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 (EOLE)

April 14, 2022 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Chu Dijon Bourogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospitalized patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of determinants which are privileged by the patients to choose a treatment
Time Frame: through study completion, an average of 18 months
through study completion, an average of 18 months
Type of determinants which are privileged by the patients to choose a treatment
Time Frame: through study completion, an average of 18 months
through study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2017

Primary Completion (ACTUAL)

December 9, 2020

Study Completion (ACTUAL)

December 19, 2020

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (ACTUAL)

November 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEJEUNE FdF 2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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