《Symptom Navi© 计划在瑞士门诊环境中的癌症患者中的实施：一项集群随机试点研究的研究方案（Symptom Navi© 试点研究）》。

Implementation of the Symptom Navi © Programme for cancer patients in the Swiss outpatient setting: a study protocol for a cluster randomised pilot study (Symptom Navi© Pilot Study).

机构信息

HedS-FR School of Health Sciences, University of Applied Science and Arts Western Switzerland, Fribourg, Switzerland.

IUFRS Institut de formation et de recherche en soins, Université de Lausanne Faculté de biologie et médecine, Lausanne, Switzerland.

出版信息

BMJ Open. 2019 Jul 9;9(7):e027942. doi: 10.1136/bmjopen-2018-027942.

DOI:10.1136/bmjopen-2018-027942

PMID:31289075

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6615799/

Abstract

INTRODUCTION

Self-management interventions show promising results on symptom outcomes and self-management behaviours. The Symptom Navi© Programme (SN©P) is a nurse-led intervention supporting patients' symptom self-management during anticancer treatment. It consists of written patient information (Symptom Navi© Flyers (SN©Flyers)), semistructured consultations and a training manual for nurses.

METHODS AND ANALYSIS

This pilot study will evaluate the implementation of the SN©P based on the Reach Effectiveness-Adoption Implementation Maintenance framework at Swiss outpatient cancer centres. We will use a cluster-randomised design and randomise the nine participating centres to the intervention or usual care group. We expect to include 140 adult cancer patients receiving first-line systemic anticancer treatment. Trained nurses at the intervention clusters will provide at least two semistructured consultations with the involvement of SN©Flyers. Outcomes include patients' accrual and retention rates, patient-reported interference of symptoms with daily functions, symptom burden, perceived self-efficacy, quality of nursing care, nurse-reported facilitators and barriers of adopting the programme, nurses' fidelity of providing the intervention as intended, and patients' safety (patients timely reporting of severe symptoms). We will use validated questionnaires for patient-reported outcomes, focus group interviews with nurses and individual interviews with oncologists. Linear mixed models will be used to analyse patient-reported outcomes. Focus group and individual interviews will be analysed by thematic analysis.

ETHICS AND DISSEMINATION

The Symptom Navi© Pilot Study has been reviewed and approved by Swiss Ethic Committee Bern (KEK-BE: 2017-00020). Results of the study will be disseminated in peer-reviewed journal and at scientific conferences.

TRIAL REGISTRATION NUMBER

NCT03649984; Pre-results.

摘要

简介

自我管理干预措施在症状结果和自我管理行为方面显示出有前景的结果。Symptom Navi© 计划（SN©P）是一项护士主导的干预措施，旨在支持癌症治疗期间患者的症状自我管理。它由书面的患者信息（Symptom Navi© 传单（SN©Flyers））、半结构化咨询和护士培训手册组成。

方法与分析

这项试点研究将根据 Reach Effectiveness-Adoption Implementation Maintenance 框架，在瑞士门诊癌症中心评估 SN©P 的实施情况。我们将采用集群随机设计，将参与的九个中心随机分为干预组和常规护理组。我们预计将纳入 140 名接受一线系统抗癌治疗的成年癌症患者。干预组的培训护士将至少提供两次涉及 SN©Flyers 的半结构化咨询。结果包括患者的入组和保留率、患者报告的症状对日常功能的干扰、症状负担、感知自我效能、护理质量、护士报告的采用该计划的促进因素和障碍、护士提供干预的忠实度以及患者的安全性（患者及时报告严重症状）。我们将使用经过验证的问卷评估患者报告的结果，对护士进行焦点小组访谈，对肿瘤学家进行个别访谈。线性混合模型将用于分析患者报告的结果。焦点小组和个别访谈将通过主题分析进行分析。