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PsychologicalAUPACNCT04517773

"Patient Autonomie" in People With Cancer

An observational study of Psychological and Oncology, run by Institut Paoli-Calmettes.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT04517773
Study groupRoleWhat they receive
study groupOncological patients
Receives: Other: writting test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. words representing autonomy

    patient will write 5 words meaning autonomy for himself

    Measured: day 0

Secondary outcomes (1)
  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.

  1. First posted18 Aug 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionMar 2021 (estimated)
  4. Study completionMar 2021 (estimated)

Resources

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)
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

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.

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