Feasibility of an Advance Care Planning Intervention (PREVOIR)

Institut de cancérologie Strasbourg Europe

Status: Enrolling

Conditions: Neoplasms

Treatments: Other: Advance Care Planning Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06149312

2023-018

2023-A02045-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Advance Care Planning Intervention

Experimental group

Description:

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.

Treatment:

Other: Advance Care Planning Intervention

Standard cares

No Intervention group

Description:

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.