ClinicalTrials.gg
TerminatedNCT03328065EOLEUpdated Apr 21, 2022

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

An observational study in Non-resectable Metastatic Cancer of the Lung, Non-resectable Metastatic Cancer of the Colon and Non-resectable Metastatic Cancer of the Rectosigmoid Junction, sponsored by Centre Hospitalier Universitaire Dijon. Terminated at 1 site in France. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Why this study was terminated
lack of inclusion
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
36
Sex
All
01

Study 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.

02

Conditions 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
03

In context

Bile Duct Neoplasms

254 studies on the registry are indexed under Bile Duct Neoplasms; 44 are open to participants now.

This study's enrollment of 36 is below the median of 216 across 42 observational studies indexed under Bile Duct Neoplasms.

Browse Bile Duct Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

hospitalized patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
36 participants (actual)
Patient registry
No

Groups and cohorts

  • Stable patients, early responders to treatment and caregivers

    Other: Interviews · Other: Questionnaires

  • Stable patients and intermediate responders and c

    Stable patients and intermediate responders to treatments and caregivers

    Other: Interviews · Other: Questionnaires

  • Doctors

    Other: Interviews · Other: Questionnaires

  • Patients in therapeutic escape and their caregivers

    Other: Interviews · Other: Questionnaires

Interventions

  • OtherInterviews

    Semi-directed interviews, recorded and transcribed for analysis

  • OtherQuestionnaires

    economic and psycho-social questionnaires

06

What researchers measure

Primary outcomes

  1. Number of determinants which are privileged by the patients to choose a treatment

    Time frame: through study completion, an average of 18 months

  2. Type of determinants which are privileged by the patients to choose a treatment

    Time frame: through study completion, an average of 18 months

07

Study locations

1 site
  • Chu Dijon Bourogne
    Dijon, 21000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03328065
Responsible party
Sponsor
First posted
Nov 1, 2017
Start date
Dec 19, 2017
Primary completion
Dec 9, 2020
Completion
Dec 19, 2020
Last update
Apr 21, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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