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Trial Title:
Feasibility of an Advance Care Planning Intervention
NCT ID:
NCT06149312
Condition:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Advance Care Planning Intervention
Description:
Standardized interview based on The letter Project (Stanford Medicine) and Questions
Prompt List
Arm group label:
Advance Care Planning Intervention
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de cancérologie Strasbourg Europe
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
Claire VIT
Phone:
(0)3 68 33 95 23
Phone ext:
+33
Email:
promotion-rc@icans.eu
Contact backup:
Last name:
Manon VOEGELIN
Investigator:
Last name:
Philippe TRENSZ, MD
Email:
Principal Investigator
Start date:
December 29, 2023
Completion date:
December 29, 2024
Lead sponsor:
Agency:
Institut de cancérologie Strasbourg Europe
Agency class:
Other
Source:
Institut de cancérologie Strasbourg Europe
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149312