An observational study in Empowerment, Patient, Mobile Application and Prostate CA, sponsored by Constantinos Zamboglou. Enrolling by invitation at 1 site in Cyprus. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Constantinos Zamboglou · Observational
The goal of this observational study is to learn if myAria MHA can help adult oncology patients better manage their health and participate in medical research. The main questions it aims to answer are:
Participants will:
Through this project-funded by the Cypriot Research and Innovation Foundation and developed in partnership between GoC and Dcentric Health-Aria's ecosystem of products aims to empower oncology patients to take control of their care while contributing to ongoing medical research. Further, for the first time the use of nomogram and measurement of empowerment in prostate cancer will take place through the use of a co-developed (between researchers and patient representatives) questionnaire for testing its feasibility and validation.
While prognostic nomograms guide clinical decisions in prostate cancer, patients rarely receive tailored, real-time feedback about their individual risk or functional outcomes during consultations. This gap can undermine their sense of control and exacerbate anxiety. The "myAria" pilot aims to transform a conventional Mobile Health Application into a patient-friendly empowerment tool by:
Integrating Two Established Risk Models:
A postoperative recurrence model predicting 5-year biochemical relapse risk after radical prostatectomy (Model B).
Delivering Electronic Patient-Reported Outcomes (ePROs):
A 13-item empowerment instrument across three sub-scales: (1) Knowledge about Prostate Cancer and Treatment; (2) Shared Decision-Making with Doctors
Each item is scored 1 ("Strongly Disagree") to 5 ("Strongly Agree"), yielding a total score range of 13-65. Higher scores indicate greater empowerment.
Evaluating Feasibility and Psychometrics:
Enhancing Patient Engagement and Reducing Anxiety: by providing personalised, real-time feedback, myAria seeks to foster greater patient empowerment, potentially lowering anxiety levels and strengthening the doctor-patient relationship.
409 studies on the registry are indexed under Patient Participation; 101 are open to participants now.
This study's planned enrollment of 50 is below the median of 170 across 80 observational studies indexed under Patient Participation.
Browse Patient Participation studies →This is the only study on the registry with Constantinos Zamboglou as lead sponsor.
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The study is open to all males aged 18 to 80 years of age with a prostate cancer diagnosis who have not received previous radiotherapy to the pelvis and wish to receive their treatment at GOC/GMI. If they are willing to take part in this research study, they will be invited to download the mobile health application on their phone (also tablets available at the Center for this purpose), complete the eligibility questionnaire, sign the consent form and provide their phone number for account registration with the app and enrollment into the study. The patient study population is via purpose sampling.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study aims to move the current concept of mobile health towards a more patient-friendly tool, in which the patient receives personalised information of their health status, in real-time. Due to the patient engagement tools, the MHA targets to gain high levels of patient empowerment, potentially reduced anxiety, better doctor-patient relationship. Although prognostic nomograms are commonly used in clinical practice to guide decision-making in prostate cancer, there is currently no concise, validated instrument to measure patient "empowerment" before and after the use of these tools during consultations. The main aims of the MHAs MyAria study is to: (1) integrate the existing MHA prototype: MyAria for Agora3.0 and incorporate two risk prediction models for prostate cancer (2) check feasibility: test whether delivering the ePROs \& the new "Empowerment Questionnaire" via a mobile app is feasible in a busy prostate cancer clinic, and (3) gather initial psychometric data for validation.
Patient monitoring: Early Detection of Unfavourable Medical Conditions
Proportion of patients for whom the mobile app detects or flags symptoms of pain, infection, or possible relapse based on electronic patient-reported outcomes (PROs) submitted through the application (e.g., pain scores, urinary symptoms, or other red-flag indicators).
Time frame: Baseline, Follow-up at 3 months
Patient empowerment: Change in Patient Empowerment Score (Pre-Post)
Change in composite empowerment score, derived from a newly developed questionnaire measuring three domains: 1. Knowledge about Prostate Cancer and Treatment 2. Shared Decision-Making with Doctors 3. Emotional Capability in Managing Prostate Cancer Measured before and after the clinical consultation using the mobile application.
Time frame: Baseline (before consultation) and Follow-up (the same day but post-consultation)
Feasibility of Mobile Health App Deployment
Proportion of enrolled participants who successfully complete both pre- and post-consultation questionnaires using the mobile app.
Time frame: 3 months Follow-up
Appropriateness: Time to Complete Empowerment Questionnaire
Average time (in minutes) required to complete the empowerment questionnaire before and after the clinical consultation whether is suitable, practicable or appropriate.
Time frame: Baseline (before consultation) and Follow-up (the same day but post-consultation)
Nomogram and recurrent disease risk prediction in practice
Exploratory analysis of the agreement between prognosis or treatment recommendations generated by standard-of-care nomogram use and the treatment plan ultimately chosen. This will be done to assess whether clinical decisions align with nomogram predictions in the context of shared decision-making. An estimated 200 patients serving as a retrospective testing cohort is estimated to provide accuracy in risk prediction and disease prognosis.
Time frame: Baseline
Plan to share: Undecided — We can provide raw and aggregated data on the responses to the various tools used (self-reported outcomes). We can also provide the individual responses to the nomogram questionnaires and the nomogram itself (which is done in consulation with the doctor).
Ran from Oct 2025 to primary completion in Jun 2026, 8 months.
Of 42 non-industry observational studies under Patient Participation, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 8 months is below that.
Counting every sponsor, half of 44 studies reached it within 17 months; a quarter within 8 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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