Quality of Life and Shared Decision Making in Prostate Cancer

NCT ID: NCT03948204

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2024-12-31

Brief 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. 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.

Conditions

Prostate Cancer

Study Design

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

Study Groups

Prostate cancer

Men diagnosed with prostate cancer

No interventions assigned to this group

Men without prostate cancer

Men without prostate cancer matched for age and county

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• All patients diagnosed with prostate cancer in Norway at or after 01.01.2017

Exclusion Criteria

-

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tom Børge Johannesen

Junior Head, Registry Dept

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Cancer Registy of Norway

Oslo, , Norway

Countries

Norway

Other Identifiers

0910

Identifier Type: -

Identifier Source: org_study_id