NeoplasmsPREVOIRNCT06149312
Feasibility of an Advance Care Planning Intervention
A study testing Advance Care Planning Intervention in people with Neoplasms, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Advance Care Planning Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 29 Dec 2023to 29 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Comprehension problems
- Patients without social security
- Allophone patients
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Claire VIT, (0)3 68 33 95 23 ext. +33, promotion-rc@icans.eu
Manon VOEGELIN
About this study
Official title: A Prospective, Randomized Trial Assessing the Feasibility of an Advance Care Planning Intervention for Patients Hospitalized in a French Cancer Center
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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- Advance Care Planning Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care Planning InterventionOther
Standardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who write advance directives of living at 3 months
Measured: At 3 months from randomization
Secondary outcomes (5)
Percentage of patients who write advance directives of living at 1 month
Measured: At 1 month from randomization
Percentage of patients who write advance directives of living at 6 months
Measured: At 6 months from randomization
Overall survival
Measured: Up to 6 months
Received anti-cancer treatment
Prevalence of antineoplastic treatment received within the 3 months that precede death
Measured: up to 6 months
Patients living trajectory
Recording of patient site of death, if applicable
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start29 Dec 2023
- Primary completion29 Dec 2024 (estimated)
- Study completion29 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149312
- Sponsor's protocol ID
- 2023-018
- Other IDs
- 2023-A02045-40
- Acronym
- PREVOIR
- Status last verified
- Mar 2024
- First submitted
- 20 Nov 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32739563
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Assessing the Feasibility of an Advance Care Planning Intervention for Patients Hospitalized in a French Cancer Center
- ClinicalTrials.gov ID
- NCT06149312
- Acronym / sponsor ID
- PREVOIR / 2023-018
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 29 Dec 2024 (estimated)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance Care Planning Intervention | Experimental | Other: Advance Care Planning InterventionPatients from experimental arm will benefit from a Standardized Advance Care Planning interview alone or in the presence of relatives within 3 days after randomization. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Care Planning InterventionStandardized interview based on The letter Project (Stanford Medicine) and Questions Prompt List | Other | Advance Care Planning Intervention |
Primary outcome
Percentage of patients who write advance directives of living at 3 months
Time frame: At 3 months from randomization
5 secondary outcomes
Percentage of patients who write advance directives of living at 1 month
Time frame: At 1 month from randomization
Percentage of patients who write advance directives of living at 6 months
Time frame: At 6 months from randomization
Overall survival
Time frame: Up to 6 months
Received anti-cancer treatment
Time frame: up to 6 months
Patients living trajectory
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 32739563Bouleuc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Institut de cancérologie Strasbourg Europe
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance Care Planning Intervention in people with Neoplasms, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who write advance directives of living at 3 months (time frame: At 3 months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06149312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.