Character Traits and Stress in Suspected Prostate Cancer

NCT ID: NCT02031029

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-18

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.

Conditions

Prostatic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunn Iren Meling, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Akershus University Hospital

Lørenskog, , Norway

Stavanger University Hospital, urological department

Stavanger, , Norway

Countries

Norway

Other Identifiers

2013/113

Identifier Type: -

Identifier Source: org_study_id