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临床试验/NCT03948204
NCT03948204Enrolling By Invitation不适用

Socioeconomic Status, Differences in Quality of Life and Shared Decision Making Among Patients With Non-metastatic Prostate Cancer

Norwegian Institute of Public Health1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
10,000
试验地点
1
主要终点
Qality of life Global health status

研究概览

简要总结

"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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
0 Years 至 110 Years(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Qality of life Global health status

时间窗: 3 years

Global health status from QLQ-C30 version 3.0 scale

Qality of life Role functioning

时间窗: 3 years

Role functioning from QLQ-C30 version 3.0 scale

Qality of life Emotional functioning

时间窗: 3 years

Emotional functioning from QLQ-C30 version 3.0 scale

Qality of life Social functioning

时间窗: 3 years

Social functioning from QLQ-C30 version 3.0 scale

Qality of life Physical functioning

时间窗: 3 years

Physical functioning from QLQ-C30 version 3.0 scale

Qality of life Cognitive functioning

时间窗: 3 years

Cognitive functioning from QLQ-C30 version 3.0 scale

次要结局

未报告次要终点

研究者

发起方
Norwegian Institute of Public Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tom Børge Johannesen

Junior Head, Registry Dept

Norwegian Institute of Public Health

研究点 (1)

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