Feasibility and potential effects of tai chi for the fatigue-sleep disturbance-depression symptom cluster in patients with breast cancer: protocol of a preliminary randomised controlled trial

Li-Qun Yao, Jing-Yu Benjamin Tan, Catherine Turner, Tao Wang, Li-Qun Yao, Jing-Yu Benjamin Tan, Catherine Turner, Tao Wang

Abstract

Introduction: The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is one of the most common and debilitating side effects in patients with breast cancer (BC) throughout their treatment trajectory. Tai chi has been supported as a promising non-pharmacological intervention for the individual symptom relief of cancer-related fatigue, sleep disturbance and depression. However, relevant evidence of using tai chi for FSDSC management in patients with BC has been lacking.

Methods: This study will be a two-arm, single-blinded pilot randomised controlled trial involving an 8-week intervention and a 4-week follow-up. Seventy-two patients with BC experiencing the FSDSC will be recruited from two tertiary medical centres in China. The participants will be randomised to either a tai chi group (n=36) or a control group (n=36). The participants in the tai chi group will receive an 8-week tai chi intervention in addition to standard care, while the participants in the control group will receive standard care only consisting of a booklet on the self-management of cancer symptoms. The primary outcomes will include a series of feasibility assessments of the study protocol in relation to the study's methodological procedures, including subject recruitment and follow-up process, completion of study questionnaires and the feasibility, acceptability and safety of the intervention. The secondary outcomes will be the clinical outcomes regarding the effects of tai chi on the FSDSC and quality of life, which will be evaluated by the Brief Fatigue Inventory, the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale and the Functional Assessment of Cancer Therapy-Breast questionnaires.

Ethics and dissemination: Ethics approval was obtained from relevant sites (H19094, KY2019133, 201932). The findings of the study will be published in peer-reviewed scientific journals and at conferences.

Trail registration number: NCT04190342; Pre-results.

Keywords: breast tumours; clinical trials; complementary medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
CONSORT flow chart of the study. BC, breast cancer; CONSORT, Consolidated Standards of Reporting Trials; FSDSC, fatigue-sleep disturbance-depression symptom cluster.

References

    1. Malvezzi M, Carioli G, Bertuccio P, et al. . European cancer mortality predictions for the year 2019 with focus on breast cancer. Ann Oncol 2019;30:781–7. 10.1093/annonc/mdz051
    1. Jain S, Boyd C, Fiorentino L, et al. . Are there efficacious treatments for treating the fatigue-sleep disturbance-depression symptom cluster in breast cancer patients? a rapid evidence assessment of the literature (REAL(©)). Breast Cancer 2015;7:267–91. 10.2147/BCTT.S25014
    1. Hsu H-T, Lin K-C, Wu L-M, et al. . Symptom cluster trajectories during chemotherapy in breast cancer outpatients. J Pain Symptom Manage 2017;53:1017–25. 10.1016/j.jpainsymman.2016.12.354
    1. Liu L, Rissling M, Natarajan L, et al. . The longitudinal relationship between fatigue and sleep in breast cancer patients undergoing chemotherapy. Sleep 2012;35:237–45. 10.5665/sleep.1630
    1. Dodd MJ, Miaskowski C, Paul SM. Symptom clusters and their effect on the functional status of patients with cancer. Oncol Nurs Forum 2001;28:465–70.
    1. Aktas A, Kirkova J, Walsh D, et al. . The psychometric properties of cancer multi-symptom assessment instruments: a comprehensive review. J Pain Symptom Manage 2012;43:334–5. 10.1016/j.jpainsymman.2011.12.038
    1. Ho S-Y, Rohan KJ, Parent J, et al. . A longitudinal study of depression, fatigue, and sleep disturbances as a symptom cluster in women with breast cancer. J Pain Symptom Manage 2015;49:707–15. 10.1016/j.jpainsymman.2014.09.009
    1. Kim H-J, Barsevick AM, Beck SL, et al. . Clinical subgroups of a psychoneurologic symptom cluster in women receiving treatment for breast cancer: a secondary analysis. Oncol Nurs Forum 2012;39:E20–30. 10.1188/12.ONF.E20-E30
    1. Hökkä M, Kaakinen P, Pölkki T. A systematic review: non-pharmacological interventions in treating pain in patients with advanced cancer. J Adv Nurs 2014;70:1954–69. 10.1111/jan.12424
    1. Larkin D, Lopez V, Aromataris E. Managing cancer-related fatigue in men with prostate cancer: a systematic review of non-pharmacological interventions. Int J Nurs Pract 2014;20:549–60. 10.1111/ijn.12211
    1. Yin C, Buchheit TE, Park JJ. Acupuncture for chronic pain: an update and critical overview. Curr Opin Anaesthesiol 2017;30:583–92. 10.1097/ACO.0000000000000501
    1. McKernan LC, Finn MTM, Patterson DR, et al. . Clinical hypnosis for chronic pain in outpatient integrative medicine: an implementation and training model. J Altern Complement Med 2020;26:107–12. 10.1089/acm.2019.0259
    1. Charalambous A, Giannakopoulou M, Bozas E, et al. . Guided imagery and progressive muscle relaxation as a cluster of symptoms management intervention in patients receiving chemotherapy: a randomized control trial. PLoS One 2016;11:e0156911. 10.1371/journal.pone.0156911
    1. Lopez G, Liu W, Milbury K, et al. . The effects of oncology massage on symptom self-report for cancer patients and their caregivers. Support Care Cancer 2017;25:3645–50. 10.1007/s00520-017-3784-7
    1. Nguyen LT, Yates P, Annoussamy LC, et al. . The effectiveness of non-pharmacological interventions in the management of symptom clusters in adult cancer patients: a systematic review protocol. JBI Database System Rev Implement Rep 2016;14:49–59. 10.11124/JBISRIR-2016-2476
    1. Zou L, Wang H, Xiao Z, et al. . Tai chi for health benefits in patients with multiple sclerosis: a systematic review. PLoS One 2017;12:e0170212. 10.1371/journal.pone.0170212
    1. Jahnke R, Larkey L, Rogers C, et al. . A comprehensive review of health benefits of qigong and tai chi. Am J Health Promot 2010;24:e1–25. 10.4278/ajhp.081013-LIT-248
    1. Irwin MR, Olmstead R, Carrillo C, et al. . Tai chi chih compared with cognitive behavioral therapy for the treatment of insomnia in survivors of breast cancer: a randomized, partially blinded, noninferiority trial. J Clin Oncol 2017;35:2656–65. 10.1200/JCO.2016.71.0285
    1. McQuade JL, Prinsloo S, Chang DZ, et al. . Qigong/tai chi for sleep and fatigue in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. Psychooncology 2017;26:1936–43. 10.1002/pon.4256
