Clinical trial NCT04863352: Health Status, Quality of Life and Function in Survivors After Radical Treatment for Prostate Cancer. Part I and IIA
Official title: Health Status, Quality of Life and Function in Survivors After Radical Treatment for Prostate Cancer. A Cross-sectional Study Focusing on Older Survivors. Part I and IIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer, radical treatment, radiotherapy, surgery
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2021-04-28
Enrollment: 657
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study group: Men having received radical treatment for prostate cancer at Innlandet Hospital Trust, see eligibility criteria

Control group: For comparison with a general population, a control group of males matched on age and education will be drawn from the Trøndelag Health Survey 4 (HUNT4) and HUNT4 70+ surveys performed in 2017-2019, targeting all inhabitants and inhabitants \>70 years in Trøndelag County, respectively

Brief summary: In this study, addressing prostate cancer survivors, i.e. men who received potentially curative (radical) treatment two to six years ago, we will investigate if older age at time of treatment is a detrimental factor with respect to long-term quality of life (Qol), health, and function. We will also compare QoL, health and function between the prostate cancer survivors and matched population based cohorts, and thereby provide realistic information on the long-term impact of radical prostate cancer treatment

Detailed description: Prostate cancer is the most common male cancer in Norway, with almost 5000 new cases yearly. More than12 % of men contract prostate cancer before the age of 75. As 5-year survival is high (\>95%), a significant proportion of the older male population are prostate cancer survivors. The quality of life (QoL) and daily function of these older males need elucidation to provide adequate health care services and information to this large patient group.

The present project includes two studies(Study I and IIA). Study I is investigating the QoL, health status, and local adverse treatment effects in all men 2-6 years after radical treatment for prostate cancer. Local adverse treatment effects are defined as problems related to organs and structures adjacent to the prostate gland (e.g. bowel and urinary problems, and sexual dysfunction). Study IIA will focus on older prostate cancer survivors, defined as men who were 70 years or older by the time of treatment. To complete the overall project, we also plan a later study, Study IIB, that will investigate in more detail the physical functioning and performance of the older survivors.

Design Study I: A cross-sectional survey targeting all patients from the catchment area of Innlandet Hospital Trust (SI-HF) who received radical treatment for localized/locally advanced prostate cancer at SI-HF from 2014 to 2018 Study II A: A supplementary cross-sectional survey targeting older participants from Study I who were \>70 years at time of treatment Control groups: For comparison with a general population, we will use existing data from male participants in the fourth wave of the Trøndelag Health Study (HUNT4) including the HUNT4 70+ survey. Control groups will be drawn, matched on age and education. HUNT4 and HUNT4 70+ were both performed in 2017-2019, and targeted all inhabitants and inhabitants \>70 years respectively in the former Nord-Trøndelag County. Jointly they include broad health assessments using questionnaires, physical examinations, and tests.

Study aims Primary study aims are

1. to investigate if older age at the time of radical treatment has a negative impact on self-reported QoL, function and local adverse effects in prostate cancer survivors
2. to investigate if health status, health problems, and use of health care services in older prostate cancer survivors differ from a general male population of the same age

Secondary aims are

1. to investigate how local adverse effects after radical prostate cancer treatment may influence QoL and functioning in both older and younger survivors, and to explore how other factors such as treatment modality and comorbidity may influence these outcomes
2. to investigate if health status, health problems, and use of health care services in younger prostate cancer survivors (being \< 70 years by the time of treatment) differ from a general male population of the same age

Study conduct

All men who are eligible according to the inclusion criteria (see sample size below and inclusion criteria), will be invited to participate. All participants will provide written informed consent.

In Study I, participants will be asked to fill in a questionnaire covering QoL (EORTC QLQ-C30 questionnaire), local adverse effects after prostate cancer treatment (the EPIC-26) and other health problems (selected items from the HUNT4 Survey). Participants in Study I, who were 70 years or more by the time they received their cancer treatment, will subsequently be asked to fill in an additional questionnaire covering a broader range of health issues also with items from the HUNT4 Survey (Study IIA). Questionnaires will be administered by post with pre-paid return envelopes attached.

To fulfill our aims, we will investigate the association between age at treatment and QoL, self-reported health status, and local adverse effects (Primary aim 1). Furthermore, we will compare self-reported health, health problems, and use of health care services between our study population and the drawn control group (Primary aim 2 and Secondary aim 2). We will also investigate how local adverse effects may influence prostate cancer survivors' QoL and functioning (Secondary aim 1).

Sample size and statistics

About 1400 men with prostate cancer received curative treatment for local or localized prostate cancer at Innlandet Hospital Trust from 2014 to 2018, and about 1200 of these are estimated to be eligible for the initial study I. Matched controls will be drawn from the HUNT4 and HUNT4 70+ surveys, distribution 1:3 (cancer survivors : controls).

Simple descriptive statistics will be used to describe our cohorts. Comparison between groups will be made using parametric and non-parametric statistics as appropriate. To assess the impact of age, treatment regimen and relevant confounding factors on outcomes, multiple regression models will be estimated.

Eligibility criteria: Inclusion Criteria. Study group:

Study I:

a) men who received radical radiotherapy or robot-assisted radical prostatectomy for prostate cancer at Innlandet Hospital Trust 01.01.2014 and 31.12.2018; b) alive and living in Innlandet County; c) fluent in Norwegian (orally and in writing); provide written informed consent

Study IIa) the subgroup of participants in Study I who were \> 70 years by the time of treatment.

Exclusion Criteria: None

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Primary outcomes:
measure: Global quality of life
timeFrame: at time of assessment (cross-sectional)
measure: General health
timeFrame: at time of assessment (cross-sectional)
Secondary outcomes:
measure: physical function
timeFrame: at assessment (cross-sectional)
measure: EPIC-26 scores
timeFrame: at assessment (cross-sectional)
measure: Activities of daily living
timeFrame: at assessment (cross-sectional)
Other outcomes:
Locations:
city: Brumunddal
country: Norway
facility: Innlandet Hospital Trust
Study officials:
affiliation: Sykehuset Innlandet HF
name: Marit Slaaen, PhD
role: STUDY_CHAIR
affiliation: Sykehuset Innlandet HF
name: Ola Berger Christiansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: