Breast CancerPhase 2ASCAPENCT04879563
Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project
A Phase 2 study testing ASCAPE-based follow-up strategy in people with Breast Cancer and Prostate Cancer, run by Region Örebro County at 5 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Quality of Life
- What is being tested?
- ASCAPE-based follow-up strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Feb 2021to 30 Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Sweden2 sites
Department of Oncology, Örebro University Hospital
Örebro
Department of Oncology, University Hospital of Uppsala
Uppsala
About this study
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.
- Conditions
- Breast Cancer, Prostate Cancer, Quality of Life, Survivorship, Toxicity
- Being tested
- ASCAPE-based follow-up strategy
- Keywords
- breast cancer, prostate cancer, quality of life, survivorship, artificial intelligence
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ASCAPE-based follow-up strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of intervention (month 12)
Secondary outcomes (6)
Patients' engagement to ASCAPE-based follow-up
Number of questionnaires submitted per patients; total time that the patients used the wearables
Measured: Every three months until the end of intervention (12 months)
Patients' adherence to AI-based proposed intervention
Measured: Every three months until the end of intervention (12 months)
Assessment of health-related QoL over time
Measured: 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
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
Measured: At the end of intervention (month 12)
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.
Measured: At the end of intervention (month 12)
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.
Measured: At the end of intervention (month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Feb 2021
- Primary completion30 Jun 2024
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- UBITECH, ATOS, Siemens Corporation, Corporate Technology, Intrasoft, University of Patras, FORTH - Foundation for Research and Technology Hellas, Sphynx Technology Solutions AG, University of Novi Sad, DFKI - German Research Center for Artificial Intelligence, CareAcross, National and Kapodistrian University of Athens, Fundacio Clinic Barcelona, Arthur's Legal, Fundacion iSYS
- Responsible party
- Sponsor
- Investigators
- Paris Kosmidis, Study director, CareAcrossSerge Autexier, Study director, German Research Center for Artificial Intelligence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879563
- Sponsor's protocol ID
- 875351
- Acronym
- ASCAPE
- Status last verified
- Nov 2024
- First submitted
- 30 Apr 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35446854
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project
- ClinicalTrials.gov ID
- NCT04879563
- Acronym / sponsor ID
- ASCAPE / 875351
- Conditions
- Breast Cancer, Prostate Cancer, Quality of Life, Survivorship, Toxicity
- Keywords
- breast cancer, prostate cancer, quality of life, survivorship, artificial intelligence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- UBITECH, ATOS, Siemens Corporation, Corporate Technology, Intrasoft, University of Patras, FORTH - Foundation for Research and Technology Hellas, Sphynx Technology Solutions AG, University of Novi Sad, DFKI - German Research Center for Artificial Intelligence, CareAcross, National and Kapodistrian University of Athens, Fundacio Clinic Barcelona, Arthur's Legal, Fundacion iSYS
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCAPE-based follow-up strategy | Experimental | Other: ASCAPE-based follow-up strategyFollow-up through ASCAPE platform including AI-based predictions for health-related QoL issues and suggestions for personalized interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASCAPE-based follow-up strategyFollow-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. | Other | ASCAPE-based follow-up strategy |
Primary outcome
Patients' experience using ASCAPE-based follow-up
Time frame: 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
6 secondary outcomes
Patients' engagement to ASCAPE-based follow-up
Time frame: Every three months until the end of intervention (12 months)
Patients' adherence to AI-based proposed intervention
Time frame: Every three months until the end of intervention (12 months)
Assessment of health-related QoL over time
Time frame: 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
Time frame: At the end of intervention (month 12)
Physicians' views and experience regarding ASCAPE-based follow-up in terms of interaction
Time frame: At the end of intervention (month 12)
Physicians' experience in using ASCAPE-based follow-up
Time frame: At the end of intervention (month 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 35446854Tzelves 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paris Kosmidis study director
CareAcross
Serge Autexier study director
German Research Center for Artificial Intelligence
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASCAPE-based follow-up strategy in people with Breast Cancer and Prostate Cancer, run by Region Örebro County at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Greece, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' experience using ASCAPE-based follow-up (time frame: At the end of intervention (month 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.