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临床试验/NCT04879563
NCT04879563进行中(未招募)2 期

Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project

Region Örebro County5 个研究点 分布在 4 个国家目标入组 500 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
500
试验地点
5
主要终点
Patients' experience using ASCAPE-based follow-up

研究概览

简要总结

ASCAPE (Artificial intelligence Supporting CAncer Patients across Europe) is a collaborative research project involving 15 partners from 7 countries, including academic medical centers, SMEs (small and medium-sized enterprises), research centers and universities, aiming to leverage the recent advances in Big Data and AI (Artificial Intelligence) to support cancer patients' Quality of Life (QoL) and health status. Specifically, ASCAPE aims to provide personalized- and AI-based predictions for QoL issues in breast- and prostate cancer patients as well as suggest potential interventions to their physicians.

This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 875351.

研究设计

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

入选标准

  • •The patient selection process varies among the different study sites. Three Hospitals (Sismanogleio General Hospital Athens (SGHA), Örebro University Hospital (ÖUH), Uppsala University Hospital (UUH)) will include patients with newly diagnosed breast- (ÖUH, UUH) or prostate cancer (SGHA, ÖUH) who are eligible for curative treatment with surgery (breast cancer in ÖUH and UUH; prostate cancer in NKUA) or radiotherapy (prostate cancer; ÖUH).
  • •One Hospital (Barcelona) will include breast cancer survivors (at least 12 months after surgery or chemotherapy) with follow-up through the Hospital.
  • •Finally, CareAcross will include patients with breast- or prostate cancer through its online platform for patients seeking for the CareAcross services.
  • •Inclusion Criteria (breast cancer; ORB and Uppsala):
  • •breast cancer diagnosis
  • •no clinical evidence of metastatic disease
  • •able for curative treatment with surgery with or without oncological treatment.
  • •Inclusion Criteria (breast cancer; Barcelona)
  • •prior early breast cancer who are at follow-up with at least 12 months after surgery or chemotherapy (whichever occurred last).
  • •Inclusion Criteria (breast cancer; CareAcross)
  • •breast cancer diagnosis (as per self-reported) irrespective of stage and treatment.
  • •Inclusion Criteria (prostate cancer; SGHA and ORB)
  • •proostate cancer diagnosis
  • •no clinical evidence of metastatic disease
  • •able for curative treatment with surgery with or without oncological treatment (SGHA) or radiotherapy (with or without prior surgery) irrespectively the type of radiotherapy (external radiotherapy, brachytherapy, or combination).
  • •Inclusion Criteria (prostate cancer; CareAcross)
  • •prostate cancer diagnosis (as per self-reported) irrespective of stage and treatment.

排除标准

  • •(common in all study sites):
  • •inability to give informed consent
  • •inability / no access to smartphones, applications or internet services
  • •patients with known medical history of allergy to the wearable material.

研究组 & 干预措施

ASCAPE-based follow-up strategy

Experimental

Follow-up through ASCAPE platform including AI-based predictions for health-related QoL issues and suggestions for personalized interventions.

干预措施: ASCAPE-based follow-up strategy (Other)

结局指标

主要结局

Patients' experience using ASCAPE-based follow-up

时间窗: At the end of intervention (month 12)

Patients' experience to be followed with the help of an AI-based system per se, patients' satisfaction with this type of follow-up, potential barriers and facilitators of using wearables during follow-up, and motivation for following interventions based on AI-based follow-up

次要结局

  • Assessment of health-related QoL over time(Every three months until the end of intervention (12 months))
  • Physicians' views and experience regarding ASCAPE-based follow-up in terms of interaction(At the end of intervention (month 12))
  • Physicians' experience in using ASCAPE-based follow-up(At the end of intervention (month 12))
  • Patients' engagement to ASCAPE-based follow-up(Every three months until the end of intervention (12 months))
  • Patients' adherence to AI-based proposed intervention(Every three months until the end of intervention (12 months))
  • Physicians' views and experience regarding ASCAPE-based follow-up in terms of implementation into clinical practice(At the end of intervention (month 12))

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Sponsor

研究点 (5)

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