Towards an Early Integration of Palliative Care in Oncology (BESACE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: 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 Type: Observational
• Enrollment (Actual): 361

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with diagnosed metastatic cancer.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auto-evaluation	Evaluation by patient and principal caregiver the health needs. Questionnaires: EORTC-QLQ C30	at baseline
Auto-evaluation	Evaluation by patient and principal caregiver the health needs. Questionnaires: SCNS-SF34	at baseline
Auto-evaluation	Evaluation by patient and principal caregiver the health needs. Questionnaires: EPICES	at baseline
Auto-evaluation	Evaluation by patient and principal caregiver the health needs. Questionnaires: Echelle de Zarit.	at baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Fondation de France
• Investigators: Principal Investigator: Marine SAHUT D'IZARN, MD, Mobile palliative care and support team, Ambroise Paré hospital, APHP

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: palliative care; oncology; metastatic cancer; health needs; early integration
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
• Other Study ID Numbers: APHP210724; 2021-A01007-34 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No