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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

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

Recruiting Locations

Mays Cancer Center
San Antonio, Texas 78229
Contact:
Epp Goodwin
210-450-5798
goodwine@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.