DEprescribing: Perceptions of PAtients Living With Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-28

Study Completion Date

2026-12-29

Brief Summary

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Polymedication in palliative oncology care is a real public health problem. This phenomenon has been shown to increase the risk of iatrogenesis, reduce patients' quality of life and increase healthcare costs. For many years, health policies have been developed in geriatrics to reduce polymedication through deprescription tools.

Recently, palliative care initiatives have been introduced, but without having studied the potential specificities of this population (younger, with a different care dynamic and life trajectory). It is important to better understand this population's perceptions of deprescribing in order to adapt tools/actions to make these approaches more efficient.

The primary aim of this study is to investigate patients' perceptions of deprescribing in palliative cancer care, and the secondary aim is to investigate factors that may influence patients' attitudes and beliefs about deprescribing. At the same time, we will study the psychometric properties of the rPATD (Revised Patients' Attitudes Towards Deprescribing) in this population (a standardized questionnaire validated in geriatric medicine to assess patients' perceptions of deprescription).An ancillary study will be carried out to investigate the link between patients' health literacy and their perception of deprescribing (health literacy is defined as the ability to acquire, understand and use information in ways that promote and maintain good health).

To meet our objectives, we will conduct a 3-year national, prospective, observational, multicenter study with an exploratory sequential mixed design. The study will comprise an initial qualitative phase. Semi-directed individual interviews using a descriptive approach will be carried out (around 25 patients, over an 8-month period). Following analysis of the qualitative data, we will then carry out a quantitative study to determine the distribution of the different profiles within this population and the factors influencing the perception of deprescription. The self-administered questionnaires, rPATD and BMQ (medication beliefs questionnaire), potentially supplemented by other items following analysis of the qualitative data, will be administered to 300 patients (over a 12-month period).The ancillary study will be carried out during this second phase, using a validated self-questionnaire to assess patients' level of literacy.

Thanks to the different results, we will improve our knowledge of the perception of deprescription in palliative oncology care, in order to develop approaches adapted to the specificities of our population to reduce polymedication and thus improve the quality of life of our patients and reduce the risks of iatrogenia.

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Detailed Description

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Conditions

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Deprescribing Palliative Care Oncology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Qualitative study

The study will comprise an initial qualitative phase. Semi-directed individual interviews using a descriptive approach will be carried out (around 25 patients, over an 8-month period).

Semi-directed individual interviews

Intervention Type OTHER

Individual semi-structured interviews (descriptive approach methodology with reflexive thematic analysis)

Quantitative study

Following analysis of the qualitative data, we will then carry out a quantitative study to determine the distribution of the different profiles within this population and the factors influencing the perception of deprescription. The self-administered questionnaires, rPATD and BMQ (medication beliefs questionnaire), potentially supplemented by other items following analysis of the qualitative data, will be administered to 300 patients (over a 12-month period).

The ancillary study will be carried out during this second phase, using a validated self-questionnaire to assess patients' level of literacy.

The self-administered questionnaires, rPATD and BMQ

Intervention Type OTHER

rPATD: The rPATD is a questionnaire validated and adapted in French to assess patients' perceptions of their treatments and deprescribing.

This self-administered questionnaire consists of 22 questions rated on a 5-point Likert scale (scale from 1 to 5, at 1 the patient completely agrees with the questionnaire's proposal, at 5 the patient strongly disagrees with the questionnaire's proposal). Following the analysis of Phase 1 "Qualitative" of the protocol, three additional questions

BMQ French version of the BMQ self-questionnaire, which studies patients' perceptions of medication .

The Beliefs about Medicine Questionnaire (BMQ) is an 18-item self-administered questionnaire designed to explore patient perceptions of medicine. It has been validated in French and is free to use.

It comprises 10 items relating to specific beliefs about prescribed treatments:

A 5-point Likert-type scale was used for each item. The higher the sum of the scores obtained, the stronger the subject's belief.

The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale)

Intervention Type OTHER

FCCHL (Functional, Communicative and Critical Health Literacy)/HLS14 (14-item health literacy scale) (https://reflis.fr/wp-content/uploads/2020/07/FCCHL-HLS14-Questionnaire-Litteratie-sante.pdf )

Validated French-language self-administered questionnaire and consisting of14 items with a 5-point Likert scale for assessing health literacy :

Functional literacy: basic reading and writing skills sufficient to function effectively in everyday situations Communicative or interactive literacy: more advanced cognitive and literacy skills that, combined with social skills, can be used to actively participate in everyday activities, extract information and meanings from different forms of communication, and apply new information to changing circumstances Critical literacy: more advanced cognitive skills which, combined with social skills, can be applied to the critical analysis of information and the use of that information to exercise greater control over life events and situations

Interventions

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Semi-directed individual interviews

Individual semi-structured interviews (descriptive approach methodology with reflexive thematic analysis)

Intervention Type OTHER

The self-administered questionnaires, rPATD and BMQ

rPATD: The rPATD is a questionnaire validated and adapted in French to assess patients' perceptions of their treatments and deprescribing.

This self-administered questionnaire consists of 22 questions rated on a 5-point Likert scale (scale from 1 to 5, at 1 the patient completely agrees with the questionnaire's proposal, at 5 the patient strongly disagrees with the questionnaire's proposal). Following the analysis of Phase 1 "Qualitative" of the protocol, three additional questions

BMQ French version of the BMQ self-questionnaire, which studies patients' perceptions of medication .

The Beliefs about Medicine Questionnaire (BMQ) is an 18-item self-administered questionnaire designed to explore patient perceptions of medicine. It has been validated in French and is free to use.

It comprises 10 items relating to specific beliefs about prescribed treatments:

A 5-point Likert-type scale was used for each item. The higher the sum of the scores obtained, the stronger the subject's belief.

Intervention Type OTHER

The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale)

FCCHL (Functional, Communicative and Critical Health Literacy)/HLS14 (14-item health literacy scale) (https://reflis.fr/wp-content/uploads/2020/07/FCCHL-HLS14-Questionnaire-Litteratie-sante.pdf )

Validated French-language self-administered questionnaire and consisting of14 items with a 5-point Likert scale for assessing health literacy :

Functional literacy: basic reading and writing skills sufficient to function effectively in everyday situations Communicative or interactive literacy: more advanced cognitive and literacy skills that, combined with social skills, can be used to actively participate in everyday activities, extract information and meanings from different forms of communication, and apply new information to changing circumstances Critical literacy: more advanced cognitive skills which, combined with social skills, can be applied to the critical analysis of information and the use of that information to exercise greater control over life events and situations

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years of age
* Locally advanced or metastatic solid cancer (i.e., palliative care as defined by the World Health Organization)
* Life expectancy estimated by the physician at inclusion of less than 1 year (use of surprise question to help clinician estimate life expectancy)
* Hospitalized or in consultation
* With at least one PIMs (identified using STOPPfrail 2)
* Patient not having expressed opposition to participating in the study after receiving information from the physician.

For qualitative study patients :

\- Patients who have signed an authorization for the recording of their voice during the semi-structured interview for the purpose of written transcription.

Exclusion Criteria

* Minor
* Major under guardianship, protected person
* Patient unable to speak or write French
* Patient with impaired judgment, cognitive or sensory impairment that prevents him/her from receiving informed information, answering questionnaires or participating in a study interview.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrien EVIN

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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