Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project

Breast Cancer Clinical Trial

— ASCAPE  

Official title:

Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04879563
• Other study ID #: 875351
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria (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.

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Quality of Life
• Survivorship
• Toxicity

Intervention

Other:
• ASCAPE-based follow-up strategy
Follow-up through ASCAPE platform including AI-based predictions for health-related QoL issues and suggestions for personalized interventions depending on the type of QoL issue that needs to be tackled. The ASCAPE-based follow-up strategy includes follow-up through validated QoL questionnaires, wearables for capturing active monitoring data, and mobile apps for answering the questionnaires and capturing potential health-related issues.

Locations

Country	Name	City	State
Greece	Urology Department, Sismanogleio General Hospital	Athens
Spain	Oncology Department, Hospital Clínic de Barcelona	Barcelona
Sweden	Department of Oncology, Örebro University Hospital	Örebro
Sweden	Department of Oncology, University Hospital of Uppsala	Uppsala
United Kingdom	CareAcross	London

Sponsors (15)

Lead Sponsor

Collaborator

Region Örebro County

Arthur's Legal, ATOS, CareAcross, DFKI - German Research Center for Artificial Intelligence, Faculty of Sciences, University of Novi Sad, Serbia, FORTH - Foundation for Research and Technology Hellas, Fundacio Clinic Barcelona, Fundacion iSYS, Intrasoft, National and Kapodistrian University of Athens, Greece, Siemens Corporation, Corporate Technology, Sphynx Technology Solutions AG, UBITECH, University of Patras

Countries where clinical trial is conducted

Greece,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' experience using ASCAPE-based follow-up	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	At the end of intervention (month 12)
Secondary	Patients' engagement to ASCAPE-based follow-up	Number of questionnaires submitted per patients; total time that the patients used the wearables	Every three months until the end of intervention (12 months)
Secondary	Patients' adherence to AI-based proposed intervention		Every three months until the end of intervention (12 months)
Secondary	Assessment of health-related QoL over time		Every three months until the end of intervention (12 months)
Secondary	Physicians' views and experience regarding ASCAPE-based follow-up in terms of implementation into clinical practice	The following aspects will be considered: improvement in patient-doctor relationship; AI-based follow-up's efficiency to capture relevant QoL issues on time; changes in management or referrals made due to AI-based predictions; usefulness of the information provided by AI-based models; acceptability of integrating AI-based follow-up into clinical practice; assessment of the time needed to use AI-based follow-up in clinical practice	At the end of intervention (month 12)
Secondary	Physicians' views and experience regarding ASCAPE-based follow-up in terms of interaction	This outcome includes issues related to the interaction between the AI-based follow-up platform and physicians as usability, accessibility, and qualitative assessment of the interface.	At the end of intervention (month 12)
Secondary	Physicians' experience in using ASCAPE-based follow-up	This outcome includes issues related to trustworthiness, how confident physicians are regarding the reliability of AI-based follow-up, and psychological aspects in using an AI-based platform in clinical practice as perceived substitution crisis and behavioural intention.	At the end of intervention (month 12)

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