Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project

Region Örebro County

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer; Quality of Life; Survivorship; Toxicity; Prostate Cancer

Treatments: Other: ASCAPE-based follow-up strategy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04879563

875351

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

ASCAPE-based follow-up strategy

Experimental group

Description:

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

Treatment:

Other: ASCAPE-based follow-up strategy