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

Abstract

Background Team-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/design This 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. Discussion The 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 registration Name of the registry: IDRCB 2019-A03116–51 Trial registration number:NCT04604873 Date of registration: October 27, 2020 URL of trial registry record

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Status, demand and practice models of palliative day-care clinics and day hospices: a scoping review

“…However, the produced results can only be interpreted in the context of the formulated goal of the palliative day-care clinic or day hospice. Following our literature search, Thery et al 45 published a study protocol for a multicentre randomised controlled trial aimed at assessing a palliative care day-hospital project for patients with advanced cancer. This trial, comparing the palliative care day-hospital with standard outpatient palliative care, 45 could represent a significant step towards achieving a standardised approach to palliative day-care.…”

“…Following our literature search, Thery et al 45 published a study protocol for a multicentre randomised controlled trial aimed at assessing a palliative care day-hospital project for patients with advanced cancer. This trial, comparing the palliative care day-hospital with standard outpatient palliative care, 45 could represent a significant step towards achieving a standardised approach to palliative day-care. However, until goals and suitable outcome measurements are clearly defined and applied for palliative day-care clinics and day hospices, cost-effectiveness will be difficult to measure.…”