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Completed

NCT Number: NCT05339945

Towards an Early Integration of Palliative Care in Oncology

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.

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Key information

Conditions

Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Palliatives Treatments Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Boulogne-Billancourt, 92100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Auto-evaluation

    Time frame: at baseline

    Evaluation by patient and principal caregiver the health needs.

    Questionnaires: EORTC-QLQ C30

  2. Auto-evaluation

    Time frame: at baseline

    Evaluation by patient and principal caregiver the health needs.

    Questionnaires: SCNS-SF34

  3. Auto-evaluation

    Time frame: at baseline

    Evaluation by patient and principal caregiver the health needs.

    Questionnaires: EPICES

  4. Auto-evaluation

    Time frame: at baseline

    Evaluation by patient and principal caregiver the health needs.

    Questionnaires: Echelle de Zarit.

Secondary outcomes

  1. Description of disease

    Time frame: at baseline

  2. Clinical trajectory description

    Time frame: at baseline

  3. Proportion (%) of patients needing palliative treatment

    Time frame: at the end of study

  4. Survivor (%)

    Time frame: at 1 year

    Vital statute of patients at 1 year

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de France

Registry information

Official study 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

Acronym: BESACE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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