Towards an Early Integration of Palliative Care in Oncology

Metastatic Cancer Clinical Trial

— BESACE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05339945
• Other study ID #: APHP210724
• Secondary ID: 2021-A01007-34
• Status: Active, not recruiting
• Start date: June 2, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 361
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Locations

Country	Name	City	State
France	Mobile palliative care and support team, Ambroise Paré hospital, APHP	Boulogne-Billancourt

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auto-evaluation	Evaluation by patient and principal caregiver the health needs.; Questionnaires: EORTC-QLQ C30	at baseline
Primary	Auto-evaluation	Evaluation by patient and principal caregiver the health needs.; Questionnaires: SCNS-SF34	at baseline
Primary	Auto-evaluation	Evaluation by patient and principal caregiver the health needs.; Questionnaires: EPICES	at baseline
Primary	Auto-evaluation	Evaluation by patient and principal caregiver the health needs.; Questionnaires: Echelle de Zarit.	at baseline
Secondary	Description of disease		at baseline
Secondary	Clinical trajectory description		at baseline
Secondary	Proportion (%) of patients needing palliative treatment		at the end of study
Secondary	Survivor (%)	Vital statute of patients at 1 year	at 1 year