Feasibility of an Advance Care Planning Intervention

Neoplasms Clinical Trial

— PREVOIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149312
• Other study ID #: 2023-018
• Secondary ID: 2023-A02045-40
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2023
• Est. completion date: December 29, 2024

Study information

• Verified date: March 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 29, 2024
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• Advance Care Planning Intervention
Standardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who write advance directives of living at 3 months		At 3 months from randomization
Secondary	Percentage of patients who write advance directives of living at 1 month		At 1 month from randomization
Secondary	Percentage of patients who write advance directives of living at 6 months		At 6 months from randomization
Secondary	Overall survival		Up to 6 months
Secondary	Received anti-cancer treatment	Prevalence of antineoplastic treatment received within the 3 months that precede death	up to 6 months
Secondary	Patients living trajectory	Recording of patient site of death, if applicable	up to 6 months