Prostate CancerNCT03948204
Quality of Life and Shared Decision Making in Prostate Cancer
An observational study of Prostate Cancer, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
"Life after prostate cancer" is a prospective, population-based, case-control study where all men diagnosed with Prostate cancer (PCa) from 01.01.2017 regardless of age and disease stage are invited to a survey by questionnaire on their health. Read more about this study
- Who is it for?
- Ages 0 to 110 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 10,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2017to 31 Dec 2024
- 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 0 to 110 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All men with prostate cancer in Norway
Who may be able to join
- All patients diagnosed with prostate cancer in Norway at or after 01.01.2017
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Socioeconomic Status, Differences in Quality of Life and Shared Decision Making Among Patients With Non-metastatic Prostate Cancer
"Life after prostate cancer" is a prospective, population-based, case-control study where all men diagnosed with Prostate cancer (PCa) from 01.01.2017 regardless of age and disease stage are invited to a survey by questionnaire on their health. Men with no history of PCa are identified through the National Registry, matched on age and region of residence, and invited to the survey as controls. Patients and controls who have signed up for an official digital mailbox are invited electronically. Those who do not have a digital mailbox are invited by regular mail. All participants have given their informed consent for all linkages planned in this study. Due to electronic reporting of histological reports to the Norwegian Prostate Cancer Registry, patients are invited to the survey shortly after diagnosis. More than 6 400 patients have submitted questionnaires per April 2019.
Read the detailed description
Survey participants complete questionnaires on adverse effects / functional outcomes and QoL. The survey questionnaire includes EQ-5D-5L and EORTC QLQ-C3). EPIC-26 is used together with additional questions on sexual interest and use of aids. Highest level of education, height, weight and marital status are also included at baseline. All those with PCa, as well as the men without PCa who participate at baseline, are invited to submit follow-up questionnaires 1 and 3 years after diagnosis. The same instruments are then used with the addition of questions on work ability together with questions on treatment and experience with the health care service including shared decision making. From Statistics Norway data on personal and household income will be available together with education level stated by participants. The Norwegian Prostate Cancer Registry, a national quality registry on PCa, is incorporated in The Cancer Registry of Norway and is in collaboration with clinical specialists from hospitals in all regions of the country. The registry publishes results regularly to patients and hospitals with updated statistics on incidence, work-up, treatment choice and outcomes. All variables concerning work-up, diagnosis (histopathological data, imaging) stage (cTNM, PSA, Gleason score), treatment (surgery, radiotherapy, endocrine treatment) and follow-up are available for linkage with questionnaire data from the patients. Patients will be stratified into low-, intermediate-, and high-risk groups as defined by the European Association of Urology based on the clinical T-category (cT), the PSA level, and the Gleason score (GS) at the time of diagnosis. Low-risk: cT1-T2a and PSA<10 ng/mL and GS<7, Intermediate-risk: cT2b or PSA 10-20 ng/ml or GS=7, high-risk localised: cT2c or PSA>20 ng/mL or GS>7, high-risk locally advanced: cT3-4 or cN1. Division will further be by initial treatment: radical prostatectomy, radiotherapy ≥74 Gy by standard fractionation with or without hormone treatment, or no local treatment consisting of active surveillance or watchful waiting. The Norwegian Patient Registry contains data on all individuals waiting for treatment or that have received treatment including both in- and outpatient specialist care. A modified version of the Charlson's comorbidity index shown to be valid for patient registry data will for this study be used.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | Men diagnosed with prostate cancer | |
| Men without prostate cancer | Men without prostate cancer matched for age and county |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qality of life Global health status
Global health status from QLQ-C30 version 3.0 scale
Measured: 3 years
Qality of life Physical functioning
Physical functioning from QLQ-C30 version 3.0 scale
Measured: 3 years
Qality of life Role functioning
Role functioning from QLQ-C30 version 3.0 scale
Measured: 3 years
Qality of life Emotional functioning
Emotional functioning from QLQ-C30 version 3.0 scale
Measured: 3 years
Qality of life Cognitive functioning
Cognitive functioning from QLQ-C30 version 3.0 scale
Measured: 3 years
Qality of life Social functioning
Social functioning from QLQ-C30 version 3.0 scale
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Jan 2017
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tom Børge Johannesen, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948204
- Sponsor's protocol ID
- 0910
- Status last verified
- Aug 2023
- First submitted
- 8 May 2019
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Status, Differences in Quality of Life and Shared Decision Making Among Patients With Non-metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT03948204
- Acronym / sponsor ID
- 0910
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 May 2019 (actual)
- 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.
