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 Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03328065
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire Dijon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Arms & Interventions

Arms

: Stable patients, early responders to treatment and caregivers

: Stable patients and intermediate responders and c

Stable patients and intermediate responders to treatments and caregivers

: Doctors

: Patients in therapeutic escape and their caregivers

Interventions

Other: - Interviews

Semi-directed interviews, recorded and transcribed for analysis

Other: - Questionnaires

economic and psycho-social questionnaires

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chu Dijon Bourogne, Dijon, France

Status

Recruiting

Address

Chu Dijon Bourogne

Dijon, , 21000

Site Contact

Catherine LEJEUNE

catherine.lejeune@u-bourgogne.fr

0380293773

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