跳至主要内容
临床试验/NCT04024345
NCT04024345Unknown不适用

Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact

Azienda Ospedaliera Universitaria Integrata Verona2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Perceived Stress Scale

研究概览

简要总结

Due to its rarity a population screening program for pancreatic cancer is not possible. For this reason, considering background data on genetic predisposition and familiarity for this lethal tumor, efforts have been pushed to build up surveillance programs for subjects at high-risk of pancreatic cancer, due to familiarity and/or genetic predisposition. These programs are based on radiological examinations (such as MRI or endoultrasonography) and laboratory tests. However, little is known about the psychological burden of these programs. Only a handful of studies investigated, in various ways, how the participation in surveillance programs for pancreatic cancer may burden the psychological status, with a consequent possible impairment of the psychological wellbeing, and a higher risk of withdraw from the surveillance program itself. The aim of this study was to assess the psychological and emotional impact in high-risk individuals participating in a surveillance program for pancreatic cancer due to familiarity and/or to genetic predisposition, using specific psychological tools, such as multiple psychological questionnaires, investigating different functioning areas, administered by a clinical psychologist.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Being enrolled in the Institutional surveillance program for pancreatic cancer
  • Ability to understand the details and implications of a study protocol.

排除标准

  • 未提供

结局指标

主要结局

Perceived Stress Scale

时间窗: 2-year

Assessment of the perceived stress

Barratt Simplified Measure of Social Status

时间窗: 2-years

Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)

General Self-Efficacy Scale

时间窗: 2-years

Self-report scale correlated to emotion, optimism, work

Multidimensional Scale of Perceived Social Support

时间窗: 2-years

to explore the subject's social support system

Global Assessment of Functioning scale

时间窗: 2-years

measure overall levels of functionality of an individual

Coping Orientation to Problems Experienced

时间窗: 2-years

evaluation of the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations

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

Erica Secchettin

Institutional Project Manager

Azienda Ospedaliera Universitaria Integrata Verona

研究点 (2)

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