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

Status

Completed

Conditions

Intervention / Treatment

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

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.

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

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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