The Impact of Melanoma and Drug Treatment in the Real World
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 819
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life (HRQL), general
研究概览
简要总结
An observational, non-interventional registry study to collect real-world data from people living with melanoma and its treatment, which will be available to researchers to further the knowledge of melanoma and improve patient care.
详细描述
The registry uses Vitaccess' digital real-world evidence platform, and has been developed in collaboration with the patient advocacy group Melanoma UK.
Eligible participants install a study app on their smartphone or tablet. Researchers access aggregated, anonymised data via a cloud-based research portal. The platform provides benefits to participants, which it is hoped will encourage persistence with data submission; these include options to upload electronic documents such as scans, and access an online melanoma community.
The aggregated data are available in close to real time via "dashboards" and can be analysed according to a number of pre-set criteria (e.g. disease stage, age, geographic location).
State-of-the-art technologies and security policies are used in the platform to ensure industry-standard data storage and privacy for all users. Participants' personally identifiable information will remain confidential at all times, and researchers will not be able to identify individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
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
- •adults with melanoma of any stage, resident in the UK with National Health Service (NHS) or Community Health Index (CHI) number, aged 18 and over, current or previous diagnosis of melanoma, willing to use their own smartphone or tablet.
排除标准
- •no specific exclusion criteria
结局指标
主要结局
Health-Related Quality of Life (HRQL), general
时间窗: Monthly throughout 4 year study duration
EQ-5D-5L
次要结局
- Health-Related Quality of Life (HRQL), symptoms(Monthly throughout 4 year study duration)
- Health-Related Quality of Life (HRQL), oncology(Monthly throughout 4 year study duration)
研究者
Mark Larkin
Director
Vitaccess Ltd
