- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04931251
Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings
November 28, 2023 updated by: UNC Lineberger Comprehensive Cancer Center
The financial burden, or financial toxicity (FT), of cancer is a consequential and growing problem, particularly for rural patients.
It is important to improve our understanding of how financial navigation (FN) can reduce the material, psychological, and behavioral burden of costs associated with cancer care in both rural and non-rural community settings.
The purpose of this study is to conduct a financial navigation program in 5 rural and 4 non-rural oncology practices in North Carolina and evaluate the effects of financial navigation on patient outcomes, including financial toxicity and health-related quality of life.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This study is designed to evaluate the implementation and effectiveness of a financial navigation intervention within 5 rural and 4 non-rural oncology settings in North Carolina.
Financial navigators from each of the 9 sites will recruit and enroll 780 patients total across all sites into a financial navigation program.
The financial navigation intervention consists of screening patients using the COST measure for financial toxicity.
If the patient scores 23 or lower, they are considered to have moderate to severe financial toxicity and will be enrolled in the study.
Patients will then complete a series of baseline questionnaires to measure their health related quality of life and then they will meet with a financial navigator for a comprehensive intake process to determine potential financial assistance resources the patient may be eligible for and continued visits with the financial navigator until all financial assistance resources have been explored and patients have received benefits or referrals to financial assistance programs.
At the end of the intervention, the patients will complete the COST measure again, and repeat baseline surveys to measure health-related quality of life and the patient's acceptability and responsiveness of the financial navigation intervention.
Patient participation depends on the depth of patient need but ranges from 2 visits to 6 visits with the financial navigator over approximately 4 months but possibly longer depending on the complexity of the patient's financial need.
Study Type
Interventional
Enrollment (Estimated)
780
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michelle L Manning, MPH
- Phone Number: 919-843-8506
- Email: mlmannin@email.unc.edu
Study Contact Backup
- Name: Mindy Gellin, RN
- Phone Number: 919-966-9519
- Email: mindy_gellin@med.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- NC Basnight Cancer Hospital
-
Contact:
- Principal Investigator
- Phone Number: 919-966-7374
- Email: Stephanie_Wheeler@unc.edu
-
Contact:
- Project Coordinator
- Phone Number: 919-632-5029
- Email: mlmannin@email.unc.edu
-
Charlotte, North Carolina, United States, 28207
- Recruiting
- Novant Health
-
Contact:
- Principal Investigator
- Phone Number: 704-384-3119
- Email: thyoung@novanthealth.org
-
Contact:
- Social Worker
- Phone Number: 704-384-9497
- Email: hmbutler@novanthealth.org
-
Greenville, North Carolina, United States, 27834
- Recruiting
- Vidant Medical Center, Cancer Center
-
Contact:
- Principal Investigator
- Phone Number: 252-816-2744
- Email: phyllis.deantonio@vidanthealth.com
-
Contact:
- Social Worker
- Phone Number: 2527179681
- Email: ashley.williams@vidanthealth.com
-
Hendersonville, North Carolina, United States, 28739
- Recruiting
- Pardee UNC Health Care, Pardee Cancer Center
-
Contact:
- Principal Investigator
- Phone Number: 828-692-8045
- Email: brian.leutner@unchealth.unc.edu
-
Contact:
- Financial Navigator
- Phone Number: (828) 694-8514
- Email: wendy.wilke@unchealth.unc.edu
-
Kinston, North Carolina, United States, 28501
- Recruiting
- UNC Lenoir Cancer Care Services
-
Contact:
- Principal Investigator
- Phone Number: 252-522-7077
- Email: derek.vestal@unchealth.unc.edu
-
Contact:
- Financial Navigator
- Phone Number: 252-522-7600
- Email: Erin.Williams@unchealth.unc.edu
-
Morehead City, North Carolina, United States, 28557
- Recruiting
- Carteret Health Care Cancer Center
-
Contact:
- Principal Investigator
- Phone Number: 252-499-6630
- Email: sking@carterethealth.org
-
Contact:
- Social Worker
- Phone Number: 252-499-6621
- Email: lsilvano@carterethealth.org
-
Nags Head, North Carolina, United States, 27959
- Recruiting
- The Outer Banks Hospital
-
Contact:
- Financial Navigator
- Phone Number: 252-449-5798
- Email: Stacy.Marshall@theobh.com
-
Contact:
- Social Worker
- Phone Number: 252-449-2314
- Email: Janet.Creef@theobh.com
-
Rocky Mount, North Carolina, United States, 27804
- Not yet recruiting
- Nash UNC Health Care
-
Contact:
- Principal Investigator
- Phone Number: 252-962-6707
- Email: sterling.grimes@unchealth.unc.edu
-
Contact:
- Financial Navigator
- Phone Number: 252-962-8107
- Email: Sheila.Chesnut@unchealth.unc.edu
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Principal Investigator
- Phone Number: 919-357-2662
- Email: rbell@wakehealth.edu
-
Contact:
- Financial Navigator
- Phone Number: (336) 713-2688
- Email: asgonzal@wakehealth.edu
-
-
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
No
Description
Inclusion Criteria:
- Patients 18 years of age and older
- Patients with any type of cancer diagnosed within 5 years and/or living with advanced disease
- Patients who score 22 or lower on the COST measure indicating high FT
- Patients must be able to read and speak English
Exclusion Criteria:
- Participants without a cancer diagnosis
- Patients diagnosed more than 5 years ago without advanced disease
- Patients or caregivers under the age of 18
- Patients who do not sign the consent form
- Patients who do not complete the baseline COST survey
- Patients who cannot read and speak English
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
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Financial Navigation
includes a financial toxicity screening measure (COST), baseline and post-intervention surveys, and approximately 2-6 visits with a financial navigator to identify financial assistance resources
|
providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COST (Comprehensive Score for Financial Toxicity) measure
Time Frame: 4-6 months
|
To evaluate the change from baseline to follow-up in scores from the Comprehensive Score for Financial Toxicity (COST) measure after participation in the financial navigation program among 780 rural and non-rural NC cancer patients with high baseline financial distress.
|
4-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-Related Quality of Life (HrQoL) Measures
Time Frame: 4-6 months
|
To evaluate the change from baseline to follow-up in scores from HRQoL, care-altering behaviors and patient perspectives on the intervention itself
|
4-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stephanie Wheeler, PhD, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
November 11, 2021
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
July 31, 2024
Study Registration Dates
First Submitted
June 11, 2021
First Submitted That Met QC Criteria
June 11, 2021
First Posted (Actual)
June 18, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC1941
- R01CA240092 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We commit to broadly sharing appropriate materials and de-identified data that are developed with support from the NIH, while protecting participant privacy and confidentiality in accordance with best human subjects research practices and Health Insurance Portability and Accountability Act (HIPAA) guidelines.
We commit to the collection, cataloging, protecting, and sharing of clinical and other research data and resources that is consistent with NIH policies, using the Research Electronic Data Capture (REDCap) platform as the mechanism for data storage, protection and sharing.
We will only share de-identified IPD.
IPD Sharing Time Frame
The de-identified data will become available after study completion.
IPD Sharing Access Criteria
The access criteria for accessing our de-identified participant data is still being developed.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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