Electrical Patient Reported Outcome of Prostate Cancer Ra... | NCT05187026

Studies
Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

NCT05187026

Sponsor

Helsinki University Central Hospital

Status

Unknown status

Last Update Posted

Jan 26, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

electronic PROMs questionnaire

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2016Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Dec 7, 2021

First Submission Date that Met QC Criteria

Dec 23, 2021

First Posted Date

Jan 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2022

Last Update Posted Date

Jan 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antti Rannikko, assistant professor, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EPIC-26 follow-up		All men will receive EPIC-26 in paper and also an electronic version.	Other: electronic PROMs questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electronic PROMs questionnaire	Other	Patients are asked to complete EPIC-26 questionnaire in paper and electronically	EPIC-26 follow-up

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

- local/locally advanced prostate cancer treated with radiotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antti S Rannikko, MD, PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital		Helsinki	Uusimaa	00029	Finland

Label	URL
study group website	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol

Time Frame

Once the study is registered in ClinicalTrials.Gov.

Access Criteria

Publicly available.

URL

http://www.hucc.fi

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided