Non-resectable Metastatic Cancer of the LungEOLENCT03328065
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 of Non-resectable Metastatic Cancer of the Lung and Non-resectable Metastatic Cancer of the Colon, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non-resectable Metastatic Cancer of the Lung, Non-resectable Metastatic Cancer of the Colon, Non-resectable Metastatic Cancer of the Rectosigmoid Junction
- What is being tested?
- Interviews and Questionnaires
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2017to 19 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: hospitalized patients
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Interviews, Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsOther
Semi-directed interviews, recorded and transcribed for analysis
QuestionnairesOther
economic and psycho-social questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Stable patients, early responders to treatment and caregivers | Not described Receives: Other: Interviews; Other: Questionnaires | |
| Stable patients and intermediate responders and c | Stable patients and intermediate responders to treatments and caregivers Receives: Other: Interviews; Other: Questionnaires | |
| Doctors | Not described Receives: Other: Interviews; Other: Questionnaires | |
| Patients in therapeutic escape and their caregivers | Not described Receives: Other: Interviews; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of determinants which are privileged by the patients to choose a treatment
Measured: through study completion, an average of 18 months
Type of determinants which are privileged by the patients to choose a treatment
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start19 Dec 2017
- Primary completion9 Dec 2020
- Study completion19 Dec 2020
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-resectable Metastatic Cancer of the LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328065
- Sponsor's protocol ID
- LEJEUNE FdF 2016
- Acronym
- EOLE
- Status last verified
- Apr 2022
- First submitted
- 4 Oct 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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, Pancreas or Lung, or Gastrointestinal Neuroendocrine Tumours
- ClinicalTrials.gov ID
- NCT03328065
- Acronym / sponsor ID
- EOLE / LEJEUNE FdF 2016
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stable patients, early responders to treatment and caregivers | – | Other: Interviews, Other: Questionnaires |
| Stable patients and intermediate responders and c | – | Other: Interviews, Other: QuestionnairesStable patients and intermediate responders to treatments and caregivers |
| Doctors | – | Other: Interviews, Other: Questionnaires |
| Patients in therapeutic escape and their caregivers | – | Other: Interviews, Other: Questionnaires |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hospitalized patients
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsSemi-directed interviews, recorded and transcribed for analysis | Other | Doctors, Patients in therapeutic escape and their caregivers, Stable patients and intermediate responders and c, Stable patients, early responders to treatment and caregivers |
| Questionnaireseconomic and psycho-social questionnaires | Other | Doctors, Patients in therapeutic escape and their caregivers, Stable patients and intermediate responders and c, Stable patients, early responders to treatment and caregivers |
Primary outcome
Number of determinants which are privileged by the patients to choose a treatment
Time frame: 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
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-resectable Metastatic Cancer of the Lung and Non-resectable Metastatic Cancer of the Colon, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of determinants which are privileged by the patients to choose a treatment (time frame: through study completion, an average of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.