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Survey Study: Financial Impact of Breast Cancer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615573
Recruitment Status : Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Other: Quality of Life Surveys

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Financial Impact of Breast Cancer Treatment Over a One Year Period for Patients at a Rural Cancer Center
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Other: Quality of Life Surveys
    Patients with breast cancer diagnosis complete questionnaires over 20-30 minutes at baseline and at 3, 6, and 12 months after enrollment.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615573


Locations
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United States, Pennsylvania
Guthrie Medical Group
Sayre, Pennsylvania, United States, 18840
Sponsors and Collaborators
The Guthrie Clinic
Investigators
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Principal Investigator: Cynthia Perry-Keaty, RN, MS, FNP-BC, AOCNP The Guthrie Clinic
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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT03615573    
Other Study ID Numbers: 1808-42
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases