Evidence map›Paper›PMID 27189614›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors.

Shelley A Johns, Linda F Brown, Kathleen Beck-Coon, Tasneem L Talib, Patrick O Monahan, R Brian Giesler, Yan Tong, Laura Wilhelm, Janet S Carpenter, Diane Von Ah and 8 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 49 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 14 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.

NCT01724333 completednot on this map

International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17

TypeobservationalSponsorOslo University HospitalRan2012 to 2015Enrolled585ConditionsQuality of Life, Adverse Effects, Late Effects, Cancer
NCT04159363 naunknown statusnot on this mapstarted 2020, after this paper: background citation

The Effectiveness of an Interactive Colorectal Cancer Self-Management Enhancement Smartphone-based Psychosocial Intervention Programme (iCanManage) on Outcomes of Patients With Colorectal Cancer and Their Family Caregivers

TypeinterventionalSponsorSingapore Cancer SocietyRan2020 to 2021Enrolled200ConditionsColorectal CancerArmsAn interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 14 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Psychological interventions for women with non-metastatic breast cancer.The Cochrane database of systematic reviews · 2023
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Effects of sleep interventions on cancer-related fatigue and quality of life in cancer patients: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Pooled it
  7. Pooled it
  8. Pooled it
  9. The effectiveness of mindfulness-based interventions among cancer patients and survivors: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2017
    Pooled it
  14. Pooled it
  15. Trial
  16. Trial
  17. The Health Promoting Mindfulness or Qigong Educational Programs for Beneficial Lifestyle Changes of Cancer Survivors.Journal of cancer education : the official journal of the American Association for Cancer Education · 2020
    Trial
  18. Acceptance and commitment therapy for symptom interference in metastatic breast cancer patients: a pilot randomized trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
    Trial
  19. Trial
  20. Trial
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

18 authors.

Shelley A JohnsIndiana University School of Medicine, Indianapolis, IN, USA. sheljohn@iu.edu.
Linda F BrownIndiana University School of Medicine, Indianapolis, IN, USA.
Kathleen Beck-CoonIndiana University School of Medicine, Indianapolis, IN, USA.
Tasneem L TalibRegenstrief Institute, Inc., 1101 West Tenth Street RF-226, Indianapolis, IN, 46202, USA.
Patrick O MonahanIndiana University School of Medicine, Indianapolis, IN, USA.
R Brian GieslerButler University, Indianapolis, IN, USA.
Yan TongIndiana University School of Medicine, Indianapolis, IN, USA.
Laura WilhelmWest Virginia University School of Medicine, Charleston, WV, USA.
Janet S CarpenterIndiana University School of Nursing, Indianapolis, IN, USA.
Diane Von AhIndiana University School of Nursing, Indianapolis, IN, USA.
Christina D WagnerDePauw University Psychology Department, Greencastle, IN, USA.
Mary de GrootIndiana University School of Medicine, Indianapolis, IN, USA.
Karen SchmidtIndiana University School of Medicine, Indianapolis, IN, USA.
Diane MonceskiIndiana University School of Medicine, Indianapolis, IN, USA.
Marie DanhIndiana University School of Medicine, Indianapolis, IN, USA.
Jennifer M AlyeaIndiana University Fairbanks School of Public Health, Indianapolis, IN, USA.
Kathy D MillerIndiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.
Kurt KroenkeIndiana University School of Medicine, Indianapolis, IN, USA.

Funding

Indiana Clinical and Translational Sciences InstituteUL1TR001108 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI DENNE, SCOTT C., SHEKHAR, ANANTHA · 2013 to 2017
$23.3M
Indiana Clinical and Translational Science Institute (UL1)UL1TR000006 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI SHEKHAR, ANANTHA · 2012 to 2013
$5.6M
Indiana Clinical and Translational Science Institute-K12 ProgramKL2TR000163 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI SHEKHAR, ANANTHA · 2012 to 2013
$720k
Research and Training for Behavioral Oncology InterventionsK05CA175048 · NCI · INDIANA UNIVERSITY INDIANAPOLIS · PI CHAMPION, VICTORIA LEE · 2014 to 2018
$484k
NCATS NIH HHS KL2 TR000163NCATS NIH HHS UL1 TR000006NCATS NIH HHS UL1 TR001108NCI NIH HHS K05 CA175048
6 · The paper itself

Abstract

purposeCancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of mindfulness-based stress reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms.

methodsBreast (n = 60) and colorectal (n = 11) cancer survivors (stage 0-III) with clinically significant CRF after completing chemotherapy and/or radiation therapy an average of 28 months prior to enrollment were randomized to MBSR or psychoeducation/support groups (PES). MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, vitality, depression, anxiety, sleep disturbance, and pain. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3) using intent-to-treat analysis.

resultsBetween-group differences in CRF interference were not significant at any time point; however, there was a trend favoring MBSR (d = -0.46, p = 0.073) at T2. MBSR participants reported significantly greater improvement in vitality (d = 0.53, p = 0.003) and were more likely to report CRF as moderately to completely improved compared to the PES group (χ2 (1) = 4.1765, p = 0.041) at T2. MBSR participants also reported significantly greater reductions in pain at T2 (d = 0.53, p = 0.014). In addition, both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes, depression, anxiety, and sleep at T2 and T3 compared to T1.

conclusionMBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted.

trial registrationClinicalTrials.gov Identifier: NCT01724333.

Indexed as

Breast NeoplasmsColorectal NeoplasmsFatigueFemaleHumansMaleMiddle AgedMindfulnessPilot ProjectsStress, PsychologicalSurvivorsTreatment OutcomeCancerFatigueMBSRMeditationMindfulnessPsychoeducation

Identifiers

PMID27189614
PMCPMC5221754

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.