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

NCT03328065 | Terminated

• 1 other identifier: LEJEUNE FdF 2016
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

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

  through study completion, an average of 18 months

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

  through study completion, an average of 18 months

Study Arms (4)

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

Interviews OTHER

Semi-directed interviews, recorded and transcribed for analysis

Doctors; Patients in therapeutic escape and their caregivers; Stable patients and intermediate responders and c; Stable patients, early responders to treatment and caregivers

Questionnaires OTHER

economic and psycho-social questionnaires

Doctors; Patients in therapeutic escape and their caregivers; Stable patients and intermediate responders and c; Stable patients, early responders to treatment and caregivers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospitalized patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Interviews as Topic; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 1, 2017
• Study Start: December 19, 2017
• Primary Completion: December 9, 2020
• Study Completion: December 19, 2020
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

FR (1)