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

NCT ID: NCT03328065

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-19

Study Completion Date

2020-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stable patients, early responders to treatment and caregivers

Interviews

Intervention Type OTHER

Semi-directed interviews, recorded and transcribed for analysis

Questionnaires

Intervention Type OTHER

economic and psycho-social questionnaires

Stable patients and intermediate responders and c

Stable patients and intermediate responders to treatments and caregivers

Interviews

Intervention Type OTHER

Semi-directed interviews, recorded and transcribed for analysis

Questionnaires

Intervention Type OTHER

economic and psycho-social questionnaires

Doctors

Interviews

Intervention Type OTHER

Semi-directed interviews, recorded and transcribed for analysis

Questionnaires

Intervention Type OTHER

economic and psycho-social questionnaires

Patients in therapeutic escape and their caregivers

Interviews

Intervention Type OTHER

Semi-directed interviews, recorded and transcribed for analysis

Questionnaires

Intervention Type OTHER

economic and psycho-social questionnaires

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interviews

Semi-directed interviews, recorded and transcribed for analysis

Intervention Type OTHER

Questionnaires

economic and psycho-social questionnaires

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Dijon Bourogne

Dijon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LEJEUNE FdF 2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.