Shelley A Johns1,2, Linda F Brown3, Kathleen Beck-Coon3,4, Tasneem L Talib5, Patrick O Monahan3, R Brian Giesler6, Yan Tong3, Laura Wilhelm7, Janet S Carpenter4, Diane Von Ah4, Christina D Wagner8, Mary de Groot3, Karen Schmidt3, Diane Monceski3, Marie Danh3, Jennifer M Alyea9, Kathy D Miller10, Kurt Kroenke3,5,11. 1. Indiana University School of Medicine, Indianapolis, IN, USA. sheljohn@iu.edu. 2. Regenstrief Institute, Inc., 1101 West Tenth Street RF-226, Indianapolis, IN, 46202, USA. sheljohn@iu.edu. 3. Indiana University School of Medicine, Indianapolis, IN, USA. 4. Indiana University School of Nursing, Indianapolis, IN, USA. 5. Regenstrief Institute, Inc., 1101 West Tenth Street RF-226, Indianapolis, IN, 46202, USA. 6. Butler University, Indianapolis, IN, USA. 7. West Virginia University School of Medicine, Charleston, WV, USA. 8. DePauw University Psychology Department, Greencastle, IN, USA. 9. Indiana University Fairbanks School of Public Health, Indianapolis, IN, USA. 10. Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA. 11. VA HSR&D Center for Health Information and Communication, Indianapolis, IN, USA.
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/orradiation 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.
RCT Entities:
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.
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