Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial

BMC Palliative Care

Amélie Anota¹  Jean-Christophe Mino²  Sylvie Dolbeault³  Anne Brédart⁴  Lorraine Waechter⁵  Timothee Marchal⁶  Celine Laouisset⁶  Carole Bouleuc⁶  Laura Thery⁶  Alexis Burnod⁶  Elisabeth Angellier⁷  Oum El Kheir Djoumakh⁸  Clemence Thebaut⁹ 

[1] Biostatistics Unit, DRCI, Centre Léon Bérard, Lyon, France;French National Platform Quality of Life and Cancer, Lyon, France;INSERM, EFS-BFC, UMR 1098- Université de Bourgogne-Franche-Comté, Besançon, France;Department of Medical Ethics, Sorbonne University Medical School, Paris, France;Department of Psycho-Oncology, Institut Curie, Paris, France;Department of Psycho-Oncology, Institut Curie, Paris, France;Laboratoire Psychopathologie et Processus de Santé, Université de Paris, F-92100, Boulogne Billancourt, Paris, France;Department of Supportive and Palliative Care, Hôpital Cochin, Paris, France;Department of Supportive and Palliative Care, Institut Curie, Paris, France;Department of Supportive and Palliative Care, Institut Curie, Saint Cloud, Paris, France;Methodological and Quality of Life Unit in Oncology (INSERM 1098), University Hospital, Besançon, France;Université de Limoges, UMR 1094 (NET), Limoges, France;Université Paris-Dauphine, PSL Research, University, LEDa [Legos], Paris, France;

关键词: Quality of life;    Palliative care;    End-of-life care;    Advanced cancer;    Study design;   

DOI  :  10.1186/s12904-021-00754-x

来源: Springer

【 摘 要 】

BackgroundTeam-based and timely integrated palliative care is a gold standard of care in oncology, but issues concerning its optimal organization remain. Palliative Care in Day-Hospital (PCDH) could be one of the most efficient service model of palliative care to deliver interdisciplinary and multidimensional care addressing the complex supportive care needs of patients with advanced cancer. We hypothesize that, compared to conventional outpatient palliative care, PCDH allows the clinical benefits of palliative care to be enhanced.Methods/designThis study is a multicentre parallel group trial with stratified randomization. Patient management in PCDH will be compared to conventional outpatient palliative care. The inclusion criteria are advanced cancer patients referred to a palliative care team with an estimated life expectancy of more than 2 months and less than 1 year. The primary endpoint is health-related quality of life with deterioration-free survival based on the EORTC QLQ-C30 questionnaire. The secondary objectives are the following: increase in patient satisfaction with care using the EORTC PATSAT-C33 and OUT-PATSAT7 questionnaires, better understanding of the prognosis using the PTPQ questionnaire and advance care planning; decrease in the need for supportive care among relatives using the SCNS-P&C-F questionnaire, and reduction in end-of-life care aggressiveness. Patients will complete one to five questionnaires on a tablet before each monthly visit over 6 months and will be followed for 1 year. A qualitative study will take place, aiming to understand the specificity of palliative care management in PCDH. Cost-effectiveness, cost-utility and, an additional economic evaluation based on capability approach will be conducted from a societal point of view.DiscussionThe first strength of this study is that it combines the main relevant outcomes assessing integrated palliative care; patient quality of life and satisfaction; discussion of the prognosis and advance care planning, family well-being and end-of-life care aggressiveness. The second strength of the study is that it is a mixed-method study associating a qualitative analysis of the specificity of PCDH organization, with a medical-economic study to analyse the cost of care.Trial registrationName of the registry: IDRCB 2019-A03116–51Trial registration number:NCT04604873Date of registration: October 27, 2020URL of trial registry record

【 授权许可】

CC BY