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Completed

NCT Number: NCT02295839

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

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.

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Key information

Conditions

Sleep Acute Lymphoblastic Leukemia Behavior Fatigue Health Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms Sleep Hygiene

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sleep Hygiene and Relaxation Education

Behavioral

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).

Primary outcomes

  1. Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)

    Time frame: 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 outcomes

  1. Nocturnal sleep (minutes)

    Time frame: Five consecutive nights on two occasions

    Sleep and wake times will be objectively collected using actigraphy.

Other outcomes

  1. Sleep Disturbances (The Children's Sleep Habits Questionnaire)

    Time frame: Baseline, Weeks 4 and 8

    The Children's Sleep Habits Questionnaire will be used to measure usual sleep habits (sleep duration, consistency of sleep and wake times during the week, and between weekdays and weekends) as well as sleep problems in the most recent, typical week

  2. School attendance

    Time frame: One month

    A calendar data form will be used by parents to mark if their child attended school for a full day, half day, or not at all. Reasons for absences will be collected.

  3. Fatigue levels (Childhood Cancer Fatigue Scale-Child (FS-C) and the Childhood Cancer Fatigue Scale-Parent (FS-P)

    Time frame: Baseline, Weeks 4 and 8

    • Fatigue levels will be measure using the Childhood Cancer Fatigue Scale-Child (FS-C) and the Childhood Cancer Fatigue Scale-Parent (FS-P)
    • Children under the age of seven will not complete the FS-C

  4. Daytime and pre-bedtime behaviours (The Family Inventory of Sleep Habits (FISH)

    Time frame: Baseline, Weeks 4 and 8

    The Family Inventory of Sleep Habits (FISH) will be used to measure daytime behaviours (e.g. exercise) and before bedtime behaviours (e.g. engaging in stimulating activity) known to influence sleep in children, along with the child's sleep environment and pre-bedtime routines.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study 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

Acronym: SHARI

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 20, 2014
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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