"Life after prostate cancer" is a prospective, population-based, case-control study where all men diagnosed with Prostate cancer (PCa) from 01.01.2017 regardless of age and disease stage are invited to a survey by questionnaire on their health. Men with no history of PCa are identified through the National Registry, matched on age and region of residence, and invited to the survey as controls. Patients and controls who have signed up for an official digital mailbox are invited electronically. Those who do not have a digital mailbox are invited by regular mail. All participants have given their informed consent for all linkages planned in this study. Due to electronic reporting of histological reports to the Norwegian Prostate Cancer Registry, patients are invited to the survey shortly after diagnosis. More than 6 400 patients have submitted questionnaires per April 2019.
Detailed description
Survey participants complete questionnaires on adverse effects / functional outcomes and QoL. The survey questionnaire includes EQ-5D-5L and EORTC QLQ-C3). EPIC-26 is used together with additional questions on sexual interest and use of aids. Highest level of education, height, weight and marital status are also included at baseline. All those with PCa, as well as the men without PCa who participate at baseline, are invited to submit follow-up questionnaires 1 and 3 years after diagnosis. The same instruments are then used with the addition of questions on work ability together with questions on treatment and experience with the health care service including shared decision making. From Statistics Norway data on personal and household income will be available together with education level stated by participants. The Norwegian Prostate Cancer Registry, a national quality registry on PCa, is incorporated in The Cancer Registry of Norway and is in collaboration with clinical specialists from hospitals in all regions of the country. The registry publishes results regularly to patients and hospitals with updated statistics on incidence, work-up, treatment choice and outcomes. All variables concerning work-up, diagnosis (histopathological data, imaging) stage (cTNM, PSA, Gleason score), treatment (surgery, radiotherapy, endocrine treatment) and follow-up are available for linkage with questionnaire data from the patients. Patients will be stratified into low-, intermediate-, and high-risk groups as defined by the European Association of Urology based on the clinical T-category (cT), the PSA level, and the Gleason score (GS) at the time of diagnosis. Low-risk: cT1-T2a and PSA<10 ng/mL and GS<7, Intermediate-risk: cT2b or PSA 10-20 ng/ml or GS=7, high-risk localised: cT2c or PSA>20 ng/mL or GS>7, high-risk locally advanced: cT3-4 or cN1. Division will further be by initial treatment: radical prostatectomy, radiotherapy ≥74 Gy by standard fractionation with or without hormone treatment, or no local treatment consisting of active surveillance or watchful waiting. The Norwegian Patient Registry contains data on all individuals waiting for treatment or that have received treatment including both in- and outpatient specialist care. A modified version of the Charlson's comorbidity index shown to be valid for patient registry data will for this study be used.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | – | –Men diagnosed with prostate cancer |
| Men without prostate cancer | – | –Men without prostate cancer matched for age and county |
Who may qualify
- Ages
- 0 to 110 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All men with prostate cancer in Norway
Key inclusion criteria (1 listed)
- All patients diagnosed with prostate cancer in Norway at or after 01.01.2017
Key exclusion criteria (1 listed)
- -
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
Qality of life Global health status
Time frame: 3 years
Global health status from QLQ-C30 version 3.0 scale
Qality of life Physical functioning
Time frame: 3 years
Physical functioning from QLQ-C30 version 3.0 scale
Qality of life Role functioning
Time frame: 3 years
Role functioning from QLQ-C30 version 3.0 scale
Qality of life Emotional functioning
Time frame: 3 years
Emotional functioning from QLQ-C30 version 3.0 scale
Qality of life Cognitive functioning
Time frame: 3 years
Cognitive functioning from QLQ-C30 version 3.0 scale
Qality of life Social functioning
Time frame: 3 years
Social functioning from QLQ-C30 version 3.0 scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Norwegian Institute of Public Health at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Qality of life Global health status (time frame: 3 years). The study lists 6 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 1 Sep 2023.