Technologies to Improve QoL of Prostate Cancer (MIO)

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Device: Mobile App M.I.O

Study type: Interventional

Funder types: Other

Identifiers

NCT06516276

2023/38PI

Details and patient eligibility

About

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.

Enrollment: 98 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

MOBILE App

Experimental group

Description:

The intervention group will receive standard nutrition, physical exercise, and emotional care recommendations according to scientific evidence and instructions on using the MIO mobile application.

Treatment:

Device: Mobile App M.I.O

Control Standard Recommendations

No Intervention group

Description:

The control group will receive the same recommendations without additional support tools.