Clinical trial NCT02295839: Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Fatigue
Acute Lymphoblastic Leukemia
Keywords: Sleep
Acute Lymphoblastic Leukemia
Fatigue
Sleep hygiene
Relaxation
RCT
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)
timeFrame: Weeks 1-4, post-intervention
Secondary outcomes:
measure: Nocturnal sleep (minutes)
timeFrame: Five consecutive nights on two occasions
Other outcomes:
measure: Sleep Disturbances (The Children's Sleep Habits Questionnaire)
timeFrame: Baseline, Weeks 4 and 8
measure: School attendance
timeFrame: One month
measure: Fatigue levels (Childhood Cancer Fatigue Scale-Child (FS-C) and the Childhood Cancer Fatigue Scale-Parent (FS-P)
timeFrame: Baseline, Weeks 4 and 8
measure: Daytime and pre-bedtime behaviours (The Family Inventory of Sleep Habits (FISH)
timeFrame: Baseline, Weeks 4 and 8
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Hospital for Sick Children (SickKids)
name: Sue Zupanec, MN, NP-Peds
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zupanec S, Jones H, McRae L, Papaconstantinou E, Weston J, Stremler R. A Sleep Hygiene and Relaxation Intervention for Children With Acute Lymphoblastic Leukemia: A Pilot Randomized Controlled Trial. Cancer Nurs. 2017 Nov/Dec;40(6):488-496. doi: 10.1097/NCC.0000000000000457.