title: Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted.
  
  
  
  ClinicalTrials.gov Identifier: NCT01724333.
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA. sheljohn@iu.edu.|Regenstrief Institute, Inc., 1101 West Tenth Street RF-226, Indianapolis, IN, 46202, USA. sheljohn@iu.edu.
authors.forename: Shelley A
authors.initials: SA
authors.lastname: Johns
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Linda F
authors.initials: LF
authors.lastname: Brown
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.|Indiana University School of Nursing, Indianapolis, IN, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Beck-Coon
authors.affiliation: Regenstrief Institute, Inc., 1101 West Tenth Street RF-226, Indianapolis, IN, 46202, USA.
authors.forename: Tasneem L
authors.initials: TL
authors.lastname: Talib
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Patrick O
authors.initials: PO
authors.lastname: Monahan
authors.affiliation: Butler University, Indianapolis, IN, USA.
authors.forename: R Brian
authors.initials: RB
authors.lastname: Giesler
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Yan
authors.initials: Y
authors.lastname: Tong
authors.affiliation: West Virginia University School of Medicine, Charleston, WV, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Wilhelm
authors.affiliation: Indiana University School of Nursing, Indianapolis, IN, USA.
authors.forename: Janet S
authors.initials: JS
authors.lastname: Carpenter
authors.affiliation: Indiana University School of Nursing, Indianapolis, IN, USA.
authors.forename: Diane
authors.initials: D
authors.lastname: Von Ah
authors.affiliation: DePauw University Psychology Department, Greencastle, IN, USA.
authors.forename: Christina D
authors.initials: CD
authors.lastname: Wagner
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: de Groot
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Schmidt
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Diane
authors.initials: D
authors.lastname: Monceski
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Danh
authors.affiliation: Indiana University Fairbanks School of Public Health, Indianapolis, IN, USA.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Alyea
authors.affiliation: Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.
authors.forename: Kathy D
authors.initials: KD
authors.lastname: Miller
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.|Regenstrief Institute, Inc., 1101 West Tenth Street RF-226, Indianapolis, IN, 46202, USA.|VA HSR&D Center for Health Information and Communication, Indianapolis, IN, USA.
authors.forename: Kurt
authors.initials: K
authors.lastname: Kroenke
mesh_terms: D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D015179:Colorectal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D005221:Fatigue / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D064866:Mindfulness / Q000379:methods*; D010865:Pilot Projects; D013315:Stress, Psychological / Q000628:therapy*; D017741:Survivors; D016896:Treatment Outcome
keywords: Cancer; Fatigue; MBSR; Meditation; Mindfulness; Psychoeducation