DEprescribing: Perceptions of PAtients Living With Advanced Cancer

NCT06193083 | Recruiting

• 1 other identifier: RC23_0563
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Deprescribing; Palliative Care; Oncology

Keywords

Deprescribing; Palliative care; Oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To investigate factors that may influence patients' attitudes and beliefs regarding de-prescribing.

  at study inclusion

• To evaluate the psychometric properties of the rPATD in this population.

  at study inclusion

Other Outcomes (1)

• ANCILLARY STUDY

  at study inclusion

Study Arms (2)

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

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

Interventions

Semi-directed individual interviews OTHER

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

Qualitative study

The self-administered questionnaires, rPATD and BMQ 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.

Quantitative study

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

Quantitative study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient over 18 years of age
• Locally advanced or metastatic solid cancer (i.e., palliative care as defined by the World Health Organization)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead
• Fondation de France: collaborator
• Nantes University: collaborator

Study Sites (8)

CHD Vendée

La Roche-sur-Yon, 85000, France

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

USP - Maison de Nicodème

Nantes, France

NOT YET RECRUITING

Hôpital Institut CURIE

Paris, 75005, France

NOT YET RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44800, France

NOT YET RECRUITING

CH ST Nazaire

Saint-Nazaire, 44600, France

NOT YET RECRUITING

CHRU Tours

Tours, France

NOT YET RECRUITING

Related Publications (1)

• Evin A, Bourdon M, Nizet P, Hardouin JB, Victorri-Vigneau C, Huon JF. DEprescribing: Perceptions of PAtients living with advanced cancer. A multicentre, prospective mixed observational study protocol. PLoS One. 2024 Aug 20;19(8):e0305737. doi: 10.1371/journal.pone.0305737. eCollection 2024.

  PMID: 39163415 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Adrien EVIN

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrien EVIN, MCU-PH

CONTACT

+33253482736; Adrien.EVIN@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: February 28, 2024
• Primary Completion: February 28, 2025
• Study Completion (Estimated): December 29, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)