跳至主要内容
临床试验/NCT06193083
NCT06193083招募中不适用

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

Nantes University Hospital8 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2024年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
325
试验地点
8
主要终点
To study patients' perceptions of deprescribing in palliative cancer care.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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).

干预措施: Semi-directed individual interviews (Other)

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.

干预措施: The self-administered questionnaires, rPATD and BMQ (Other)

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.

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

结局指标

主要结局

To study patients' perceptions of deprescribing in palliative cancer care.

时间窗: at study inclusion

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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