Metastatic CancerBESACENCT05339945
Towards an Early Integration of Palliative Care in Oncology
An observational study of Metastatic Cancer and Palliatives Treatments, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study is to describe the nature and to estimate the prevalence the health needs of patients with metastatic cancer and their main caregivers, between the period from diagnosis to death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Palliatives Treatments
- How many people
- 361 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2022to 21 Oct 2024
- Phase
- Observational
- 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
Study population: Adult patients with diagnosed metastatic cancer.
Who may be able to join
- Patients ≥ 18 years;
- Diagnosed metastatic cancer;
- Outpatient or inpatient care at a participating site to the study;
- Affiliation to the social security scheme;
- Patient informed and non-opposed to participate to the study.
Who cannot join
- Testicular or choriocarcinoma ovarian cancer;
- Hematology cancer;
- No understanding french language;
- Unable to express if needed his non-opposition opinion, according to physician investigator;
- Visually impaired, hearing impaired or aphasic.
Trial locations and contacts
1 site in 1 country.
France1 site
Mobile palliative care and support team, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100
About this study
Official title: Towards an Early Integration of Palliative Care in Oncology: Descriptive Study of Needs for Patients With Metastatic Cancer and the Adequacy of These Needs With Healthcare Facilities
The primary objective of the study is to describe the nature and to estimate the prevalence the health needs of patients with metastatic cancer and their main caregivers, between the period from diagnosis to death.
As secondary objectives, the study aims:
- to determinate the proportion of patients with an indication for palliative care according to Hui et al., and to describe the adequation of health needs and the services for them;
- to study the association between clinical pathway and the indication of targeted palliative care;
- to study the association between the integration of palliative care service and the adequation of health needs service of patients;
- to study the factors such as the disease, the practice and the care, contribute to the patient's survivor of 1 year.
Read the detailed description
This is a descriptive, transversal, multicenter study, which will be performed in healthcare facilities in Ile de France area.
Each investigator center will be composed by oncologist / palliative care and support team. 10 centers will participate to the study, enrollement will be perfomed during 6 months targetting 400 patients with advanced cancer.
- Conditions
- Metastatic Cancer, Palliatives Treatments
- Keywords
- metastatic cancer, palliative care, oncology, health needs, early integration
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Auto-evaluation
Evaluation by patient and principal caregiver the health needs.
Questionnaires: EORTC-QLQ C30
Measured: at baseline
Auto-evaluation
Evaluation by patient and principal caregiver the health needs.
Questionnaires: SCNS-SF34
Measured: at baseline
Auto-evaluation
Evaluation by patient and principal caregiver the health needs.
Questionnaires: EPICES
Measured: at baseline
Auto-evaluation
Evaluation by patient and principal caregiver the health needs.
Questionnaires: Echelle de Zarit.
Measured: at baseline
Secondary outcomes (4)
Description of disease
Measured: at baseline
Clinical trajectory description
Measured: at baseline
Proportion (%) of patients needing palliative treatment
Measured: at the end of study
Survivor (%)
Vital statute of patients at 1 year
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start2 Jun 2022
- Primary completion10 May 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- Marine SAHUT D'IZARN, MD, Principal investigator, Mobile palliative care and support team, Ambroise Paré hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339945
- Sponsor's protocol ID
- APHP210724
- Other IDs
- 2021-A01007-34
- Acronym
- BESACE
- Status last verified
- Nov 2024
- First submitted
- 6 Apr 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hui D, Mori M, Watanabe SM, Caraceni A, Strasser F, Saarto T, Cherny N, Glare P, Kaasa S, Bruera E. Referral criteria for outpatient specialty palliative cancer care: an international consensus. Lancet Oncol. 2016 Dec;17(12):e552-e559. doi: 10.1016/S1470-2045(16)30577-0.
PubMed 27924753Sahut d'Izarn M, Vinant P, Bouleuc C, Joffin I, Vincent B, Barth C, Serresse L, Codogno A, Behal F, Ya-de Rauglaudre L, Jacota M, Gassama M, de Stampa M. Healthcare needs of patients with metastatic cancer and impacts of social vulnerability: a multicentric cross-sectional study in France. BMC Palliat Care. 2025 Sep 29;24(1):233. doi: 10.1186/s12904-025-01882-4.
