跳至主要内容
临床试验/NCT06909968
NCT06909968已完成不适用

Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS5 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2020年12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
178
试验地点
5
主要终点
Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze the appropriateness of progressive palliative care approach

研究概览

简要总结

This is a prospective observational study done on 3 patient populations (cancer, chronic pulmonary and renal disease). All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

详细描述

This is a prospective observational study done on 3 patient populations (cancer, chronic pulmonary and renal disease). All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. The primary objective is to analyze appropriateness and timeliness of progressive palliative care approach (initially simultaneously with ongoing disease-oriented treatment and subsequently possibly as the only modality of care to avoid aggressiveness of care) in patients with:

  • First diagnosis of advanced metastatic non-small cell lung cancer, or advanced gastric cancer or advanced pancreatic adenocarcinoma
  • advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).
  • advanced chronic renal failure

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Both sex;
  • All ethnic background;
  • Age ≥18 years;
  • Subjects who are, in the opinion of the Investigator, able to understand this study and to cooperate with the study procedures;
  • Written informed consent;
  • Not receiving care from the palliative care service
  • Inclusion Criteria specific for POPULATION A:
  • Diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma within the previous eight weeks, any T, any N, M+ or T4 inoperable (neoadjuvant excluded);
  • Life expectancy >2 months;
  • Inclusion Criteria specific for POPULATION B:
  • Diagnosis of chronic obstructive pulmonary disease (COPD) with at least two of these characteristics: age > 70 years, FEV1 <30 % predicted, oxygen-therapy dependency, > 1 admission/year in hospital for COPD exacerbated, congestive heart failure and/or other comorbidity, weight loss/cachexia, reduced functional autonomy, increase dependence.
  • or idiopathic pulmonary fibrosis (IPF) diagnosis with at least two of these characteristics: age > 70 years, histological pattern "UIP" (if known), dependence on oxygen-therapy, radiological aspect of "Honeycomb" to the HRTC of the thorax, reduced functional autonomy, increased dependence.
  • Inclusion Criteria specific for POPULATION C:
  • - Diagnosis advanced chronic renal failure with at least two of these characteristics: age > 75 years, advanced malignancy, severe malnutrition, cardiac or pulmonary pathology terminal, Multiple Organ Failure in Intensive Care.

排除标准

  • 未提供

结局指标

主要结局

Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze the appropriateness of progressive palliative care approach

时间窗: 55 months

Initially simultaneously with ongoing disease-oriented treatment and subsequently as the only modality of care to avoid aggressiveness of care.

Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze timeliness of progressive palliative care approach

时间窗: 55 months

Initially simultaneously with ongoing disease-oriented treatment and subsequently as the only modality of care to avoid aggressiveness of care.

次要结局

未报告次要终点

研究者

发起方
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
申办方类型
Other
责任方
Sponsor

研究点 (5)

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