NCT04032483

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

July 23, 2019

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norris Cotton Cancer Center

Saint Johnsbury, Vermont, 05819, United States

Location

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 25, 2019

Study Start

January 8, 2020

Primary Completion

December 28, 2023

Study Completion

March 1, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations