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临床试验/NCT01783145
NCT01783145进行中(未招募)不适用

Shared Care Follow-up After Chemotherapy for Testicular Cancer

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
163
试验地点
1
主要终点
Safety of a shared care survivorship care plan (SCP).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • Mental disability

结局指标

主要结局

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

时间窗: 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).

时间窗: 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.

次要结局

  • Satisfaction with the SCP of testicular cancer survivors, GPs and oncologists.(Up to two years.)
  • Willingness to migrate from hospital care to primary care.(Up to two years.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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