跳至主要内容
临床试验/NCT05534178
NCT05534178招募中不适用

Machine Learning Model to Predict Hospital Length of Stay (HOLS) and Mortality After Discharge in Hospitalized Oncologic Patients [Plantology Database]: a Multicenter Cross-validation Study

Vall d'Hebron Institute of Oncology3 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2020年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
3
主要终点
Predict Mortality

研究概览

简要总结

The study aims to understand which are the most relevant parameters at admission which may allow to predict the hospital length of stay (HOLS) and mortality after discharge of oncologic hospitalized patients.

This is the first multicentric prospective observational study that tries to understand the complexity of the hospitalized oncologic patients. A comprehensive analysis will be performed with the help of the nutrition, nursery, internal medicine and oncology teams.

详细描述

BACKGROUND:

Cancer is the second leading cause of death worldwide and is responsible for about 18.1 million new cases and 9.6 million deaths in 2018 alone according to the International Agency for Research on Cancer. Cancer is anticipated to rank as the leading cause of death and the most important barrier to increasing life expectancy in every country of the world in the mid-21st century1. The economic impact of cancer is significant. The annual economic cost of cancer in 2010 was estimated at approximately US$ 1.16 trillion. The reasons are complex but both cancer incidence and mortality are increasing worldwide due to aging and increasing risk factors for cancer, several of which are associated with socioeconomic development. Cancer will probably soon reach the top leading cause of death due to the rapid population growth and the declines in mortality rates by stroke or coronary heart disease in many developed countries.

Cancer patients often require inpatient care due to treatment toxicities, complications from cancer such as thrombosis, illness not related to the disease itself or terminally ill patients. Among these individuals, their treatment should balance prolongation of survival and maximization of the quality of remaining life. However, hospitalization is a stressful event for individuals with advanced cancer and their caregivers. Hospitalization often antagonizes these goals, contributing to the high cost of cancer care, worsens survival, and is increasingly recognized as poor-quality cancer care. Thus, interventions that reduce unnecessary hospitalizations, or shorten them, will likely improve quality of life and reduce costs.

Some studies relate malnutrition, which presents a marked sarcopenia and loss of lean mass, with prolonged hospitalization, reduced response to treatment, a worse overall survival and impaired quality of life. A study published in 2007 found that lung cancer patients had a longer hospitalization and required inpatient hospital treatment more frequently than any other type of tumor. Moreover, in the surgical setting there have been studies linking preoperative opioid usage and increased opioid doses with increased length of stay. Based on this data, there have been protocols developed like the ERAS (Enhanced recovery after surgery) applied first to colorectal cancer and now being tested in other settings like head and neck and gynecologic tumors, showing that it is possible to reduce opioid use with good pain control and a statistically significant shorter average length of stay.

Prognostic factors for oncologic patients after surgery or curative systemic treatment have been described, but there is no solid evidence on which combination of parameters predict mortality after hospitalization of metastatic cancer patients under active treatment. A potential solution to improve this scenario might be nutritional support to malnourished cancer patients that also has proven to be effective in shorten hospital stay and improve survival, or community based palliative care interventions that are proven to improve quality of life and reduce costs of terminally ill patients. Thus, a prognostic tool would be useful to help physicians adjust medical interventions for hospitalized cancer patients.

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

  • ≥18 years-old.
  • Histological cancer confirmation.
  • Hospitalization in oncology ward.

排除标准

  • <18 years-old.
  • Not histological malignancy confirmed.
  • Less than 24 hours in the hospital.

结局指标

主要结局

Predict Mortality

时间窗: 30 days after discharge

Mortality at 30-day after discharge

Predict hospital length of stay

时间窗: Through study completion, an average of 3 years

Number of days hospitalized

次要结局

  • Validate standardized test HOSPITAL score: Risk of readmission(Evaluated at discharge through study completion, an average of 3 years. The outcome is the probability of readmission within the first 30 days after discharge.)
  • Tumor Characteristics and Comorbidities(Within 24 hours of admission through study completion, an average of 3 years)
  • Sarcopenia Test(Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years)
  • Nutrition Assessment(Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years)
  • Measure the impact of Quality of life (QoL)(Within 24 hours of admission)
  • Sarcopenia Assessment(Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years)
  • Measure the impact of Anxiety and Depression(Within 24 hours of admission)
  • Opioids Intake(Within 24 hours of admission and 24 hours before discharge through study completion, an average of 3 years)

研究者

发起方
Vall d'Hebron Institute of Oncology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oriol Mirallas

Principal Investigator

Vall d'Hebron Institute of Oncology

研究点 (3)

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