Patient Empowerment Via Mobile Health Applications (MHAs)

NCT07828951 | Enrolling By Invitation

• 2 other identifiers: 2025-ΜΗΑ-270U1111-1323-7409
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 willingness to share health data for research?
• Does the app promote patient empowerment through the use of the nomograms? 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.

Conditions

Mobile Application; Prostate CA; Empowerment, Patient

Keywords

patient empowerment; nomogram; quality of life; patient reported outcomes; digital health application

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline (before consultation) and Follow-up (the same day but post-consultation)

Secondary Outcomes (3)

• Feasibility of Mobile Health App Deployment

  3 months Follow-up

• Appropriateness: Time to Complete Empowerment Questionnaire

  Baseline (before consultation) and Follow-up (the same day but post-consultation)

• Nomogram and recurrent disease risk prediction in practice

  Baseline

Interventions

Digital health application engagement and empowerment BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: prostate cancer only patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Constantinos Zamboglou: lead
• Dcentric Health Ltd: collaborator

Study Sites (1)

German Oncology Center

Limassol, 4108, Cyprus

Location

Related Publications (4)

• 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.

  PMID: 37853026 BACKGROUND

• Zamboglou 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.

  PMID: 37219907 BACKGROUND

• Kumar 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.

  PMID: 23867031 BACKGROUND

• Anderson 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.

  PMID: 19682830 BACKGROUND

Related Links

• MyAria app - DCentric Health Ltd

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: September 18, 2026
• Study Start: October 15, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

CY (1)