Technologies to Improve QoL of Prostate Cancer
NCT Number: NCT06516276
Acronym: MIO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: DEVICE: Mobile App M.I.O
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2025-12-31

Summary:
The M.I.O Project, which stands for Comprehensive Oncological Medicine, aims to comprehensively and multidisciplinary address the effects of prostate cancer, specifically in patients with hormone-sensitive metastatic prostate cancer (HSMPC), an advanced stage of the disease that still offers prolonged survival due to new medications. The proposal seeks to develop a healthcare approach that promotes self-care and improves the physical and mental health of patients.

Despite growing scientific evidence supporting an integrative approach in oncological care, the provision of personalized options for exercise, nutrition, and psychological therapy before, during, and after diagnosis remains limited. The project proposes to develop tools such as a dedicated mobile application that provides HSMPC patients access to various resources and therapies to improve their health, focusing on nutrition, exercise, and emotional well-being.

M.I.O represents an innovative and holistic approach to addressing these patients' needs and improving their overall well-being. The main goal is to measure the quality of life of the application users through validated questionnaires in a randomized health education study to assess if there is a substantial improvement in their well-being.

Primary Outcome Measures: Measure the quality of life of patients with metastatic prostate cancer using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)., "Quality of life of patients with hormone-sensitive metastatic prostate cancer" refers to the well-being and daily functioning of individuals diagnosed with this condition, including their physical, emotional, and social health, and their ability to perform everyday activities despite cancer progression.

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a standardized tool used to assess cancer patients' quality of life. It includes 30 items covering physical functioning, emotional well-being, cognitive functioning, social interactions, and symptoms like fatigue and pain.

Scores range from 0 to 100. Higher scores in functional scales and global health status indicate better functioning and quality of life, while higher scores in symptom scales/items indicate worse symptoms or problems., At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
Secondary Outcome Measures: assess treatment adherence using the Morisky Medication Adherence Scale (MMAS), "Improving adherence to treatments" refers to enhancing patients' consistency in following prescribed medical regimens, such as taking medications correctly, attending scheduled appointments, and adhering to recommended lifestyle changes. The goal is to ensure that patients receive the full benefit of their treatments, leading to better health outcomes and more effective disease management. The Morisky Medication Adherence Scale (MMAS) is a validated questionnaire used to measure a patient's adherence to their medication regimen. It consists of a series of questions designed to identify patterns of behavior related to medication-taking.

Scores range from 0 to 8. Higher scores indicate better adherence to the prescribed medication regimen. Specifically, for MMAS-8:

A score of 8 suggests high adherence. A score of 6 to \<8 indicates medium adherence. A score of \<6 suggests low adherence., At 3 and 6 months after use of the standard recommendatiosn/ Mobile App|Clinical progression using the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire and the Visual Analogue Scale (VAS)., Assessing the impact of the application on clinical progression through pain and fatigue. The Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire measures fatigue and its impact on quality of life in cancer patients, with scores ranging from 0 to 52; higher scores indicate better quality of life and less fatigue.

The Visual Analogue Scale (VAS) measures subjective symptoms like pain or fatigue. It consists of a 10 cm line with "no pain" at one end and "worst pain imaginable" at the other. Patients mark their current state on the line, resulting in a score from 0 to 100; higher scores indicate greater symptom severity, At 3 and 6 months after use of the standard recommendatiosn/ Mobile App|Assessment of Compliance with Recommendations (Percentage Based on M.I.O. Application and Clinical Interview for Control Group), The objective is to measure the percentage of recommendations that were followed. This will be assessed using the M.I.O. application for the intervention group and through clinical interviews for the control group. The compliance rate will be calculated as the percentage of the total recommendations that each participant adhered to during the study period., At 3 and 6 months after use of the standard recommendatiosn/ Mobile App