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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
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 prot...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9036432/ https://www.ncbi.nlm.nih.gov/pubmed/35459679 http://dx.doi.org/10.1136/bmjopen-2021-060317 |
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author | Chvetzoff, Gisele Girodet, Magali Despax, Johanna Baudry, Valentine Duranti, Julie Mastroianni, Bénédicte Vanacker, Hélène Vinceneux, Armelle Brahmi, Mehdi Renard, Olivier Gautier, Julien Britel, Manon Ducimetière, Françoise Anota, Amélie Cassier, Philippe Christophe, Véronique |
author_facet | Chvetzoff, Gisele Girodet, Magali Despax, Johanna Baudry, Valentine Duranti, Julie Mastroianni, Bénédicte Vanacker, Hélène Vinceneux, Armelle Brahmi, Mehdi Renard, Olivier Gautier, Julien Britel, Manon Ducimetière, Françoise Anota, Amélie Cassier, Philippe Christophe, Véronique |
author_sort | Chvetzoff, Gisele |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9036432 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-90364322022-05-06 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 Chvetzoff, Gisele Girodet, Magali Despax, Johanna Baudry, Valentine Duranti, Julie Mastroianni, Bénédicte Vanacker, Hélène Vinceneux, Armelle Brahmi, Mehdi Renard, Olivier Gautier, Julien Britel, Manon Ducimetière, Françoise Anota, Amélie Cassier, Philippe Christophe, Véronique BMJ Open Oncology 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. BMJ Publishing Group 2022-04-22 /pmc/articles/PMC9036432/ /pubmed/35459679 http://dx.doi.org/10.1136/bmjopen-2021-060317 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Oncology Chvetzoff, Gisele Girodet, Magali Despax, Johanna Baudry, Valentine Duranti, Julie Mastroianni, Bénédicte Vanacker, Hélène Vinceneux, Armelle Brahmi, Mehdi Renard, Olivier Gautier, Julien Britel, Manon Ducimetière, Françoise Anota, Amélie Cassier, Philippe Christophe, Véronique 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9036432/ https://www.ncbi.nlm.nih.gov/pubmed/35459679 http://dx.doi.org/10.1136/bmjopen-2021-060317 |
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