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
|Condition or disease||Intervention/treatment||Phase|
|Sleep Fatigue Acute Lymphoblastic Leukemia||Behavioral: Sleep Hygiene and Relaxation Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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|
|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).
- 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.
- Nocturnal sleep (minutes) [ Time Frame: Five consecutive nights on two occasions ]Sleep and wake times will be objectively collected using actigraphy.
- 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
- 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.
- 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
- 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.
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
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Sue Zupanec, MN, NP-Peds||Hospital for Sick Children (SickKids)|