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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03328065
Other study ID # LEJEUNE FdF 2016
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 19, 2017
Est. completion date December 19, 2020

Study information

Verified date April 2022
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Reflexion on the therapeutic strategies to implement in patients at the end of life is advancing rapidly in France. However, beyond the choices presented to patients, sometimes even the decision to carry on, to limit or to stop treatments is also questioned. This decision is subjective; it is influenced by the patient's representation system (emotions, beliefs, values, practices, etc). In addition, even though he or she is the focus of the decision, the patient is not alone; other actors, accompanying the patient, play an important role in the final decision making. These actors, namely the doctors and close relatives, are also influenced in their decision making. This coexistence of representation systems may interfere with objective indicators that help in decision making (functional, clinical and biological) or with the knowledge acquired by doctors in their training and may complicate the decision-making process.


Recruitment information / eligibility

Status Terminated
Enrollment 36
Est. completion date December 19, 2020
Est. primary completion date December 9, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: I- PATIENTS - men or women - who have been informed about the study - and who have provided verbal consent to take part in the study - able to understand written and spoken French - with non-resectable metastatic cancer of: the colon, or the rectosigmoid junction or the stomach or bile ducts or rectum or gastrointestinal neuroendocrine tumor or lung (not small-cell cancer) or pancreas - with a caregiver designated as the principal caregiver (family, friend, neighbour) - who has consented to the principal caregiver taking part in a qualitative interview - able to take part in an interview lasting roughly one hour II- CAREGIVERS - men or women - who have been informed about the study - who have provided verbal consent to take part in the study - able to understand written and spoken French - able to follow an interview lasting roughly one hour III-DOCTORS - men or women - who have been informed about the study - who have provided verbal consent to take part in the study - specialised in specific organ or oncologist prescriber Exclusion Criteria: I- PATIENTS - under guardianship or ward of court - with a severe handicap (neurological disease: Parkinson, Alzheimer, other dementia, multiple sclerosis, severe mental retardation etc.) II- CAREGIVERS - under guardianship or ward of court, - with a severe handicap (neurological disease: Parkinson, Alzheimer, other dementia, multiple sclerosis…), - with severe mental retardation impairing ability to understand.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interviews
Semi-directed interviews, recorded and transcribed for analysis
Questionnaires
economic and psycho-social questionnaires

Locations

Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of determinants which are privileged by the patients to choose a treatment through study completion, an average of 18 months
Primary Type of determinants which are privileged by the patients to choose a treatment through study completion, an average of 18 months