Technologies to Improve QoL of Prostate Cancer

NCT06516276 | Not Yet Recruiting

• 1 other identifier: 2023/38PI
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• assess treatment adherence using the Morisky Medication Adherence Scale (MMAS)

  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).

  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)

  At 3 and 6 months after use of the standard recommendatiosn/ Mobile App

Study Arms (2)

MOBILE App

EXPERIMENTAL

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.

Device: Mobile App M.I.O

Control Standard Recommendations

NO INTERVENTION

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

Interventions

Mobile App M.I.O 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.

MOBILE App

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 23, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07