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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02852629
Acronym
CBP-Aggrav
Enrollment
483
Registered
2016-08-02
Start date
2014-02-28
Completion date
2016-03-31
Last updated
2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

decision-support sheet

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.

Interventions

OTHERobservational study

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emergent Serious Adverse Events1 year and a halfThe 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

MeasureTime frameDescription
Patient feeling assessment using phone interview questionnaire3 months after patient inclusionPatients 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 v4.0first dayassessment at inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026