Character Traits and Stress in Suspected Prostate Cancer

Prostatic Diseases Clinical Trial

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02031029
• Other study ID #: 2013/113
• Status: Terminated
• Phase: N/A
• First received: October 9, 2013
• Last updated: March 30, 2017
• Start date: December 2013
• Est. completion date: December 18, 2015

Study information

• Verified date: March 2017
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: December 18, 2015
• Est. primary completion date: December 18, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostatic Diseases
• Prostatic Neoplasms

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog
Norway	Stavanger University Hospital, urological department	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MGRSS questionnaire	The profile of the answering patterns will be compared to baseline using psychiatric and statistical evaluation.	2 years
Primary	Testosterone	Testosterone at baseline and 2 years will be related to wether the patient has confirmed cancer or not.	2 years
Primary	Cholesterol	Cholesterol at baseline and 2 years will be related to wether the patient has confirmed cancer or not.	2 years
Secondary	Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP)	Blood values at baseline and 2 years will be related to wether the patient has confirmed cancer or not.	2 years
Secondary	coffee and green tea consumption	The consumption of coffee and green tea will be related to wether the patient has confirmed cancer or not.	2 years