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| ID | Type | Description | Link |
|---|---|---|---|
| HSC20200462E | Other Identifier | UT Health Science Center San Antonio IRB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term survivors of TGCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Score for financial toxicity (COST) | Other | Measure indirect and direct health care cost that burden patients and their loved ones. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Long-term survivors
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Patients diagnosed with testicular germ cell tumors TGCT, divided into non-seminomatous germ cell tumors (NSGCT) and seminomas; both of which are treated with a combination of surgery and chemotherapy or radiation depending on stage of disease.
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| Name | Affiliation | Role |
|---|---|---|
| Deepak Pruthi, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mays Cancer Center | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27716900 | Background | de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7. | |
| 25030752 |
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| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
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| ID | Term |
|---|---|
| D003365 | Costs and Cost Analysis |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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| 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. |
|
| Result |
| Nigam M, Aschebrook-Kilfoy B, Shikanov S, Eggener S. Increasing incidence of testicular cancer in the United States and Europe between 1992 and 2009. World J Urol. 2015 May;33(5):623-31. doi: 10.1007/s00345-014-1361-y. Epub 2014 Jul 17. |
| 29671528 | Result | Baird DC, Meyers GJ, Hu JS. Testicular Cancer: Diagnosis and Treatment. Am Fam Physician. 2018 Feb 15;97(4):261-268. |
| 31378580 | Result | Palumbo C, Mistretta FA, Mazzone E, Knipper S, Tian Z, Perrotte P, Antonelli A, Montorsi F, Shariat SF, Saad F, Simeone C, Briganti A, Lattouf JB, Karakiewicz PI. Contemporary Incidence and Mortality Rates in Patients With Testicular Germ Cell Tumors. Clin Genitourin Cancer. 2019 Oct;17(5):e1026-e1035. doi: 10.1016/j.clgc.2019.06.003. Epub 2019 Jun 13. |
| 21228314 | Result | Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12. |
| 30419889 | Result | Sztankay M, Aaronson NK, Arraras JI, Basso U, Bumbasirevic U, Efficace F, Giesinger JM, Johnson CD, van Leeuwen M, Oberguggenberger AS, Sosnowski R, Young T, Holzner B; European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG). International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26. BMC Cancer. 2018 Nov 12;18(1):1104. doi: 10.1186/s12885-018-5036-8. |
| D014565 |
| Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |