Technologies to Improve QoL of Prostate Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients histologically diagnosed with prostate cancer

Metastases confirmed by validated imaging studies

Not meet criteria for castration resistance.

Disqualifiers

Do not have a smartphone device

Refuse to participate

Not sign the informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: MOBILE AppExperimental treatment 1 intervention
Group B: Control Standard RecommendationsNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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

"Improving adherence to treatments" refers to enhancing patients' consistency in following prescribed medical regimens, such as taking medications correctly, attending scheduled appointments, and adhering to recommended lifestyle changes. The goal is to ensure that patients receive the full benefit of their treatments, leading to better health outcomes and more effective disease management. The Morisky Medication Adherence Scale (MMAS) is a validated questionnaire used to measure a patient's adherence to their medication regimen. It consists of a series of questions designed to identify patterns of behavior related to medication-taking. Scores range from 0 to 8. Higher scores indicate better adherence to the prescribed medication regimen. Specifically, for MMAS-8: A score of 8 suggests high adherence. A score of 6 to \<8 indicates medium adherence. A score of \<6 suggests low adherence.

Time frame
At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
2

Clinical progression using the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire and the Visual Analogue Scale (VAS).

Assessing the impact of the application on clinical progression through pain and fatigue. The Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire measures fatigue and its impact on quality of life in cancer patients, with scores ranging from 0 to 52; higher scores indicate better quality of life and less fatigue. The Visual Analogue Scale (VAS) measures subjective symptoms like pain or fatigue. It consists of a 10 cm line with "no pain" at one end and "worst pain imaginable" at the other. Patients mark their current state on the line, resulting in a score from 0 to 100; higher scores indicate greater symptom severity

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

Assessment of Compliance with Recommendations (Percentage Based on M.I.O. Application and Clinical Interview for Control Group)

The objective is to measure the percentage of recommendations that were followed. This will be assessed using the M.I.O. application for the intervention group and through clinical interviews for the control group. The compliance rate will be calculated as the percentage of the total recommendations that each participant adhered to during the study period.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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