NCT02852629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

February 15, 2016

Last Update Submit

September 15, 2017

Conditions

Lung Cancer

Keywords

decision-support sheet

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patient feeling assessment using phone interview questionnaire

    3 months after patient inclusion

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

    first day

Interventions

observational studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung cancer patients will be recruited in the appreciation of the doctor (Md) of the service

You may qualify if:

  • 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.

You may not qualify if:

  • Minor patient
  • Refusal of participation of the patient in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (5)

  • 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.

    PMID: 25618207BACKGROUND

  • 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.

    PMID: 25323247BACKGROUND

  • 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.

    PMID: 20332506BACKGROUND

  • 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.

    PMID: 23765237BACKGROUND

  • 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.

    PMID: 31927479DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

August 2, 2016

Study Start

February 1, 2014

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

September 18, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)