Character Traits and Stress in Suspected Prostate Cancer

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?

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02031029

Enrollment

Registered

2014-01-09

Start date

2013-12-31

Completion date

2015-12-18

Last updated

2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Diseases

Keywords

personality scores

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
MGRSS questionnaire	2 years	The profile of the answering patterns will be compared to baseline using psychiatric and statistical evaluation.
Testosterone	2 years	Testosterone at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
Cholesterol	2 years	Cholesterol at baseline and 2 years will be related to wether the patient has confirmed cancer or not.

Secondary

Measure	Time frame	Description
Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP)	2 years	Blood values at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
coffee and green tea consumption	2 years	The consumption of coffee and green tea will be related to wether the patient has confirmed cancer or not.

Countries

Norway

Outcome results