Evidence map›Paper›PMID 34357593›Full record

Trial reportCancer2021

Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial.

Yohannes W Woldeamanuel, Douglas W Blayney, Booil Jo, Sophie E Fisher, Catherine Benedict, Ingrid Oakley-Girvan, Shelli R Kesler, Oxana Palesh

3 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 44% 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.

NCT02165839 nacompletednot on this map

Brief Behavioral Intervention for Insomnia During Chemotherapy

TypeinterventionalSponsorStanford UniversityRan2015 to 2020Enrolled139ConditionsBreast Cancer, InsomniaArmsBrief Behavioral Therapy for Insomnia (BBT-I), Healthy Eating Education Learning (HEAL)
NCT05415020 narecruitingnot on this mapstarted 2022, after this paper: background citation

Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine

TypeinterventionalSponsorMayo ClinicRan2022 to 2027Enrolled60ConditionsMigraine, Headache, Migraine Disorders, Chronic MigraineArmsLifestyle Behavior Protocol, Sham Behavior Protocol
NCT06170281 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention

TypeinterventionalSponsorMayo ClinicRan2026 to 2028Enrolled24ConditionsMigraine, Headache, Chronic Migraine, Headache DisordersArmsMigraine Behavioral Treatment
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. 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

8 authors at 4 institutions in 2 countries.

Yohannes W WoldeamanuelDivision of Headache Medicine, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Palo Alto, California.ORCID 0000-0003-4879-6098
Douglas W BlayneyStanford Cancer Institute, Stanford University School of Medicine, Palo Alto, California.ORCID 0000-0002-7931-4533
Booil JoDepartment of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California.
Sophie E FisherStanford Cancer Survivorship Research, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California.ORCID 0000-0002-6771-6113
Catherine BenedictDepartment of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California.ORCID 0000-0001-9622-249X
Ingrid Oakley-GirvanThe Data and Technology Proving Ground, Public Health Institute, Oakland, California.
Shelli R KeslerCancer Neuroscience Laboratory, School of Nursing, University of Texas at Austin, Austin, Texas.
Oxana PaleshStanford Cancer Institute, Stanford University School of Medicine, Palo Alto, California.
Stanford University · USAlbemarle (United States) · USAustin College · USPalo Alto University · US

Funding

Multicenter Randomized Controlled Trial of Brief Behavioral Therapy for Cancer Related InsomniaR01CA239714 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI PALESH, OXANA G · 2020 to 2025
$4.5M
Very-long Term Neurocognitive Outcomes in Breast Cancer Survivors (ProbC2)R01CA172145 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI KESLER, SHELLI R, PALESH, OXANA G · 2012 to 2024
$3.3M
Brief Behavioral Intervention for Insomnia During ChemotherapyR01CA181659 · NCI · STANFORD UNIVERSITY · PI PALESH, OXANA G · 2014 to 2018
$3.1M
Predicting Long-Term Chemotherapy-Related Cognitive ImpairmentR01CA226080 · NCI · UNIVERSITY OF TEXAS AT AUSTIN · PI KESLER, SHELLI R, PALESH, OXANA G · 2019 to 2024
$3.1M
NCI NIH HHS R01 CA172145NCI NIH HHS R01 CA181659NCI NIH HHS R01 CA239714
6 · The paper itself

Abstract

backgroundBreast cancer survivors often have persisting headache. In a secondary analysis of the Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) clinical trial (ClinicalTrials.gov identifier NCT02165839), the authors examined the effects of BBT-CI on headache outcomes in patients with breast cancer.

methodsPatients with breast cancer who were receiving chemotherapy were randomly assigned to receive either the BBT-CI intervention or the Healthy EAting Education Learning for healthy sleep (HEAL) control intervention, and both were delivered over 6 weeks by trained staff. Headache outcomes and heart rate variability (HRV) were measured at baseline, 6 weeks, 6 months, and 12 months. Mixed-effects models were used to examine longitudinal headache outcomes in the groups according to the intention to treat. Principal component analysis and agglomerative hierarchical clustering were conducted to reduce 16 variables for data-driven phenotyping.

resultsPatients in the BBT-CI arm (n = 73) exhibited a significant reduction in headache burden over time (P = .02; effect size [Cohen d] = 0.43), whereas the reduction was not significant among those in the HEAL arm (n = 66). The first principal component was positively loaded by headache, sleep, fatigue, and nausea/vomiting and was negatively loaded by cognitive, physical, and emotional functioning. Agglomerative hierarchical clustering revealed 3 natural clusters. Cluster I (n = 58) featured the highest burden of headache, insomnia, and nausea/vomiting; cluster II (n = 50) featured the lowest HRV despite a low burden of headache and insomnia; and cluster III (n = 31) showed an inverse relation between HRV and headache-insomnia, signifying autonomic dysfunction.

conclusionsBBT-CI is efficacious in reducing headache burden in breast cancer survivors. Patient phenotyping demonstrates a headache type featuring sleep disturbance, nausea/vomiting, and low physical functioning-revealing similarities to migraine. LAY SUMMARY: Breast cancer survivors often have persisting headache symptoms. In patients with cancer, treatment of chronic headache disorders using daily medications may be challenging because of drug interactions with chemotherapy and other cancer therapies as well as patients' reluctance to add more drugs to their medicine list. Headache and sleep disorders are closely related to each other. This study demonstrates that a sleep behavioral therapy reduced headache burden in breast cancer survivors. In addition, the majority of headache sufferers had a headache type with similarities to migraine-featuring sleep disturbance, nausea/vomiting, and low physical functioning.

Indexed as

Breast NeoplasmsCancer SurvivorsCognitive Behavioral TherapySleep Initiation and Maintenance DisordersBehavior TherapyFemaleHeadacheHumansSleepTreatment Outcomebehavior therapybreast neoplasmsclinical trialheadachesleep initiation and maintenance disorders

Identifiers

PMID34357593
PMCPMC8578351
OpenAlexW3189795990

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.