Financial Toxicity and Quality of Life in Patients With TGCT

Testicular Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531709
• Other study ID #: CTMS 20-0061
• Secondary ID: HSC20200462E
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Deepak Pruthi, MD
• Phone: 210-371-4388
• Email: pruthi[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Financial Stress
• Testicular Neoplasm
• Testicular Neoplasms

Intervention

Other:
• Comprehensive Score for financial toxicity (COST)
Measure indirect and direct health care cost that burden patients and their loved ones.
• Functional Assessment of Cancer Therapy: General (FACT-G)
General quality of life instrument
• EORTC QLQ C-30
Assess quality of life in cancer patients
• EORTC 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.

Locations

Country	Name	City	State
United States	Mays Cancer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (6)

Baird DC, Meyers GJ, Hu JS. Testicular Cancer: Diagnosis and Treatment. Am Fam Physician. 2018 Feb 15;97(4):261-268. — View Citation

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. — View Citation

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. Erratum In: J Natl Cancer Inst. 2011 Ap — View Citation

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. — View Citation

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. Cli — View Citation

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 (EORT — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.		5 years