Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

NCT05187026 | Unknown

• 1 other identifier: 2067/2016
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study where prostate cancer related PROMs (EPIC-26) is collected using two different methods (by paper questionnaires and electronically) and patient experience and preference is asked.

Conditions

Prostate Cancer

Keywords

PROM; EPIC-26; electronic; questionnaire; mobile; quality of life; radiation therapy

Outcome Measures

Primary Outcomes (1)

• preference

  patient preference for type of questionnaire (paper versus electronic)

  through study completion, an average of 1 year

Secondary Outcomes (1)

• QoL as measured using the validated EPIC-26 questionnaire

  through study completion, an average of 1 year

Study Arms (1)

EPIC-26 follow-up

All men will receive EPIC-26 in paper and also an electronic version.

Other: electronic PROMs questionnaire

Interventions

electronic PROMs questionnaire OTHER

Patients are asked to complete EPIC-26 questionnaire in paper and electronically

EPIC-26 follow-up

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- local/locally advanced prostate cancer treated with radiotherapy

You may qualify if:

• cT1-4N0M0, gleason 6-10, PSA \< 100, WHO ≤ 2 prostate cancer eligible for radiation therapy
• willing to complete EPIC-26 questionnaires both in paper and electronically
• willing to consent for the study

You may not qualify if:

• not able to complete EPIC-26 both in paper and electronically

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Links

• study group website

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

• Antti S Rannikko, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 11, 2022
• Study Start: December 9, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once the study is registered in ClinicalTrials.Gov.
• Access Criteria: Publicly available.

Locations

FI (1)