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CompletedNCT05339945BESACEUpdated Dec 4, 2024

Towards an Early Integration of Palliative Care in Oncology

An observational study in Metastatic Cancer and Palliatives Treatments, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
361
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Metastatic Cancer
  • Palliatives Treatments

Keywords

  • metastatic cancer
  • palliative care
  • oncology
  • health needs
  • early integration
03

In context

Neoplasm Metastasis

3,562 studies on the registry are indexed under Neoplasm Metastasis; 875 are open to participants now.

This study's enrollment of 361 is above the median of 120 across 604 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with diagnosed metastatic cancer.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
361 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Auto-evaluation

    Evaluation by patient and principal caregiver the health needs. Questionnaires: EORTC-QLQ C30

    Time frame: at baseline

  2. Auto-evaluation

    Evaluation by patient and principal caregiver the health needs. Questionnaires: SCNS-SF34

    Time frame: at baseline

  3. Auto-evaluation

    Evaluation by patient and principal caregiver the health needs. Questionnaires: EPICES

    Time frame: at baseline

  4. Auto-evaluation

    Evaluation by patient and principal caregiver the health needs. Questionnaires: Echelle de Zarit.

    Time frame: at baseline

Secondary outcomes

  1. Description of disease

    Time frame: at baseline

  2. Clinical trajectory description

    Time frame: at baseline

  3. Proportion (%) of patients needing palliative treatment

    Time frame: at the end of study

  4. Survivor (%)

    Vital statute of patients at 1 year

    Time frame: at 1 year

07

Study locations

1 site
  • Mobile palliative care and support team, Ambroise Paré hospital, APHP
    Boulogne-Billancourt, 92100, France
08

References and documents

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 27924753 ↗
  • Sahut 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in May 2024, 23 months.

Of 238 non-industry observational studies under Neoplasm Metastasis, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 172. This study's 23 months is below that.

Counting every sponsor, half of 256 studies reached it within 56 months; a quarter within 34 and three quarters within 172.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2022
First posted
Apr 21, 2022
StartActual
Jun 2, 2022
Primary completionActual
May 10, 2024
CompletionActual
Oct 21, 2024
Last update
Dec 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05339945
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de France
Responsible party
Sponsor
First posted
Apr 21, 2022
Start date
Jun 2, 2022
Primary completion
May 10, 2024
Completion
Oct 21, 2024
Last update
Dec 4, 2024

Study contacts

Marine SAHUT D'IZARN, MD
principal investigator · Mobile palliative care and support team, Ambroise Paré hospital, APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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