Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Change in the quality of life and anxiety
研究概览
简要总结
Over 500 patients were participating in the IPMN follow up between september 2014 and august 2016 at the Helsinki University Hospital. In this study we are going to determine the effects of the IPMN surveillance on the quality of life and anxiety levels of the patients.
详细描述
Intraductal papillary mucinous neoplasm (IPMN) is a cystic neoplasm of the pancreas. The incidence of the tumors has increased during the last years. Some of the IPMN-tumors develop over time increasing dysplasia and at the end IPMN associated carcinoma. All IPMN-patients are kept under surveillance because of the cancer risk. This follow up can last decades and includes MRI and blood samples every 6 to 12 months. This is very expensive and the effects on the patients quality of life have not been studied before to our knowledge.
This study determines the effects of the surveillance on the patients quality of life and anxiety levels. The study will be conducted by 15D- quality of life -questionnaire and state-trait anxiety inventory (STAI) -questionaire. Both will be send to the patients before a IPMN follow up MRI and 3 months later. It is anticipated that the anxiety and the effect on the quality of life would be the highest right before the MRI and would normalize a few months after the MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients under IPMN surveillance
排除标准
- •no exclusion criteria, all patients under IPMN surveillance are included
结局指标
主要结局
Change in the quality of life and anxiety
时间窗: Before and 3 months after IPMN follow up MRI
15D quality of life and STAI -questionnaire
次要结局
未报告次要终点
研究者
Heini Nieminen
licensed physician
Helsinki University Central Hospital
