A Prospective, Randomized Trial Assessing the Feasibility of an Advance Care Planning Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasms

Intervention / Treatment
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* Other: Advance Care Planning Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advance Care Planning Intervention<br>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<br>* Standardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List<br>|
| No Intervention: Standard cares<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |
| --- | --- | --- |
| 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 | 
| Impact on overall survival |  | Up to 6 months | 
| Impact on received anti-cancer treatment | Prevalence of antineoplastic treatment received within the 3 months that precede death | up to 6 months | 
| Impact on patients living trajectory | Recording of patient site of death, if applicable | up to 6 months |