Feasibility of an Advance Care Planning Intervention

NCT ID: NCT06149312

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-29

Study Completion Date

2024-12-29

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.

Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Advance Care Planning Intervention

Intervention Type OTHER

Standardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Advance Care Planning Intervention

Standardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de cancérologie Strasbourg Europe

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Claire VIT

Role: primary

(0)3 68 33 95 23 ext. +33

Manon VOEGELIN

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32739563 (View on PubMed)

Other Identifiers

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2023-A02045-40

Identifier Type: OTHER

Identifier Source: secondary_id

2023-018

Identifier Type: -

Identifier Source: org_study_id

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