NCT04879563

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Feb 2021

Typical duration for phase_2 breast-cancer

Geographic Reach
4 countries

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

3.4 years

First QC Date

April 30, 2021

Last Update Submit

November 15, 2024

Conditions

Breast CancerProstate CancerQuality of LifeSurvivorshipToxicity

Keywords

breast cancerprostate cancerquality of lifesurvivorshipartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • 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

    At the end of intervention (month 12)

Secondary Outcomes (6)

  • Patients' engagement to ASCAPE-based follow-up

    Every three months until the end of intervention (12 months)

  • Patients' adherence to AI-based proposed intervention

    Every three months until the end of intervention (12 months)

  • Assessment of health-related QoL over time

    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

    At the end of intervention (month 12)

  • Physicians' views and experience regarding ASCAPE-based follow-up in terms of interaction

    At the end of intervention (month 12)

  • +1 more secondary outcomes

Study Arms (1)

ASCAPE-based follow-up strategy

EXPERIMENTAL

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

Interventions

ASCAPE-based follow-up strategyOTHER

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.

ASCAPE-based follow-up strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • breast cancer diagnosis
  • no clinical evidence of metastatic disease
  • able for curative treatment with surgery with or without oncological treatment.
  • prior early breast cancer who are at follow-up with at least 12 months after surgery or chemotherapy (whichever occurred last).
  • breast cancer diagnosis (as per self-reported) irrespective of stage and treatment.
  • 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).
  • prostate cancer diagnosis (as per self-reported) irrespective of stage and treatment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Urology Department, Sismanogleio General Hospital

Athens, Greece

Location

Oncology Department, Hospital Clínic de Barcelona

Barcelona, Spain

Location

Department of Oncology, Örebro University Hospital

Örebro, Sweden

Location

Department of Oncology, University Hospital of Uppsala

Uppsala, Sweden

Location

CareAcross

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35446854DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Paris Kosmidis

    CareAcross

    STUDY DIRECTOR

  • Serge Autexier

    German Research Center for Artificial Intelligence

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 10, 2021

Study Start

February 1, 2021

Primary Completion

June 30, 2024

Study Completion

August 30, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES(1)GB(1)GR(1)SE(2)