Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children with a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep.

Detailed Description
-----------------
Sleep is an essential restorative function that promotes both physical and cognitive health. Previous studies have demonstrated that children on Acute Lymphoblastic Leukemia (ALL) maintenance therapy have problematic sleep patterns and experience fatigue. This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children aged 4-10, with a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep. Sleep tips were evaluated by intervention group families.

Official Title
-----------------
Feasibility, Acceptability, and Effectiveness of a Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy for Acute Lymphoblastic Leukemia

Conditions
-----------------
Sleep, Fatigue, Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Behavioral: Sleep Hygiene and Relaxation Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child aged 4-10 with a diagnosis of precursor acute B lymphoblastic leukemia (B ALL) in maintenance phase of therapy beyond 3rd course (protocol AALL0331) Child and parent able to understand and read English Child is within one year of age-appropriate grade in school Exclusion Criteria: Child who is receiving palliative care Child with diagnosis of depression Child who has been prescribed medications for insomnia Child who has a physician-diagnosed sleep disorder (e.g. narcolepsy, restless legs syndrome) Child who has received radiation therapy Child has potential sleep disordered breathing (measured by Children's Sleep Habits Questionnaire)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br> | |
| Experimental: Sleep Hygiene and Relaxation Education<br> | Behavioral: Sleep Hygiene and Relaxation Education<br>* Intervention group participants receive a nurse-led, one-hour 1:1 educational session including education about sleep in children and a description of what is known about sleep and fatigue issues in children with cancer. The session also includes strategies to improve sleep hygiene in children. Information about relaxation to promote sleep is outlined and two children's books designed to promote relaxation using the principles of deep breathing are given to the parent(s). A handout containing all the information covered is given to the parent(s).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form) | The Evaluation of Sleep Tips form will use open-ended questions to ask parents about factors that promoted or prevented implementing the sleep hygiene and relaxation interventions, and which components of the intervention they implemented and in what frequency. | Weeks 1-4, post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal sleep (minutes) | Sleep and wake times will be objectively collected using actigraphy. | Five consecutive nights on two occasions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatigue, Sleep hygiene, Sleep, Acute Lymphoblastic Leukemia, Relaxation, RCT