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NCT05187026 Clinical Trial

Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

Prostate Cancer Clinical Trial

— ePRO-PCaRT  

Official title:
Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05187026
Other study ID # 2067/2016
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 9, 2016
Est. completion date December 31, 2022

Study information
Verified date January 2022
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Prostate cancer patients that are treated with radiation therapy for local prostate cancer receive EPIC-26 before treatment and during follow-up. EPIC-26 is collected both traditionally using paper questionnaires and electronically. Patients experience and preference for these are asked.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender Male
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - not able to complete EPIC-26 both in paper and electronically

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• electronic PROMs questionnaire
Patients are asked to complete EPIC-26 questionnaire in paper and electronically

Locations
Country Name City State
Finland Helsinki University Hospital Helsinki Uusimaa

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary preference patient preference for type of questionnaire (paper versus electronic) through study completion, an average of 1 year
Secondary QoL as measured using the validated EPIC-26 questionnaire Patient QoL after RT (EPIC-26, scale 0-100) through study completion, an average of 1 year
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