Shared Care Follow-up After Chemotherapy for Testicular Cancer

Testicular Cancer Clinical Trial

— SCFU-TC  

Official title:

Shared Care Follow-up After Chemotherapy for Testicular Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01783145
• Other study ID #: SCFU-TC 1.2011
• Secondary ID: 38710
• Status: Active, not recruiting
• Start date: October 2012
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of a shared care survivorship care plan (SCP).	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.
Primary	Feasibility of a shared care survivorship care plan (SCP).	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	Satisfaction with the SCP of testicular cancer survivors, GPs and oncologists.	The satisfaction with the SCP of testicular cancer survivors, GPs and oncologists will be evaluated by using questionnaires.	Up to two years.
Secondary	Willingness to migrate from hospital care to primary care.	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.