Feasibility of an Advance Care Planning Intervention

Not Applicable

Recruiting

• Conditions: Neoplasms
• Interventions: Other: Advance Care Planning Intervention

• Registration Number: NCT06149312
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-28
• Study Start: 2023-12-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-12-29
• Study Completion: 2024-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advance Care Planning Intervention	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients who write advance directives of living at 3 months	At 3 months from randomization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France