Towards an Early Integration of Palliative Care in Oncology

NCT05339945 | Completed

• 2 other identifiers: APHP2107242021-A01007-34
• Study Type: observational
• Target: 361
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Palliatives Treatments

Keywords

metastatic cancer; palliative care; oncology; health needs; early integration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with diagnosed metastatic cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation de France: collaborator

Study Sites (1)

Mobile palliative care and support team, Ambroise Paré hospital, APHP

Boulogne-Billancourt, 92100, France

Location

Related Publications (2)

• 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.

  PMID: 27924753 BACKGROUND

• 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.

  PMID: 41024046 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marine SAHUT D'IZARN, MD

  Mobile palliative care and support team, Ambroise Paré hospital, APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 21, 2022
• Study Start: June 2, 2022
• Primary Completion: May 10, 2024
• Study Completion: October 21, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)