Clinical trial NCT01783145: Shared Care Follow-up After Chemotherapy for Testicular Cancer
Official title: Shared Care Follow-up After Chemotherapy for Testicular Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Testicular Cancer
Keywords: survivorship care
testicular cancer
shared care model
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 163
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of a shared care survivorship care plan (SCP).
timeFrame: Monitoring of safety will be done on a continuous basis with average duration of two years per participant.
measure: Feasibility of a shared care survivorship care plan (SCP).
timeFrame: Monitoring of feasibility will be done on a continuous basis with average duration of two years per participant.
Secondary outcomes:
measure: Satisfaction with the SCP of testicular cancer survivors, GPs and oncologists.
timeFrame: Up to two years.
measure: Willingness to migrate from hospital care to primary care.
timeFrame: Up to two years.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: J.A. Gietema, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: