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

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
October 1, 2016
Shelley A Johns et al. (18 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the efficacy of mindfulness-based stress reduction (MBSR) versus psychoeducation/support groups (PES) in reducing cancer-related fatigue (CRF) and associated symptoms in cancer survivors.

Results Summary

MBSR showed a trend toward reducing CRF interference and significantly improved vitality and pain reduction compared to PES at post-intervention. Both interventions led to moderate-to-large within-group improvements in fatigue, depression, anxiety, and sleep.

Population

Breast (n=60) and colorectal (n=11) cancer survivors (stage 0-III) with clinically significant CRF after completing chemotherapy and/or radiation therapy.

Effective Dosage

Not specified

Duration

Not specified (assessed at baseline, post-intervention, and 6-month follow-up)

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
mindfulness-based stress reduction (MBSR)
decrease
CRF interference
Breast and colorectal cancer survivors (stage 0-III) with clinically significant CRF
d = -0.46, p = 0.073
trend favoring
#1
mindfulness-based stress reduction (MBSR)
increase
vitality
Breast and colorectal cancer survivors (stage 0-III) with clinically significant CRF
d = 0.53, p = 0.003
significantly greater improvement
#2
mindfulness-based stress reduction (MBSR)
increase
CRF global improvement
Breast and colorectal cancer survivors (stage 0-III) with clinically significant CRF
χ2 (1) = 4.1765, p = 0.041
more likely to report CRF as moderately to completely improved
#3
mindfulness-based stress reduction (MBSR)
decrease
pain
Breast and colorectal cancer survivors (stage 0-III) with clinically significant CRF
d = 0.53, p = 0.014
significantly greater reductions
#4
mindfulness-based stress reduction (MBSR)
improvement
all fatigue outcomes, depression, anxiety, and sleep
Breast and colorectal cancer survivors (stage 0-III) with clinically significant CRF
moderate-to-large and significant
produced moderate-to-large and significant within-group improvements
#5
psychoeducation/support groups (PES)
improvement
all fatigue outcomes, depression, anxiety, and sleep
Breast and colorectal cancer survivors (stage 0-III) with clinically significant CRF
moderate-to-large and significant
produced moderate-to-large and significant within-group improvements
#6
Abstract

PURPOSE: Cancer-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. METHODS: Breast (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. RESULTS: Between-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. CONCLUSION: MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01724333.

Medical Subject Headings (MeSH)
Breast NeoplasmsColorectal NeoplasmsFatigueFemaleHumansMaleMiddle AgedMindfulnessPilot ProjectsStress, PsychologicalSurvivorsTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality80/10
Citation Metrics
Total Citations80
Citations/Year8.9
Relative Citation Ratio3.53
NIH Percentile88.1%
Research Impact Scores
APT Score0.95
Weight Score2.05
Normalized Score0.66
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