We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04931251
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : March 2, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Carcinoma Behavioral: Financial Navigation Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a multi-site, single arm, financial navigation intervention
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Health Services Research
Official Title: Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings
Actual Study Start Date : November 11, 2021
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : July 31, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 Behavioral: Financial Navigation
providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04931251


Contacts
Layout table for location contacts
Contact: Michelle L Manning, MPH 919-843-8506 mlmannin@email.unc.edu
Contact: Mindy Gellin, RN 919-966-9519 mindy_gellin@med.unc.edu

Locations
Layout table for location information
United States, North Carolina
Novant Health Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Principal Investigator    704-384-3119    thyoung@novanthealth.org   
Contact: Social Worker    704-384-9497    deborah.johnson@novanthealth.org   
Vidant Medical Center, Cancer Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Principal Investigator    252-816-2744    phyllis.deantonio@vidanthealth.com   
Contact: Social Worker    2527179681    ashley.williams@vidanthealth.com   
Pardee UNC Health Care, Pardee Cancer Center Not yet recruiting
Hendersonville, North Carolina, United States, 28739
Contact: Principal Investigator    828-692-8045    devan.spear@unchealth.unc.edu   
Contact: Financial Navigator    (828)694-8028    amber.minugh@unchealth.unc.edu   
UNC Lenoir Cancer Care Services Recruiting
Kinston, North Carolina, United States, 28501
Contact: Principal Investigator    252-522-7077    dvestal@lenoir.org   
Contact: Social Worker    252-522-7600    mevans@lenoir.org   
Carteret Health Care Cancer Center Recruiting
Morehead City, North Carolina, United States, 28557
Contact: Principal Investigator    252-499-6630    sking@carterethealth.org   
Contact: Social Worker    252-499-6621    lsilvano@carterethealth.org   
The Outer Banks Hospital Recruiting
Nags Head, North Carolina, United States, 27959
Contact: Financial Navigator    252-449-5798    Stacy.Marshall@theobh.com   
Contact: Social Worker    252-449-2314    Janet.Creef@theobh.com   
CarolinaEast Health System Not yet recruiting
New Bern, North Carolina, United States, 28560
Contact: Principal Investigator    252-636-5135    SCarroll@carolinaeasthealth.com   
Nash UNC Health Care Not yet recruiting
Rocky Mount, North Carolina, United States, 27804
Contact: Principal Investigator    252-962-6707    sterling.grimes@unchealth.unc.edu   
Contact: Financial Navigator    252-962-8107    Sheila.Chesnut@unchealth.unc.edu   
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Principal Investigator    919-357-2662    sbirken@wakehealth.edu   
Contact: Financial Navigator    (336) 713-2688    pledfor@wakehealth.edu   
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Stephanie Wheeler, PhD Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04931251    
Other Study ID Numbers: LCCC1941
R01CA240092 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: The de-identified data will become available after study completion.
Access Criteria: The access criteria for accessing our de-identified participant data is still being developed.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Financial Toxicity
Cancer
Financial Navigation
Carcinoma
Neoplasms
Additional relevant MeSH terms:
Layout table for MeSH terms
Financial Stress
Stress, Psychological
Behavioral Symptoms