Quality of Life and Shared Decision Making in Prostate Cancer

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0377
    • The Cancer Registy of Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 110 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All men with prostate cancer in Norway

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prostate cancer; Men diagnosed with prostate cancer
Men without prostate cancer; Men without prostate cancer matched for age and county

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qality of life Global health status	Global health status from QLQ-C30 version 3.0 scale	3 years
Qality of life Physical functioning	Physical functioning from QLQ-C30 version 3.0 scale	3 years
Qality of life Role functioning	Role functioning from QLQ-C30 version 3.0 scale	3 years
Qality of life Emotional functioning	Emotional functioning from QLQ-C30 version 3.0 scale	3 years
Qality of life Cognitive functioning	Cognitive functioning from QLQ-C30 version 3.0 scale	3 years
Qality of life Social functioning	Social functioning from QLQ-C30 version 3.0 scale	3 years

Collaborators and Investigators

• Sponsor: Cancer Registry of Norway

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 0910

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No