Feasibility of an Advance Care Planning Intervention

NCT06149312 | Recruiting

• 2 other identifiers: 2023-0182023-A02045-40
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who write advance directives of living at 3 months

  At 3 months from randomization

Secondary Outcomes (5)

• Percentage of patients who write advance directives of living at 1 month

  At 1 month from randomization

• Percentage of patients who write advance directives of living at 6 months

  At 6 months from randomization

• Overall survival

  Up to 6 months

• Received anti-cancer treatment

  up to 6 months

• Patients living trajectory

  up to 6 months

Study Arms (2)

Advance Care Planning Intervention

EXPERIMENTAL

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

Standard cares

NO INTERVENTION

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.

Interventions

Advance Care Planning Intervention OTHER

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

Advance Care Planning Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

Related 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.

  PMID: 32739563 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: December 29, 2023
• Primary Completion: December 29, 2024
• Study Completion: December 29, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)