Financial Toxicity and Quality of Life in Patients With TGCT

Study Overview
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Brief Summary
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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.

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

Conditions
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Testicular Neoplasm

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recently diagnosed TGCT<br> | Other: Comprehensive Score for financial toxicity (COST)<br>* Measure indirect and direct health care cost that burden patients and their loved ones.<br>Other: Functional Assessment of Cancer Therapy: General (FACT-G)<br>* General quality of life instrument<br>Other: EORTC QLQ C-30<br>* Assess quality of life in cancer patients<br>Other: EORTC QLQ-TC26.<br>* To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire.<br>|
| Long-term survivors of TGCT<br> | Other: Comprehensive Score for financial toxicity (COST)<br>* Measure indirect and direct health care cost that burden patients and their loved ones.<br>Other: Functional Assessment of Cancer Therapy: General (FACT-G)<br>* General quality of life instrument<br>Other: EORTC QLQ C-30<br>* Assess quality of life in cancer patients<br>Other: EORTC QLQ-TC26.<br>* To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT. |  | 5 years |