Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy
SHARI
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedSeptember 13, 2019
September 1, 2019
2.1 years
November 17, 2014
September 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Nocturnal sleep (minutes)
Five consecutive nights on two occasions
Other Outcomes (4)
Sleep Disturbances (The Children's Sleep Habits Questionnaire)
Baseline, Weeks 4 and 8
School attendance
One month
Fatigue levels (Childhood Cancer Fatigue Scale-Child (FS-C) and the Childhood Cancer Fatigue Scale-Parent (FS-P)
Baseline, Weeks 4 and 8
- +1 more other outcomes
Study Arms (2)
Usual care
NO INTERVENTIONSleep Hygiene and Relaxation Education
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (1)
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.
PMID: 27922922RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sue Zupanec, MN, NP-Peds
Hospital for Sick Children (SickKids)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse Practitioner
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 20, 2014
Study Start
May 1, 2011
Primary Completion
June 1, 2013
Study Completion
August 1, 2014
Last Updated
September 13, 2019
Record last verified: 2019-09