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

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ClinicalTrials.gov Identifier: NCT02295839
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sue Zupanec, 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.

Condition or disease Intervention/treatment Phase
Sleep Fatigue Acute Lymphoblastic Leukemia Behavioral: Sleep Hygiene and Relaxation Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : May 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual care
Experimental: Sleep Hygiene and Relaxation Education Behavioral: 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).




Primary Outcome Measures :
  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 Outcome Measures :
  1. Nocturnal sleep (minutes) [ Time Frame: Five consecutive nights on two occasions ]
    Sleep and wake times will be objectively collected using actigraphy.


Other Outcome Measures:
  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.



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295839


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Sue Zupanec, MN, NP-Peds Hospital for Sick Children (SickKids)

Publications of Results:
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Responsible Party: Sue Zupanec, Nurse Practitioner, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02295839     History of Changes
Other Study ID Numbers: 1000025162
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Keywords provided by Sue Zupanec, The Hospital for Sick Children:
Sleep
Acute Lymphoblastic Leukemia
Fatigue
Sleep hygiene
Relaxation
RCT
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Fatigue
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms