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Trial Title:
Technologies to Improve QoL of Prostate Cancer
NCT ID:
NCT06516276
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Mobile App M.I.O
Description:
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.
Arm group label:
MOBILE App
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.
Criteria for 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.
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Agency class:
Other
Source:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06516276