    1. Zhang L-L, Wang S-Z, Chen H-L, et al. . Tai chi exercise for cancer-related fatigue in patients with lung cancer undergoing chemotherapy: a randomized controlled trial. J Pain Symptom Manage 2016;51:504–11. 10.1016/j.jpainsymman.2015.11.020
    1. Browne RH. On the use of a pilot sample for sample size determination. Stat Med 1995;14:1933–40. 10.1002/sim.4780141709
    1. Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health 2008;31:180–91. 10.1002/nur.20247
    1. Campo RA, O'Connor K, Light KC, et al. . Feasibility and acceptability of a tai chi chih randomized controlled trial in senior female cancer survivors. Integr Cancer Ther 2013;12:464–74. 10.1177/1534735413485418
    1. Yao L-Q, Tan J-Y, Turner C, et al. . Development and validation of a tai chi intervention protocol for managing the fatigue-sleep disturbance-depression symptom cluster in female breast cancer patients. Complement Ther Med 2021;56:102634. 10.1016/j.ctim.2020.102634
    1. Berger AM, Mooney K, Alvarez-Perez A, et al. . Cancer-related fatigue, version 2.2015. J Natl Compr Canc Netw 2015;13:1012–39. 10.6004/jnccn.2015.0122
    1. Department of health at the government of Western Australia . Resources. Available:
    1. Berger AM, Mooney K, Alvarez-Perez A. National comprehensive cancer network. cancer-related fatigue, version 2. J Natl Compr Canc Netw 2015;13:1012–39. 10.6004/jnccn.2015.0122
    1. Berger AM, Mitchell SA, Jacobsen PB, et al. . Screening, evaluation, and management of cancer-related fatigue: ready for implementation to practice? CA Cancer J Clin 2015;65:190–211. 10.3322/caac.21268
    1. Li M, Fitzgerald P, Rodin G. Evidence-based treatment of depression in patients with cancer. J Clin Oncol 2012;30:1187–96. 10.1200/JCO.2011.39.7372
    1. Mendoza TR, Wang XS, Cleeland CS, et al. . The rapid assessment of fatigue severity in cancer patients: use of the brief fatigue inventory. Cancer 1999;85:1186–96. 10.1002/(sici)1097-0142(19990301)85:5<1186::aid-cncr24>;2-n
    1. Nunes AF, Bezerra CO, Custódio JDS, et al. . Clinimetric properties of the brief fatigue inventory applied to oncological patients hospitalized for chemotherapy. J Pain Symptom Manage 2019;57:297–303. 10.1016/j.jpainsymman.2018.10.508
    1. Wang XS, Hao X-S, Wang Y, et al. . Validation study of the Chinese version of the brief fatigue inventory (BFI-C). J Pain Symptom Manage 2004;27:322–32. 10.1016/j.jpainsymman.2003.09.008
    1. Buysse DJ, Reynolds CF, Monk TH, et al. . The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res 1989;28:193–213. 10.1016/0165-1781(89)90047-4
    1. Tsai P-S, Wang S-Y, Wang M-Y, et al. . Psychometric evaluation of the Chinese version of the Pittsburgh sleep quality index (CPSQI) in primary insomnia and control subjects. Qual Life Res 2005;14:1943–52. 10.1007/s11136-005-4346-x
    1. Smith RP, Zigmond AS. The hospital anxiety and depression scale manual. Windsor: NFER—Nelson, 1994.
    1. Wang W, Chair SY, Thompson DR, et al. . A psychometric evaluation of the Chinese version of the hospital anxiety and depression scale in patients with coronary heart disease. J Clin Nurs 2009;18:1908–15. 10.1111/j.1365-2702.2008.02736.x
    1. Wan C, Zhang D, Yang Z, et al. . Validation of the simplified Chinese version of the FACT-B for measuring quality of life for patients with breast cancer. Breast Cancer Res Treat 2007;106:413–8. 10.1007/s10549-007-9511-1
    1. Portney LG, Watkins MP. Foundations of clinical research: applications to practice (Vol. 892). upper saddle river. NJ: Pearson/Prentice Hall, 2009.
    1. Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale, NJ: Lawrence Erlbaum Associates, 1988.
    1. Fitzgerald P, Lo C, Li M, et al. . The relationship between depression and physical symptom burden in advanced cancer. BMJ Support Palliat Care 2015;5:381–8. 10.1136/bmjspcare-2012-000380
    1. Oh H, Seo Y, Jeong H, et al. . The identification of multiple symptom clusters and their effects on functional performance in cancer patients. J Clin Nurs 2012;21:2832–42. 10.1111/j.1365-2702.2011.04057.x
