Clinical trial NCT04879563: Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project
Official title: Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Prostate Cancer
Quality of Life
Survivorship
Toxicity
Keywords: breast cancer
prostate cancer
quality of life
survivorship
artificial intelligence
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: UBITECH
name: ATOS
name: Siemens Corporation, Corporate Technology
name: Intrasoft
name: University of Patras
name: FORTH - Foundation for Research and Technology Hellas
name: Sphynx Technology Solutions AG
name: Faculty of Sciences, University of Novi Sad, Serbia
name: DFKI - German Research Center for Artificial Intelligence
name: CareAcross
name: National and Kapodistrian University of Athens, Greece
name: Fundacio Clinic Barcelona
name: Arthur's Legal
name: Fundacion iSYS
First posted: 2021-05-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Patients' experience using ASCAPE-based follow-up
timeFrame: At the end of intervention (month 12)
Secondary outcomes:
measure: Patients' engagement to ASCAPE-based follow-up
timeFrame: Every three months until the end of intervention (12 months)
measure: Patients' adherence to AI-based proposed intervention
timeFrame: Every three months until the end of intervention (12 months)
measure: Assessment of health-related QoL over time
timeFrame: Every three months until the end of intervention (12 months)
measure: Physicians' views and experience regarding ASCAPE-based follow-up in terms of implementation into clinical practice
timeFrame: At the end of intervention (month 12)
measure: Physicians' views and experience regarding ASCAPE-based follow-up in terms of interaction
timeFrame: At the end of intervention (month 12)
measure: Physicians' experience in using ASCAPE-based follow-up
timeFrame: At the end of intervention (month 12)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Urology Department, Sismanogleio General Hospital
city: Barcelona
country: Spain
facility: Oncology Department, Hospital Clínic de Barcelona
city: Uppsala
country: Sweden
facility: Department of Oncology, University Hospital of Uppsala
city: Örebro
country: Sweden
facility: Department of Oncology, Örebro University Hospital
city: London
country: United Kingdom
facility: CareAcross
Study officials:
affiliation: CareAcross
name: Paris Kosmidis
role: STUDY_DIRECTOR
affiliation: German Research Center for Artificial Intelligence
name: Serge Autexier
role: STUDY_DIRECTOR
References:
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.