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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04032483
Other study ID # D19068
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 8, 2020
Est. completion date March 1, 2024

Study information

Verified date March 2024
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project aims to elucidate the prevalence of financial toxicity, identify significant risk factors for toxicity, and understand the burdens of the specific St. Johnsbury rural population. These data will drive future, larger studies to investigate how to alleviate the burden of financial toxicity, especially in vulnerable patient populations.


Description:

"Financial toxicity" refers to a side effect of cancer treatment that is financial in nature, and has become increasingly important to oncologists, patients, and researchers because of its implications in adverse social outcomes for patients. Financial toxicity in the context of cancer care is the monetary cost, and subsequent social implications of the cost, on patients undergoing cancer treatment. Although financial toxicity for patients undergoing cancer treatment has some research attention, financial toxicity associated with radiation therapy for cancer patients has not. There is preliminary data that has shown that there are two forms of financial toxicity: the direct cost of cancer therapy (medical services) and the indirect costs (gas for travel, lost wages for sick days, etc.). However, the degree of cost and sources have not been fully investigated. Specifically, financial toxicity in the context of cancer patients from rural populations (such as those at NCCC) has not been fully explored. This project will attempt to understand the salient factors, costs, and magnitudes of financial toxicity in radiation therapy that will allow for more targeted studies to investigate vulnerable patient populations who experience greater financial toxicity. Study recruitment temporarily halted due to COVID-19.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 1, 2024
Est. primary completion date December 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - At least 18 years of age - Undergoing treatment at Norris Cotton Cancer Center North, St. Johnsbury, VT - Current radiation/oncology patient - Ability to speak or write in English

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Norris Cotton Cancer Center Saint Johnsbury Vermont

Sponsors (1)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Financial toxicity Both qualitative and quantitative surveys will be given to patients and will ask them for their financial information. These surveys will be given each week, on the day the physician sees the patient. The survey will ask for the following information to determine their direct costs of radiation treatment: employment, race, ethnicity, gender, income, insurance status, co-payments, wage-earner status, out-of-pocket costs for treatment, transportation to treatments, and drug costs. The survey will also ask questions to determine their indirect costs of radiation treatment: productivity days lost, disability days, if they have sold anything in the past week, if they have cut down on leisure activities, concern about paying for bills, ability to meet monthly expenses, and how much they deem their cancer treatment has impacted their satisfaction with financial status. The time frame will once a week for 3-9 weeks, dependent on the treatment duration of the patient.
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