Fear of Cancer RecurrenceNCT04535921
Fear of Cancer Recurrence in Genitourinary Cancer
An observational study of Fear of Cancer Recurrence and Prostate Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear of Cancer Recurrence, Prostate Cancer, Renal Cell Cancer
- What is being tested?
- FCR7 questionnaire
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 5 Nov 2019to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed genitourinary malignant disease undergoing curative surgical treatment
Who may be able to join
- histologically confirmed diagnosis of either prostate, urothelial cell, testicular or renal cell cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Fear of Cancer Recurrence, Prostate Cancer, Renal Cell Cancer, Urothelial Carcinoma, Testicle Cancer
- Being tested
- FCR7 questionnaire
- Medical subject headings
- Prostatic Neoplasms, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCR7 questionnaireOther
A 7 item questionnaire about fear of cancer recurrence
| Study group | Role | What they receive |
|---|---|---|
| Prostatectomy | FCR7 questionnaire pre and postoperative Receives: Other: FCR7 questionnaire | |
| Cystectomy | FCR7 questionnaire pre and postoperative, 6 months follow Receives: Other: FCR7 questionnaire | |
| Nephrectomy | FCR7 questionnaire pre and postoperative Receives: Other: FCR7 questionnaire | |
| Orchidectomy | FCR7 questionnaire pre and postoperative Receives: Other: FCR7 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fear of cancer recurrence pre- and postoperatively
Changes in the FCR7 score pre- and postoperatively
Measured: 7 to 10 days after initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start5 Nov 2019
- Primary completion30 Apr 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of Cancer RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannic Volz, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535921
- Sponsor's protocol ID
- FCR2020
- Status last verified
- Dec 2023
- First submitted
- 27 Aug 2020
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Cancer Recurrence in Malignant Diseases of the Genitourinary Tract
- ClinicalTrials.gov ID
- NCT04535921
- Acronym / sponsor ID
- FCR2020
- Conditions
- Fear of Cancer Recurrence, Prostate Cancer, Renal Cell Cancer, Urothelial Carcinoma, Testicle Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prostatectomy | – | Other: FCR7 questionnaireFCR7 questionnaire pre and postoperative |
| Cystectomy | – | Other: FCR7 questionnaireFCR7 questionnaire pre and postoperative, 6 months follow |
| Nephrectomy | – | Other: FCR7 questionnaireFCR7 questionnaire pre and postoperative |
| Orchidectomy | – | Other: FCR7 questionnaireFCR7 questionnaire pre and postoperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed genitourinary malignant disease undergoing curative surgical treatment
Key inclusion criteria (1 listed)
- histologically confirmed diagnosis of either prostate, urothelial cell, testicular or renal cell cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCR7 questionnaireA 7 item questionnaire about fear of cancer recurrence | Other | Cystectomy, Nephrectomy, Orchidectomy, Prostatectomy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear of Cancer Recurrence and Prostate Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fear of cancer recurrence pre- and postoperatively (time frame: 7 to 10 days after initial surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.