跳至主要内容
临床试验/NCT03131076
NCT03131076Unknown不适用

Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu

Helsinki University Central Hospital0 个研究点目标入组 300 人开始时间: 2017年5月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heini Nieminen

licensed physician

Helsinki University Central Hospital

相似试验