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Financial Toxicity and Quality of Life in Patients With TGCT

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Testicular Neoplasm

Treatments

Other: Functional Assessment of Cancer Therapy: General (FACT-G)
Other: Comprehensive Score for financial toxicity (COST)
Other: EORTC QLQ C-30
Other: EORTC QLQ-TC26.

Study type

Observational

Funder types

Other

Identifiers

NCT04531709
CTMS 20-0061
HSC20200462E (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

24 participants in 1 patient group

Long-term survivors of TGCT
Treatment:
Other: EORTC QLQ-TC26.
Other: EORTC QLQ C-30
Other: Comprehensive Score for financial toxicity (COST)
Other: Functional Assessment of Cancer Therapy: General (FACT-G)

Trial contacts and locations

1

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Central trial contact

Deepak Pruthi, MD

Data sourced from clinicaltrials.gov

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