Empowerment, PatientMyAriaNCT07828951
Patient Empowerment Via Mobile Health Applications (MHAs)
An observational study of Empowerment, Patient and Mobile Application, run by Constantinos Zamboglou at 1 site in Cyprus.
Trial summary
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: Does using the app improve patients' ability to track and self-manage symptoms? Does the app increase engagement and… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Empowerment, Patient, Mobile Application, Prostate CA
- What is being tested?
- Digital health application engagement and empowerment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Oct 2025to 20 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- At least 18 and below 80 years of age
- Prostate cancer diagnosis
- Speak fluent English or Greek
- Not had previous radiotherapy to the pelvis
- Wishing to receive treatment at the German Oncology Center (GOC) or German Medical Institute (GMI)
- Willing to take part in this research study, which lasts up to six months
- Sign an informed consent form
Who cannot join
- Younger than 18 years or over 80 years of age
- Other than prostate cancer diagnosis
- Previous radiotherapy to the pelvis
- Not wishing to receive treatment at the German Oncology Center (GOC) or German Medical Institute (GMI)
- Not willing to take part in this research study
- No signed informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient Empowerment Via Mobile Health Applications: MyAria
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:
- Does using the app improve patients' ability to track and self-manage symptoms?
- Does the app increase engagement and willingness to share health data for research?
- Does the app promote patient empowerment through the use of the nomograms?
Read more
Participants will:
- Install and use the patient-facing mobile app developed through the Agora3.0 project.
- Regularly log symptom information, treatment side effects, and any changes in their daily well-being.
- Complete brief, periodic questionnaires about their experience using the app.
- Access the nomogram tool during consultation with doctor for discussion of results and treatment plan.
- Consent (within the app) to share anonymized health data and survey responses with researchers.
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.
Read the detailed description
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 diagnostic model estimating the probability of clinically significant prostate cancer (Model A).
- A postoperative recurrence model predicting 5-year biochemical relapse risk after radical prostatectomy (Model B). Delivering Electronic Patient-Reported Outcomes (ePROs):
- IPSS (International Prostate Symptom Score): Seven questions on urinary symptoms; total score 0-35 (higher = more severe lower urinary tract symptoms [LUTS]).
- IIEF-5 (International Index of Erectile Function-5): Five items measuring erectile function; total score 1-25 (higher = better function; <21 suggests erectile dysfunction).
- EPIC-CP (Expanded Prostate Cancer Index Composite-Clinical Practice): A concise, 16-item version capturing urinary, bowel, sexual, vitality/hormonal, and overall bother domains; scores 0-76 (lower = better health-related QoL).
- HADS (Hospital Anxiety and Depression Scale): 14 items (7 anxiety, 7 depression); two subscales each 0-21 (higher = greater symptomatology). A 13-item empowerment instrument across three sub-scales: (1) Knowledge about Prostate Cancer and Treatment; (2) Shared Decision-Making with Doctors
- Emotional capability in managing prostate cancer; designed to quantify patients' perceived control, understanding of their health status, and confidence during consultations.
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:
- Determining whether delivering ePROs and the Empowerment Questionnaire via an MHA is practical in a busy clinic.
- Collecting pilot data to assess reliability (Cronbach's α) and construct validity (e.g., correlations with anxiety scores and ePROs) of the Empowerment Questionnaire.
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.
- Conditions
- Empowerment, Patient, Mobile Application, Prostate CA
- Being tested
- Digital health application engagement and empowerment
- Keywords
- patient empowerment, nomogram, quality of life, patient reported outcomes, digital health application
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital health application engagement and empowermentBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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:
- Knowledge about Prostate Cancer and Treatment
- Shared Decision-Making with Doctors
- Emotional Capability in Managing Prostate Cancer Measured before and after the clinical consultation using the mobile application.
Measured: Baseline (before consultation) and Follow-up (the same day but post-consultation)
Secondary outcomes (3)
Feasibility of Mobile Health App Deployment
Proportion of enrolled participants who successfully complete both pre- and post-consultation questionnaires using the mobile app.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Oct 2025
- Primary completion30 Jun 2026
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Empowerment, PatientStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Constantinos Zamboglou
- Sponsor type
- University, hospital or other
- Collaborators
- Dcentric Health Ltd
- Responsible party
- Sponsor-investigator, Constantinos Zamboglou, German Oncology Center, Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828951
- Sponsor's protocol ID
- 2025-ΜΗΑ-270
- Other IDs
- U1111-1323-7409
- Acronym
- MyAria
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
Zhang Z, Cai Q, Wang J, Yao Z, Ji F, Hang Y, Ma J, Jiang H, Yan B, Zhanghuang C. Development and validation of a nomogram to predict cancer-specific survival in nonsurgically treated elderly patients with prostate cancer. Sci Rep. 2023 Oct 18;13(1):17719. doi: 10.1038/s41598-023-44911-z.
PubMed 37853026Zamboglou C, Peeken JC, Janbain A, Katsahian S, Strouthos I, Ferentinos K, Farolfi A, Koerber SA, Debus J, Vogel ME, Combs SE, Vrachimis A, Morganti AG, Spohn SKB, Shelan M, Aebersold DM, Grosu AL, Ceci F, Henkenberens C, Kroeze SGC, Guckenberger M, Fanti S, Belka C, Bartenstein P, Hruby G, Scharl S, Wiegel T, Emmett L, Arnoux A, Schmidt-Hegemann NS. Development and Validation of a Multi-institutional Nomogram of Outcomes for PSMA-PET-Based Salvage Radiotherapy for Recurrent Prostate Cancer. JAMA Netw Open. 2023 May 1;6(5):e2314748. doi: 10.1001/jamanetworkopen.2023.14748.
PubMed 37219907Kumar S, Nilsen WJ, Abernethy A, Atienza A, Patrick K, Pavel M, Riley WT, Shar A, Spring B, Spruijt-Metz D, Hedeker D, Honavar V, Kravitz R, Lefebvre RC, Mohr DC, Murphy SA, Quinn C, Shusterman V, Swendeman D. Mobile health technology evaluation: the mHealth evidence workshop. Am J Prev Med. 2013 Aug;45(2):228-36. doi: 10.1016/j.amepre.2013.03.017.
PubMed 23867031Anderson RM, Funnell MM. Patient empowerment: myths and misconceptions. Patient Educ Couns. 2010 Jun;79(3):277-82. doi: 10.1016/j.pec.2009.07.025. Epub 2009 Aug 13.
PubMed 19682830