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

Not Applicable

Completed

• Conditions: Sleep; Fatigue; Acute Lymphoblastic Leukemia
• Interventions: Behavioral: Sleep Hygiene and Relaxation Education

• Registration Number: NCT02295839
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2013-06
• Study Completion: 2014-08
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene and Relaxation Education	Sleep Hygiene and Relaxation Education	-

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)	Weeks 1-4, post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Nocturnal sleep (minutes)	Five consecutive nights on two occasions	Sleep and wake times will be objectively collected using actigraphy.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada