Evidence map›Paper›PMID 35776489›Full record

ArticleJMIR research protocols2022

Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance.

Jennifer Huberty, Nishat Bhuiyan, Ryan Eckert, Linda Larkey, Megan Petrov, Michael Todd, Ruben Mesa

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05294991 (Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 24% 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.

NCT05294991 naactive not recruitingnot on this mapstarted 2023, after this paper: background citation

Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients

TypeinterventionalSponsorThe University of Texas Health Science Center at San AntonioRan2023 to 2026Enrolled276ConditionsCancer, Sleep Disturbance, Anxiety, DepressionArmsWellness app intervention #1, Wellness app intervention #2
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. 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

7 authors at 2 institutions in 1 country.

Jennifer Huberty *Science, Calm, San Francisco, CA, United States.ORCID https://orcid.org/0000-0002-0276-4640
Nishat Bhuiyan *College of Health solutions, Arizona State University, Phoenix, AZ, United States.ORCID https://orcid.org/0000-0002-2947-6673
Ryan Eckert *Mays Cancer Center, University of Texas Health San Antonio, San Antonio, TX, United States.ORCID https://orcid.org/0000-0001-9105-5354
Linda Larkey *Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.ORCID https://orcid.org/0000-0001-7681-6813
Megan Petrov *Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.ORCID https://orcid.org/0000-0001-5443-7548
Michael Todd *Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.ORCID https://orcid.org/0000-0002-1981-4245
Ruben Mesa *Mays Cancer Center, University of Texas Health San Antonio, San Antonio, TX, United States.ORCID https://orcid.org/0000-0001-5880-7972
Arizona State University · USThe University of Texas Health Science Center at San Antonio · US

Funding

Consumer-based meditation app, Calm, for treatment of sleep disturbance in hematological cancer patientsR01CA262041 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Jennifer Lynne Huberty, Ruben A. Mesa · 2022 to 2026
$2.8M
NCI NIH HHS R01 CA262041
6 · The paper itself

Abstract

backgroundTo address the need for long-term, accessible, nonpharmacologic interventions targeting sleep in patients with chronic hematological cancer, we propose the first randomized controlled trial to determine the effects of a consumer-based mobile meditation app, Calm, on sleep disturbance in this population.

objectiveThis study aims to test the efficacy of daily meditation delivered via Calm compared with a health education podcast control group in improving the primary outcome of self-reported sleep disturbance, as well as secondary sleep outcomes, including sleep impairment and sleep efficiency; test the efficacy of daily meditation delivered via Calm compared with a health education podcast control group on inflammatory markers, fatigue, and emotional distress; and explore free-living use during a 12-week follow-up period and the sustained effects of Calm in patients with chronic hematological cancer.

methodsIn a double-blinded randomized controlled trial, we will recruit 276 patients with chronic hematological cancer to an 8-week app-based wellness intervention-the active, daily, app-based meditation intervention or the health education podcast app control group, followed by a 12-week follow-up period. Participants will be asked to use their assigned app for at least 10 minutes per day during the 8-week intervention period; complete web-based surveys assessing self-reported sleep disturbance, fatigue, and emotional distress at baseline, 8 weeks, and 20 weeks; complete sleep diaries and wear an actigraphy device during the 8-week intervention period and at 20 weeks; and complete blood draws to assess inflammatory markers (tumor necrosis factor-α, interleukin-6, interleukin-8, and C-reactive protein) at baseline, 8 weeks, and 20 weeks.

resultsThis project was funded by the National Institutes of Health National Cancer Institute (R01CA262041). The projects began in April 2022, and study recruitment is scheduled to begin in October 2022, with a total project duration of 5 years. We anticipate that we will be able to achieve our enrollment goal of 276 patients with chronic hematological cancers within the allotted project time frame.

conclusionsThis research will contribute to broader public health efforts by providing researchers and clinicians with an evidence-based commercial product to improve sleep in the long term in an underserved and understudied cancer population with a high incidence of sleep disturbance.

trial registrationClinicalTrials.gov NCT05294991; https://clinicaltrials.gov/ct2/show/NCT05294991. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39007.

Indexed as

hematological cancersmeditationmHealthmobile healthmobile phonesleep disturbance

Identifiers

PMID35776489
PMCPMC9288097
OpenAlexW4281658866

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.