Clinical trial NCT06149312: Feasibility of an Advance Care Planning Intervention
Official title: A Prospective, Randomized Trial Assessing the Feasibility of an Advance Care Planning Intervention for Patients Hospitalized in a French Cancer Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who write advance directives of living at 3 months
timeFrame: At 3 months from randomization
Secondary outcomes:
measure: Percentage of patients who write advance directives of living at 1 month
timeFrame: At 1 month from randomization
measure: Percentage of patients who write advance directives of living at 6 months
timeFrame: At 6 months from randomization
measure: Overall survival
timeFrame: Up to 6 months
measure: Received anti-cancer treatment
timeFrame: up to 6 months
measure: Patients living trajectory
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References:
citation: 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.