Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients

Completed

• Conditions: Lung Cancer

• Registration Number: NCT02852629
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Observational two year study to evaluate the utility of a decision-support sheet on how to proceed in case of aggravation of a patient's condition with advanced disease.

Detailed Description

Prospective and multicenter study conducted in the Rhône-Alpes-Auvergne area. All patients suffering from lung cancer admitted to a pulmonology unit in 2014 will be included. This document will be used if a decision to withhold life-sustaining treatment is decided. Investigators will assess the relationship between the planned intensity of care and those established when the patient develops an organ failure. Patient characteristics and factors associated with proposed levels and types of care will be analyzed. Patient and family opinions will be obtained after 3 months. The number of subjects is 468.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2016-02-15
• Primary Completion: 2016-03-31
• Study Completion: 2016-03-31
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

Inclusion Criteria

• Any patient with lung cancer, hospitalized in pulmonology unit in one of the participating centers.
• Patient who requires a decision to withhold life-sustaining treatment
• One patient can be included at each hospitalization.

Exclusion Criteria

• Minor patient
• Refusal of participation of the patient in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Emergent Serious Adverse Events	1 year and a half	The main objective of this study is to assess the relationship between the planned intensity of care and those established when the patient develops organ failure. The agreement will be assessed using Cohen's kappa coefficient .

Secondary Outcome Measures

Name	Time	Method
Patient feeling assessment using phone interview questionnaire	3 months after patient inclusion	Patients will be contacted by the investigator, to evaluate their feeling according to the collect of their opinion and wishes using a phone interview questionnaire within 30 minutes duration
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	first day	assessment at inclusion

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France