BESACE: Towards an Early Integration of Palliative Care in Oncology

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05339945

Collaborator

Fondation de France (Other)

400

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer Palliatives Treatments

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

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Outcome Measures

Primary Outcome Measures

Auto-evaluation [at baseline]
Evaluation by patient and principal caregiver the health needs. Questionnaires: EORTC-QLQ C30
Auto-evaluation [at baseline]
Evaluation by patient and principal caregiver the health needs. Questionnaires: SCNS-SF34
Auto-evaluation [at baseline]
Evaluation by patient and principal caregiver the health needs. Questionnaires: EPICES
Auto-evaluation [at baseline]
Evaluation by patient and principal caregiver the health needs. Questionnaires: Echelle de Zarit.

Secondary Outcome Measures

Description of disease [at baseline]
Clinical trajectory description [at baseline]
Proportion (%) of patients needing palliative treatment [at the end of study]
Survivor (%) [at 1 year]
Vital statute of patients at 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.