DEprescribing: Perceptions of PAtients Living With Advanced Cancer (DEPAL)

DEprescribing: Perceptions of PAtients Living With Advanced Cancer. A Multicentre, Prospective Mixed Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Deprescribing; Palliative Care; Oncology
• Intervention / Treatment: Other: Semi-directed individual interviews; Other: The self-administered questionnaires, rPATD and BMQ; Other: The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale)

• Study Type: Observational
• Enrollment (Estimated): 325

Contacts and Locations

• Study Contact: Name: Adrien EVIN, MCU-PH; Phone Number: +33253482736; Email: adrien.evin@chu-nantes.fr

Study Locations

• France
  • La Roche-sur-Yon, France, 85000
    • Not yet recruiting
    • CHD Vendee
    • Contact: Caroline HENNION, PH; Phone Number: 0251446161; Email: caroline.hennion@ght85.fr
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Adrien EVIN, MCU-PH; Phone Number: +33253482736; Email: adrien.evin@chu-nantes.fr
    • Principal Investigator: Adrien EVIN, MCU-PH
    • Sub-Investigator: Yann TOUCHEFEU, PU-PH
    • Sub-Investigator: André COLPAERT, PH
    • Sub-Investigator: Elvire PONS-TOSTIVIN, MCU-PH
    • Sub-Investigator: Gaëlle QUEREUX BAUMGARTNER, MCU-PH
  • Saint-Herblain, France, 44800
    • Not yet recruiting
    • Institut de Cancérologie de l'Ouest
    • Contact: Véronique BARBAROT; Phone Number: 0240679900; Email: veronique.barbarot@ico.unicancer.fr
    • Principal Investigator: BARBAROT Véronique
  • Saint-Nazaire, France, 44600
    • Not yet recruiting
    • CH ST Nazaire
    • Contact: Virginie DESSUS-CHEVREL; Phone Number: 0272278000; Email: v.dessus-chevrel@ch-saintnazaire.fr
    • Principal Investigator: Virginie DESSUS-CHEVREL, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We'll be looking at major patients with "solid" cancer in a palliative situation (locally advanced or metastatic cancer, thus requiring palliative care as defined by the World Health Organization), who have at least one PIMs, followed up on an inpatient or outpatient basis, with a life expectancy estimated at less than 1 year by the doctor caring for the patient.

To identify whether a patient has at least one PIMs, we will use the STOPPFrail 2 tool . This is a tool developed in geriatrics, validated for a population with an estimated life expectancy of less than 1 year, and which is not specific to oncology. Life expectancy of less than one year will be estimated by the question surprised by the doctor caring for the patient ("Would you be surprised if your patient died within a year?") .

We will carry out a multicenter study in oncology and/or palliative care departments of hospitals located in western France.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: Semi-directed individual interviews; 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.	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) 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study patients' perceptions of deprescribing in palliative cancer care.	To describe, understand and explain patients' attitudes and beliefs concerning deprescribing by means of individual semi-structured interviews (descriptive approach methodology with reflexive thematic analysis) and secondly using the rPATD questionnaire (questionnaire for assessing patients' perceptions of their treatments and deprescribing), which can be adapted following analysis of qualitative data. 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	at study inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate factors that may influence patients' attitudes and beliefs regarding de-prescribing.	Influence of gender, age, level of education, type of cancer, number of metastatic sites, Performans status score, presence of systemic cancer treatment (chemotherapy, targeted therapy, immunotherapy, hormonal therapy, etc.), follow-up by a palliative care team, and other factors. ), follow-up by a palliative care team, patient's place of care, persons in charge of treatment, number of medications, number of potentially inappropriate medications (PIMs), prognosis assessed by the referring physician, patient's level of education and beliefs about treatments in general (BMQ questionnaire) on scores from the rPATD questionnaire.	at study inclusion
To evaluate the psychometric properties of the rPATD in this population.	Description of rPATD validation data in our population: validation of questionnaire structure, measurement of score reliability, concurrent validation with the BMQ questionnaire. BMQ French version of the BMQ self-questionnaire, which studies patients' perceptions of medication . 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.	at study inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ANCILLARY STUDY	For patients who wish to do so (depending on their fatigability), we will study the link between patients' level of 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 do this, we will assess the link between patients' level of literacy (using the FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale) self-questionnaire) and their perception of deprescription.	at study inclusion

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Fondation de France; Nantes Université
• Investigators: Principal Investigator: Adrien EVIN, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): December 29, 2026

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Palliative care; Oncology; Deprescribing
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RC23_0563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No