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临床试验/NCT04936568
NCT04936568已完成不适用

Implementation of a Standardized Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease: Impact on Patient and Caregiver Satisfaction With Care and Use of Health Care Resources.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano2 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2021年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
380
试验地点
2
主要终点
patient reported experience

研究概览

简要总结

Early palliative care (EPC) in the clinical pathway of advanced cancer patients improves symptom control, quality of life and has a positive impact on overall quality of care. EPC contributes to realistic and attainable goals of treatment, facilitating patient choices, favouring adequate communication with patients and families and assessing patient values and preferences with regard to advance care planning. EPC is likely to promote a more appropriate use of health care resources and less aggressive cancer treatment in the last weeks of life. At present standardised criteria for appropriate referral for EPC in oncology outpatients setting are lacking. Therefore the aim of this project is to identify referral criteria and procedures to implement appropriate EPC for advanced patients (the Palliative Care Referral System) and test them in a pre-post experimental design evaluating their impact on quality of care and on the use of healthcare resources. A quasi-experimental, longitudinal, pretest-posttest study will be carried out. Two different cohorts of 150 advanced cancer patients each will be enrolled before (pretest) and after (posttest) the introduction of the PCRS in outpatient clinics of a Comprehensive Cancer Centre. Eligible patients will undergo patient-reported outcome measure (PROMs) evaluation at baseline and then monthly for at least 6 months from enrollment or till death. Use health care resources and quality of care indicators will be collected monthly by a dedicated research nurse.

详细描述

As above.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • age >18 years;
  • recent diagnosis of inoperable locally advanced and/or metastatic cancer not eligible to anticancer treatment with curative intent;

排除标准

  • cognitive impairment that would prevent self-assessments
  • current palliative care treatment

结局指标

主要结局

patient reported experience

时间窗: through study completion, up to 6 months

patient satisfaction with care, measured with the FAMCARE-P13

次要结局

  • Hospitalization(through study completion, up to 6 months)
  • caregiver experience of care(through study completion, up to 6 months)
  • Activation of a Palliative Care service(through study completion, up to 6 months)
  • Health related quality of life(through study completion, up to 6 months)
  • Multidisciplinary team visits(through study completion, up to 6 months)
  • Emergency department accesses(through study completion, up to 6 months)

研究者

发起方
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
申办方类型
Other
责任方
Principal Investigator
主要研究者

Augusto Caraceni

director of Palliative Care Unit

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

研究点 (2)

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