PubMed 41024046
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards an Early Integration of Palliative Care in Oncology: Descriptive Study of Needs for Patients With Metastatic Cancer and the Adequacy of These Needs With Healthcare Facilities
- ClinicalTrials.gov ID
- NCT05339945
- Acronym / sponsor ID
- BESACE / APHP210724
- Conditions
- Metastatic Cancer, Palliatives Treatments
- Keywords
- metastatic cancer, palliative care, oncology, health needs, early integration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 21 Apr 2022 (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.
The primary objective of the study is to describe the nature and to estimate the prevalence the health needs of patients with metastatic cancer and their main caregivers, between the period from diagnosis to death.
As secondary objectives, the study aims:
- to determinate the proportion of patients with an indication for palliative care according to Hui et al., and to describe the adequation of health needs and the services for them;
- to study the association between clinical pathway and the indication of targeted palliative care;
- to study the association between the integration of palliative care service and the adequation of health needs service of patients;
- to study the factors such as the disease, the practice and the care, contribute to the patient's survivor of 1 year.
Detailed description
This is a descriptive, transversal, multicenter study, which will be performed in healthcare facilities in Ile de France area.
Each investigator center will be composed by oncologist / palliative care and support team. 10 centers will participate to the study, enrollement will be perfomed during 6 months targetting 400 patients with advanced cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosed metastatic cancer.
Key inclusion criteria (5 listed)
- Patients ≥ 18 years;
- Diagnosed metastatic cancer;
- Outpatient or inpatient care at a participating site to the study;
- Affiliation to the social security scheme;
- Patient informed and non-opposed to participate to the study.
Key exclusion criteria (5 listed)
- Testicular or choriocarcinoma ovarian cancer;
- Hematology cancer;
- No understanding french language;
- Unable to express if needed his non-opposition opinion, according to physician investigator;
- Visually impaired, hearing impaired or aphasic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Auto-evaluation
Time frame: at baseline
Evaluation by patient and principal caregiver the health needs. Questionnaires: EORTC-QLQ C30
Auto-evaluation
Time frame: at baseline
Evaluation by patient and principal caregiver the health needs. Questionnaires: SCNS-SF34
Auto-evaluation
Time frame: at baseline
Evaluation by patient and principal caregiver the health needs. Questionnaires: EPICES
Auto-evaluation
Time frame: at baseline
Evaluation by patient and principal caregiver the health needs. Questionnaires: Echelle de Zarit.
4 secondary outcomes
Description of disease
Time frame: at baseline
Clinical trajectory description
Time frame: at baseline
Proportion (%) of patients needing palliative treatment
Time frame: at the end of study
Survivor (%)
Time frame: at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 27924753Hui D, Mori M, Watanabe SM, Caraceni A, Strasser F, Saarto T, Cherny N, Glare P, Kaasa S, Bruera E. Referral criteria for outpatient specialty palliative cancer care: an international consensus. Lancet Oncol. 2016 Dec;17(12):e552-e559. doi: 10.1016/S1470-2045(16)30577-0.
- Derived from this study: PubMed 41024046Sahut d'Izarn M, Vinant P, Bouleuc C, Joffin I, Vincent B, Barth C, Serresse L, Codogno A, Behal F, Ya-de Rauglaudre L, Jacota M, Gassama M, de Stampa M. Healthcare needs of patients with metastatic cancer and impacts of social vulnerability: a multicentric cross-sectional study in France. BMC Palliat Care. 2025 Sep 29;24(1):233. doi: 10.1186/s12904-025-01882-4.
- 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.
Marine SAHUT D'IZARN, MD principal investigator
Mobile palliative care and support team, Ambroise Paré hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Palliatives Treatments, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 4 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auto-evaluation (time frame: at baseline). The study lists 4 primary outcomes in all. 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 NCT05339945, which also lists 2 linked publications.
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 4 Dec 2024.