Character Traits and Stress in Suspected Prostate Cancer

NCT02031029 | Terminated

• 1 other identifier: 2013/113
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostatic Diseases

Keywords

personality scores

Outcome Measures

Primary Outcomes (3)

• MGRSS questionnaire

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

  2 years

• Testosterone

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

  2 years

• Cholesterol

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

  2 years

Secondary Outcomes (2)

• Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP)

  2 years

• coffee and green tea consumption

  2 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men referred to urological outdoor department or gastroenterological outdoor department

You may qualify if:

• 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

You may not qualify if:

• known prostate cancer
• Reduced consent
• Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)

Sponsors & Collaborators

• Helse Stavanger HF: lead
• University Hospital, Akershus: collaborator

Study Sites (2)

Akershus University Hospital

Lørenskog, NO-1478, Norway

Location

Stavanger University Hospital, urological department

Stavanger, NO-4011, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gunn Iren Meling, MD PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: January 9, 2014
• Study Start: December 1, 2013
• Primary Completion: December 18, 2015
• Study Completion: December 18, 2015
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)