Evidence map›Paper›PMID 31081596›Full record

Trial reportPediatric blood & cancer2019

A pilot randomized controlled trial to improve sleep and fatigue in children with central nervous system tumors hospitalized for high-dose chemotherapy.

Valerie E Rogers, Shijun Zhu, Sonia Ancoli-Israel, Lianqi Liu, Belinda N Mandrell, Pamela S Hinds

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric blood & cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00666614 (A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00666614 nacompletednot on this map

A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy

TypeinterventionalSponsorSt. Jude Children's Research HospitalRan2008 to 2011Enrolled43ConditionsSleep, FatigueArmsSleep Environment Intervention, Normal Hospital Environment
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Relationship between circadian activity rhythms and fatigue in hospitalized children with CNS cancers receiving high-dose chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Valerie E RogersUniversity of Maryland, Baltimore, Maryland.ORCID 0000-0001-7380-2889
Shijun ZhuUniversity of Maryland, Baltimore, Maryland.
Sonia Ancoli-IsraelUniversity of California, San Diego, California.
Lianqi LiuUniversity of California, San Diego, California.
Belinda N MandrellSt. Jude Children's Research Hospital, Memphis, Tennessee.
Pamela S HindsChildren's National Health System, George Washington University, Washington, District of Columbia.ORCID 0000-0001-6491-6649

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
NCI NIH HHS P30 CA021765NIH HHS CA 21765
6 · The paper itself

Abstract

objectivesTo determine whether a sleep intervention compared with standard of care (SOC) was successful in preserving nighttime sleep in children with central nervous system cancers hospitalized for high-dose chemotherapy (HDCT) and autologous stem cell rescue, and to explore associations between sleep and fatigue during treatment.

methodsAn unblinded, randomized, controlled, multicomponent intervention (NCT00666614) including evidence-based cognitive and behavioral strategies to improve sleep was implemented in 33 children (age 4-12 years) and adolescents (age 13-19 years) during hospitalization. Children wore an actigraph to measure sleep and wake, and reported fatigue scores daily. Parents concurrently kept a sleep diary and reported fatigue scores for their children.

resultsThe mean age was 9.5 ± 3.9 years, 81.8% were white, and 60.6% were male. Sleep in all children was seriously disturbed throughout the study. Children in the intervention group maintained their longest nighttime sleep across the study, while it declined in children receiving SOC (P = 0.009 for interaction). There were few other differences in sleep between groups. Controlling for age and baseline fatigue, higher nighttime activity score, and lower percent sleep were significantly associated with higher next-day adolescent-reported fatigue (P < 0.05); longest sleep was significantly positively associated with next-day child-reported fatigue (P = 0.018).

conclusionIn this sample of children undergoing HDCT, a multicomponent sleep intervention modestly preserved nighttime sleep duration, although overall sleep was poor in both groups. Sleep is an integral component of health, and may influence outcomes of children receiving HDCT. Further investigation into methods of preserving sleep in children undergoing intensive cancer therapy is warranted.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCentral Nervous System NeoplasmsChildChild, PreschoolEarly Medical InterventionFatigueFemaleFollow-Up StudiesHumansMalePilot ProjectsPrognosisSleep Wake DisordersactigraphyadolescentschemotherapychildrenCNS tumorsleep

Identifiers

PMID31081596
PMCPMC7416343

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.