Monitoring of Adverse Events Caused by Systemic Cancer Treatment. Identifying Adverse Events Related to Immunotherapy Treatment Before and After Implementation of Personalized Digital Patient Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Incidence and severity of immunotherapy related adverse events (irAEs)
研究概览
简要总结
The goal of this clinical trial is to investigate patient harm/ adverse events, overall survival and health related quality of life under treatment with immunotherapy medication in cancer patients when they are followed up by a personalized digital program where the patients report symptoms directly to health care personnel.
The main questions the clinical trial aims to answer are:
- How often and how severe are immunotherapy related adverse events/ side effects when patients are followed up by a digital personalized patient-reporting system compared to standard follow-up?
- How are life quality and survival affected for patients followed up by a digital personalized patient-reporting system compared to follow-up standard follow-up??
Participants under immunotherapy cancer treatment will be followed up by a digital patient reporting program in one group, and compared to a group of cancer patients receiving the same treatment, but with standard follow-up without a digital program in another group. Researchers will compare the two groups to see if there any differences in how many patients who develop immunotherapy related patient harm and how long the patients live.
详细描述
Cancer patients experience more frequently patient harm than other patients, mostly from systemic anticancer treatment. To reduce avoidable patient harm from modern cancer treatment such as immunotherapy and targeted therapies, precise and clinically relevant measurements are needed.
The study aims through three different sub-studies/ work pacages (WP) to develop electronic methods for measuring automatically injuries in cancer patients, and investigate if electronic patient follow-up (ePRO) can prevent injuries, affect quality of life and survival in patients receiving immunotherapy cancer treatment.
Research has shown that the recommended method for measuring patient harm and medication related adverse events is not specific or sensitive enough to detect cancer-related patient harm. In recent years, three patient harm measurement tools for cancer have been validated based on a manual retrospective review of the patient record. Based on existing technology and research, in WP1 the aim is to develop and validate a fully automatic patient harm measurement tool for retrospective detection of harm in cancer patients receiving immunotherapy. The development of the technological solution is done by Datavarehuset Helse Nord and SAS Institute in an already existing solution (Nordic Clinical Analytics Framework - NCAF) which is used daily in all health trusts in Helse Nord, Northern Norway.
In order to prevent avoidable patient harm and adverse events, it is important to involve the patient in their own treatment. Research on follow-up with ePRO revealed more side effects, increased quality of life and overall survival in cancer patients.
In WP2, the technology developed in WP1 is used to prospectively examine whether follow-up with ePRO compared to standard follow-up results in less adverse events. In WP3, quality of life and survival are investigated with ePRO follow-up compared to standard follow-up. WP1 is a retrospective diagnostic study. WP2 and 3 are clinical cohort studies where a prospective intervention group of cancer patients are followed with ePRO during immunotherapy treatment and compared with a retrospective group of cancer patients followed with standard clinical follow-up. WP2 investigates rates, severity and types of immunotherapy related adverse events in patients monitored with ePRO compared to standard follow-up. WP3 investigates quality of life in the ePRO cohort, and overall survival in patients monitored to standard follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Above 18 years of age
- •Cancer diagnosis as primary or secondary diagnosis according to the ICD-10 classification
- •Receiving immunotherapy as systemic anticancer treatment reported with ATC codes for medications.
排除标准
- •Hematological cancer
- •Gynecological cancer
结局指标
主要结局
Incidence and severity of immunotherapy related adverse events (irAEs)
时间窗: 3 years
Incidence of irAEs per 100 patients and per patient, and severity of irAEs graded by Common Terminology Critera for Adverse Events (CTCAE) 0-5 where 0 is no harm, and 5 is death. Consequence of the irAEs are graded by National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index category E-I where E is an error contributing to or resulted in temporary harm and required intervention. I is the maximum value, where an error occurred that may have contributed to or resulted in a patient death.
次要结局
- Overall survival(3 years)
- Health related quality of life(3 years)