法国某地区综合性癌症中心早期临床试验纳入患者对早期姑息治疗接受和拒绝的原因：一项定性研究方案。

Reasons for acceptance and refusal of early palliative care in patients included in early-phase clinical trials in a regional comprehensive cancer centre in France: protocol for a qualitative study.

机构信息

Department of Oncology Patient Support Care, Centre Léon Bérard, Lyon, France.

Research on Healthcare Performance (RESHAPE), INSERM U1290, Universite Claude Bernard Lyon 1, Lyon, France.

出版信息

BMJ Open. 2022 Apr 22;12(4):e060317. doi: 10.1136/bmjopen-2021-060317.

DOI:10.1136/bmjopen-2021-060317

PMID:35459679

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9036432/

Abstract

INTRODUCTION

A few studies have highlighted the potential synergy between early palliative care and inclusion in an early-phase clinical trial that may improve quality of life, reduce symptoms of exhaustion related to the side effects of treatment and allow patients to complete their treatment protocol. The primary objective of this qualitative study is to evaluate the reasons for acceptance or refusal of early palliative care in patients included in early-phase clinical trials.

METHOD AND ANALYSIS

All patients from the Centre Léon Bérard (Comprehensive Cancer Centre in Lyon, France) who consent to one of the early-phase clinical trials proposed at the centre will be invited to participate in this study. The cohort will consist of a subgroup (n=20) of patients who accept palliative care together with their clinical trial, and a second subgroup (n=20) of patients who decline it. Patients will be interviewed in exploratory interviews conducted by a psychology researcher before the start of their clinical trial. The interviews will be audio-recorded. Patients will also be asked to complete quality of life and anxiety/depression questionnaires both before the beginning of the treatment and at the end of their clinical trial. The content of the interviews will be analysed thematically. Descriptive and comparative statistical analysis of both cohorts will also be conducted.

ETHICS AND DISSEMINATION

Personal data will be collected and processed in accordance with the laws and regulations in force. All patients will give informed consent to participate. This study complies with reference methodology MR004 of the Commission Nationale de l'Informatique et des Libertés. The protocol has received the validation of an ethics committee (Groupe de Réflexion Ethique du CLB, number: 2020-006). The results will be disseminated through conference presentations and peer-reviewed publications.

TRIAL REGISTRATION NUMBER

NCT04717440.

摘要

简介

一些研究强调了早期姑息治疗与早期临床试验纳入之间的潜在协同作用，这可能会提高生活质量，减轻与治疗副作用相关的疲惫症状，并使患者能够完成治疗方案。本定性研究的主要目的是评估纳入早期临床试验的患者接受或拒绝早期姑息治疗的原因。

方法与分析

里昂贝尔拉德中心（法国里昂综合癌症中心）同意参与中心提出的一项早期临床试验的所有患者都将被邀请参与这项研究。该队列将包括接受姑息治疗的患者亚组（n=20）和拒绝姑息治疗的患者亚组（n=20）。在开始临床试验之前，将由一名心理学研究员对患者进行探索性访谈。将对访谈进行录音。患者还将被要求在开始治疗前和临床试验结束时填写生活质量和焦虑/抑郁问卷。将对访谈内容进行主题分析。还将对两个队列进行描述性和比较性统计分析。

伦理与传播

将根据现行法律法规收集和处理个人数据。所有患者都将给予参与的知情同意。本研究符合 Commission Nationale de l'Informatique et des Libertés 的参考方法 MR004。该方案已获得伦理委员会（CLB 小组的伦理思考，编号：2020-006）的批准。结果将通过会议演示和同行评审出版物进行传播。