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临床试验/NCT05412420
NCT05412420已完成不适用

Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients

Institut de Cancérologie de Lorraine2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年8月3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
500
试验地点
2
主要终点
Number of unscheduled medical consultations or re-hospitalisations

研究概览

简要总结

During treatment, cancer patients may experience side effects related to their disease but also to the different treatments they receive.

Currently, adverse effects and toxicities are well codified in the oncology community, notably via the NCI CTCAE criteria.

Unlike objective data such as a blood sample or a CTscan, a major bias in patient assessment is the subjective assessment of the physician or its team at a given time, which may not reflect the overall situation (for better or worse). Several studies had already highlighted the discrepancies between medical and patient data collection.

Self-assessment of symptoms is one way to overcome this bias. Moreover, there are now a large number of solutions that allow to perform these self-assessments at home.

Thanks to these tools, there are now two situations, the scheduled evaluation (before a chemotherapy treatment, or after a surgical procedure for instance) and the unscheduled situations, where it is the patient himself who can trigger an evaluation form.

These new evaluation methods also allow to take a quality of life approach. Patient-reported outcomes (PROs) is now a valid evidence-based assay to detect patient's symptoms and therefore provide helpful clinical information to healthcare providers.

The goal of this study is to go one step further than the previous PROs studies and evaluate the ability to train a machine learning algorithm to detect at-risk situations and lay the foundation for a viable solution for future prospective and randomized trials.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Follow-up for a solid tumor
  • Chemotherapy treatment (oral and/or injectable) scheduled or in progress
  • Life expectancy > 3 months
  • Performance Status (PS) < 3
  • Have an internet connection or assistance to answer questions throughout the study (nurse, family members, etc.)
  • Patient having understood, signed and dated the consent form
  • Patient affiliated to the social security system

排除标准

  • Lack of means to answer the online questionnaires
  • Patient in another therapeutic trial with an experimental molecule
  • Patients and their families who cannot read or speak French
  • Persons deprived of liberty or under guardianship (including curatorship)

结局指标

主要结局

Number of unscheduled medical consultations or re-hospitalisations

时间窗: 3 months

The number of unscheduled medical consultations or re-hospitalisations will be assessed based on abnormalities identified through the patient's self-report of symptoms.

次要结局

  • Occurrence of toxicities(3 months)
  • Anticipation of the preparation of injectable chemotherapy(3 months)
  • Patient Satisfaction(3 months)
  • Dose of treatments(3 months)
  • Adherence to oral treatment(3 months)
  • Handling of the digital tool(3 months)
  • Predicting the occurrence of sarcopenia(3 months)

研究者

发起方
Institut de Cancérologie de Lorraine
申办方类型
Other
责任方
Sponsor

研究点 (2)

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