PsychologicalAUPACNCT04517773
"Patient Autonomie" in People With Cancer
An observational study of Psychological and Oncology, run by Institut Paoli-Calmettes.
Trial summary
In France, the notion of autonomy concerning the patient's place in the healthcare system has been written into legal texts for several years. This notion is also fully recognized in our society and in the medical field by caregivers. However, the notion of autonomy is polysemous and complex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological, Oncology
- What is being tested?
- writting test
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncological patients
Who may be able to join
- 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.
Who cannot join
- cognitive disorders ;
- Patients at the end of their life.
- Person in an emergency situation, or unable to express a non-opposition.
About this study
In France, the notion of autonomy concerning the patient's place in the healthcare system has been written into legal texts for several years. This notion is also fully recognized in our society and in the medical field by caregivers. 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. A precedent thesis on the "representation of the autonomous patient in decision-making in the context of recurrence". Physicians practicing in oncology have been 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 results shows that for doctors, the "autonomous patient" is a patient with all of his physical, motor and intellectual capacities. Based on these findings, it would be interesting to study the autonomy perceived by the patient himself.
Read the 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.
- Conditions
- Psychological, Oncology
- Being tested
- writting test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
writting testOther
Patients will be invitated to fill a questionary about self-autonomy
| Study group | Role | What they receive |
|---|---|---|
| study group | Oncological patients Receives: Other: writting test |
What is being measured
The primary outcome is the main question the study is designed to answer.
words representing autonomy
patient will write 5 words meaning autonomy for himself
Measured: day 0
Secondary outcomes (1)
comparaition of "patients autonomy" for doctors and "patients autonomy" for patients
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study startDec 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- University of Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517773
- Sponsor's protocol ID
- AUPAC-IPC 2020-008
- Acronym
- AUPAC
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Patient Autonomie" in People With Cancer
- ClinicalTrials.gov ID
- NCT04517773
- Acronym / sponsor ID
- AUPAC / AUPAC-IPC 2020-008
- Conditions
- Psychological, Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- University of Marseille
- Study start
- Dec 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 18 Aug 2020 (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.
In France, the notion of autonomy concerning the patient's place in the healthcare system has been written into legal texts for several years. This notion is also fully recognized in our society and in the medical field by caregivers. 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. A precedent thesis on the "representation of the autonomous patient in decision-making in the context of recurrence". Physicians practicing in oncology have been 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 results shows that for doctors, the "autonomous patient" is a patient with all of his physical, motor and intellectual capacities. Based on these findings, it would be interesting to study the autonomy perceived by the patient himself.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: writting testOncological patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncological patients
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- cognitive disorders ;
- Patients at the end of their life.
- Person in an emergency situation, or unable to express a non-opposition.
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 |
|---|---|---|
| writting testPatients will be invitated to fill a questionary about self-autonomy | Other | study group |
Primary outcome
words representing autonomy
Time frame: day 0
patient will write 5 words meaning autonomy for himself
1 secondary outcome
comparaition of "patients autonomy" for doctors and "patients autonomy" for patients
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological and Oncology, run by Institut Paoli-Calmettes.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
words representing autonomy (time frame: day 0). 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 18 Aug 2020.