Financial Toxicity and Quality of Life in Patients With TGCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-02-04

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.

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Detailed Description

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Conditions

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Testicular Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long-term survivors of TGCT

Comprehensive Score for financial toxicity (COST)

Intervention Type OTHER

Measure indirect and direct health care cost that burden patients and their loved ones.

Functional Assessment of Cancer Therapy: General (FACT-G)

Intervention Type OTHER

General quality of life instrument

EORTC QLQ C-30

Intervention Type OTHER

Assess quality of life in cancer patients

EORTC QLQ-TC26.

Intervention Type 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.

Interventions

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Comprehensive Score for financial toxicity (COST)

Measure indirect and direct health care cost that burden patients and their loved ones.

Intervention Type OTHER

Functional Assessment of Cancer Therapy: General (FACT-G)

General quality of life instrument

Intervention Type OTHER

EORTC QLQ C-30

Assess quality of life in cancer patients

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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