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

Primary Purpose

Breast Cancer, Prostate Cancer, Quality of Life

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASCAPE-based follow-up strategy
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, prostate cancer, quality of life, survivorship, artificial intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology Department, Sismanogleio General HospitalRecruiting
  • Oncology Department, Hospital Clínic de Barcelona
  • Department of Oncology, University Hospital of UppsalaRecruiting
  • Department of Oncology, Örebro University HospitalRecruiting
  • CareAcross

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASCAPE-based follow-up strategy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patients' engagement to ASCAPE-based follow-up
Number of questionnaires submitted per patients; total time that the patients used the wearables
Patients' adherence to AI-based proposed intervention
Assessment of health-related QoL over time
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
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.
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.

Full Information

First Posted
April 30, 2021
Last Updated
October 28, 2022
Sponsor
Region Örebro County
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT04879563
Brief Title
Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project
Acronym
ASCAPE
Official Title
Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer, Quality of Life, Survivorship, Toxicity
Keywords
breast cancer, prostate cancer, quality of life, survivorship, artificial intelligence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASCAPE-based follow-up strategy
Arm Type
Experimental
Arm Description
Follow-up through ASCAPE platform including AI-based predictions for health-related QoL issues and suggestions for personalized interventions.
Intervention Type
Other
Intervention Name(s)
ASCAPE-based follow-up strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patients' experience using ASCAPE-based follow-up
Description
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
Time Frame
At the end of intervention (month 12)
Secondary Outcome Measure Information:
Title
Patients' engagement to ASCAPE-based follow-up
Description
Number of questionnaires submitted per patients; total time that the patients used the wearables
Time Frame
Every three months until the end of intervention (12 months)
Title
Patients' adherence to AI-based proposed intervention
Time Frame
Every three months until the end of intervention (12 months)
Title
Assessment of health-related QoL over time
Time Frame
Every three months until the end of intervention (12 months)
Title
Physicians' views and experience regarding ASCAPE-based follow-up in terms of implementation into clinical practice
Description
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
Time Frame
At the end of intervention (month 12)
Title
Physicians' views and experience regarding ASCAPE-based follow-up in terms of interaction
Description
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.
Time Frame
At the end of intervention (month 12)
Title
Physicians' experience in using ASCAPE-based follow-up
Description
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.
Time Frame
At the end of intervention (month 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonios Valachis
Phone
+46196021792
Email
antonios.valachis@oru.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paris Kosmidis
Organizational Affiliation
CareAcross
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Serge Autexier
Organizational Affiliation
German Research Center for Artificial Intelligence
Official's Role
Study Director
Facility Information:
Facility Name
Urology Department, Sismanogleio General Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Varkarakis, Prof
Phone
+30 213 2058253
Email
medvark3@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lazaros Tzelves, MD
Email
lazarostzelves@gmail.com
First Name & Middle Initial & Last Name & Degree
Ioannis Varkarakis, Prof
First Name & Middle Initial & Last Name & Degree
Lazaros Tzelves, MD
First Name & Middle Initial & Last Name & Degree
Ioannis Manolitsis, MD
Facility Name
Oncology Department, Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Department of Oncology, University Hospital of Uppsala
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Lindman, Assoc Prof
Email
henrik-lindman@igp.uu.se
First Name & Middle Initial & Last Name & Degree
Henrik Lindman, Assoc Prof
Facility Name
Department of Oncology, Örebro University Hospital
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonios Valachis, Assoc Prof
Phone
+46196021792
Email
antonios.valachis@oru.se
First Name & Middle Initial & Last Name & Degree
Antonios Valachis, Assoc Prof
Facility Name
CareAcross
City
London
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35446854
Citation
Tzelves L, Manolitsis I, Varkarakis I, Ivanovic M, Kokkonidis M, Useros CS, Kosmidis T, Munoz M, Grau I, Athanatos M, Vizitiu A, Lampropoulos K, Koutsouri T, Stefanatou D, Perrakis K, Stratigaki C, Autexier S, Kosmidis P, Valachis A. Artificial intelligence supporting cancer patients across Europe-The ASCAPE project. PLoS One. 2022 Apr 21;17(4):e0265127. doi: 10.1371/journal.pone.0265127. eCollection 2022.
Results Reference
derived
Links:
URL
https://ascape-project.eu/artificial-intelligence-supporting-cancer-patients-across-europe
Description
Related Info

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Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project

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