Assessment of the Reasons for Accepting or Refusing Early Palliative Care

NCT04717440 | Completed

• 1 other identifier: ET20-101 PALPHA-1
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicentre study, considered as " non-RIPH ("Recherche n'Impliquant pas la Personne Humaine - Research that does not involve humans ". Indeed, the patient's participation in the study and the completion of the various questionnaires has no impact on patient's safety and is not likely to change patients' management. Patients accepting to take part to an early phase trial will be proposed to participate in the PALPHA-1 trial. They can accept or refuse to have palliative supportive care. The main objective of this study is to assess the reasons for accepting and refusing early palliative care in patients included in an early phase clinical trial. The secondary objectives will enable to describe and analyze the number (effective) and the rate (%) of acceptance and/or refusal of early palliative support, to assess patients' understanding and perception of the " combined " management by comparing the semantic content of the patient-investigator ecological interaction during the proposal for inclusion in the trial (i.e. what was explicitly said), with that of the semi-structured post-consultation inclusion interviews ( ie what the patients understood, perceived), to compare the quality of life and the anxiety-depression of patients according to their acceptance or refusal of the mixed care at the inclusion and at the end of the early phase trial, to compare the clinical, medical and socio-demographic characteristics of the patients, the overall survival of patients according to their acceptance or refusal of the combined management and finally for the patients accepting the Palliative Care Management (PCM), to describe throughout the study, the patients' compliance to palliative supportive care undertaken.

Conditions

Cancer

Keywords

Cancer; Palliative care; Early phase trial

Outcome Measures

Primary Outcomes (1)

• Assessment of the reasons for accepting / refusing early palliative care in patients included in an early phase clinical trial

  Thematic content analysis of semi-directive qualitative interviews

  At baseline

Secondary Outcomes (14)

• Description and analysis of the number (effective) of acceptance of early palliative support

  At baseline

• Description and analysis of the percentage of acceptance of early palliative support

  At baseline

• Assessment of patients' understanding and perception of the early palliative care management

  At baseline

• Comparison of the quality of life of patients according to their acceptance or refusal of the mixed care

  Up to 24 months

• Comparison of the anxiety-depression of patients according to their acceptance or refusal of the mixed care

  Up to 24 months

Study Arms (2)

Patients accepting palliative care

Patients included in an early phase trial and accepting palliative care

Patients refusing palliative car

Patients included in an early phase trial but refusing palliative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, multicentre study, considered as " non-RIPH (Recherche n'Impliquant pas la Personne Humaine - Research that does not involve humans ". Indeed, the patient's participation in the study and the completion of the various questionnaires has no impact on patient's safety and is not likely to change patient's management. Patients accepting to take part to an early phase trial will be proposed to participate in the PALPHA-1 trial. They can accept or refuse to have palliative supportive care. Patients' follow up will be performed according to the palliative standard procedures.

You may qualify if:

• Age over 18
• Patient included in an early phase clinical trial
• Patient who has not been taken in charge for palliative care
• Life expectancy of at least 16 weeks
• Patient not opposed to data's collection and processing for the study
• Patient affiliated to a social security system

You may not qualify if:

• Patient unable to read/understand the French language
• Patient with psychological disability (e.g. too great vulnerability, psychiatric disorder) or physical disability (e.g. physical / motor disability)
• Patients under autorship, curators or legal protection,
• Patients already participating in a clinical trial or interventional study related to supportive care.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

Location

Related Publications (1)

• Chvetzoff G, Girodet M, Despax J, Baudry V, Duranti J, Mastroianni B, Vanacker H, Vinceneux A, Brahmi M, Renard O, Gautier J, Britel M, Ducimetiere F, Anota A, Cassier P, Christophe V. 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. BMJ Open. 2022 Apr 22;12(4):e060317. doi: 10.1136/bmjopen-2021-060317.

  PMID: 35459679 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Gisèle CHVETZOFF, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: January 22, 2021
• Study Start: February 4, 2021
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

FR (1)