Shared Care Follow-up After Chemotherapy for Testicular Cancer (SCFU-TC)

May 20, 2025 updated by: University Medical Center Groningen
The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Rationale: Since the introduction of cisplatin, metastatic testicular cancer (TC) has become a highly curable disease. Successfully treated TC patients have a small chance of a relapse. In case of a relapse, early treatment will improve outcome. This stresses the need for a frequent and stringent follow-up scheme. Although chemotherapy is a very effective treatment, a downside of this treatment has now become apparent: chemotherapy-related complications such as the increased risk for cardiovascular disease (CVD) and secondary malignancies. CVD can manifest during treatment, but also years or decades thereafter. We recently observed early development of cardiovascular risk factors in TC patients, clustered into the metabolic syndrome. Monitoring and treatment of cardiovascular risk factors during follow-up is important to lower the chance of developing CVD.

Since TC survivors are discharged from follow-up after 10 years, collaboration between oncologists and general practitioners (GPs), in other words shared care, will ensure monitoring of cardiovascular risk factors and timely detection and treatment of late effects (cardiovascular risk management). Survivorship care plans for cancer survivors, GPs and oncologists facilitate care for long-term survivors. The testicular cancer survivor himself is the key person, who can be empowered to participate in follow-up programs and make lifestyle adjustments to decrease the risk of late effects and improve quality of life and life expectancy. However, data are scarce on the design of an evidence based effective follow-up schedule. For childhood cancer survivors a detailed guideline has been developed that can serve as a framework for adult cancer survivor follow-up.

Objective: To examine the safety and feasibility of a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.

Study population: Patients that achieved a complete remission after chemotherapy for metastatic testicular cancer who are starting with follow-up or are currently in active follow-up.

Study Type

Observational

Enrollment (Actual)

163

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

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

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 disseminated TC who have finished their chemotherapy, if needed followed by surgery, and who are in complete remission and currently in active follow-up.

Description

Inclusion Criteria:

  • Patients with disseminated testicular cancer;
  • Complete remission after chemotherapy with or without adjunctive surgery and in active follow-up;
  • Age 18 years or older;
  • Started with chemotherapy after January 1st 2003;
  • Written informed consent.

Exclusion Criteria:

•Mental disability

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
Patients
Patients with disseminated TC who have finished their chemotherapy, if needed followed by surgery, and who are in complete remission and currently in active follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of a shared care survivorship care plan (SCP).
Time Frame: Monitoring of safety will be done on a continuous basis with average duration of two years per participant.
The aim of this study is to develop and evaluate a shared care SCP to follow-up patients with disseminated TC after completion of chemotherapy. Participants in the SCP will be patients, GPs and oncologists. The SCP will be defined according to follow-up guidelines for TC patients, with a focus on disease relapse and late effects.
Monitoring of safety will be done on a continuous basis with average duration of two years per participant.
Feasibility of a shared care survivorship care plan (SCP).
Time Frame: Monitoring of feasibility will be done on a continuous basis with average duration of two years per participant.
The aim of this study is to develop and evaluate a shared care SCP to follow-up patients with disseminated TC after completion of chemotherapy. Participants in the SCP will be patients, GPs and oncologists. The SCP will be defined according to follow-up guidelines for TC patients, with a focus on disease relapse and late effects.
Monitoring of feasibility will be done on a continuous basis with average duration of two years per participant.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the SCP of testicular cancer survivors, GPs and oncologists.
Time Frame: Up to two years.
The satisfaction with the SCP of testicular cancer survivors, GPs and oncologists will be evaluated by using questionnaires.
Up to two years.
Willingness to migrate from hospital care to primary care.
Time Frame: Up to two years.
The willingness to migrate from hospital care to primary care will be evaluated by specifying the decisions made within the SCP and by questionnaires to patients and GPs.
Up to two years.

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: J.A. Gietema, MD, PhD, University Medical Center Groningen

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)

October 1, 2012

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 27, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimated)

February 4, 2013

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCFU-TC 1.2011
  • 38710 (Other Identifier: ABR form CCMO)

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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