Evidence map›Paper›PMID 30026614›Full record

Trial reportBritish journal of cancer2018

Feasibility and acceptability of brief behavioral therapy for cancer-related insomnia: effects on insomnia and circadian rhythm during chemotherapy: a phase II randomised multicentre controlled trial.

Oxana Palesh, Caroline Scheiber, Shelli Kesler, Michelle C Janelsins, Joseph J Guido, Charles Heckler, Mallory G Cases, Jessica Miller, Nick G Chrysson, Karen M Mustian

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 9 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.

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

35 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  13. Telehealth cognitive behaviour therapy for the management of sleep disturbance in women with early breast cancer receiving chemotherapy: a feasibility study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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  16. Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 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.

Oxana PaleshDepartment of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. opalesh@stanford.edu.
Caroline ScheiberDepartment of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
Shelli KeslerUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Michelle C JanelsinsUniversity of Rochester Medical Center, James P. Wilmot Cancer Institute, Rochester, NY, USA.
Joseph J GuidoUniversity of Rochester Medical Center, James P. Wilmot Cancer Institute, Rochester, NY, USA.
Charles HecklerUniversity of Rochester Medical Center, James P. Wilmot Cancer Institute, Rochester, NY, USA.
Mallory G CasesDepartment of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
Jessica MillerMetro-Minnesota Community Oncology Research Consortium, Minneapolis, MN, USA.
Nick G ChryssonNovant Health Oncology Specialists, Winston-Salem, NC, USA.
Karen M MustianUniversity of Rochester Medical Center, James P. Wilmot Cancer Institute, Rochester, NY, USA.

Funding

URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
UNIVERSITY OF ROCHESTER--CCOP RESEARCH BASEU10CA037420 · NCI · UNIVERSITY OF ROCHESTER · PI MORROW, GARY R · 1985 to 2014
$21.1M
Brief Behavioral Intervention for Insomnia During ChemotherapyR01CA181659 · NCI · STANFORD UNIVERSITY · PI PALESH, OXANA G · 2014 to 2018
$3.1M
RCT for Mechanisms and Management of Sleep Utilizing Multicenter Clinical Oncology NetworkR21CA185678 · NCI · STANFORD UNIVERSITY · PI MUSTIAN, KAREN M., PALESH, OXANA G · 2015 to 2016
$381k
NCI NIH HHS R01 CA181659NCI NIH HHS R21 CA185678NCI NIH HHS U10 CA037420NCI NIH HHS UG1 CA189961
6 · The paper itself

Abstract

backgroundThis phase II RCT was conducted to determine the feasibility and acceptability of brief behavioral therapy for cancer-related insomnia (BBT-CI) in breast cancer patients undergoing chemotherapy. We also assessed the preliminary effects of BBT-CI on insomnia and circadian rhythm in comparison to a Healthy Eating Education Learning control condition (HEAL).

methodsOf the 71 participants recruited, 34 were randomised to receive BBT-CI and 37 to receive HEAL. Oncology staff was trained to deliver the intervention in four community clinics affiliated with the NCI. Insomnia was assessed with the Insomnia Severity Index (ISI), and circadian rhythm was assessed using a wrist-worn actiwatch.

resultsCommunity staff interveners delivered 72% of the intervention components, with a recruitment rate of 77% and an adherence rate of 73%, meeting acceptability and feasibility benchmarks. Those randomised to BBT-CI improved their ISI scores by 6.3 points compared to a 2.5-point improvement in those randomised to HEAL (P = 0.041). Actigraphy data indicated that circadian functioning improved in the BBT-CI arm as compared to the HEAL arm at post-intervention (all P-values <0.05).

conclusionsBBT-CI is an acceptable and feasible intervention that can be delivered directly in the community oncology setting by trained staff. The BBT-CI arm experienced significant improvements in insomnia and circadian rhythm as compared to the control condition.

Indexed as

Cognitive Behavioral TherapyCircadian RhythmExerciseFeasibility StudiesFemaleHumansMaleMiddle AgedNeoplasmsSleepSleep Initiation and Maintenance DisordersSleep Wake DisordersSurveys and QuestionnairesTreatment Outcome

Identifiers

PMID30026614
PMCPMC6068121

What OpenQuestion holds

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LicenceCC BY
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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.