Evidence map›Paper›PMID 26542272›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial.

Charles E Heckler, Sheila N Garland, Anita R Peoples, Michael L Perlis, Michelle Shayne, Gary R Morrow, Charles Kamen, Jenine Hoefler, Joseph A Roscoe

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 5 pooled it
8.4field-weighted citation impact, top 2% 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

28 citing papers in PubMed, 5 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Sleep Disorders in Cancer-A Systematic Review.International journal of environmental research and public health · 2021
    Pooled it
  3. The efficacy of placebo for the treatment of cancer-related fatigue: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Factors associated with significant improvement in cancer-related fatigue after completing cognitive behavioral therapy for insomnia in cancer survivors.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Trial
  8. Trial
  9. Therapy for insomnia with chronic obstructive pulmonary disease: a randomized trial of components.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Trial
  10. Trial
  11. The effect of a group cognitive behavioral therapy on the quality of life and emotional disturbance of women with breast cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Trial
  12. Trial
  13. 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
    Trial
  14. Trial
  15. Trial
  16. Review
  17. Article
  18. Article
  19. Article
  20. The relationship between sleep hygiene, mood, and insomnia symptoms in men with prostate cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
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

9 authors at 3 institutions in 2 countries.

Charles E HecklerDepartment of Surgery, University of Rochester James P. Wilmot Cancer Center, 265 Crittenden Blvd. CU 420658, Rochester, NY, 14642, USA. Charles_Heckler@urmc.rochester.edu.
Sheila N GarlandDepartment of Psychology, Memorial University of Newfoundland, St. John's, NL, Canada.
Anita R PeoplesDepartment of Surgery, University of Rochester James P. Wilmot Cancer Center, 265 Crittenden Blvd. CU 420658, Rochester, NY, 14642, USA.
Michael L PerlisDepartment of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA, 19104, USA.
Michelle ShayneDepartment of Surgery, University of Rochester James P. Wilmot Cancer Center, 265 Crittenden Blvd. CU 420658, Rochester, NY, 14642, USA.
Gary R MorrowDepartment of Surgery, University of Rochester James P. Wilmot Cancer Center, 265 Crittenden Blvd. CU 420658, Rochester, NY, 14642, USA.
Charles KamenDepartment of Surgery, University of Rochester James P. Wilmot Cancer Center, 265 Crittenden Blvd. CU 420658, Rochester, NY, 14642, USA.
Jenine HoeflerDepartment of Surgery, University of Rochester James P. Wilmot Cancer Center, 265 Crittenden Blvd. CU 420658, Rochester, NY, 14642, USA.
Joseph A RoscoeDepartment of Surgery, University of Rochester James P. Wilmot Cancer Center, 265 Crittenden Blvd. CU 420658, Rochester, NY, 14642, USA.
University of Rochester · USMemorial University of Newfoundland · CAUniversity of Pennsylvania · 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
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 5 R01 CA126968NCI NIH HHS K07 CA190529NCI NIH HHS R01 CA126968NCI NIH HHS R25 CA102618NCI NIH HHS UG1 CA18961NCI NIH HHS UG1 CA189961
6 · The paper itself

Abstract

purposeFatigue is a prevalent, distressing side effect of cancer and cancer treatment which commonly coexists with insomnia. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia in cancer patients, but less is known about its ability to impact fatigue. This work is the analysis for a secondary aim of a four-arm randomized controlled trial (RCT) study assessing the combined and comparative effect of CBT-I and a wakefulness-promoting agent, armodafinil (A), to improve sleep and daytime functioning in cancer survivors. Herein, we examine the effect of CBT-I, with and without A, on fatigue in cancer survivors. PATIENTS AND

methodsThis study was a four-arm factorial study with CBTI-I (yes/no) versus A (yes/no). It consisted of 96 cancer survivors (average age 56 years; 88 % female; 68 % breast cancer). Fatigue was assessed by the brief fatigue inventory (BFI) and the FACIT-Fatigue scale. The analysis assessed the additive effects of CBT-I and A and possible non-additive effects where the effect of CBT-I changes depending on the presence or absence of A.

resultsAnalyses adjusting for baseline differences showed that CBT-I improved fatigue as measured by two separate scales (BFI: P = 0.002, Std. error = 0.32, effect size (ES) = 0.46; FACIT-Fatigue: P < 0.001, Std. error = 1.74, ES = 0.64). Armodafinil alone did not show a statistically significant effect on fatigue levels (all Ps > 0.40) nor did the drug influence the efficacy of CBT-I. Structural equation analysis revealed that reductions in insomnia severity were directly responsible for improving cancer-related fatigue.

conclusionsCBT-I with and without armodafinil resulted in a clinically and statistically significant reduction of subjective daytime fatigue in cancer survivors with chronic insomnia. Armodafinil did not improve cancer-related fatigue (CRF) and did not change the efficacy of CBT-I. Patients reporting CRF should be screened and, if indicated, treated for insomnia as part of a comprehensive fatigue management program.

Indexed as

Cognitive Behavioral TherapySurvivorsBenzhydryl CompoundsCombined Modality TherapyFatigueFemaleFollow-Up StudiesHumansMaleMiddle AgedModafinilNeoplasmsSleepSleep Initiation and Maintenance DisordersTreatment OutcomeWakefulness-Promoting AgentsBenzhydryl CompoundsModafinilWakefulness-Promoting AgentsArmodafinilCancerCancer-related fatigueCBT-I

Identifiers

PMID26542272
PMCPMC4805518
OpenAlexW2226595066

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.