Feasibility of an Advance Care Planning Intervention (PREVOIR)

A Prospective, Randomized Trial Assessing the Feasibility of an Advance Care Planning Intervention for Patients Hospitalized in a French Cancer Center

Advanced Cancer patients hospitalized in a Cancer center inpatient unit have a dismal prognosis. Palliative Care interventions have shown multiple benefit for those patients, regarding quality of life, symptom management, illness understanding and aggressiveness of care criteria. Although Advance Care planning (ACP) is part of usual Palliative Care, specific interventions dedicated to ACP are understudied.

This study aims at showing that a simple and systematic Advance Care Planning intervention is likely to clarify the understanding of the goals of care by patients, to help with ACP documentation and and potentially to modify the trajectory of illness for patients during and after hospitalization.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Other: Advance Care Planning Intervention

Detailed Description

PREVOIR is a randomized, single-center, two-arm trial: patients from experimental arm will benefit from a systematic interview on the care plan whereas patients from control arm will received standard cares.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67033
    • Recruiting
    • Institut de cancérologie Strasbourg Europe
    • Contact: Claire VIT; Phone Number: +33 (0)3 68 33 95 23; Email: promotion-rc@icans.eu
    • Contact: Manon VOEGELIN
    • Principal Investigator: Philippe TRENSZ, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years or older
• Patients with a diagnosis of advanced or metastatic solid cancer
• Patients hospitalized in a conventional oncology, radiotherapy or hematology department
• Agreement obtained from the referring oncologist or senior doctor responsible for the patient during hospitalization
• Patient hospitalized for less than 7 days
• Patients who have not yet written advance directives
• Signature of informed consent

Exclusion Criteria:

• Patients treated for hematologic malignancies
• Presence of uncontrolled symptoms that do not allow an interview to be carried out
• Patients with planned hospitalization for chemotherapy or biopsy or performance of a procedure
• Patients < 18 years old or patients ≥ 18 years old under supervision
• Patients placed under judicial protection or guardianship
• Decompensated neuropsychiatric disorders
• Comprehension problems
• Patients without social security
• Allophone patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advance Care Planning Intervention; Patients from experimental arm will benefit from a Standardized Advance Care Planning interview alone or in the presence of relatives within 3 days after randomization.	Other: Advance Care Planning Intervention; Standardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List
No Intervention: Standard cares; Patients from control arm will be treated without specific intervention, which does not exclude the possibility of resorting to non standardized advance care planning interviews with an oncologist or a physician specialized in palliative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who write advance directives of living at 3 months	At 3 months from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		Up to 6 months
Percentage of patients who write advance directives of living at 1 month		At 1 month from randomization
Percentage of patients who write advance directives of living at 6 months		At 6 months from randomization
Received anti-cancer treatment	Prevalence of antineoplastic treatment received within the 3 months that precede death	up to 6 months
Patients living trajectory	Recording of patient site of death, if applicable	up to 6 months

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe

Publications and helpful links

General Publications

• Bouleuc C, Savignoni A, Chevrier M, Renault-Tessier E, Burnod A, Chvetzoff G, Poulain P, Copel L, Cottu P, Pierga JY, Bredart A, Dolbeault S. A Question Prompt List for Advanced Cancer Patients Promoting Advance Care Planning: A French Randomized Trial. J Pain Symptom Manage. 2021 Feb;61(2):331-341.e8. doi: 10.1016/j.jpainsymman.2020.07.026. Epub 2020 Jul 31.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2023
• Primary Completion (Estimated): December 29, 2024
• Study Completion (Estimated): December 29, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-018; 2023-A02045-40 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No