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

Lung Cancer Clinical Trial

— CBP-Aggrav  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852629
• Other study ID #: CBP-AGGRAV_CIC
• Status: Completed
• Phase: N/A
• First received: February 15, 2016
• Last updated: September 15, 2017
• Start date: February 2014
• Est. completion date: March 31, 2016

Study information

• Verified date: September 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Other:
• observational study

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345. — View Citation

Garrouste-Orgeas M, Tabah A, Vesin A, Philippart F, Kpodji A, Bruel C, Grégoire C, Max A, Timsit JF, Misset B. The ETHICA study (part II): simulation study of determinants and variability of ICU physician decisions in patients aged 80 or over. Intensive Care Med. 2013 Sep;39(9):1574-83. doi: 10.1007/s00134-013-2977-x. Epub 2013 Jun 14. — View Citation

Toffart AC, Pizarro CA, Schwebel C, Sakhri L, Minet C, Duruisseaux M, Azoulay E, Moro-Sibilot D, Timsit JF. Selection criteria for intensive care unit referral of lung cancer patients: a pilot study. Eur Respir J. 2015 Feb;45(2):491-500. doi: 10.1183/09031936.00118114. Epub 2014 Oct 16. — View Citation

Toffart AC, Sakhri L, Girard N, Couraud S, Merle P, Fournel P, Perol M, Souquet PJ, Timsit JF, Moro-Sibilot D. [Assessment of a tool for decision making in case of worsening condition of cancer patients]. Rev Mal Respir. 2015 Jan;32(1):66-72. doi: 10.1016/j.rmr.2014.02.006. Epub 2014 Mar 20. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergent Serious Adverse Events	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 .	1 year and a half
Secondary	Patient feeling assessment using phone interview questionnaire	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	3 months after patient inclusion
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	assessment at inclusion	first day