Acupuncture for Rectal Cancer Patients with Low Anterior Resection Syndrome: A Mixed Method Pilot Study Protocol

Ming Yang, Honglin Jiang, Lin Xu, Qiaoli Zhang, Xun Li, Liu Han, Yudong Bao, Lu Yang, Mi Zhang, Lihua Zheng, Ningyuan Liu, Jianping Liu, Jinchang Huang
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Abstract

Background: This protocol aims to facilitate the evaluation of acupuncture in the treatment of low anterior resection syndrome (LARS) on the bowel in rectal cancer patients.Methods: This pragmatic pilot study was designed using a convergent parallel mixed methods design combining a single-arm trial and semi-structured qualitative interview.Results: Sixty patients with LARS will be recruited from out/inpatient departments. For evaluation of efficacy, the single-arm objective performance criteria will be used in the pilot study in which all eligible participants will receive electroacupuncture mainly on Baliao acupoints three times a week for four weeks. The LARS scale, Memorial Sloan Kettering Cancer Centre Bowel Function Index, and anorectal manometry will be used to assess symptoms and pressure changes. The European Quality of Life Five Dimensions Questionnaire and the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 will be used to evaluate quality of life. Semi-structured interviews will be conducted among twenty participants to understand their experience and feelings. The qualitative and quantitative data will be analyzed and summarized before comparative analysis. Qualitative themes derived from qualitative analysis will be ranked with the variables of quantitative statistics. Finally, we will answer the research question from multiple perspectives by comparing different types of evidence for the same dimension.Conclusion: This mixed method study design will potentially evaluate the feasibility and effects of electroacupuncture for LARS and gain an in-depth understanding of the attitudes, experiences, feelings, and acceptance among patients with LARS.
针刺治疗直肠癌前低位切除综合征:一项混合方法的初步研究方案
背景:本方案旨在促进针刺治疗直肠癌患者肠前低位切除综合征(LARS)的评价。方法:本实用主义先导研究采用单臂试验和半结构化定性访谈相结合的收敛平行混合方法设计。结果:将从门诊/住院部招募60例LARS患者。为了评估疗效,试验研究将采用单臂客观表现标准,所有符合条件的参与者将接受电针治疗,主要针对八髎穴,每周3次,持续4周。LARS量表、纪念斯隆-凯特琳癌症中心肠功能指数和肛肠测压法将用于评估症状和压力变化。将使用欧洲生活质量五维度问卷和欧洲癌症研究与治疗组织生活质量问卷-核心30来评估生活质量。将对20名参与者进行半结构化访谈,以了解他们的经历和感受。在比较分析之前,将对定性和定量数据进行分析和总结。从定性分析得出的定性主题将与定量统计的变量排序。最后,我们将通过比较同一维度的不同类型的证据,从多个角度回答研究问题。结论:该混合方法研究设计将有可能评估电针治疗LARS的可行性和效果,并深入了解LARS患者的态度、经历、感受和接受程度。
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