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Completed

NCT Number: NCT04531709

Financial Toxicity and Quality of Life in Patients With TGCT

This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors.

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Key information

Conditions

Testicular Neoplasm Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Mays Cancer Center

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years of age
  • Patients with histologically or clinically confirmed germ cell tumor.
  • Completed treatment for germ cell tumor with multicycle (> 2 cycles) / multiagent chemotherapy.
  • Within years 1-5 of surveillance since Day 1 of last cycle of chemotherapy
  • Signed informed consent

Exclusion criteria

  • Long-term survivors
  • Patients undergoing active chemotherapy
  • Patients who did not complete 1st line chemotherapy.

Treatment and study plan

Comprehensive Score for financial toxicity (COST)

Other

Measure indirect and direct health care cost that burden patients and their loved ones.

Functional Assessment of Cancer Therapy: General (FACT-G)

Other

General quality of life instrument

EORTC QLQ C-30

Other

Assess quality of life in cancer patients

EORTC QLQ-TC26.

Other

To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire.

Primary outcomes

  1. Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.

    Time frame: 5 years

Secondary outcomes

  1. Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Financial Toxicity and Quality of Life in Patients With Testicular Germ Cell Tumors

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2020
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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