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

Terminated

• Conditions: Non-resectable Metastatic Cancer of the Bile Duct; Non-resectable Metastatic Cancer of Gastrointestinal Neuroendocrine Tumour; 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 Rectum; Non-resecable Metastatic Cancer of the Pancreas
• Interventions: Other: Interviews; Other: Questionnaires

• Registration Number: NCT03328065
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2017-12-19
• Primary Completion: 2020-12-09
• Study Completion: 2020-12-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Doctors	Questionnaires	-
Stable patients, early responders to treatment and caregivers	Interviews	-
Stable patients, early responders to treatment and caregivers	Questionnaires	-
Stable patients and intermediate responders and c	Interviews	Stable patients and intermediate responders to treatments and caregivers
Patients in therapeutic escape and their caregivers	Interviews	-
Doctors	Interviews	-
Patients in therapeutic escape and their caregivers	Questionnaires	-
Stable patients and intermediate responders and c	Questionnaires	Stable patients and intermediate responders to treatments and caregivers

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France