Evidence map›Paper›PMID 32307658›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2020

A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance).

Debra L Barton, Pamela J Atherton, Daniel V Satele, Rui Qin, Shaker Dakhil, Teri Pipe, Timothy Hobday, Kelli Fee-Schroeder, Charles L Loprinzi

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00993928 (A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances), which is not on this map. Cited by 5 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 3 pooled it
0.5field-weighted citation impact, top 31% 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.

NCT00993928 phase2terminatednot on this map

A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2010 to 2019Enrolled93ConditionsCancer Survivor, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Sleep DisordersArmsHome-based sleep intervention
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 3 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Article
  5. Sleep disturbance in cancer survivors with lymphedema: a scoping review.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 7 institutions in 2 countries.

Debra L BartonUniversity of Michigan School of Nursing, 400 N. Ingalls, Room 4320, Ann Arbor, MI, 48109-5482, USA. debbartn@med.umich.edu.
Pamela J AthertonAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Daniel V SateleAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Rui QinJanssen Pharmaceuticals, Raritan, NJ, Belgium.
Shaker DakhilWichita NCORP, Wichita, KS, USA.
Teri PipeArizona State University, Tempe, AZ, USA.
Timothy HobdayMayo Clinic Cancer Center, Rochester, MN, USA.
Kelli Fee-SchroederMayo Clinic Cancer Center, Rochester, MN, USA.
Charles L LoprinziMayo Clinic Cancer Center, Rochester, MN, USA.
Mayo Clinic in Arizona · USAlliance Data (United States) · USArizona State University · USJanssen (Belgium) · BEMayo Clinic · USUniversity of Michigan–Ann Arbor · USWichita Clinic · US

Funding

Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
NCORP of the Carolinas (Greenville Health System NCORP)UG1CA189972 · NCI · PRISMA HEALTH - UPSTATE · PI Ki Young Chung · 2014 to 2026
$17.9M
Iowa-Wide Oncology Research Coalition (I-WORC)UG1CA189816 · NCI · IOWA ONCOLOGY RESEARCH ASSOCIATION · PI Seema Harichand, Arshin Sheybani · 2014 to 2026
$14.9M
Ozark Health Ventures, LLC dba Cancer Research for the Ozarks (CRO)UG1CA189822 · NCI · OZARK HEALTH VENTURES, LLC · PI Jay W Carlson · 2014 to 2026
$14.2M
Sanford Community Cancer Program of the North Central Plains (NCORP)UG1CA189825 · NCI · SANFORD RESEARCH/USD · PI Daniel Almquist, SAMUEL J. MILANOVICH · 2014 to 2026
$13.6M
Georgia CaResUG1CA189851 · NCI · AUGUSTA UNIVERSITY · PI Anand P Jillella · 2014 to 2026
$13.3M
National Community Oncology Research ProjectUG1CA189808 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 2014 to 2018
$8.6M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
Ochsner NCI Community Oncology Research ProgramUG1CA189870 · NCI · OCHSNER CLINIC FOUNDATION · PI COLE, JOHN T · 2014 to 2018
$3.5M
Division of Cancer Prevention, National Cancer Institute U10CA180790Division of Cancer Prevention, National Cancer Institute UG1CA189808Division of Cancer Prevention, National Cancer Institute UG1CA189823NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180836NCI NIH HHS U10 CA180866NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189816NCI NIH HHS UG1 CA189822NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA189825NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189851NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189870NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA189972
6 · The paper itself

Abstract

purposeSleep disturbance is a prevalent problem for cancer survivors and effective behavioral treatments are not widely used for this population. This study evaluated home-based sleep interventions based on cognitive behavioral therapy for insomnia (CBT-I).

methodsThis phase II randomized controlled trial evaluated two manualized interventions over 7 weeks. The intervention group received sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording. The control group was similar, but without sleep restriction and used audio recordings of bedtime short stories instead of imagery. Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7 days. Patients with diagnoses of sleep or mental health disorders were excluded. The primary endpoint was change in time to fall asleep or falling back to sleep after awakening, from baseline to week 7. Two-sample T tests evaluated differences between arms for this endpoint.

resultsNinety-three of 168 planned participants were enrolled from 20 institutions. The study closed early for poor accrual. Baseline time to sleep was 45 min and 52 min for the intervention and control group, respectively. At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85). Secondary outcomes improved in both groups with no significant differences between arms.

conclusionsImprovement in sleep outcomes in both arms was consistent with other CBT-I interventions delivered through alternative approaches to provider-delivered therapy. More research on optimal scalable delivery of CBT-I is needed. CLINICAL RELEVANCE: This study supports the effectiveness of CBT-I based behavioral interventions for sleep but also the need for better delivery methods to improve uptake and effect size.

trial registrationClinicalTrials.gov identifier: NCT00993928.

Indexed as

Cancer SurvivorsAdultAgedAged, 80 and overCognitive Behavioral TherapyFemaleHumansMaleMiddle AgedNeoplasmsSleepSleep Initiation and Maintenance DisordersTreatment OutcomeBehavioral interventionCancer survivorsCBT-ISleep disturbance

Identifiers

PMID32307658
PMCPMC7572569
OpenAlexW3017016503

What OpenQuestion holds

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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.