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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 or Lung, or Gastrointestinal Neuroendocrine Tumours (EOLE)

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ClinicalTrials.gov Identifier: NCT03328065
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 Other: Interviews Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 315 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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 or Lung, or Gastrointestinal Neuroendocrine Tumours
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021


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




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
hospitalized patients
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)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328065


Locations
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France
Chu Dijon Bourogne Recruiting
Dijon, France, 21000
Contact: Catherine LEJEUNE    0380293773    catherine.lejeune@u-bourgogne.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03328065    
Other Study ID Numbers: LEJEUNE FdF 2016
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasm Metastasis
Neoplasms, Second Primary
Lung Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Rectal Neoplasms
Bile Duct Neoplasms
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Biliary Tract Neoplasms
Neoplastic Processes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases