Johns, S.A., Brown, L.F., Beck-Coon, K., Talib, T.L., Monahan, P.O., Giesler, R.B., . . . Kroenke, K. (2016). 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, 24, 4085–4096.

To compare mindfulness-based stress reduction (MBSR) with psychoeducation/support groups (PES) as interventions to treat cancer-related fatigue (CFR) and associated symptoms of anxiety, depression, vitality, sleep disturbances, and pain. An active treatment control group (PES) was used to determine the effect size of MBSR in reducing CRF.

Breast cancer survivors (BCSs) and colorectal cancer survivors (CRCSs) were blinded and randomized into the MBSR group or the PES intervention. The primary outcome was CRF interference, and secondary outcomes of CRF were severity, vitality, anxiety, depression, sleep disturbances, and pain at baseline (T1), postintervention (T2) and at six months postintervention (T3). Both arms of the study included a structured curriculum that lasted two hours weekly for eight weeks. As the MBSR cohort had required exercises and practice assigned between classes, the PES arm was also given between-session practice and supplemental readings related to class topics. Treatment fidelity to each of the interventions was maintained by use of standardized manuals for each (MBSR and PES), audio recordings of the sessions with review by investigators using checklists created to evaluate the interventions. The MBSR intervention was adapted from standard approaches to eliminate the use of a retreat, the addition of psychoeducation, a brief body scan at bedtime, and shorter home practices. The PES program incorporated group discussions.

• N = 69   
• MEAN AGE = BCS: 56.9 years (SD = 9.9 years), CRCS: 56.4 years (12.7 years)
• MALES: 9.9%, FEMALES: 90.1%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Adults aged 18 years or older with nonmetastatic (stage 0–III) BCSs or CRCSs who reported CRF as 4 or greater on the Fatigue Symptom Inventory (FSI)
• OTHER KEY SAMPLE CHARACTERISTICS: Participants had completed active treatment an average of 2.4 years prior to the study and were predominantly Caucasian (70.4%). Forty-six percent of the BCSs were on endocrine therapy at the time of the study, and the only statistically significant difference between groups at baseline was income (p = 0.07).

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: National Cancer Institute–designated comprehensive cancer center clinics

PHASE OF CARE: Late effects and survivorship

Single-blind, two-armed, randomized clinical pilot trail

• FSI
• SF-36 Vitality Scale
• Patient Health Questionnaire-8 (PHQ-8)
• Generalized Anxiety Disorder-7 scale
• Patient Health Questionnaire-9 (PHQ-9) for depression 
• Insomnia Severity Index
• PEG three-item abbreviated version of the Brief Pain Inventory (BPI)
• Global Improvement in Fatigue measure was a single item asking participants to rate their CRF compared to the beginning of the study.

The primary outcome of CRF interference did not significantly differ between MBSR and PES, although a trend (insignificant) toward MBSR was observed at T2 (d = –0.46, p = 0.073). Secondary outcome of vitality demonstrated moderate and significant effect size in the MBSR arm compared to the PES arm (d = 0.53, p = 0.003) at T2; however, the between group difference did not last through the T3 measurement. The MBSR maintained improvement in vitality, whereas vitality improved in the PES group. In addition, at T2, the MBSR participants were significantly more likely to report CRF global improvement (58.8 versus 34.3%, respectively, X² (1) = 4.176, p = 0.041). Both groups continued to report similar global improvements in CRF at T3 (MBSR = 45.5 versus PES = 54.3%, X² (1) = 0.53, p = 0.467). Pain was the only between group secondary outcome in which MBSR demonstrated moderate and significant improvement at T3 compared to PES (d = –0.50, p = 0.014).

Within group effects: Both MBSR and PES participants demonstrated moderate to large effects and significant improvements on all fatigue outcomes at T2 and T3 compared to T1. Participants in both groups also reported moderate to large effects and significant improvements at T2 and T3 from baseline in depression (p < 0.001), anxiety (p < 0.001), and sleep disturbance (p < 0.001).

Although the aim of this study was to rigorously test MBSR as an intervention for CRF in preparation for a phase-III randomized, controlled trial, the study supported the strength of PES as an intervention as well.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (sample characteristics)
• Findings not generalizable

Although MBSR has been shown an effective intervention for numerous cancer-related symptoms, including CRF, a structured PES intervention was also clearly effective in helping survivors manage fatigue and other symptoms. However, given the more immediate effect of MBSR for participants, MBSR may provide results sooner. Both interventions are efficacious and therefore provide cancer survivors a choice in interventions effective in reducing CRF and its interference in daily life through anxiety, depression, and sleep disturbance.