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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03615573
Other study ID # 1808-42
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 4, 2018
Est. completion date November 30, 2024

Study information

Verified date January 2023
Source The Guthrie Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 103
Est. completion date November 30, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Guthrie Medical Group Sayre Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in level of self-reported financial burden 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 Change in level of self-reported health insurance literacy Will evaluate the change in Health Insurance Literacy Measurements (HILM) from baseline to 1 year follow up Baseline through 1 year
Secondary Self-reported access and utilization of institutional support services 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
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