Financial ToxicityNCT04032483
A Survey of Financial Toxicity in Rural Cancer Patients
An observational study of Financial Toxicity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Financial Toxicity
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2020to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: With 100 participants, we are trying to show the prevalence of financial toxicity in radiation patients and make our findings as generalizable as possible to the broader population of rural radiation oncology patients in the US.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Cotton Cancer Center
Saint Johnsbury, Vermont, 05819
About this study
Official title: A Survey of Financial Toxicity of Radiation Treatment in Rural Cancer Patients
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.
Read the detailed 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.
- Conditions
- Financial Toxicity
- Medical subject headings
- Financial Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The time frame will once a week for 3-9 weeks, dependent on the treatment duration of the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start8 Jan 2020
- Primary completion28 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial ToxicityStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav.S.Kapadia, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032483
- Sponsor's protocol ID
- D19068
- Status last verified
- Mar 2024
- First submitted
- 23 Jul 2019
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Financial Toxicity of Radiation Treatment in Rural Cancer Patients
- ClinicalTrials.gov ID
- NCT04032483
- Acronym / sponsor ID
- D19068
- Conditions
- Financial Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- With 100 participants, we are trying to show the prevalence of financial toxicity in radiation patients and make our findings as generalizable as possible to the broader population of rural radiation oncology patients in the US.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Financial toxicity
Time frame: The time frame will once a week for 3-9 weeks, dependent on the treatment duration of the patient.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Financial Toxicity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial toxicity (time frame: The time frame will once a week for 3-9 weeks, dependent on the treatment duration of the patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.