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Character Traits and Stress in Suspected Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02031029
Recruitment Status : Terminated (Stopped by the sponsor due to discrepancies in the recruitment process.)
First Posted : January 9, 2014
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Helse Stavanger HF

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.

Condition or disease
Prostatic Diseases

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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?
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 18, 2015
Actual Study Completion Date : December 18, 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. MGRSS questionnaire [ Time Frame: 2 years ]
    The profile of the answering patterns will be compared to baseline using psychiatric and statistical evaluation.

  2. Testosterone [ Time Frame: 2 years ]
    Testosterone at baseline and 2 years will be related to wether the patient has confirmed cancer or not.

  3. Cholesterol [ Time Frame: 2 years ]
    Cholesterol at baseline and 2 years will be related to wether the patient has confirmed cancer or not.


Secondary Outcome Measures :
  1. Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP) [ Time Frame: 2 years ]
    Blood values at baseline and 2 years will be related to wether the patient has confirmed cancer or not.

  2. coffee and green tea consumption [ Time Frame: 2 years ]
    The consumption of coffee and green tea will be related to wether the patient has confirmed cancer or not.


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Men referred to urological outdoor department or gastroenterological outdoor department
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031029


Locations
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Norway
Akershus University Hospital
Lørenskog, Norway, NO-1478
Stavanger University Hospital, urological department
Stavanger, Norway, NO-4011
Sponsors and Collaborators
Helse Stavanger HF
University Hospital, Akershus
Investigators
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Principal Investigator: Gunn Iren Meling, MD PhD Helse Stavanger HF

Additional Information:

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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT02031029    
Other Study ID Numbers: 2013/113
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helse Stavanger HF:
personality scores
Additional relevant MeSH terms:
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Prostatic Diseases
Genital Diseases, Male