Quality of Life, Psychological Impact and Care-related Challenges in Patients Affected by Von Hippel-Lindau Syndrome: a Single-centre Observational, Transversal, Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Completion of a self- administered questionnaire
研究概览
简要总结
This is a single-centre, cross-sectional observational study aiming to assess the psychological burden, quality of life, and perceived barriers to care in patients with von Hippel-Lindau syndrome (VHL). Data will be collected through an anonymous online questionnaire, specifically designed for the study and administered via Google Forms.
详细描述
This is a single-centre, cross-sectional observational study designed to assess the psychological burden and health-related quality of life in individuals with von Hippel-Lindau (VHL) syndrome, and to explore perceived barriers to healthcare access and the perceived adequacy of multidisciplinary care.
The hypothesis underlying this study is that individuals affected by VHL experience a substantial psychological burden and face variable access to appropriate care pathways, which may differ based on demographic or clinical factors.
The study will involve a single group of participants (n ≈ 200). No control group or randomization is foreseen. The study duration is estimated at 10 years, including data collection and analysis.
Each participant will be involved once, with a single data collection session (approx. 25-30 minutes) through the study-specific questionnaire "VHL: Accesso alle cure e vita quotidiana". The questionnaire, administered in Italian via the Google Forms platform, is not part of routine clinical practice and is administered exclusively for research purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Genetically confirmed diagnosis of von Hippel- Lindau syndrome
排除标准
- •Inability to understand or complete the questionnaire, either independently or with assistance
研究组 & 干预措施
Single - centre, cross - sectional observational study with additional procedure.
Adult subjects (≥ 18 years) with confirmed diagnosis of von Hippel - Lindau syndrome
结局指标
主要结局
Completion of a self- administered questionnaire
时间窗: Single time point (approximately 25-30minutes).
The research activity consists in the anonymous collection of patient- reported data through an online questionnaire. No diagnostic, therapeutic, or experimental interventions are foreseen. The study fully complies with the definition of non-interventional observational research.
次要结局
未报告次要终点
研究者
Larcher Alessandro
Medical Doctor
IRCCS Ospedale San Raffaele