心理障碍对晚期复发性癌症患者使用阿片类镇痛药治疗疼痛的影响（BAROC）：一项多中心队列研究方案。

Psychological barriers to the use of opioid analgesics for treating pain in patients with advanced recurrent cancer (BAROC): protocol for a multicentre cohort study.

机构信息

Department of Pharmacy, Yokohama City University Medical Center, Yokohama, Japan.

Department of Analytical Chemistry, Tokyo University of Pharmacy and Life Science, Tokyo, Japan.

出版信息

BMJ Open. 2022 Mar 31;12(3):e054914. doi: 10.1136/bmjopen-2021-054914.

DOI:10.1136/bmjopen-2021-054914

PMID:35361645

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8971793/

Abstract

INTRODUCTION

Opioid analgesics are essential for treating cancer pain. However, patients are sometimes reluctant to use them because of concerns about addiction and dependence. Rapid pain relief following opioid administration may help overcome the psychological barriers to opioid analgesic use. This study aims to determine the relationship between psychological resistance to strong opioid analgesic use and pain amelioration speed in patients with advanced recurrent cancer.

METHODS AND ANALYSIS

This ongoing, multicentre, observational study enrols patients aged 20 years or older with distant metastasis or advanced recurrent cancer receiving strong opioid analgesics for cancer pain for the first time. All participants, both inpatient and outpatient, were recruited from five Japanese hospitals. We are investigating the relationship between psychological barriers at the start of treatment and pain relief during the first week of treatment in these patients. The primary outcome is the Japanese version of the Barriers Questionnaire-II score at baseline. The secondary outcomes are the relationships between psychological barriers to strong opioid analgesic use and changes in pain over time. The participants are asked to fill out an electronic patient-reported outcome daily during the first week of treatment. The sample size was determined based on the number of patients in the year prior to study commencement who used strong opioid analgesics, met the eligibility criteria and could be expected to consent to participate in the study.

ETHICS AND DISSEMINATION

The study protocol was approved by the ethics committee (approval ID B200600091) of Yokohama City University on 24 August 2020. The protocol has been reviewed by the institutional review boards at the four participating study sites. The results will be published in a peer-reviewed journal and will be presented at a relevant meeting.

TRIAL REGISTRATION NUMBER

UMIN000042443.

摘要

简介

阿片类镇痛药是治疗癌痛的必备药物。然而，由于担心成瘾和依赖，患者有时不愿意使用阿片类药物。阿片类药物给药后迅速缓解疼痛可能有助于克服使用阿片类药物的心理障碍。本研究旨在确定晚期复发性癌症患者对强阿片类药物使用的心理抵制与疼痛缓解速度之间的关系。

方法与分析

这是一项正在进行的、多中心、观察性研究，纳入了首次接受强阿片类药物治疗癌痛的年龄在 20 岁或以上、有远处转移或晚期复发性癌症的患者。所有参与者，包括住院患者和门诊患者，均来自日本的五家医院。我们正在调查治疗开始时的心理障碍与治疗第一周的疼痛缓解之间的关系。主要结局指标为基线时的日本版障碍问卷- II 评分。次要结局指标为强阿片类药物使用的心理障碍与随时间变化的疼痛变化之间的关系。在治疗的第一周，参与者被要求每天填写一份电子患者报告的结局。样本量是根据研究开始前一年使用强阿片类药物、符合入选标准且预计同意参与研究的患者人数确定的。