Clinical trial NCT05339945: Towards an Early Integration of Palliative Care in Oncology
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Palliatives Treatments
Keywords: metastatic cancer
palliative care
oncology
health needs
early integration
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2022-04-21
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with diagnosed metastatic cancer.

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Auto-evaluation
timeFrame: at baseline
measure: Auto-evaluation
timeFrame: at baseline
measure: Auto-evaluation
timeFrame: at baseline
measure: Auto-evaluation
timeFrame: at baseline
Secondary outcomes:
measure: Description of disease
timeFrame: at baseline
measure: Clinical trajectory description
timeFrame: at baseline
measure: Proportion (%) of patients needing palliative treatment
timeFrame: at the end of study
measure: Survivor (%)
timeFrame: at 1 year
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Mobile palliative care and support team, Ambroise Paré hospital, APHP
Study officials:
affiliation: Mobile palliative care and support team, Ambroise Paré hospital, APHP
name: Marine SAHUT D'IZARN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.