietic stem cell transplantation for any indication and expected to be an inpatient for at least three weeks after the initiation of their chemotherapy. The conditioning regimen may either be myeloablative or reduced intensity."

Answered by AI

Are there still vacancies for enrollees in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this trial is currently seeking participants; it was first posted on October 1st 2014 and most recently updated on November 9th 2022. 210 individuals are being recruited from 3 sites for the study's purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Yoga Fatigue Study

Lillian Sung 2014. "Yoga Fatigue Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02134782.