Titre officiel
A Randomized Controlled Trial of Individualized Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
Sommaire:
La
fatigue est un problème majeur chez les enfants, les adolescents et les adultes
soumis à une chimiothérapie intensive anticancéreuse et chez les patients
subissant une greffe de la cellule souche hématopoïétique (GCSH). Les
directives de la National Comprehensive Cancer Network (réseau national global
du cancer) proposent que tous les patients, y compris les enfants âgés
seulement de 5 ans, soient soumis systématiquement au test de fatigue lors
de la première visite et à des intervalles réguliers durant et après la
thérapie anticancéreuse. Ces directives proposent aussi que la fatigue soit
être gérée conformément aux guides de pratique clinique. Cependant, les signes
démontrant des interventions efficaces contre la fatigue chez les enfants
atteints de cancer sont rares. La pratique d'exercices est une intervention
efficace contre la fatigue due au cancer chez les patients de tous âges. Mais,
les patients recevant les traitements les plus intensifs peuvent être trop malades
pour participer à un programme d'exercices normalisé. Une intervention unique
et potentiellement efficace qui associe décontraction et yoga. Cet essai
randomisé et contrôlé (ERC) déterminera si un programme de yoga individualisé
de 3 semaines réduit la fatigue, améliore la qualité de vie et diminue
l'utilisation systémique de l'opioïde par rapport au programme de contrôle
d'une tablette Apple (iPad), aux jeux, à la musique, aux films ou à la lecture
de livres. Cette étude est un essai multicentrique, parallèle et randomisé du
yoga individualisé pour lutter contre la fatigue. Les sujets sont des malades
hospitalisés, âgés de 8-18 ans et soumis à une chimiothérapie intensive
contre le cancer ou à une GCSH, et qui devraient rester à l'hôpital pendant
3 semaines. Les participants seront affectés aléatoirement au programme de
yoga individualisé ou au programme de contrôle des activités de l'iPad. Pour
ceux qui restent hospitalisés le 21ème jour, une intervention secondaire sera
offerte pendant 1 semaine et la stratégie préférée sera déterminée. Le
yoga a le potentiel de réduire considérablement la fatigue, un symptôme courant
et stressant, chez les enfants atteints de cancer et ayant subi la GCSH. Les
experts cliniques ont réuni une équipe optimale possédant l'expertise et des
références nécessaires pour exécuter cet essai important. Cet essai est une
étape supplémentaire et hautement importante d'un programme de recherche visant
à améliorer la santé des enfants qui courent un risque élevé d'avoir une
mauvaise qualité de vie. Les résultats peuvent avoir une applicabilité large à
d'autres populations pédiatriques hospitalisées et ils peuvent changer les
soins offerts à ces patients à l'hôpital.
Description de l'essai
Primary Outcome:
- Change in proxy-reported general fatigue (PedsQL MFS)
Secondary Outcome:
- Change in proxy-reported other fatigue outcomes (PedsQL MFS)
- Change in proxy-reported fatigue outcomes (FS-P)
- Change in proxy-reported fatigue outcomes (PedsQL Acute Cancer Module)
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-centre, 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.
Voir cet essai sur ClinicalTrials.gov
