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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

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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.

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Acknowledgments

This project was funded, in part, by the Walther Cancer Foundation (0106–01) and the Indiana Clinical and Translational Sciences Institute (#TR000163 and #TR000006) from the National Institutes of Health, National Center for Advancing Translational Sciences. Mentoring support was provided by Dr. Victoria Champion through the National Cancer Institute of the National Institutes of Health (#K05CA175048). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Correspondence to Shelley A. Johns.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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The authors declare that they have no competing interests.

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Johns, S.A., Brown, L.F., Beck-Coon, K. et al. Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors. Support Care Cancer 24, 4085–4096 (2016). https://doi.org/10.1007/s00520-016-3220-4

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