Clinical trial NCT02852629: Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients
Official title: Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: decision-support sheet
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients will be recruited in the appreciation of the doctor (Md) of the service

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.

Eligibility 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

Primary outcomes:
measure: Emergent Serious Adverse Events
timeFrame: 1 year and a half
Secondary outcomes:
measure: Patient feeling assessment using phone interview questionnaire
timeFrame: 3 months after patient inclusion
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: first day
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
References:
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.
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.
citation: 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.
citation: Garrouste-Orgeas M, Tabah A, Vesin A, Philippart F, Kpodji A, Bruel C, Gregoire 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.
citation: Denis N, Timsit JF, Giaj Levra M, Sakhri L, Duruisseaux M, Schwebel C, Merle P, Pinsolle J, Ferrer L, Moro-Sibilot D, Toffart AC. Impact of systematic advanced care planning in lung cancer patients: A prospective study. Respir Med Res. 2020 Mar;77:11-17. doi: 10.1016/j.resmer.2019.09.003. Epub 2019 Oct 28.