Clinical trial · Observational
Financial Toxicity and Quality of Life in Patients With TGCT
Financial Toxicity and Quality of Life in Patients With Testicular Germ Cell Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Neoplasm | Testicular Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Score for financial toxicity (COST) | Other | — | UNRESOLVED |
| EORTC QLQ C-30 | Other | — | UNRESOLVED |
| EORTC QLQ-TC26. | Other | — | UNRESOLVED |
| Functional Assessment of Cancer Therapy: General (FACT-G) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Long-term survivors of TGCT
- interventionNames
- 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.
Primary outcomes (1)
- measure
- Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDde 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. PMID 27716900
- RESULTNigam 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. PMID 25030752
- RESULTBaird DC, Meyers GJ, Hu JS. Testicular Cancer: Diagnosis and Treatment. Am Fam Physician. 2018 Feb 15;97(4):261-268. PMID 29671528
- RESULTPalumbo 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. PMID 31378580
- RESULTMariotto 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. PMID 21228314
- RESULTSztankay 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. PMID 30419889