ePRO-PCaRT: Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05187026

Collaborator

(none)

300

Enrollment

Location

72.7

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: electronic PROMs questionnaire

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

Actual Study Start Date :

Dec 9, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
EPIC-26 follow-up All men will receive EPIC-26 in paper and also an electronic version.	Other: electronic PROMs questionnaire Patients are asked to complete EPIC-26 questionnaire in paper and electronically

Arm

Intervention/Treatment

EPIC-26 follow-up

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

Other: electronic PROMs questionnaire

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

Outcome Measures

Primary Outcome Measures

preference [through study completion, an average of 1 year]
patient preference for type of questionnaire (paper versus electronic)

Secondary Outcome Measures

QoL as measured using the validated EPIC-26 questionnaire [through study completion, an average of 1 year]
Patient QoL after RT (EPIC-26, scale 0-100)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Male

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