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Feasibility of an Advance Care Planning Intervention

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06149312
Acronym
PREVOIR
Enrollment
120
Registered
2023-11-28
Start date
2023-12-29
Completion date
2024-12-29
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

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.

Interventions

Standardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List

Sponsors

Institut de cancérologie Strasbourg Europe
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of patients who write advance directives of living at 3 monthsAt 3 months from randomization

Secondary

MeasureTime frameDescription
Received anti-cancer treatmentup to 6 monthsPrevalence of antineoplastic treatment received within the 3 months that precede death
Patients living trajectoryup to 6 monthsRecording of patient site of death, if applicable
Percentage of patients who write advance directives of living at 1 monthAt 1 month from randomization
Percentage of patients who write advance directives of living at 6 monthsAt 6 months from randomization
Overall survivalUp to 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026