Clinical trial NCT06516276: Technologies to Improve QoL of Prostate Cancer
Official title: Application of New Technologies to Improve the Quality of Life of Prostate Cancer Patients:
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 98
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients histologically diagnosed with prostate cancer
* Metastases confirmed by validated imaging studies
* Not meet criteria for castration resistance.

Exclusion Criteria:

* Do not have a smartphone device
* Refuse to participate
* Not sign the informed consent.

Primary outcomes:
measure: 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).
timeFrame: At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
Secondary outcomes:
measure: assess treatment adherence using the Morisky Medication Adherence Scale (MMAS)
timeFrame: At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
measure: Clinical progression using the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire and the Visual Analogue Scale (VAS).
timeFrame: At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
measure: Assessment of Compliance with Recommendations (Percentage Based on M.I.O. Application and Clinical Interview for Control Group)
timeFrame: At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
Other outcomes:
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