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Prospective multicenter trail to evaluate the quality of life of patients with clinical stage I germ cell cancer. Does the therapy modality influence the quality of life of the patients in the course of the disease?

Prospective multicenter trail to evaluate the quality of life of patients with clinical stage I germ cell cancer. Does the therapy modality influence the quality of life of the patients in the course of the disease?

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00020991
Enrollment
600
Registered
2020-03-16
Start date
2015-10-30
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C62 C62.0 C62.1 C62.9

Interventions

Group 1: Testicular cancer patients in clinical stage I, Seminoma or Nonseminoma, are provided with a portfolio including the QoL questionnaires of the EORTC QLQ C-30, QLQ TC-26. They are supposed to

Sponsors

Bundeswehrzentralkrankenhaus Koblenz
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Seminoma or Nonseminoma clinical stage I - normalization of tumor markers after surgery - age >18 years - male - WHO Performance Status 0-2

Exclusion criteria

Exclusion criteria: - NSGCT CSI with marker Elevation after Ablatio testis - known malign tumor disease in the last 5 years before study recruitment - known infection with HIV, Hepatitis B or Hepatitis C - known severe disease or an uncontrolled desease, or active infection - psychological disease - female or Intersexual - age <18 Jahre - WHO-Performance-Status 3-4

Design outcomes

Primary

MeasureTime frame
Quality of life evaluated with the questionnaires: EORTC QLQ-C30 and QLQ-TC26. Longitudinal presentation of quality of life of testicular cancer patients in clinical stage I, 5 years after initial therapy, influence of different therapies on development of quality of life.

Secondary

MeasureTime frame
Type and duration of surgery, complications of surgery, early and late toxicities, duration of Hospital stay, duration of sick leave Identification of demographic and socioeconomical variables which might go along with a deterioration of qol like: level of education, work status, social status, family situation. Do risk profiles exist which go along with a reduced QoL? Evaluation of QoL in recruiting clinics Evaluation of different dimensions of QoL during different timelines. Evaluation of hormonal status and an potential infertility during therapy Problems with sexuality during therapy Use of psychoncological assistance

Countries

Germany

Contacts

Public ContactKristin Zimmermann

Klinik für UrologieBundeswehrzentralkrankenhaus Koblenz

kristinzimmermann@bundeswehr.org026128131801

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026