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Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients (CBP-Aggrav)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852629
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lung Cancer Other: observational study

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.

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Study Type : Observational
Actual Enrollment : 483 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients
Actual Study Start Date : February 2014
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lung cancer patients will be recruited in the appreciation of the doctor (Md) of the service
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852629


Locations
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France
University Hospital Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02852629    
Other Study ID Numbers: CBP-AGGRAV_CIC
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Grenoble:
decision-support sheet