Evidence map›Paper›PMID 40204663›Full record

Trial reportPsycho-oncology2025

Combined Treatment With Cognitive Behavioral Therapy for Insomnia and Acceptance and Commitment Therapy Enhances Objective and Subjective Reports of Sleep in Patients With Advanced Cancer.

Sharla Wells-Di Gregorio, Stacy Flowers, Juan Peng, Donald R Marks, Danielle Probst, Alexandra Zaleta, Don Benson, David E Cohn, Maryam Lustberg, William Carson and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Psycho-oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01929720 (Worry, Uncertainty and Insomnia), 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
–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.

NCT01929720 nacompletednot on this map

Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors

TypeinterventionalSponsorOhio State University Comprehensive Cancer CenterRan2011 to 2014Enrolled33ConditionsAnxiety Disorder, Worry, Uncertainty, Sleep DisordersArmsCognitive-behavioral therapy for worry, uncertainty & insomnia
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  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

13 authors.

Sharla Wells-Di GregorioDivision of Palliative Medicine, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.ORCID 0000-0002-5193-7448
Stacy FlowersDepartment of Family Medicine, Boonshoft School of Medicine, Wright State University, Dayton, Ohio, USA.
Juan PengCenter for Biostatistics, The Ohio State University, Columbus, Ohio, USA.
Donald R MarksDivision of Palliative Medicine, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Danielle ProbstDivision of Palliative Medicine, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Alexandra ZaletaDivision of Palliative Medicine, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Don BensonDivision of Hematology-Oncology, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
David E CohnDivision of Gynecologic Oncology, Department of Obstetrics & Gynecology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Maryam LustbergBreast Medical Oncology, Yale Cancer Center, New Haven, Connecticut, USA.
William CarsonDivision of Surgical Oncology, Department of Surgery, The Ohio State Wexner Medical Center, Columbus, Ohio, USA.
Uly MagalangDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Sarah BaltimoreDivision of Palliative Medicine, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Sonia Ancoli-IsraelDepartment of Psychiatry, University of California San Diego School of Medicine, San Diego, California, USA.

Funding

The Ohio State University Center for clinical and Translational ScienceUL1TR001070 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2013 to 2017
$22.6M
Randomized clinical trial of a telemedicine-mHealth symptom cluster intervention for advanced cancer patients: Increasing access in underserved rural communitiesR01CA281885 · NCI · OHIO STATE UNIVERSITY · PI Sharla Maelyn Wells-Di Gregorio · 2024 to 2026
$2.0M
American Cancer Society Grant IRG-67-003-47Lance Armstrong Foundation Survivorship Center for Excellence GrantNCATS NIH HHS UL1 TR001070NCI NIH HHS R01 CA281885Ohio State Clinical Research Center via the National Center for Advancing Translational Sciences Grant UL1TR001070Ohio State Comprehensive Cancer Center Cancer Control Grant CCP194Tzagournis Medical Research Endowment Fund
6 · The paper itself

Abstract

backgroundSleep difficulties are common for people with advanced cancer and are associated with poorer mood, lower quality of life, and reduced survival. For these patients, insomnia severity ratings are tied to nighttime awakenings, but little is known about the reasons for awakenings.

aimsThis study reports actigraphy sleep outcomes, longitudinal self-reported insomnia severity, and circadian rhythm disruptions from a randomized pilot study comparing a multi-symptom intervention with a wait-list control group for people with advanced cancer.

methodsTwenty-eight people with advanced cancer completed a brief intervention, Finding Our Center Under Stress (FOCUS), designed to enhance sleep and alleviate worry, depression, and fatigue. Participants completed questionnaires and wore an Actiwatch for 7 consecutive 24-h periods pre- and post-intervention.

resultsThere were no significant group × time actigraphy effects. However, sensitivity analyses with the full intervention sample including the wait-list control arm demonstrated significant effects on actigraphy sleep efficiency, minutes awake after sleep onset (WASO), number of awakenings, naps, and activity at rest. Insomnia severity ratings on the Insomnia Severity Index were maintained longitudinally with 61% meeting the cut-off for insomnia at baseline compared to 18% at 1 year. Participants demonstrated reductions in key reasons for awakenings.

conclusionsMulti-symptom interventions may be necessary for sustained insomnia improvements for people with advanced cancer. The FOCUS intervention is one of the first to demonstrate improvements on self-reported and actigraphic measures of sleep in addition to other symptoms (i.e., worry, uncertainty, depression, fatigue interference, distress) for this population. Future effectiveness studies are warranted given results of this pilot trial.

trial registrationCognitive-behavioral intervention for worry, uncertainty, and insomnia for cancer survivors (NCT01929720).

Indexed as

Acceptance and Commitment TherapyCognitive Behavioral TherapyNeoplasmsSleep Initiation and Maintenance DisordersActigraphyAdultAgedCombined Modality TherapyDepressionFatigueFemaleHumansMaleMiddle AgedPilot ProjectsQuality of Lifeacceptance and commitment therapycancercognitive behavioral therapydepressionfatigueoncologysleepuncertaintyworry

Identifiers

PMID40204663
PMCPMC11981972

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.