Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project (ASCAPE)

April 9, 2024 updated by: Region Örebro County

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASCAPE-based follow-up strategy
Follow-up through ASCAPE platform including AI-based predictions for health-related QoL issues and suggestions for personalized interventions.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' experience using ASCAPE-based follow-up
Time Frame: 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
At the end of intervention (month 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' engagement to ASCAPE-based follow-up
Time Frame: Every three months until the end of intervention (12 months)
Number of questionnaires submitted per patients; total time that the patients used the wearables
Every three months until the end of intervention (12 months)
Patients' adherence to AI-based proposed intervention
Time Frame: Every three months until the end of intervention (12 months)
Every three months until the end of intervention (12 months)
Assessment of health-related QoL over time
Time Frame: Every three months until the end of intervention (12 months)
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
Time Frame: At the end of intervention (month 12)
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)
Physicians' views and experience regarding ASCAPE-based follow-up in terms of interaction
Time Frame: At the end of intervention (month 12)
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)
Physicians' experience in using ASCAPE-based follow-up
Time Frame: At the end of intervention (month 12)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Collaborators

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

Investigators

  • Study Director: Paris Kosmidis, CareAcross
  • Study Director: Serge Autexier, German Research Center for Artificial Intelligence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 875351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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