Johannsen, M., O'Connor, M., O'Toole, M.S., Jensen, A.B., Hojris, I., & Zachariae, R. (2016). Efficacy of mindfulness-based cognitive therapy on late post-treatment pain in women treated for primary breast cancer: A randomized controlled trial. Journal of Clinical Oncology, 34, 3390–3399.

DOI Link

Study Purpose

To assess the efficacy of mindfulness-based therapy on pain and distress in women treated for breast cancer

Intervention Characteristics/Basic Study Process

After completing baseline questionnaires, patients were randomized to the intervention or waitlist control group. The intervention was adapted from a standard intervention manual to the use of a shorter two-hour session, shorter meditation exercises, more gentle yoga exercises, and the elimination of all day sessions. The intervention was delivered in groups during eight consecutive weeks. All sessions were facilitated by a trained mindfulness instructor. Study measurements were conducted after the intervention and at three and six months after completion.

Sample Characteristics

  • N = 107  
  • MEAN AGE = 56.4 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: All had breast cancer and the majority had surgery and radiotherapy; 72% were on endocrine therapy. The average time since surgery was 40.6 months.
  • OTHER KEY SAMPLE CHARACTERISTICS: Sixty-four percent were married or cohabitating, and 45.2% were retired.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Netherlands

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

Randomized, controlled trial with waitlist control

Measurement Instruments/Methods

  • Carlson Comorbidity Index
  • Short-Form McGill Pain Questionnaire (SP-MPQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • Report of pain medication use
  • Adherence assessed by sessions attended and time spent on homework via self-report

Results

Pain intensity and neuropathic pain declined over time in the intervention group compared to the control group (p = 0.036). No differences in anxiety or depression over time were reported between groups. The average number of sessions attended was five, and the average amount of time spent on homework was 24 minutes per day. A direct correlation between number of sessions attended (p = 0.01) and time spent on practice (p = 0.01) was reported. The dropout rate was 22% across both study groups; only four dropouts were in the control group.

Conclusions

Participation in the mindfulness-based intervention was associated with a reported reduction in pain intensity; however, a large percentage of those allocated to the intervention dropped out of the study or were lost to follow-up, suggesting that the intervention as provided may not be practical to many patients.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%  
  • Intention to treat analysis may have overestimated effects—the intervention group had lower pain scores at baseline and had a large percentage of dropouts.

Nursing Implications

Mindfulness-based group therapy may be helpful in the management of long-term pain with breast cancer but was not shown to have an affect on anxiety or depression over time. The strength of findings in this study is limited because of study limitations.