Viewpoints on the Social Representations and Rationale Co... | NCT03328065

Studies
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

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Terminated

Last Update Posted

Apr 21, 2022Actual

Enrollment

36Actual

Phase

Not provided

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

Interventions

Interviews
Questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of inclusion

Expanded Access Info

Start Date

Dec 19, 2017Actual

Primary Completion Date

Dec 9, 2020Actual

Completion Date

Dec 19, 2020Actual

First Submitted Date

Oct 4, 2017

First Submission Date that Met QC Criteria

Oct 27, 2017

First Posted Date

Nov 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2022

Last Update Posted Date

Apr 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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) 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

hospitalized patients

Sampling Method

Non-Probability Sample

ID	Term
D007407	Interviews as Topic
D011795	Surveys and Questionnaires

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D011634	Public Health
D004778	Environment and Public Health