Feasibility of a mindful yoga program for women with metastatic breast cancer: results of a randomized pilot study
Patients with metastatic breast cancer (MBC) experience high levels of symptoms. Yoga interventions have shown promise for improving cancer symptoms but have rarely been tested in patients with advanced disease. This study examined the acceptability of a comprehensive yoga program for MBC and the feasibility of conducting a randomized trial testing the intervention.
Sixty-three women with MBC were randomized with a 2:1 allocation to yoga or a support group comparison condition. Both interventions involved eight weekly group sessions. Feasibility was quantified using rates of accrual, attrition, and session attendance. Acceptability was assessed with a standardized self-report measure. Pain, fatigue, sleep quality, psychological distress, mindfulness, and functional capacity were assessed at baseline, post-intervention, and 3 and 6 months post-intervention.
We met goals for accrual and retention, with 50% of eligible patients enrolled and 87% of randomized participants completing post-intervention surveys. Sixty-five percent of women in the yoga condition and 90% in the support group attended ≥ 4 sessions. Eighty percent of participants in the yoga condition and 65% in the support group indicated that they were highly satisfied with the intervention. Following treatment, women in the yoga intervention had modest improvements in some outcomes; however, overall symptom levels were low for women in both conditions.
Findings suggest that the yoga intervention content was highly acceptable to patients with MBC, but that there are challenges to implementing an intervention involving eight group-based in-person sessions. Alternative modes of delivery may be necessary to reach patients most in need of intervention.
KeywordsYoga Symptom management Metastatic breast cancer Randomized trial
The authors gratefully acknowledge the contributions of study staff including Jessyka Glatz, M.A., Emily Patterson, M.S.W., L.C.S.W., Barbara Walukas, B.S.R.N., C.C.R.P., Nancy Kimberly, M.A., E-RYT, Katheryn Harlan, R.N, E-RYT, Robin Turner, M.D., and the Data Safety Monitoring Board members: Diana Wilkie, PhD, RN, FAAN; Mary Jane Ott, NP, MN, RYT; Christopher Corcoran, PhD; and Beverly Moy, MD. They also extend their gratitude to all of the study participants for their time and effort.
This work was supported by the National Institutes of Health [R01 AT007572]. Dr. Jones is supported by AKTIV Against Cancer, the Kavli Trust, and the Memorial Sloan Kettering Cancer Center Support Grant/Core Grant (P30 CA008748).
Compliance with ethical standards
All study procedures were approved by the Duke Medical Center Institutional Review Board (IRB). Informed consent was obtained from all individual participants included in the study. Participants were recruited between May, 2014, and January, 2018, from the Duke breast oncology clinic. Contact with potential participants was initiated by each patient’s oncologist via an IRB-approved introductory letter. Individuals who did not refuse further contact were called by study staff who explained the study, answered questions, and verified eligibility. If the patient was eligible and chose to participate, arrangements were made to obtain written consent and administer the baseline assessment. Each participant was paid $190 for full study participation.
Conflict of interest
The work of Drs. Porter, Carson, Olsen, Keefe, Westbrook, Ms. Carson, and Ms. Sanders on this study was supported by a grant from the National Institutes of Health. Dr. Jones owns stock in Pacylex, Inc.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
- 3.Office of Cancer Complementary and Alternative Medicine Yoga and Cancer. https://cam.cancer.gov/health_information/highlights/yoga_cancer_highlight.htm. Accessed 23 Sept 2016
- 6.Office of Cancer Complementary and Alternative Medicine Research Priorities. https://cam.cancer.gov/about_us/about_occam.htm#priorities. Accessed 23 Sept 2016
- 8.Yoga Alliance (2010-2012) Styles of yoga. http://yogaalliance.org/content/understanding-different-styles-yoga. Accessed 18 Oct 2012
- 14.Atkinson TM, Mendoza TR, Sit L, Passik S, Scher HI, Cleeland C, Basch E (2010) The Brief Pain Inventory and its “pain at its worst in the last 24 hours” item: clinical trial endpoint considerations. Pain Med (Malden, Mass) 11(3):337–346. https://doi.org/10.1111/j.1526-4637.2009.00774.x CrossRefGoogle Scholar
- 15.Cleeland CS, Ryan KM (1994) Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap 23:129–138Google Scholar
- 16.Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL (1999) The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer 85(5):1186–1196. https://doi.org/10.1002/(SICI)1097-0142(19990301)85:5<1186::AID-CNCR24>3.0.CO;2-N CrossRefGoogle Scholar
- 24.Breitbart W, Rosenfeld B, Gibson C, Pessin H, Poppito S, Nelson C, Tomarken A, Timm AK, Berg A, Jacobson C, Sorger B, Abbey J, Olden M (2010) Meaning-centered group psychotherapy for patients with advanced cancer: a pilot randomized controlled trial. Psycho-Oncology 19(1):21–28CrossRefGoogle Scholar
- 28.Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM (2016) Defining feasibility and pilot studies in preparation for randomized controlled trials: development of a conceptual framework. PLoS One 11(3):e0150205. https://doi.org/10.1371/journal.pone/0150205 CrossRefGoogle Scholar