Fear of Cancer Recurrence in Genitourinary Cancer

December 8, 2023 updated by: Yannic Volz, Ludwig-Maximilians - University of Munich

Fear of Cancer Recurrence in Malignant Diseases of the Genitourinary Tract

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

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

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80796
        • Ludwig-Maximilian-Universität

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed genitourinary malignant disease undergoing curative surgical treatment

Description

Inclusion Criteria:

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 to 10 days after initial surgery

Collaborators and Investigators

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

Sponsor

Ludwig-Maximilians - University of Munich

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)

November 5, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCR2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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