Prostate CancerMIONCT06516276
Technologies to Improve QoL of Prostate Cancer
A study testing Mobile App M.I.O in people with Prostate Cancer, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Mobile App M.I.O
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients histologically diagnosed with prostate cancer
- Metastases confirmed by validated imaging studies
- Not meet criteria for castration resistance.
Who cannot join
- Do not have a smartphone device
- Refuse to participate
- Not sign the informed consent.
About this study
Official title: Application of New Technologies to Improve the Quality of Life of Prostate Cancer Patients:
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
- Being tested
- Mobile App M.I.O
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile App M.I.ODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mobile App M.I.O |
| Control Standard Recommendations | No intervention | The control group will receive the same recommendations without additional support tools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
"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.
Measured: 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).
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
Measured: 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)
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.
Measured: At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inés Nuño de la Rosa García, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516276
- Sponsor's protocol ID
- 2023/38PI
- Acronym
- MIO
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of New Technologies to Improve the Quality of Life of Prostate Cancer Patients:
- ClinicalTrials.gov ID
- NCT06516276
- Acronym / sponsor ID
- MIO / 2023/38PI
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOBILE App | Experimental | Device: Mobile App M.I.OThe intervention group will receive standard nutrition, physical exercise, and emotional care recommendations according to scientific evidence and instructions on using the MIO mobile application. |
| Control Standard Recommendations | No intervention | –The control group will receive the same recommendations without additional support tools. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients histologically diagnosed with prostate cancer
- Metastases confirmed by validated imaging studies
- Not meet criteria for castration resistance.
Key exclusion criteria (3 listed)
- Do not have a smartphone device
- Refuse to participate
- Not sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile App M.I.OThis 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. | Device | MOBILE App |
Primary outcome
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).
Time frame: At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
"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.
3 secondary outcomes
assess treatment adherence using the Morisky Medication Adherence Scale (MMAS)
Time frame: 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).
Time frame: 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)
Time frame: At 3 and 6 months after use of the standard recommendatiosn/ Mobile App
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile App M.I.O in people with Prostate Cancer, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: At 3 and 6 months after use of the standard recommendatiosn/ Mobile App). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.