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

Sponsor
Institut de cancérologie Strasbourg Europe (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06149312
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Advance Care Planning Intervention
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Prospective, Randomized Trial Assessing the Feasibility of an Advance Care Planning Intervention for Patients Hospitalized in a French Cancer Center
Anticipated Study Start Date :
Dec 11, 2023
Anticipated Primary Completion Date :
Dec 11, 2024
Anticipated Study Completion Date :
Dec 11, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Advance Care Planning Intervention

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
Standardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List
No Intervention: Standard cares

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients who write advance directives of living at 3 months [At 3 months from randomization]

Secondary Outcome Measures

  1. Percentage of patients who write advance directives of living at 1 month [At 1 month from randomization]

  2. Percentage of patients who write advance directives of living at 6 months [At 6 months from randomization]

  3. Impact on overall survival [Up to 6 months]

  4. Impact on received anti-cancer treatment [up to 6 months]

    Prevalence of antineoplastic treatment received within the 3 months that precede death

  5. Impact on patients living trajectory [up to 6 months]

    Recording of patient site of death, if applicable

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de cancérologie Strasbourg Europe Strasbourg France 67033

Sponsors and Collaborators

  • Institut de cancérologie Strasbourg Europe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Institut de cancérologie Strasbourg Europe
ClinicalTrials.gov Identifier:
NCT06149312
Other Study ID Numbers:
  • 2023-018
  • 2023-A02045-40
First Posted:
Nov 28, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 28, 2023