Clinical trial NCT03328065: Viewpoints on the Social Representations and Rationale Concerning the Choices of Patients, Doctors and Caregivers With Regard to the Management of Patients With Non-resectable Metastatic Cancer of the Colon, Stomach, Bile Ducts, Rectum, Pancreas or Lung, or Gastrointestinal Neuroendocrine Tumours
Official title: Viewpoints on the Social Representations and Rationale Concerning the Choices of Patients, Doctors and Caregivers With Regard to the Management of Patients With Non-resectable Metastatic Cancer of the Colon, Stomach, Bile Ducts, Rectum, Pancreas or Lung, or Gastrointestinal Neuroendocrine Tumours
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-resectable Metastatic Cancer of the Lung
Non-resectable Metastatic Cancer of the Colon
Non-resectable Metastatic Cancer of the Rectosigmoid Junction
Non-resectable Metastatic Cancer of the Stomach
Non-resectable Metastatic Cancer of the Bile Duct
Non-resectable Metastatic Cancer of the Rectum
Non-resectable Metastatic Cancer of Gastrointestinal Neuroendocrine Tumour
Non-resecable Metastatic Cancer of the Pancreas
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of determinants which are privileged by the patients to choose a treatment
timeFrame: through study completion, an average of 18 months
measure: Type of determinants which are privileged by the patients to choose a treatment
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: