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Enrolling by invitation

NCT Number: NCT07828951

Patient Empowerment Via Mobile Health Applications (MHAs)

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.

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Key information

Conditions

Empowerment, Patient Behavior Health Behavior Mobile Application Patient Acceptance of Health Care Patient Participation Prostate CA Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

German Oncology Center

Limassol, 4108, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Patient monitoring: Early Detection of Unfavourable Medical Conditions

    Time frame: Baseline, Follow-up at 3 months

    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).

  2. Patient empowerment: Change in Patient Empowerment Score (Pre-Post)

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

    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.

Secondary outcomes

  1. Feasibility of Mobile Health App Deployment

    Time frame: 3 months Follow-up

    Proportion of enrolled participants who successfully complete both pre- and post-consultation questionnaires using the mobile app.

  2. Appropriateness: Time to Complete Empowerment Questionnaire

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

    Average time (in minutes) required to complete the empowerment questionnaire before and after the clinical consultation whether is suitable, practicable or appropriate.

  3. Nomogram and recurrent disease risk prediction in practice

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Constantinos Zamboglou

Other

Collaborators

  • Dcentric Health Ltd

Registry information

Official study title

Patient Empowerment Via Mobile Health Applications: MyAria

Acronym: MyAria

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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