跳至主要内容
临床试验/NCT02031029
NCT02031029终止不适用

A Questionnaire Study by Elevated Prostate Specific Antigen (PSA): Do Men Where Subsequent Assessment Shows Prostate Cancer, Higher Levels of Neuroticism and Stress Compared to Those Who do Not Get the Diagnosis?

Helse Stavanger HF2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
51
试验地点
2
主要终点
Cholesterol

研究概览

简要总结

It has previously been reported that men with prostate cancer are 1 ) reduced quality of life after diagnosis and treatment, 2 ) neuroticism increases the reduction in QoL related to treatment side effects, and 3) often have very involved and active spouses who seems to have been handed over / taken over parts of the men's responsibility for their own health. We postulate herein a new hypothesis that the stress level is elevated when harbouring undetected prostate cancer. We will investigate whether those who are diagnosed with prostate cancer already in beforehand have an increased degree of masculine stress ( experience of not living up to their own perception of the ideal man ) and neuroticism in the typology. We will examine different personality and QoL questionnaires for patients with elevated PSA, and compare those whose clinical assessment later reveals prostate cancer, with three control groups: 1) men with elevated PSA who are not diagnosed with prostate cancer, 2) men with normal PSA treated for benign prostate enlargement and 3) patient with substantial risk of colorectal cancer (CRC) who undergo colonoscopy, with regard to increased level of masculine stress and the personality trait neuroticism.

详细描述

Inclusion criteria:

  1. Men who are being referred as new urological outpatient and meet the following criteria:

  2. Wanted clinical examined because of elevated PSA

  3. Not strong family history of prostate cancer

  4. It is taken biopsy as part of routine investigation.

  5. Control groups: Men being referred to urological / gastroenterological outpatient clinic, and which meet the following criteria:

  6. urination complaints, normal PSA, and study shows prostate size> 40cc

  7. Or melena and cancer suspicion in colorectum

  8. Age> 18 years and <75 years

Outcome measures:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men who be referred a new urological outpatient and satisfy the following:
  • Wanted examined because of elevated PSA
  • Not strong family history of prostate cancer
  • It is taken biopsy as part of routine investigation.
  • Control group: Men referred to urological outpatient clinic, and who satisfy the following
  • urination complaints
  • Normal PSA
  • examination shows prostate size> 40cc
  • Control group: Men first time referred urological / gastroenterological outpatient clinic, and which satisfy the following
  • - symptoms that might indicate cancer suspicion in colorectum
  • Age> 40 years and <75 years
  • Exclusion criteria:
  • known prostate cancer
  • Reduced consent
  • 4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)

排除标准

  • 未提供

结局指标

主要结局

Cholesterol

时间窗: 2 years

Cholesterol at baseline and 2 years will be related to wether the patient has confirmed cancer or not.

Testosterone

时间窗: 2 years

Testosterone at baseline and 2 years will be related to wether the patient has confirmed cancer or not.

MGRSS questionnaire

时间窗: 2 years

The profile of the answering patterns will be compared to baseline using psychiatric and statistical evaluation.

次要结局

  • Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP)(2 years)
  • coffee and green tea consumption(2 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Character Traits and Stress in Suspected Prostate... | 临床试验