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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01783145
First Posted: February 4, 2013
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
J.A. Gietema, University Medical Center Groningen
January 27, 2013
February 4, 2013
November 13, 2017
October 2012
July 2018   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Feasibility and 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 survivorship care plan (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. The feasibility and safety of the shared care SCP will be evaluated.
Complete list of historical versions of study NCT01783145 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Shared Care Follow-up After Chemotherapy for Testicular Cancer
Shared Care Follow-up After Chemotherapy for Testicular Cancer
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, serum, plasma
Non-Probability Sample
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.
Testicular Cancer
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
163
July 2018
July 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01783145
SCFU-TC 1.2011
38710 ( Other Identifier: ABR form CCMO )
No
Not Provided
Not Provided
J.A. Gietema, University Medical Center Groningen
University Medical Center Groningen
Not Provided
Principal Investigator: J.A. Gietema, MD, PhD University Medical Center Groningen
University Medical Center Groningen
November 2017