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增强结直肠癌患者自我护理活动的患者教育——一项随机试验的研究方案

Empowering patient education on self-care activity among patients with colorectal cancer - a research protocol for a randomised trial.

作者信息

Tuominen Leena, Ritmala-Castrén Marita, Nikander Pia, Mäkelä Siru, Vahlberg Tero, Leino-Kilpi Helena

机构信息

Comprehensive Cancer Center, Helsinki University Hospital, Haartmaninkatu 4, 0029, Helsinki, Finland.

Department of Nursing Science, University of Turku|, Joukahaisenkatu 3-5, 20014, Turku, Finland.

出版信息

BMC Nurs. 2021 Jun 10;20(1):94. doi: 10.1186/s12912-021-00617-z.

Abstract

BACKGROUND

Chemotherapy-induced side effects may have a negative effect on nutrition intake, thus increasing the risk of malnutrition and consequently, other serious complications for patients with cancer. The prevalence of malnutrition is common among patients with colorectal cancer. Nurse-led empowering education may have a positive effect on self-care activity in this patient group. Therefore, our purpose is to develop an empowering educational nursing intervention and test its effect on self-care activation and knowledge level among patients with colorectal cancer during chemotherapy. Secondary outcomes are quality of life and risk of malnutrition.

METHODS

An interdisciplinary expert group developed a face-to-face empowering educational intervention using teach-back method. A two-arm, single-centre, superiority trial with stratified randomisation (1:1) and pre-post measures will be used to assess the effect of the intervention compared to standard care. Patients (N = 40 + 40) will be recruited in one university hospital outpatient clinic in Finland. Eligibility criteria are adult patients diagnosed with colorectal cancer starting oral fluoropyrimidine or combination chemotherapy treatment. A registered nurse experienced in oncology will deliver the intervention 2 weeks after the first chemotherapy. Outcomes are measured before intervention (M0) and after a two-month follow-up period (M1).

DISCUSSION

This study will assess whether nurse-led empowering education using teach-back method is effective on self-care activity among patients with colorectal cancer. If the intervention has a positive effect, it may be implemented into patient education in a corresponding context.

TRIAL REGISTRATION

ClinicalTrials.gov : NCT04160650 Registered 12 November 2019 - retrospectively registered.

摘要

背景

化疗引起的副作用可能会对营养摄入产生负面影响,从而增加营养不良的风险,进而增加癌症患者出现其他严重并发症的风险。营养不良在结直肠癌患者中很常见。由护士主导的赋能教育可能会对该患者群体的自我护理活动产生积极影响。因此,我们的目的是开发一种赋能教育护理干预措施,并测试其对结直肠癌化疗患者自我护理激活和知识水平的影响。次要结果是生活质量和营养不良风险。

方法

一个跨学科专家组采用反馈教学法开发了一种面对面的赋能教育干预措施。将采用双臂、单中心、优越性试验,分层随机化(1:1)和前后测量,以评估该干预措施与标准护理相比的效果。将在芬兰的一家大学医院门诊招募患者(N = 40 + 40)。纳入标准为诊断为结直肠癌并开始口服氟嘧啶或联合化疗的成年患者。一名有肿瘤学经验的注册护士将在首次化疗后2周进行干预。在干预前(M0)和两个月的随访期后(M1)测量结果。

讨论

本研究将评估采用反馈教学法由护士主导的赋能教育对结直肠癌患者自我护理活动是否有效。如果该干预措施有积极效果,可能会在相应背景下应用于患者教育。

试验注册

ClinicalTrials.gov:NCT04160650 于2019年11月12日注册——追溯注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe6a/8194018/699ed781ee4d/12912_2021_617_Fig1_HTML.jpg

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