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Survey Study: Financial Impact of Breast Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03615573
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

Tracking Information
First Submitted Date July 31, 2018
First Posted Date August 6, 2018
Last Update Posted Date February 3, 2021
Actual Study Start Date September 4, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 4, 2018)
  • 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
  • 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.
Original Secondary Outcome Measures
 (submitted: August 3, 2018)
  • 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
  • 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 diagnosis of cancer.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Survey Study: Financial Impact of Breast Cancer Treatment
Official Title Determining the Financial Impact of Breast Cancer Treatment Over a One Year Period for Patients at a Rural Cancer Center
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Breast Cancer
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 3, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Jennifer Panek, MS 5708874852 Jennifer.Panek@guthrie.org
Contact: Michelle Hunter, CCRP 5708872156 Michelle.Hunter@guthrie.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03615573
Other Study ID Numbers 1808-42
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The Guthrie Clinic
Study Sponsor The Guthrie Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Cynthia Perry-Keaty, RN, MS, FNP-BC, AOCNP The Guthrie Clinic
PRS Account The Guthrie Clinic
Verification Date February 2021