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Completed

NCT Number: NCT02852629

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

observational study

Other

Primary outcomes

  1. Emergent Serious Adverse Events

    Time frame: 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 outcomes

  1. Patient feeling assessment using phone interview questionnaire

    Time frame: 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

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: first day

    assessment at inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: CBP-Aggrav

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2016
Registry last updated
Sep 18, 2017

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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