Johns, S.A., Von Ah, D., Brown, L.F., Beck-Coon, K., Talib, T.L., Alyea, J.M., . . . Giesler, R.B. (2016). Randomized controlled pilot trial of mindfulness-based stress reduction for breast and colorectal cancer survivors: Effects on cancer-related cognitive impairment. Journal of Cancer Survivorship, 10, 437–448. 

DOI Link

Study Purpose

To examine the effect of an eight-week Mindfulness-Based Stress Reduction (MBSR) program compared to an eight-week education and support (ES) program on subjectively and objectively assessed cognitive function among breast and colorectal survivors experiencing fatigue

Intervention Characteristics/Basic Study Process

Seventy-one breast and colorectal survivors experiencing moderate-to-severe fatigue were randomized into the MBSR group (n = 35) and ES group (n = 36). The MBSR group received a modified eight-week mindfulness meditation and movement training course facilitated by experienced MBSR teachers certified by the Center for Mindfulness at the University of Massachusetts. The training included the use of body scans, hatha yoga, sitting meditation, and loving-kindness meditation. The ES group received an eight-week education and support course taught by social workers that included both didactic content and group discussion regarding cancer-related symptoms and late effects of cancer treatment. Classes for the MBSR and ES groups were held on the same night, and the class size was limited to 10 participants in each group. All class and meditation sessions were two hours long and delivered over eight weeks. The final all-day meditation retreat typical of the MBSR training program was eliminated for this cohort because of fatigue.

Sample Characteristics

  • N = 69  
  • AGE = 56.9 years
  • MALES: 9.9%, FEMALES: 90.1%
  • KEY DISEASE CHARACTERISTICS: Causasian (70.4%), not college educated (56.3%), employed (52.1%), married or partnered (54.9%), self-reported “comfortable income level” (52.1%)
  • OTHER KEY SAMPLE CHARACTERISTICS: Cancer type: Breast (MBSR 51.7%), (ES 48.3%), CRC MBSR (36.4%), (ES 63.6%). Average years since treatment completed was 2.4 years. Any individual reporting experience with meditation was excluded from the sample. Over 50% did not have more than a high school education.

Setting

  • SITE: Single site  
  • SETTING TYPE: Multiple settings  
  • LOCATION: Midwestern National Cancer Institute–designated cancer center and affiliate clinics

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Two-arm, randomized, clinical trial, pilot study

Measurement Instruments/Methods

Attentional Functional Index (AFI), the subjective measure, is a 13-item self-report measure of assessing levels of attention required for common activities requiring attention and working memory. Three subscales are identified in this instrument: effective action, attentional lapses, and interpersonal effectiveness. This instrument provides respondents with a 100 mm–long horizontal line starting at “not at all” to “extremely well or a great deal.” The total length of each reply is added together to score a person's AFI. A higher score indicates greater capacity to direct attention.  
 
Stroop Color and Word Test, the objective measure, is a test of executive function that specifically evaluates selective attention, cognitive flexibility, and control. Participants are asked to look at a color word and then quickly select the actual color of the word presented. Accuracy rates and reaction times are recorded as testing outcomes.
 
Five Facets Mindfulness Questionnaire (FFMQ) is a 39-item measure of tendencies toward mindful behaviors in everyday life presented on a five-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The instrument identifies five facets/elements of mindfulness: observing, describing, acting with awareness, nonjudgment of inner experience, and nonreactivity to inner experience. A higher mean score across all scales is associated with a greater tendency toward mindful behavior.
 
MBSR, AFI, and Stroop were measured at baseline. AFI and Stroop were repeated at the completion of the eight-week intervention (T2) and six months after the intervention (T3).

Results

MBSR participants reported significantly greater improvements in overall AFI scores at T2 and T3. The Effective Action and Attentional Lapses subscales were significantly and substantially higher in the MBSR group at T2 and remained stable six months later. The Interpersonal Effectiveness subscales scores were higher but not significantly so in the MBSR group.
 
MBSR participants performed significantly better on the Stroop accuracy at T2 and T3 (p ≤ 0.03). No difference between ES and MBSR was noted at T1, suggesting that improvement may be related to MBSR training. No significant between-group difference in reaction time existed. When within group accuracy and reaction times were examined, the MBSR group had a lower error rate at T3 relative to T1, which the ES group did not realize.                                                                           
 
AFI and lapses data were higher in the MBSR group at eight weeks (p ≤ 0.004) and at six months (p < 0.027), with reported effect sizes (standard response mean) ranging from 0.55–0.9. Both groups showed improvement in cognitive function over time.

Conclusions

This pilot study demonstrated that MBSR offers significant and sustained improvements in both subjectively and objectively measured chemotherapy-related cognitive impairment. The findings indicated that the MBSR intervention addressed issues of executive function and attentional control in breast and colorectal survivors reporting cancer-related fatigue and cognitive impairment.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Fatigue levels were used as a proxy for the presence of chemotherapy-related cognitive impairment in the selection of sample. The presence of chemotherapy-related cognitive impairment was assessed at baseline after selection of the study sample, and, at that time, a \"large majority of participants reported cognitive impairment as measured by the baseline AFI.\"

Nursing Implications

The findings of this study suggest that MBSR may improve late effect cognitive/emotional fatigue and cognitive impairment in patients with cancer. As no identified adverse effects of MBSR training or mindfulness meditation exist, this low-risk intervention may be beneficial for patients.