NCT04535921

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

August 27, 2020

Last Update Submit

December 8, 2023

Conditions

Fear of Cancer RecurrenceProstate CancerRenal Cell CancerUrothelial CarcinomaTesticle Cancer

Outcome Measures

Primary Outcomes (1)

  • Changes in fear of cancer recurrence pre- and postoperatively

    Changes in the FCR7 score pre- and postoperatively

    7 to 10 days after initial surgery

Study Arms (4)

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

FCR7 questionnaireOTHER

A 7 item questionnaire about fear of cancer recurrence

CystectomyNephrectomyOrchidectomyProstatectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed genitourinary malignant disease undergoing curative surgical treatment

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig-Maximilian-Universität

Munich, Bavaria, 80796, Germany

Location

MeSH Terms

Conditions

Prostatic NeoplasmsCarcinoma, Renal CellCarcinoma, Transitional CellTesticular Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesEndocrine Gland NeoplasmsEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant doctor

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 2, 2020

Study Start

November 5, 2019

Primary Completion

April 30, 2021

Study Completion

August 31, 2022

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)