Lengacher, C.A., Johnson-Mallard, V., Post-White, J., Moscoso, M.S., Jacobsen, P.B., Klein, T.W., … Kip, K.E. (2009). Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psycho-Oncology, 18, 1261–1272.

To determine whether, compared to usual care, a mindfulness-based stress-reduction (MBSR) intervention involving breast cancer (BC) survivors is efficacious in improving psychological and physical status

Patients were randomized into one of two arms: the group receiving MBSR for BC patients (MBSR (BC)) and the group receiving usual care. Assignment to group was random and stratified by stage of cancer and treatment received; if desired, members of the usual-care group were wait-listed to receive the MBSR (BC) intervention. Assessments were completed at an initial baseline orientation and within two weeks of the end of the six-week intervention or control period. Data collectors were blinded to treatment assignment. The MBSR (BC) group received six weekly two-hour sessions led by a single trained psychologist. Class size was 4–8. Subjects received a training manual and four audiotapes to support home meditation practices. Members of the MBSR (BC) group kept a daily diary. Participants completed various activities during the six-week period. The intervention comprised three specific components:

• Educational material related to relaxation, meditation, and the mind-body connection
• Practice of meditation in group meetings and homework assignments
• Discussion, among group members, related to barriers to practicing meditation, application of mindfulness in daily situations, and use of a support group.

• Sample size was 82. Participants were enrolled during the 18-month post-treatment survivorship period.
• Mean patient age was 57.5 years (SD = 9.4 years).
• Of the participants:
  • 100% were female.
  • 70% had been diagnosed with cancer at stage 0 or I; 30%, at stage II or III; and 39% had received chemotherapy in combination with radiation therapy.
  • 30% had hypertension; 10%, diabetes mellitus.
  • 25% were taking antidepressants.

• Single site
• Outpatient
• H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida

Transition phase

Randomized controlled trial

• Concerns About Recurrence Scale
• State-Trait Anxiety Inventory
• Center for Epidemiological Studies Depression Scale
• Life Orientation Test, six items assessing positive or negative life-outcome expectations
• Perceived Stress Scale-10 item
• Medical Outcomes Study (MOS) SF-36, measuring quality of life
• MOS Social Support Survey, a 19-item measure of social support
• Two Likert-scaled items widely used in epidemiologic research to measure spirituality
• MD Anderson Symptoms Inventory, which measured self-reported symptoms

• Compared to participants receiving usual care, at six weeks participants receiving MBSR (BC) had significantly lower adjusted mean levels of
  • depression (6.3 versus 9.6, p = 0.03).
  • anxiety (28.3 versus 33.0, p = 0.03).
  • trait anxiety (30.4 versus 34.5, p = 0.004).
  • fear of recurrence (9.3 versus 11.6, p = 0.007).
  • recurrence concerns (26.7 versus 36.5, p = 0.01).
• Compared to participants receiving usual care, at six weeks participants receiving MBSR (BC) had higher
  • energy (53.5 versus 49.2, p = 0.02).
  • physical functioning (50.1 versus 47, p = 0.01).
  • physical role function (49.1 versus 42.8, p = 0.03).
• In stratified analyses, subjects more compliant with MBSR tended to experience greater improvements in measures of energy and physical functioning.
• Adjusted mean scores at six weeks—for social support, perceived stress, optimism, and spirituality—did not differ by treatment assignment.

Compared to usual care, the six-week MBSR (BC) program for BC survivors, within 18 months of treatment, resulted in significant improvements in psychological status and quality of life.

• The study had a small sample size, with fewer than 100 participants; therefore, the study was underpowered. Are outcomes sustainable?
• The study did not include long-term follow-up—especially important in this case because fear and anxiety can increase as patients get further from the treatment period.
• The study did not include an attention-only or support group as a control group.
• Only 70% of MBSR subjects were considered intervention-compliant.
• Many outcomes were self-reported using validated measures. Replicating this type of program may not be feasible. The ability to generalize study results is limited.

The symptoms this study addressed continue to be of great concern to patients with cancer. Nurses must know how to help patients with these symptoms during and after treatment. Nurses should explore alternative ways to educate patients about interventions that can improve outcomes.