Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fear of Cancer Recurrence in Genitourinary Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535921
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Yannic Volz, Ludwig-Maximilians - University of Munich

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment
Fear of Cancer Recurrence Prostate Cancer Renal Cell Cancer Urothelial Carcinoma Testicle Cancer Other: FCR7 questionnaire

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fear of Cancer Recurrence in Malignant Diseases of the Genitourinary Tract
Actual Study Start Date : November 5, 2019
Actual Primary Completion Date : April 30, 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Prostatectomy
FCR7 questionnaire pre and postoperative
 Other: FCR7 questionnaire
A 7 item questionnaire about fear of cancer recurrence
Cystectomy
FCR7 questionnaire pre and postoperative, 6 months follow
 Other: FCR7 questionnaire
A 7 item questionnaire about fear of cancer recurrence
Nephrectomy
FCR7 questionnaire pre and postoperative
 Other: FCR7 questionnaire
A 7 item questionnaire about fear of cancer recurrence
Orchidectomy
FCR7 questionnaire pre and postoperative
 Other: FCR7 questionnaire
A 7 item questionnaire about fear of cancer recurrence


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in fear of cancer recurrence pre- and postoperatively [ Time Frame: 7 to 10 days after initial surgery ]
    Changes in the FCR7 score pre- and postoperatively


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with confirmed genitourinary malignant disease undergoing curative surgical treatment
Criteria

Inclusion Criteria:

  • histologically confirmed diagnosis of either prostate, urothelial cell, testicular or renal cell cancer
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535921


Locations
Layout table for location information
Germany
Ludwig-Maximilian-Universität Recruiting
Munich, Bavaria, Germany, 80796
Contact: Yannic Volz, MD    089440073530    yannic.volz@med.uni-muenchen.de   
Contact: Severin Rodler, MD    089440073530    severin.rodler@med.uni-muenchen.de   
Sub-Investigator: Yannic Volz, MD         
Principal Investigator: Severin Rodler, MD         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yannic Volz, Assistant doctor, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT04535921    
Other Study ID Numbers: FCR2020
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Recurrence
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Disease Attributes
Pathologic Processes
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases