Evaluation of End of Life Quality of Care

NCT03775304 | Completed

• 1 other identifier: NI10031
• Study Type: observational
• Target: 997
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Neoplasm Malignant; Quality of Life; End of Life Care

Outcome Measures

Primary Outcomes (1)

• Use of emergency services within last 30 days before death

  Through study completion, up to 1 year

Secondary Outcomes (5)

• Patients received chemotherapy in the last 14 days of life

  Through study completion, up to 1 year

• Location of death

  Through study completion, up to 1 year

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

  Through study completion, up to 1 year

• Admission in intensive care unit within last 30 days before death

  Through study completion, up to 1 year

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

  Through study completion, up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients deceased in 2010, among all patients identified in the DRG database of the 5 participating center with a diagnosis of metastatic cancer, during at least one stay between Oct 1st, 2009 and Dec 31, 2010. 200 patients per study center were randomly selected for the study.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (5)

APHP Hôpital Cochin

Paris, France

Location

APHP Hôpital Européen Georges Pompidou

Paris, France

Location

APHP Hôpital Henri Mondor

Paris, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Institut Curie

Paris, Île-de-France Region, 75005, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 13, 2018
• Study Start: January 1, 2011
• Primary Completion: December 15, 2015
• Study Completion: December 15, 2015
• Last Updated: December 13, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)