Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy (ePRO-PCaRT)

January 13, 2022 updated by: Antti Rannikko, Helsinki University Central Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

- local/locally advanced prostate cancer treated with radiotherapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preference
Time Frame: through study completion, an average of 1 year
patient preference for type of questionnaire (paper versus electronic)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL as measured using the validated EPIC-26 questionnaire
Time Frame: through study completion, an average of 1 year
Patient QoL after RT (EPIC-26, scale 0-100)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2016

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2067/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Protocol will be shared on the study group website once registered in ClinicalTrials.Gov.

IPD Sharing Time Frame

Once the study is registered in ClinicalTrials.Gov.

IPD Sharing Access Criteria

Publicly available.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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