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Shared Care Follow-up After Chemotherapy for Testicular Cancer


N/A
18 Years
N/A
Open (Enrolling)
Male
Testicular Cancer

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Trial Information

Shared Care Follow-up After Chemotherapy for Testicular Cancer


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Safety of a shared care survivorship care plan (SCP).

Outcome Description:

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.

Outcome Time Frame:

Monitoring of safety will be done on a continuous basis with average duration of two years per participant.

Safety Issue:

Yes

Principal Investigator

J.A. Gietema, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Groningen

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

SCFU-TC 1.2011

NCT ID:

NCT01783145

Start Date:

October 2012

Completion Date:

October 2016

Related Keywords:

  • Testicular Cancer
  • survivorship care
  • testicular cancer
  • shared care model
  • Testicular Neoplasms

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