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Completed

NCT Number: NCT03775304

Evaluation of End of Life Quality of Care

The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records.

The study was approved by the French data protection authority (CNIL) number 611273.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Curie, Paris, Île-de-France Region, France

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Who can participate

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

Inclusion criteria

  • Patients aged ≥ 18,
  • diagnosed with advanced cancer (recruited from hospital activity data, by a stay with a ICD code of metastatic cancer between Oct 1st, 2009 and Dec 31, 2010)
  • deceased between, Jan 1st, 2010 and Dec 31, 2010 (vital status identified either from hospital activity data, or from national mortality statistics)

Exclusion criteria

  • diagnosis with non solid tumor (haematology)
  • age < 18

Treatment and study plan

Primary outcomes

  1. Use of emergency services within last 30 days before death

    Time frame: Through study completion, up to 1 year

Secondary outcomes

  1. Patients received chemotherapy in the last 14 days of life

    Time frame: Through study completion, up to 1 year

  2. Location of death

    Time frame: Through study completion, up to 1 year

  3. Among patients who died in palliative care unit, those who died within 3 days after admission

    Time frame: Through study completion, up to 1 year

  4. Admission in intensive care unit within last 30 days before death

    Time frame: Through study completion, up to 1 year

  5. Among patients with pain relief opioid treatment, those with combined short term and long acting opioid orders

    Time frame: Through study completion, up to 1 year

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evaluation of the Relevance Indicators of Quality of Care for Dying Patients Based on Analysis of Care and Follow-up Course of the Leonetti Law. EFIQUAVIE Study

Acronym: EFIQUAVIE

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2018
Registry last updated
Dec 13, 2018

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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