Application of New Technologies to Improve the Quality of Life of Prostate Cancer Patients:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients histologically diagnosed with prostate cancer
- •Metastases confirmed by validated imaging studies
- •Not meet criteria for castration resistance.
排除标准
- •Do not have a smartphone device
- •Refuse to participate
- •Not sign the informed consent.
结局指标
主要结局
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).
时间窗: 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.
次要结局
- 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)
- assess treatment adherence using the Morisky Medication Adherence Scale (MMAS)(At 3 and 6 months after use of the standard recommendatiosn/ Mobile App)
研究者
Inés Nuño de la Rosa García
Dr
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana