1 Wang T, et al. BMJ Open 2022;12:e054597. doi:10.1136/bmjopen-2021-054597 Open access Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: study protocol of a phase II randomised controlled trial Tao Wang , 1 Jing-Yu (Benjamin) Tan , 2 Xian-Liang Liu, 1 Si-Lin Zheng, 3 Isabella Zhao, 1,4 Sabina Eliseeva, 1,5 Mary Janice Polotan, 1,5 Hui-Lin Cheng , 1,6 Hou-Qiang Huang 3 To cite: Wang T, Tan J-YB, Liu X-L, et al. Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: study protocol of a phase II randomised controlled trial. BMJ Open 2022;12:e054597. doi:10.1136/ bmjopen-2021-054597 ► Prepublication history and additional supplemental material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2021-054597). Received 21 June 2021 Accepted 20 December 2021 For numbered affliations see end of article. Correspondence to Professor Jing-Yu (Benjamin) Tan; benjamin.tan@cdu.edu.au Protocol © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ABSTRACT Introduction The fatigue-sleep disturbance-depression (FSD) symptom cluster, as one of the most common symptom clusters in breast cancer (BC) survivors, can signifcantly decrease patients’ quality of life. Since the management of the FSD symptom cluster has been unsatisfactory with the use of pharmacological treatments alone, non-pharmacological approaches have, therefore, been recommended. Somatic acupressure (SA) is a promising approach given its potential benefts of cancer-related symptom alleviation and the convenience of self-practice. However, research evidence on using acupressure to manage the FSD symptom cluster has been limited. The proposed trial aims to examine the feasibility and preliminary effects of an evidence-based SA intervention for FSD symptom cluster management in BC survivors. Methods and analysis This study will be a phase II randomised controlled trial with three study arms and 1:1:1 allocation. Fifty-one early-stage BC survivors who are experiencing the FSD symptom cluster will be randomly assigned to a true SA group, a sham SA group or a usual care group. All participants will receive an education booklet regarding FSD symptom cluster management advice as the usual care package. The participants in the true SA group will additionally receive a 7-week self-administered SA intervention. The participants in the sham SA group will additionally receive self-administered light acupressure at non-acupoints with the same frequency, session and duration as the true SA group. The primary outcomes will be feasibility outcomes related to subject recruitment and completion of study questionnaires and interventions. The secondary outcomes will be the effects of SA on fatigue, sleep disturbance, depression and quality of life. Descriptive statistics will be used to present all the outcomes. The secondary outcomes will be analysed using an intent-to- treat approach. Ethics and dissemination Ethical approvals of this trial have been granted by the Human Research Ethics Committee at Charles Darwin University (H19017) and the Clinical Trial Ethics Committee at The Affliated Hospital of Southwest Medical University (KY2019039). Findings from this trial will be published in peer-reviewed journals and presented at professional conferences. Trial registration number This trial was registered at ClinicalTrials.gov and the registration number is NCT04118140, with the stage at Recruiting. INTRODUCTION As the most common cancer diagnosis among females worldwide, breast cancer (BC) has become a curable condition in 70%–80% Strengths and limitations of this study ► The design of this study will follow the Medical Research Council Framework for Developing and Evaluating Complex Interventions, which will im- prove the study’s ft with clinical practice in a local context and increase its likelihood of success. ► This study will use an evidence-based and research- informed method to develop the somatic acupres- sure (SA) intervention protocol on the basis of widely recognised theories, best available research evi- dence and practice standards, and the consensus of an expert panel. ► This trial will adopt a sham SA comparison, which will enable the measurement of potential placebo effects of the SA interventions. ► This study will be challenging to maintain a suc- cessful blind design among the participants due to the visible nature of the intervention. on April 14, 2022 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2021-054597 on 20 January 2022. Downloaded from