    1. Qiang WM, Dong FQ, Yan L. Comparison of two different exercise programs in breast cancer patients after postoperative adjuvant chemotherapy. Chin J Nurs 2011;46:e540:537.
    1. Jiang MY. Influence of shadowboxing on improving cancer-related fatigue and sleeping quality of patients with advanced lung cancer. Chin Nurs Res 2013;27:420.
    1. Larkey LK, Roe DJ, Weihs KL, et al. . Randomized controlled trial of Qigong/Tai chi easy on cancer-related fatigue in breast cancer survivors. Ann Behav Med 2015;49:165–76. 10.1007/s12160-014-9645-4
    1. Tadros G, Ormerod S, Dobson-Smyth P, et al. . The management of behavioural and psychological symptoms of dementia in residential homes: does tai chi have any role for people with dementia? Dementia 2013;12:268–79. 10.1177/1471301211422769
    1. Li F, Fisher KJ, Harmer P, et al. . A simpler eight-form easy tai chi for elderly adults. J Aging Phys Act 2003;11:206–18. 10.1123/japa.11.2.206
    1. Craig P, Dieppe P, Macintyre S, et al. . Developing and evaluating complex interventions: the new medical research council guidance. BMJ 2008;337:a1655. 10.1136/bmj.a1655
    1. HL M, Tan JY, Yang LH. Current evidence on traditional Chinese exercises for cancer-related fatigue: a quantitative synthesis of randomized controlled trials. Eur J Integr Med 2016;8:707–14. 10.1016/j.eujim.2016.05.007
    1. Wayne PM, Lee MS, Novakowski J, et al. . Tai chi and Qigong for cancer-related symptoms and quality of life: a systematic review and meta-analysis. J Cancer Surviv 2018;12:256–67. 10.1007/s11764-017-0665-5
    1. Song S, Yu J, Ruan Y, et al. . Ameliorative effects of tai chi on cancer-related fatigue: a meta-analysis of randomized controlled trials. Support Care Cancer 2018;26:2091–102. 10.1007/s00520-018-4136-y
    1. Van Vu D, Molassiotis A, Ching SSY, et al. . Effects of Qigong on symptom management in cancer patients: a systematic review. Complement Ther Clin Pract 2017;29:111–21. 10.1016/j.ctcp.2017.09.005
    1. Xiang Y, Lu L, Chen X, et al. . Does tai chi relieve fatigue? a systematic review and meta-analysis of randomized controlled trials. PLoS One 2017;12:e0174872. 10.1371/journal.pone.0174872
    1. Yao L-Q, Tan J-Y, Turner C, et al. . Traditional Chinese exercise for cancer-related sleep disturbance: a systematic review and descriptive analysis of randomized controlled trials. Complement Ther Clin Pract 2020;40:101197. 10.1016/j.ctcp.2020.101197
    1. Zeng Y, Xie X, Cheng ASK. Qigong or tai chi in cancer care: an updated systematic review and meta-analysis. Curr Oncol Rep 2019;21:48. 10.1007/s11912-019-0786-2
    1. Ni X, Chan RJ, Yates P, et al. . The effects of tai chi on quality of life of cancer survivors: a systematic review and meta-analysis. Support Care Cancer 2019;27:3701–16. 10.1007/s00520-019-04911-0
    1. Hilfiker R, Meichtry A, Eicher M, et al. . Exercise and other non-pharmaceutical interventions for cancer-related fatigue in patients during or after cancer treatment: a systematic review incorporating an indirect-comparisons meta-analysis. Br J Sports Med 2018;52:651–8. 10.1136/bjsports-2016-096422
    1. Bower JE, Irwin MR. Mind-body therapies and control of inflammatory biology: a descriptive review. Brain Behav Immun 2016;51:1–11. 10.1016/j.bbi.2015.06.012
    1. Larkey L, Jahnke R, Etnier J, et al. . Meditative movement as a category of exercise: implications for research. J Phys Act Health 2009;6:230–8. 10.1123/jpah.6.2.230
    1. Committee of Chinese Sports College Textbook . Chinese Wushu textbook (Part I). Beijing: People’s Sports Publishing House of China, 2003.
    1. Jia X, Jiang C, Tao J, et al. . Effects of core strength training combined with tai chi chuan for the musculoskeletal system and cardiopulmonary function in older adults: a study protocol for a randomized controlled trial. Medicine 2018;97:e12024. 10.1097/MD.0000000000012024

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