Trial record 3 of 42 for:    Open Studies | "Testicular Neoplasms"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
J.A. Gietema, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01783145
First received: January 27, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition
Testicular Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shared Care Follow-up After Chemotherapy for Testicular Cancer

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Satisfaction with the SCP of testicular cancer survivors, GPs and oncologists. [ Time Frame: Up to two years. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma


Estimated Enrollment: 245
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783145

Contacts
Contact: J.A. Gietema, MD, PhD +31 50 361 2821/1847 j.a.gietema@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: J.A. Gietema, MD, PhD    +31 50 361 2821/1847    j.a.gietema@umcg.nl   
Principal Investigator: J.A. Gietema, MD, PhD         
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: J.A. Gietema, MD, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: J.A. Gietema, Principal investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01783145     History of Changes
Other Study ID Numbers: SCFU-TC 1.2011, 38710
Study First Received: January 27, 2013
Last Updated: August 14, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
survivorship care
testicular cancer
shared care model

Additional relevant MeSH terms:
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 28, 2014