- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01783145
Shared Care Follow-up After Chemotherapy for Testicular Cancer (SCFU-TC)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9713 GZ
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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.
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Monitoring of safety will be done on a continuous basis with average duration of two years per participant.
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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.
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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.
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Monitoring of feasibility will be done on a continuous basis with average duration of two years per participant.
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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.
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The satisfaction with the SCP of testicular cancer survivors, GPs and oncologists will be evaluated by using questionnaires.
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Up to two years.
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Willingness to migrate from hospital care to primary care.
Time Frame: Up to two years.
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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.
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Up to two years.
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Collaborators and Investigators
Investigators
- Principal Investigator: J.A. Gietema, MD, PhD, University Medical Center Groningen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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