- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04517773
"Patient Autonomie" in People With Cancer (AUPAC)
Study Overview
Detailed Description
In France, the notion of autonomy concerning the patient's place in the healthcare system has been written into legal texts for several years (Loi Kouchner, 2002; Loi Leonetti, 2005; Loi Leonetti-Claeys, 2016, etc.) . In addition,government policies are trying to adapt a strategy for transforming the health system. One of the priorities is to place "the patient at the heart of the system ". This orientation of positioning the patient at the center of the healthcare system taken by the Government, proves the importance of a contemporary reflection on the subject of the patient's autonomy. This notion is also fully recognized in our society and in the medical field by caregivers. Indeed, it constitutes a fundamental right of respect for the patient to decide for himself - in particular at the level of his health - what seems to be suitable, his therapeutic plan, his care, etc. However, the notion of autonomy is polysemous and complex. There is no unambiguous definition given the existence of plural conceptions of autonomy, especially in the field of psychology. Thus, through the literature, it can be understood as a psychological state, a personality variable, an attitude, a value, even a standard (Auzoult, 2008).
Given its omnipresence in public health, legislative, ethical, institutional as well as among caregivers, the investigators assume in our study that autonomy could be the object of social valuation and thus be understood as a shared norm. and conveyed. (Dubois & Beauvois, 2002). Norms are defined in particular as "cultural rules which guide behavior in a society" (Ross, 1973). In this perspective, the investigators can rely on the results of the work of Sonia Hadj Cherif's thesis on the "representation of the autonomous patient in decision-making in the context of recurrence". In this questionnaire survey of physicians practicing in oncology, the participants were asked to perform a verbal association task inviting them to evoke the 5 words or expressions that came to their mind following the inductive word "autonomous patient". The most salient elements associated with autonomy were: a good general state, management of daily life, valid, capacity for comprehension, hygiene, cognitive capacities preserved, movement, etc., thus representing the "autonomous patient" as a patient with all of his physical, motor and intellectual capacities. It is thus a functional autonomy in which the recognition of the patient depends first of all on his capacity to act and to do, which seems to prevail in medical discourse. Based on these findings, it would be interesting to study the autonomy perceived by the patient himself.
To do this, in our research, we will build a questionnaire intended for patients, the first part of which will be composed of a series of questions relating to the most significant associated words and their associated values for each patient to define his own representation of the "autonomous patient". The second part of the questionnaire will consist of three sub-questionnaires including items relating to patient autonomy. The items of these three questionnaires will be identical in all respects. Only the instruction requested from the patient will differ. In fact, patients will first of all be asked to respond as authentically as possible in order to situate their own perceived autonomy . Secondly, they will have to respond with a fictitious perspective of giving their doctor a favorable image of themselves. Finally, as a last step, they will have to give an unfavorable image of themselves to their doctor. These questionnaires will allow us to know whether cancer patients use different self-presentation strategies depending on whether they present to themselves, or to their doctor.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All types of cancer;
- Minimum18 years old;
- Patients treated on the Paoli-Calmettes Institute;
- Non-objection of the patient following the information provided;
- Able to Read and understand;
- French Speaker;
- Affiliation to a social security scheme, or beneficiary of such a scheme.
Exclusion Criteria:
- cognitive disorders ;
- Patients at the end of their life.
- Person in an emergency situation, or unable to express a non-opposition.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
study group
Oncological patients
|
Patients will be invitated to fill a questionary about self-autonomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
words representing autonomy
Time Frame: day 0
|
patient will write 5 words meaning autonomy for himself
|
day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
comparaition of "patients autonomy" for doctors and "patients autonomy" for patients
Time Frame: day 0
|
day 0
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUPAC-IPC 2020-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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