Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project

Sponsor
Region Örebro County (Other)
Overall Status
Recruiting
CT.gov ID
NCT04879563
Collaborator
UBITECH (Other), ATOS (Other), Siemens Corporation, Corporate Technology (Industry), Intrasoft (Other), University of Patras (Other), FORTH - Foundation for Research and Technology Hellas (Other), Sphynx Technology Solutions AG (Other), Faculty of Sciences, University of Novi Sad, Serbia (Other), DFKI - German Research Center for Artificial Intelligence (Other), CareAcross (Other), National and Kapodistrian University of Athens, Greece (Other), Fundacio Clinic Barcelona (Other), Arthur's Legal (Other), Fundacion iSYS (Other)
500
5
1
22.9
100
4.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: ASCAPE-based follow-up strategy
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Patients' experience using ASCAPE-based follow-up [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

Secondary Outcome Measures

  1. Patients' engagement to ASCAPE-based follow-up [Every three months until the end of intervention (12 months)]

    Number of questionnaires submitted per patients; total time that the patients used the wearables

  2. Patients' adherence to AI-based proposed intervention [Every three months until the end of intervention (12 months)]

  3. Assessment of health-related QoL over time [Every three months until the end of intervention (12 months)]

  4. Physicians' views and experience regarding ASCAPE-based follow-up in terms of implementation into clinical practice [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

  5. Physicians' views and experience regarding ASCAPE-based follow-up in terms of interaction [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.

  6. Physicians' experience in using ASCAPE-based follow-up [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urology Department, Sismanogleio General Hospital Athens Greece
2 Oncology Department, Hospital Clínic de Barcelona Barcelona Spain
3 Department of Oncology, University Hospital of Uppsala Uppsala Sweden
4 Department of Oncology, Örebro University Hospital Örebro Sweden
5 CareAcross London United Kingdom

Sponsors and Collaborators

  • Region Örebro County
  • UBITECH
  • ATOS
  • Siemens Corporation, Corporate Technology
  • Intrasoft
  • University of Patras
  • 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
  • Fundacio Clinic Barcelona
  • Arthur's Legal
  • Fundacion iSYS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Region Örebro County
ClinicalTrials.gov Identifier:
NCT04879563
Other Study ID Numbers:
  • 875351
First Posted:
May 10, 2021
Last Update Posted:
May 12, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Region Örebro County
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2021