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      A Sleep Hygiene and Relaxation Intervention for Children With Acute Lymphoblastic Leukemia : A Pilot Randomized Controlled Trial

      , MN, NP-Peds, , MN, NP-Peds, , RN, BScN, , RN, PhD, , RN, MSc, , RN, PhD
      Cancer Nursing
      Lippincott Williams & Wilkins
      Actigraphy, Child, Fatigue, Leukemia, Parent, Randomized controlled trial, Relaxation, Sleep, Sleep hygiene

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          Sleep disturbance and fatigue are common and distressing pediatric cancer-related outcomes. Sleep hygiene education and relaxation techniques are recommended to improve sleep in healthy children and adult cancer survivors. No studies have tested these interventions to improve sleep and fatigue for children with acute lymphoblastic leukemia (ALL) in the home setting.


          The aim of this study is to establish the feasibility and acceptability of a sleep hygiene and relaxation intervention to improve sleep and fatigue for children receiving maintenance chemotherapy for ALL. The child's fatigue and sleep data were collected to inform sample size calculations for a future trial.


          In this pilot randomized controlled trial, 20 children were allocated randomly to the sleep intervention or control group. The sleep intervention group received a 60-minute educational session to discuss sleep and fatigue in children with cancer and strategies to improve sleep, including use of 2 storybooks to teach deep breathing and progressive muscle relaxation. Objective sleep data were collected using actigraphy and fatigue was measured using the Childhood Cancer Fatigue Scale.


          The intervention was acceptable to families, and feasibility of the intervention and data collection was clearly established. Although not statistically significant, increases in mean nighttime sleep and decreases in mean wake time after sleep onset in the sleep intervention group represented clinically important improvements.


          This pilot study demonstrated the feasibility and acceptability of a sleep hygiene and relaxation intervention for children undergoing maintenance chemotherapy for ALL.

          Implications for practice:

          Given the clinically important improvements in sleep observed, replication in a larger, adequately powered randomized controlled trial is merited.

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          Most cited references30

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          Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.

          Persistent insomnia is a common complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavior therapy (CBT) for insomnia, delivered by oncology nurses. Randomized, controlled, pragmatic, two-center trial of CBT versus treatment as usual (TAU) in 150 patients (103 females; mean age, 61 years.) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer. The study conformed to CONSORT guidelines. Primary outcomes were sleep diary measures at baseline, post-treatment, and 6-month follow-up. Actigraphic sleep, health-related quality of life (QOL), psychopathology, and fatigue were secondary measures. CBT comprised five, small group sessions across consecutive weeks, after a manualized protocol. TAU represented normal clinical practice; the appropriate control for a clinical effectiveness study. CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in TAU. These outcomes were sustained 6 months after treatment. Standardized relative effect sizes were large for complaints of difficulty initiating sleep, waking from sleep during the night, and for sleep efficiency (percentage of time in bed spent asleep). CBT was associated with moderate to large effect sizes for five of seven QOL outcomes, including significant reduction in daytime fatigue. There was no significant interaction effect between any of these outcomes and baseline demographic, clinical, or sleep characteristics. CBT for insomnia may be both clinically effective and feasible to deliver in real world practice.
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            Sleep/wake patterns derived from activity monitoring and maternal report for healthy 1- to 5-year-old children.

            To describe behavioral sleep/wake patterns of young children from actigraphy and mothers' reports, assess age-group and sex differences, describe daytime napping, and investigate the impact of family demographic variables on sleep-wake measures. Cross-sectional sample of children wore actigraphs for 1 week; mothers kept concurrent diaries. Children studied in their homes. 169 normal healthy children in 7 age groups (12, 18, 24, 30, 36, 48, and 60 months old); 84 boys and 85 girls. N/A. Nocturnal sleep/wake measures estimated from activity recordings using a validated algorithm; mothers' reports of nocturnal sleep/wake patterns and daytime naps obtained from concurrent diaries. Bedtimes and sleep start times were earliest and time in bed and sleep period times were longest for 12-month-old children. Rise time, sleep end time, and nocturnal sleep minutes did not differ across age groups. Actigraphic estimates indicated that children aged 1 to 5 years slept an average of 8.7 hours at night. Actigraph-based nocturnal wake minutes and wake bouts were higher than maternal diary reports for all age groups. Daytime naps decreased monotonically across age groups and accounted for most of the difference in 24-hour total sleep over age groups. Children in families with lower socioeconomic status had later rise times, longer time in bed, more nocturnal wake minutes and bouts, and more night-to-night variability in bedtime and sleep period time. Children with longer naps slept less at night. Individual differences in sleep/wake measures reflect characteristics of children, parents, or parent-child interactions.
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              The importance of piloting an RCT intervention.

              The pilot study provides a unique opportunity to identify and prepare for the challenges of evaluating an intervention. Ultimately, it will enhance the scientific rigour and value of the full-scale study. Although some journals publish reports of pilot studies, little attention has been given to the types of research questions and issues specific to these studies. This article focuses on the utility of a pilot randomized controlled trial (RCT) as a first step towards conducting an RCT. Three major objectives of a pilot RCT are discussed: assessing the feasibility and acceptability of the intervention, assessing the feasibility and acceptability of the design and procedures, and facilitating the determination of effect sizes for use in sample-size calculations.

                Author and article information

                Cancer Nurs
                Cancer Nurs
                Cancer Nursing
                Lippincott Williams & Wilkins
                November 2017
                05 December 2016
                : 40
                : 6
                : 488-496
                Author Affiliations: Division of Haematology/Oncology (SickKids) (Mss Zupanec and Jones) and Division of Neurosurgery, Neurology, & Trauma (Ms McRae), The Hospital for Sick Children (SickKids); Faculty of Health Sciences, University of Ontario Institute of Technology (Dr Papaconstantinou), Oshawa; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada (Ms Weston and Dr Stremler).
                Author notes
                Correspondence: Robyn Stremler, RN, PhD, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Toronto, ON, Canada M5T 1P8 ( robyn.stremler@ 123456utoronto.ca ).
                NCC50191 00008
                Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

                : 12 October 2016
                Page count
                Pages: 0
                Custom metadata

                actigraphy,child,fatigue,leukemia,parent,randomized controlled trial,relaxation,sleep,sleep hygiene


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