EOLE: 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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Terminated

CT.gov ID

NCT03328065

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Interviews Other: Questionnaires

Study Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 19, 2017

Actual Primary Completion Date :

Dec 9, 2020

Actual Study Completion Date :

Dec 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Stable patients, early responders to treatment and caregivers	Other: Interviews Semi-directed interviews, recorded and transcribed for analysis Other: Questionnaires economic and psycho-social questionnaires
Stable patients and intermediate responders and c Stable patients and intermediate responders to treatments and caregivers	Other: Interviews Semi-directed interviews, recorded and transcribed for analysis Other: Questionnaires economic and psycho-social questionnaires
Doctors	Other: Interviews Semi-directed interviews, recorded and transcribed for analysis Other: Questionnaires economic and psycho-social questionnaires
Patients in therapeutic escape and their caregivers	Other: Interviews Semi-directed interviews, recorded and transcribed for analysis Other: Questionnaires economic and psycho-social questionnaires

Outcome Measures

Primary Outcome Measures

Number of determinants which are privileged by the patients to choose a treatment [through study completion, an average of 18 months]
Type of determinants which are privileged by the patients to choose a treatment [through study completion, an average of 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.