Testicular Neoplasm
Conditions
Brief 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.
Interventions
OTHERComprehensive Score for financial toxicity (COST)
Measure indirect and direct health care cost that burden patients and their loved ones.
OTHERFunctional Assessment of Cancer Therapy: General (FACT-G)
General quality of life instrument
OTHEREORTC QLQ C-30
Assess quality of life in cancer patients
OTHEREORTC QLQ-TC26.
To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT. | 5 years |
Countries
United States
Outcome results
None listed