CRITICALLY APPRAISED PAPER (CAP) Siedentopf, F., Utz-Billing, I., Gairing, S., Schoenegg, W., Kentenich, H., & Kollak, I. (2013). Yoga for patients with early breast cancer and its impact on quality of life: A randomized controlled trial. Geburtshilfe Frauenheilkd, 73(4), 311 317. http://dx.doi.org/10.1055/s-0032-1328438 CLINICAL BOTTOM LINE: Yoga has been identified as an emerging area of practice of occupational therapy; however, there is limited research about its use immediately following surgery. This study compared a 5- week program of Asana yoga that started 2 3 days following breast cancer surgery to a yoga program that started 5 weeks post surgery. The results of this study support the use of yoga as an intervention to improve quality of life in post-surgical women newly diagnosed with breast cancer. Specifically, the study showed greater efficacy for those participants who started yoga within 2 3 days following breast cancer surgery. With this evidence, occupational therapy practitioners could implement yoga in acute care practice settings with the goal of elevating a woman s quality of life. The specific yoga poses in this study encouraged participants to stretch their arms, shoulders, legs, and feet while maintaining balance for strong core muscles. Eye exercises were included to alleviate vision issues linked to chemotherapy. Each yoga session concluded with concentration exercises to help participants relax and concentrate on the effects of yoga participation. Each yoga pose was able to be modified, with regard to any physical limitations of the participants. RESEARCH OBJECTIVE(S) List study objectives. Determine whether patients diagnosed with early breast cancer who participate in yoga immediately post-surgery experienced improved quality of life versus those who receive it 5 weeks post-surgery. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial 1
SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. The subjects were patients receiving breast cancer treatment at the breast center of DRK Kliniken Westend in Berlin, Germany. The specific selection process of subjects was not noted in this study. Participants were randomly assigned to a group, which then was randomly determined to be either the immediate or 5-week later group. Inclusion Criteria The subjects had to be able to attend 10 yoga classes over a 14-week period; had been able to start yoga classes 2 3 days post surgery; had undergone surgery of mastectomy, breastconserving therapy, sentinel node biopsy (SLN), or axillary lymph node dissection (ALND); and had been able to begin yoga 5 weeks post-surgery. Exclusion Criteria Subjects who did not have surgery, SLN, or ALND; had distant metastases; had already attended yoga on a regular basis had limited German language skills; abused illicit drugs or alcohol; or had psychotic disorders. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 93 #/ (%) Male 0 (0%) #/ (%) Female 93 (100%) Ethnicity 82 subjects were German, 3 subjects are marked as other. The sum does not equate to 93 due to missing values. Disease/disability diagnosis Early breast cancer INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: Intervention Brief description of the intervention Women in the early stages of breast cancer who were undergoing surgery began yoga 2 3 days after the surgery was performed. Yoga was performed for 75 minutes twice a week for 5 weeks. The type of yoga performed was asana, or sitting yoga, combined with standing and sitting yoga. Mobilization was gradual throughout the session, beginning with a lying down position and progressing to greater movement of the arms and legs. Sessions focused on breathing, emphasized flexibility and strengthening, and included eye exercises due to the vision problems that are associated with chemotherapy. Details of the eye exercises were not provided. 2
How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Group 2: Control Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? Modified versions of each pose were available based on participants needs. 49 A gym within the DRK Kliniken Westend hospital. Two certified yoga instructors 75 minutes for each session, twice a week 5 weeks This group contained women in the early stages of breast cancer who were undergoing surgery. These participants began yoga 5 weeks following their treatment. The type of yoga performed was asana, or sitting yoga, combined with standing and sitting yoga. 44 A gym within the DRK Kliniken Westend hospital Two certified yoga instructors 75 minutes for each session, twice a week. 5 weeks Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: NO Co-intervention: YES Timing: NO Some participants were given adjuvant treatment, which may have influenced the outcomes. 3
Site: NO Use of different therapists to provide intervention: NO MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of measure used: What outcome was measured? Is the measure reliable? Is the measure valid? When is the measure used? European Organization of Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 and breast-cancer specific QLQ- BR23) Quality of life of patient Yes Yes At baseline, after intervention, and 3 months after intervention. Measure 2: Name/type of measure used: What outcome was measured? Is the measure reliable? Is the measure valid? When is the measure used? Subjective question of the subjects perception on their level of physical activity from yoga. Influence of yoga on physical activity. The measure asked whether practicing yoga increased subjective level of physical activity of patient. NR NR After 3 months Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. 4
Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Recall or memory bias. Check yes, no, or NR, and if yes, explain. Others (list and explain): RESULTS List key findings based on study objectives Include statistical significance where appropriate (p < 0.05) Include effect size if reported Measurements of the EORTC quality of life questionnaire were recorded at the baseline of the yoga intervention, after yoga classes, and 3 months after intervention. Participants from the intervention group reported a higher quality of life (p = 0.002) and functional status (p = 0.005) 5 weeks after surgery than participants who had waited 5 weeks to begin yoga (recorded at the same 5 weeks post-surgery). The intervention group had fewer physical symptoms within 5 weeks of beginning yoga. Alternatively, the control group had more symptoms after yoga, but these had decreased within 3 months (p = 0.01). Physical symptoms, including fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite, and additional gastrointestinal issues improved over time. Symptoms that were breast cancer specific, such as anxiety of hair loss, side effects of systemic therapy, and breast and arm symptoms, were less bothersome to the women as yoga continued. 24 of 28 intervention group participants (86%) reported their subjective perception of their physical activity had improved compared to 10 out of the 17 (59%) participants in the control group (p = 0.04). More participants from the intervention group (97%) expressed interest in continuing yoga after the study concluded than from the control group (p = 0.03). Correlations of EORTC scores were noted depending on the age of the participants and the type of surgery performed. Participants who had undergone a mastectomy reported a lower functioning status than those who had breast-conserving therapy (p = 0.05). Participants over 60 years old who had undergone sentinel node biopsy reported with lower symptom scales than those with axillary lymph node dissection (p = 0.000). Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. 5
Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. YES Was the percent/number of subjects/participants who dropped out of the study reported? YES Limitations: What are the overall study limitations? Initially, many women agreed to take part of this study (49 placed in intervention group, 44 placed in control group), but there was a high dropout rate from the beginning of the study (15 from intervention group and 13 from control group) to the end. The dropout rate of participants led to limited statistical significance when comparing results of the intervention and control groups. The study was reported by the authors as underpowered. The authors of this study cannot prove that the changes in quality of life scales were not due to the different lengths of time that elapsed from surgery for both groups. The authors of this study reported that they were low on funding and other personal resources. The authors did not articulate what areas of the study were affected by low resources. CONCLUSIONS State the authors conclusions related to the research objectives. A good quality of life reveals a patient s capacity to confront the hardship of cancer and somatic therapy. To best encourage the patient s coping mechanisms, it is imperative to advocate for the selfmanagement of cancer. Increased motivation for continued yoga training is higher for women who begin yoga immediately after breast cancer related surgery. 6
This work is based on the evidence-based literature review completed by Jacquelyn Repice, OTS, University of the Sciences. Faculty mentors: Colleen Maher, OTD, OTR/L, CHT, and Rochelle Mendonca, PhD, OTR/L 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
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