Clinical trial · Observational
Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients
NCT02852629CI-TRIAL-00029585CBP-AggravcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Emergent Serious Adverse Events
- timeFrame
- 1 year and a half
- description
- 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 (2)
- measure
- Patient feeling assessment using phone interview questionnaire
- timeFrame
- 3 months after patient inclusion
- description
- 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
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- first day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDToffart 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. PMID 25618207
- BACKGROUNDToffart 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. PMID 25323247
- BACKGROUNDDetering 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. PMID 20332506
- BACKGROUNDGarrouste-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. PMID 23765237
- DERIVEDDenis 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. PMID 31927479