Technologies to Improve QoL of Prostate Cancer

NCT ID: NCT06516276

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MOBILE App

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.

Group Type EXPERIMENTAL

Mobile App M.I.O

Intervention Type DEVICE

This mobile app provides patients with access to various resources and therapies focused on nutrition, exercise, and emotional well-being. The main objective is to measure the quality of life of the app users through validated questionnaires in a randomized health education study to evaluate whether a substantial improvement in their well-being is achieved.

Control Standard Recommendations

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile App M.I.O

This mobile app provides patients with access to various resources and therapies focused on nutrition, exercise, and emotional well-being. The main objective is to measure the quality of life of the app users through validated questionnaires in a randomized health education study to evaluate whether a substantial improvement in their well-being is achieved.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Inés Nuño de la Rosa García

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2023/38PI

Identifier Type: -

Identifier Source: org_study_id

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