Evidence map›Paper›PMID 27318221›Full record

Trial reportSleep medicine2016

Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors.

Sheila N Garland, Joseph A Roscoe, Charles E Heckler, Holly Barilla, Philip Gehrman, James C Findley, Anita R Peoples, Gary R Morrow, Charles Kamen, Michael L Perlis

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 12% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Sleep Disorders in Cancer-A Systematic Review.International journal of environmental research and public health · 2021
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  5. Cognitive Behavioral Therapy for Insomnia Reduces Depression in Cancer Survivors.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2019
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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

10 authors at 2 institutions in 2 countries.

Sheila N GarlandDepartment of Family Medicine and Community Health, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA; Abramson Cancer Center, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, USA; Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA; Department of Psychology, Memorial University of Newfoundland, 232 Elizabeth Avenue, St. John's, NL A1B 3X9, Canada. Electronic address: sheila.garland@mun.ca.
Joseph A RoscoeJames P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Charles E HecklerJames P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Holly BarillaBehavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA.
Philip GehrmanBehavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA.
James C FindleyBehavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA.
Anita R PeoplesJames P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Gary R MorrowJames P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Charles KamenJames P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Michael L PerlisBehavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA. Electronic address: mperlis@exchange.upenn.edu.
University of Pennsylvania · USUniversity of Rochester · US

Funding

URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
Cancer Control Research Training Curriculum (R25T)R25CA102618 · NCI · UNIVERSITY OF ROCHESTER · PI JANELSINS, MICHELLE C, MORROW, GARY R · 2004 to 2018
$6.7M
CBT +/- Modafinil for Insomnia and Fatigue following ChemotherapyR01CA126968 · NCI · UNIVERSITY OF ROCHESTER · PI ROSCOE, JOSEPH A · 2008 to 2012
$2.4M
Prospective Assessment of The Etiology of Insomnia in Middle Aged & Elder AdultsR01AG041783 · NIA · UNIVERSITY OF PENNSYLVANIA · PI PERLIS, MICHAEL LLOYD · 2013 to 2016
$2.4M
Exercise Intervention for Lesbian, Gay, Bisexual, and Transgender Cancer SurvivorsK07CA190529 · NCI · UNIVERSITY OF ROCHESTER · PI KAMEN, CHARLES STEWART · 2015 to 2019
$830k
NCI NIH HHS K07 CA190529NCI NIH HHS R01 CA126968NCI NIH HHS R25 CA102618NCI NIH HHS UG1 CA189961NIA NIH HHS R01 AG041783
6 · The paper itself

Abstract

STUDY

objectivesThis study involves the analysis of a secondary outcome of a trial examining whether cognitive behavior therapy for insomnia (CBT-I), a wake-promoting medication (armodafinil), or both results in greater improvement in prospectively assessed sleep continuity and daytime sleepiness than a placebo-alone group among a heterogeneous group of cancer survivors. Whether or not armodafinil alone, and/or when combined with CBT-I, affected adherence with CBT-I was evaluated.

designThis study is a randomized, placebo-controlled, clinical trial.

settingThis study was conducted at two northeastern academic medical centers.

participantsEighty-eight cancer survivors with chronic insomnia were recruited between October 2008 and November 2012. Participants were assigned to one of four conditions: 1) CBT-I and placebo (CBT-I+P); 2) CBT-I and armodafinil (CBT-I + A); 2) armodafinil alone (ARM); or 4) placebo alone (PLA).

interventionsCBT-I was delivered in seven weekly individual therapy sessions (three in person, four via telephone). The armodafinil dosage was 50 mg BID. MEASUREMENTS AND

resultsSleep continuity was measured with daily sleep diaries assessing sleep latency (SL), wake after sleep onset (WASO), and total sleep time (TST). The Epworth Sleepiness Scale (ESS) measured daytime sleepiness. Compared to the PLA group, the CBT-I+P and CBT-I+A groups reported a significant reduction in SL with effect sizes of 0.67 and 0.58, respectively. A significant reduction was observed in WASO in the CBT-I+A group with an effect size of 0.64. An increasing trend of TST was observed in the CBT-I+P, CBT-I+A, and PLA groups, but not in the ARM group. No statistically significant reductions in daytime sleepiness (ESS) were observed for any of the groups.

conclusionCBT-I alone and in combination with armodafinil caused significant improvement in sleep continuity. The addition of armodafinil did not appear to improve daytime sleepiness or enhance adherence to CBT-I.

Indexed as

SurvivorsBenzhydryl CompoundsCognitive Behavioral TherapyDisorders of Excessive SomnolenceFemaleHumansMaleMiddle AgedModafinilNeoplasmsSleep Initiation and Maintenance DisordersSleep StagesWakefulness-Promoting AgentsBenzhydryl CompoundsModafinilWakefulness-Promoting AgentsArmodafinilCancerCBT-ICognitive behavior therapyInsomniaSleepiness

Identifiers

PMID27318221
PMCPMC5267578
OpenAlexW2216464249

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.