- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02295839
Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy (SHARI)
September 11, 2019 updated by: Sue Zupanec, The Hospital for Sick Children
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
|
|
Experimental: Sleep Hygiene and Relaxation Education
|
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).
|
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)
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.
|
Weeks 1-4, post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nocturnal sleep (minutes)
Time Frame: Five consecutive nights on two occasions
|
Sleep and wake times will be objectively collected using actigraphy.
|
Five consecutive nights on two occasions
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, Weeks 4 and 8
|
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.
|
One month
|
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
|
|
Baseline, Weeks 4 and 8
|
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.
|
Baseline, Weeks 4 and 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sue Zupanec, MN, NP-Peds, Hospital for Sick Children (Sickkids)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
November 17, 2014
First Submitted That Met QC Criteria
November 19, 2014
First Posted (Estimate)
November 20, 2014
Study Record Updates
Last Update Posted (Actual)
September 13, 2019
Last Update Submitted That Met QC Criteria
September 11, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000025162
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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