Financial Toxicity and Quality of Life in Patients With TGCT

  • STATUS
    Recruiting
  • End date
    Dec 2, 2025
  • participants needed
    60
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 2 April 2021

Summary

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.

Details
Condition Malignant neoplasm of testis, Testicular Cancer, testicular tumor, tumor testis
Treatment Comprehensive Score for financial toxicity (COST), Functional Assessment of Cancer Therapy: General (FACT-G), EORTC QLQ C-30, EORTC QLQ-TC26.
Clinical Study IdentifierNCT04531709
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on2 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Recently diagnosed TGCT
Patients with histologically or clinically confirmed germ cell tumor
Age > 18 years of age
Anticipated treatment with multicycle (> 2 cycles) / multiagent chemotherapy
Within 4 weeks of starting C1D1 chemotherapy
Signed informed consent
Long-term survivors
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

Recently diagnosed TGCT
Patients planned to receive <2 cycles of chemotherapy
Starting chemotherapy greater than 4 weeks after signing consent and completing initial survey
Starting chemotherapy prior to consenting and completing initial survey
Long-term survivors
Patients undergoing active chemotherapy
Patients who did not complete 1st line chemotherapy
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