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

Primary Purpose

Sleep, Fatigue, Acute Lymphoblastic Leukemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleep Hygiene and Relaxation Education
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep focused on measuring Sleep, Acute Lymphoblastic Leukemia, Fatigue, Sleep hygiene, Relaxation, RCT

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Sleep Hygiene and Relaxation Education

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Nocturnal sleep (minutes)
Sleep and wake times will be objectively collected using actigraphy.

Full Information

First Posted
November 17, 2014
Last Updated
September 11, 2019
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02295839
Brief Title
Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy
Acronym
SHARI
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Fatigue, Acute Lymphoblastic Leukemia
Keywords
Sleep, Acute Lymphoblastic Leukemia, Fatigue, Sleep hygiene, Relaxation, RCT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Sleep Hygiene and Relaxation Education
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene and Relaxation Education
Intervention Description
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 Measure Information:
Title
Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)
Description
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.
Time Frame
Weeks 1-4, post-intervention
Secondary Outcome Measure Information:
Title
Nocturnal sleep (minutes)
Description
Sleep and wake times will be objectively collected using actigraphy.
Time Frame
Five consecutive nights on two occasions
Other Pre-specified Outcome Measures:
Title
Sleep Disturbances (The Children's Sleep Habits Questionnaire)
Description
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
Time Frame
Baseline, Weeks 4 and 8
Title
School attendance
Description
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.
Time Frame
One month
Title
Fatigue levels (Childhood Cancer Fatigue Scale-Child (FS-C) and the Childhood Cancer Fatigue Scale-Parent (FS-P)
Description
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
Time Frame
Baseline, Weeks 4 and 8
Title
Daytime and pre-bedtime behaviours (The Family Inventory of Sleep Habits (FISH)
Description
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.
Time Frame
Baseline, Weeks 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Zupanec, MN, NP-Peds
Organizational Affiliation
Hospital for Sick Children (SickKids)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27922922
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.
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Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy

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