CRITICALLY APPRAISED PAPER (CAP) Lengacher, C. A., Reich, R. R., Paterson, C. L., Ramesar, S., Park, J. Y., Alinat, C., &... Kip, K. E. (2016). Examination of broad symptom improvement resulting from mindfulness-based stress reduction in breast cancer survivors: A randomized controlled trial. Journal of Clinical Oncology, 34(24), 2827 2834. https://doi.org/10.1200/jco.2015.65.7874 CLINICAL BOTTOM LINE This study assessed the effectiveness of mindfulness-based stress reduction (MBSR) to reduce both physical symptoms (e.g., pain and fatigue) and psychological symptoms (e.g., anxiety, depression, fear of recurrence, and perceived stress) for breast cancer survivors. In addition, this study focused on the impact of MBSR on quality of life. MBSR has been shown to reduce pain, fatigue, stress, anxiety, depression, and fear of recurrence among breast cancer survivors. This intervention has widespread implications for both clinical and community-based occupational therapy practice, because improved quality of life and posttraumatic growth can influence engagement in activities of daily living. RESEARCH OBJECTIVE(S) Evaluate the efficacy of MBSR on physical symptoms (pain and fatigue) of breast cancer survivors Evaluate the efficacy of MBSR on psychological symptoms (anxiety, depression, fear of recurrence) and perceived stress of breast cancer survivors Evaluate the impact of MBSR on the quality of life of breast cancer survivors Evaluate whether breast cancer survivors with higher levels of baseline stress yield the greatest benefits from MBSR practice DESIGN TYPE AND LEVEL OF EVIDENCE Level I: Randomized controlled trial PARTICIPANT SELECTION 1
How were participants recruited and selected to participate? Enrollment occurred over a 4-year period (April 2009 to March 2013). Participants were recruited from three treatment facilities in Tampa, Florida: Carol and Frank Morsani Center for Advanced Healthcare, Life Hope Medical Group, and Moffit Cancer Center. Inclusion criteria: Age 21 years or older Diagnosis of Stage 0 to Stage III breast cancer Treatment completion from 2 weeks to 2 years prior to the start of the study Exclusion criteria: Diagnosis of Stage IV cancer Recurring breast cancer Severe mental disorder PARTICIPANT CHARACTERISTICS N= 322 #/ % Male: 0/0% #/ % Female: 322/100% Ethnicity: Disease/disability diagnosis: n = 222 White non-hispanic n = 37 Black non-hispanic n = 33 Hispanic n = 12 other single race or ethnicity n = 16 more than one race or ethnicity reported Breast cancer Stage 0 to Stage III INTERVENTION AND CONTROL GROUPS Group 1: MBSR intervention group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? MBSR intervention sessions included educational materials (CD and training manual), practice sessions of four meditative techniques (walking meditation, sitting meditation, body scan, and Hatha yoga), and supportive group interaction focused on identifying barriers to practice and applying practice to daily routine. 155 Clinic sessions and home practice Clinical psychologist One 2-hour session weekly 2
For how long? 6 weeks Group 2: Control group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Participants in the control group received standard posttreatment follow-up care. They were offered an opportunity to participate in MBSR after study completion. 167 Follow-up clinic Not specified Not reported 6 weeks INTERVENTION BIASES Contamination: YES NO Co-intervention: Explanation: The control group was not introduced to the intervention during the study. Explanation: Cointervention might have occurred for both the MBSR group and the control group, because they were also undergoing standard-of-care treatment for breast cancer. Timing of intervention: Site of intervention: Explanation: Because this study was conducted over a 4-year period, timing of the intervention might have been influenced by changes in cancer treatment protocols or disease progression, remission, or recurrence of the disease among participants. Explanation: Sites did vary between the MBSR practice group and the control group, which might have contributed to higher levels of satisfaction in the intervention group. Use of different therapists to provide intervention: Explanation: The medical providers varied for the control group on the basis of medical needs. 3
Baseline equality: YES NO Explanation: Baseline equality was noted. MEASURES AND OUTCOMES Measure 1: Brief Pain Inventory What outcome is reliable (as reported in the article)? valid (as reported in the article)? Brief Pain Inventory Pain and impact on daily living YES Not Reported YES Not Reported Measure 2: Fatigue Symptom Inventory What outcome is reliable as reported in the article? valid as reported in the article? Fatigue Symptom Inventory Perceived impact of fatigue on quality of life YES Not Reported YES Not Reported Measure 3: Center for Epidemiologic Studies Depression Scale Center for Epidemiologic Studies Depression Scale What outcome is Depression YES Not Reported reliable as reported in the article? valid YES Not Reported 4
as reported in the article? Measure 4: State Trait Anxiety Inventory State Trait Anxiety Inventory Situational anxiety YES NR YES NR Measure 5: Perceived Stress Scale Perceived Stress Scale Stress YES NR YES NR Measure 6: Concerns About Recurrence Scale Concerns About Recurrence Scale Fear of recurrence YES NR YES NR 5
Measure 7: Demographic data and clinical history Demographic data and clinical history Updated demographic data and clinical history YES NR YES NR MEASUREMENT BIASES Were the evaluators blind to treatment status? YES NO Was there recall or memory bias? Other measurement biases: Explanation: Blinding was not possible after baseline assessment because of the use of a wait-list control design. Explanation: Given the short duration of the study from baseline to final testing (12 weeks), recall bias is possible, because participants and evaluators might have recalled ratings and potentially thus inflated scores. RESULTS List key findings based on study objectives: Results demonstrated that the MBSR intervention improved both psychological symptoms anxiety (p =.007), overall fear of recurrence (p <.1), and depression (p =.06) and physical symptoms fatigue severity and interference (p <.01) as compared with standard care for breast cancer survivors. Overall effect sizes were largest for fear of recurrence problems (d = 0.35) and fatigue severity (d = 0.27). Moderate effect sizes showed that breast cancer survivors with the highest levels of stress at baseline experienced the greatest benefit from MBSR. The MBSR program significantly improved a broad range of symptoms among breast cancer survivors up to 6 weeks after MBSR training, with generally small to moderate overall effect sizes. Was this study adequately powered (large enough to show a difference)? Explanation: A total of 322 participants were involved in this study. 6
Were the analysis methods appropriate? Explanation: The authors used linear mixed models to assess the effectiveness of MBSR over the duration of the study. Were statistics appropriately reported (in written or table format)? Explanation: Statistics were clearly presented in table format. Was participant dropout less than 20% in total sample and balanced between groups? Explanation: 7.14% (n = 23) What are the overall study limitations? The authors stated that the study had a 9% rate of attrition. Lack of diversity among program participants limits generalizability to a broader population. Participants were primarily White, married, well-educated women with a mean age of 56.6 years. An active-attention comparison treatment trial design would have allowed greater control for time, attention, and expectancy efforts. CONCLUSIONS The authors concluded that this study provides evidence to promote the use of MBSR as an effective clinical intervention for breast cancer survivors experiencing physical or emotional distress. Benefits of MBSR included the ability to improve outcomes for those breast cancer survivors experiencing the most distress and to simultaneously address multiple physical and psychological symptoms of distress. The authors recommended additional research and development of technology-based intervention strategies for efficacious use. This work is based on the evidence-based literature review completed by Marit A. Watson, OTR/L, and Sarah L. Smith, DSc, OTR/L, faculty advisor, Creighton University. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 7