Fear of Cancer Recurrence in Genitourinary Cancer | NCT04535921

Studies
Fear of Cancer Recurrence in Genitourinary Cancer

NCT04535921

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Dec 11, 2023Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Fear of Cancer Recurrence
Prostate Cancer
Renal Cell Cancer
Urothelial Carcinoma
Testicle Cancer

Interventions

FCR7 questionnaire

Countries

Germany

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2019Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Aug 31, 2022Actual

First Submitted Date

Aug 27, 2020

First Submission Date that Met QC Criteria

Sep 1, 2020

First Posted Date

Sep 2, 2020Actual

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

Dec 8, 2023

Last Update Posted Date

Dec 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yannic Volz, Assistant doctor, Ludwig-Maximilians - University of MunichPrincipal Investigator

Lead Sponsor

Ludwig-Maximilians - University of MunichOTHER

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

To perform an analysis of independent predictors of fear of cancer recurrence in patients with malignant genitourinary diseases and their impact on quality of life and survival

Detailed Description

Not provided

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

500Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Prostatectomy	FCR7 questionnaire pre and postoperative	Other: FCR7 questionnaire
Cystectomy	FCR7 questionnaire pre and postoperative, 6 months follow	Other: FCR7 questionnaire
Nephrectomy	FCR7 questionnaire pre and postoperative	Other: FCR7 questionnaire
Orchidectomy	FCR7 questionnaire pre and postoperative	Other: FCR7 questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FCR7 questionnaire	Other	A 7 item questionnaire about fear of cancer recurrence	Cystectomy Nephrectomy Orchidectomy Prostatectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in fear of cancer recurrence pre- and postoperatively	Changes in the FCR7 score pre- and postoperatively	7 to 10 days after initial surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically confirmed diagnosis of either prostate, urothelial cell, testicular or renal cell cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with confirmed genitourinary malignant disease undergoing curative surgical treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ludwig-Maximilian-Universität		Munich	Bavaria	80796	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D002292	Carcinoma, Renal Cell
D002295	Carcinoma, Transitional Cell
D013736	Testicular 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