Clinical trial NCT02031029: Character Traits and Stress in Suspected Prostate Cancer
Official title: 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?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostatic Diseases
Keywords: personality scores
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Akershus
First posted: 2014-01-09
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men referred to urological outdoor department or gastroenterological outdoor department

Brief summary: 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.

Detailed description: Inclusion criteria:

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

   1. Wanted clinical examined because of elevated PSA
   2. Not strong family history of prostate cancer
   3. It is taken biopsy as part of routine investigation.
2. Control groups: Men being referred to urological / gastroenterological outpatient clinic, and which meet the following criteria:

   1. urination complaints, normal PSA, and study shows prostate size\> 40cc
   2. Or melena and cancer suspicion in colorectum
3. Age\> 18 years and \<75 years

Outcome measures:

Together with statistician look for patterns / covariance in replies from those who are diagnosed with prostate cancer in the questionnaires personality evaluation adapted to normal population (Neo-FFI), gender differentiated stress response questionnaire (MGRSS) and questionnaires related to resilience, relationship and quality of life index, compared with the control groups.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Control group: Men referred to urological outpatient clinic, and who satisfy the following

   * urination complaints
   * Normal PSA
   * examination shows prostate size\> 40cc
3. Control group: Men first time referred urological / gastroenterological outpatient clinic, and which satisfy the following

   -- symptoms that might indicate cancer suspicion in colorectum
4. Age\> 40 years and \<75 years

Exclusion criteria:

1. known prostate cancer
2. Reduced consent

4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)

Primary outcomes:
measure: MGRSS questionnaire
timeFrame: 2 years
measure: Testosterone
timeFrame: 2 years
measure: Cholesterol
timeFrame: 2 years
Secondary outcomes:
measure: Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP)
timeFrame: 2 years
measure: coffee and green tea consumption
timeFrame: 2 years
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital, urological department
Study officials:
affiliation: Helse Stavanger HF
name: Gunn Iren Meling, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: