Prostatic DiseasesNCT02031029
Character Traits and Stress in Suspected Prostate Cancer
An observational study of Prostatic Diseases, run by Helse Stavanger HF at 2 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Diseases
- How many people
- 51 participants
- Where
- 2 sitesNorway
- Study dates
- Dec 2013to 18 Dec 2015
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men referred to urological outdoor department or gastroenterological outdoor department
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- known prostate cancer
- Reduced consent
- 4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Lørenskog, NO-1478
Stavanger University Hospital, urological department
Stavanger, NO-4011
About this study
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?
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.
Read the detailed description
Inclusion criteria:
- Men who are being referred as new urological outpatient and meet the following criteria:
- Wanted clinical examined because of elevated PSA
- Not strong family history of prostate cancer
- It is taken biopsy as part of routine investigation.
- Control groups: Men being referred to urological / gastroenterological outpatient clinic, and which meet the following criteria:
- urination complaints, normal PSA, and study shows prostate size> 40cc
- Or melena and cancer suspicion in colorectum
- 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
- Keywords
- personality scores
- Medical subject headings
- Prostatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
MGRSS questionnaire
The profile of the answering patterns will be compared to baseline using psychiatric and statistical evaluation.
Measured: 2 years
Testosterone
Testosterone at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
Measured: 2 years
Cholesterol
Cholesterol at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 years
coffee and green tea consumption
The consumption of coffee and green tea will be related to wether the patient has confirmed cancer or not.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startDec 2013
- Primary completion18 Dec 2015
- Study completion18 Dec 2015
Why it stopped: Stopped by the sponsor due to discrepancies in the recruitment process.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Gunn Iren Meling, MD PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031029
- Sponsor's protocol ID
- 2013/113
- Status last verified
- Mar 2017
- First submitted
- 9 Oct 2013
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02031029
- Acronym / sponsor ID
- 2013/113
- Conditions
- Prostatic Diseases
- Keywords
- personality scores
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Stopped by the sponsor due to discrepancies in the recruitment process.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- University Hospital, Akershus
- Study start
- Dec 2013 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Men who are being referred as new urological outpatient and meet the following criteria:
- Wanted clinical examined because of elevated PSA
- Not strong family history of prostate cancer
- It is taken biopsy as part of routine investigation.
- Control groups: Men being referred to urological / gastroenterological outpatient clinic, and which meet the following criteria:
- urination complaints, normal PSA, and study shows prostate size> 40cc
- Or melena and cancer suspicion in colorectum
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men referred to urological outdoor department or gastroenterological outdoor department
Key inclusion criteria (11 listed)
- Men who be referred a new urological outpatient and satisfy the following:
- Control group: Men referred to urological outpatient clinic, and who satisfy the following
- 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
Key exclusion criteria (3 listed)
- known prostate cancer
- Reduced consent
- 4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MGRSS questionnaire
Time frame: 2 years
The profile of the answering patterns will be compared to baseline using psychiatric and statistical evaluation.
Testosterone
Time frame: 2 years
Testosterone at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
Cholesterol
Time frame: 2 years
Cholesterol at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
2 secondary outcomes
Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP)
Time frame: 2 years
coffee and green tea consumption
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Stopped by the sponsor due to discrepancies in the recruitment process.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunn Iren Meling, MD PhD principal investigator
Helse Stavanger HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Diseases, run by Helse Stavanger HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopped by the sponsor due to discrepancies in the recruitment process.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MGRSS questionnaire (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.