Health Status, Quality of Life and Function in Survivors After Radical Treatment for Prostate Cancer. Part I and IIA

NCT04863352 | Completed

• 1 other identifier: 150410
• Study Type: observational
• Target: 657
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

prostate cancer, radical treatment, radiotherapy, surgery

Outcome Measures

Primary Outcomes (2)

• Global quality of life

  Global quality of life assessed by the EORTC QLQ-C30 questionnaire's global QoL scale ranging from 0 to 100, higher scores indicate better QoL

  at time of assessment (cross-sectional)

• General health

  self-reported using items from the Trøndelag Health Survey 4, categorical scale: bad/not so go good/good/very good

  at time of assessment (cross-sectional)

Secondary Outcomes (3)

• physical function

  at assessment (cross-sectional)

• EPIC-26 scores

  at assessment (cross-sectional)

• Activities of daily living

  at assessment (cross-sectional)

Study Arms (2)

Study group

Men who have been treated for localized or locally advanced prostate cancer with curative intent

Matched population based controls

Existing population based data from men who participated in the Trøndelag Health Survey 2017-2019

Eligibility Criteria

• Gender Eligibility Details: Study group: Men who have received radical treatment for prostate cancer at Innlandet Hospital Trust 2014 to 2018
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Innlandet Hospital Trust

Brumunddal, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Marit Slaaen, PhD

  Sykehuset Innlandet HF

  STUDY CHAIR

• Ola Berger Christiansen, PhD

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 28, 2021
• Study Start: May 4, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: November 18, 2023

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)