Patient Empowerment Via Mobile Health Applications: MyAria
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient monitoring: Early Detection of Unfavourable Medical Conditions
研究概览
简要总结
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.
详细描述
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 3. Emotional capability in managing prostate cancer; designed to quantify patients' perceived control, understanding of their health status, and confidence during consultations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient monitoring: Early Detection of Unfavourable Medical Conditions
时间窗: 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).
Patient empowerment: Change in Patient Empowerment Score (Pre-Post)
时间窗: 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: 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.
次要结局
- 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)
研究者
Constantinos Zamboglou
Prof
German Oncology Center, Cyprus