- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03615573
Survey Study: Financial Impact of Breast Cancer Treatment
November 6, 2024 updated by: The Guthrie Clinic
Determining the Financial Impact of Breast Cancer Treatment Over a One Year Period for Patients at a Rural Cancer Center
A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year.
The study will also look at the health insurance literacy and patient's utilization of support services.
Study Overview
Study Type
Observational
Enrollment (Actual)
103
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
-
-
Pennsylvania
-
Sayre, Pennsylvania, United States, 18840
- Guthrie Medical Group
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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
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients seen at rural cancer center with diagnosis of breast cancer or a recurrence of breast cancer within the past 2 years
Description
Inclusion Criteria:
- 18 years or older
- Diagnosed with breast cancer or a recurrence of breast cancer within the past 2 years
- Willing to sign consent
- Able to read and complete surveys in English
Exclusion Criteria:
- Cancer diagnosis other than breast cancer
- More than 2 years since diagnosis with breast cancer or recurrence
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in level of self-reported financial burden
Time Frame: Baseline through 1 year
|
Will evaluate the change in Comprehensive Score for Financial Toxicity (COST-FACIT) measurements from baseline to 1 year follow up.
This survey consists of 14 questions related to finances.Responses include 5 options with lower scores representing worse outcomes.
Scores at 1 year will be compared to baseline scores.
|
Baseline through 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in level of self-reported health insurance literacy
Time Frame: Baseline through 1 year
|
Will evaluate the change in Health Insurance Literacy Measurements (HILM) from baseline to 1 year follow up
|
Baseline through 1 year
|
|
Self-reported access and utilization of institutional support services
Time Frame: Baseline through 1 year
|
Will evaluate reported access and utilization of institutional support services and its association to financial burden in the first 12 months after enrollment.
|
Baseline through 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia Perry-Keaty, RN FNP AOCNP, The Guthrie Clinic
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)
September 4, 2018
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
February 10, 2024
Study Registration Dates
First Submitted
July 31, 2018
First Submitted That Met QC Criteria
August 3, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
November 7, 2024
Last Update Submitted That Met QC Criteria
November 6, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1808-42
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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