DEprescribing: Perceptions of PAtients Living With Advanced Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Другое Semi-directed individual interviews
  Individual semi-structured interviews (descriptive approach methodology with reflexive thematic analysis)
• Другое 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
• Другое 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 ad

Первичные конечные точки

• To study patients' perceptions of deprescribing in palliative cancer care. [Срок оценки: at study inclusion]

Вторичные конечные точки (2)

• To investigate factors that may influence patients' attitudes and beliefs regarding de-prescribing. [Срок оценки: at study inclusion]
• To evaluate the psychometric properties of the rPATD in this population. [Срок оценки: at study inclusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 8 центров

• CHD Vendée — La Roche-sur-Yon
• Hospices Civils de Lyon — Lyon
• CHU de Nantes — Nantes
• USP - Maison de Nicodème — Nantes
• Hôpital Institut CURIE — Paris
• Institut de Cancérologie de l'Ouest — Saint-Herblain
• CH ST Nazaire — Saint-Nazaire
• CHRU Tours — Tours

Публикации

• 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

Идентификаторы

NCT: NCT06193083 · RC23_0563

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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