Financial Toxicity and Quality of Life in Patients With TGCT

April 3, 2023 updated by: The University of Texas Health Science Center at San Antonio

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Mays Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMS 20-0061
  • HSC20200462E (Other Identifier: UT Health Science Center San Antonio IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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