NeoplasmsNCT04931251
Addressing Cancer-Related Financial Toxicity in North Carolina Oncology Care Settings
A study testing Financial Navigation in people with Neoplasms and Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Financial Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Nov 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
NC Basnight Cancer Hospital
Chapel Hill, North Carolina, 27514
Novant Health
Charlotte, North Carolina, 28207
Vidant Medical Center, Cancer Center
Greenville, North Carolina, 27834
Pardee UNC Health Care, Pardee Cancer Center
Hendersonville, North Carolina, 28739
UNC Lenoir Cancer Care Services
Kinston, North Carolina, 28501
Carteret Health Care Cancer Center
Morehead City, North Carolina, 28557
The Outer Banks Hospital
Nags Head, North Carolina, 27959
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Addressing Cancer-Related Financial Toxicity in Rural and Non-Rural North Carolina Oncology Care Settings
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 4 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.
Read the detailed description
The objective of this study was to evaluate changes in financial toxicity, as measured by the COmprehensive Score for financial Toxicity (FACIT-COST) from baseline to follow-up after participation in a financial navigation program among rural and non-rural cancer patients in North Carolina with moderate to severe financial toxicity.
After providing informed consent, participants completed the FACIT-COST measure (score range: 0-44, with lower scores indicating greater financial toxicity). Participants with a score of 22 or lower, indicating moderate to severe financial toxicity, were eligible to enroll in the financial navigation intervention. Those with scores of 23 or higher were not eligible.
This implementation study was conducted across eight oncology practices in North Carolina (four rural and four non-rural). Eligible participants completed baseline questionnaires assessing health-related quality of life before meeting with a financial navigator for a comprehensive assessment of financial needs and identification of available financial assistance resources. Participants continued to work with the financial navigator until all appropriate assistance options had been explored and applications, benefits, or referrals were completed.
At the conclusion of the intervention, participants repeated the FACIT-COST measure and baseline questionnaires to assess changes in financial toxicity, health-related quality of life, and the acceptability of the financial navigation program. The intervention typically involved two to six visits with a financial navigator over approximately four months, although participation could extend longer depending on the complexity of the participant's financial needs.
- Being tested
- Financial Navigation
- Keywords
- Financial Toxicity, Cancer, Financial Navigation, Carcinoma, Neoplasms
- Medical subject headings
- Neoplasms, Carcinoma, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial NavigationBehavioural
providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer
| Study group | Role | What they receive |
|---|---|---|
| Financial Navigation | Other | 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 Receives: Behavioral: Financial Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
COST (Comprehensive Score for Financial Toxicity) Measure
To evaluate changes in financial toxicity from baseline to follow-up, participants completed the 12-item Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) before and after the financial navigation intervention. FACIT-COST scores range from 0 to 44, with higher scores indicating lower financial toxicity (less financial distress) and lower scores indicating greater financial toxicity (more financial distress). Therefore, an increase in score reflects improvement, whereas a decrease reflects worsening financial toxicity.
Measured: 4-6 months
Secondary outcomes (1)
Health-Related Quality of Life (HrQoL) Measures
To evaluate changes in health-related quality of life (HRQoL) from baseline to follow-up, participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Physical Health, Global Mental Health, Anxiety 6a, Depression 4a, and Psychosocial Illness Impact-Positive instruments. PROMIS T-scores are standardized with a mean of 50 (SD = 10). For Global Physical Health, Global Mental Health, and Psychosocial Illness Impact-Positive, higher scores indicate better health or more positive psychosocial functioning. For Anxiety and Depression, higher scores indicate greater symptom severity; therefore, decreases in these scores reflect improvement, whereas increases reflect worsening symptoms.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start11 Nov 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-site, single arm, financial navigation intervention
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie Wheeler, PhD, Principal investigator, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931251
- Sponsor's protocol ID
- LCCC1941
- Other IDs
- 5R01CA240092, P30CA016086
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2021
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data are available upon reasonable request by contacting the study authors and signing the study Data Use Agreement.
Publications
Wheeler SB, Biddell CB, Manning ML, Gellin MS, Padilla NR, Spees LP, Rogers CD, Rodriguez-O'Donnell J, Samuel-Ryals C, Birken SA, Reeder-Hayes KE, Petermann VM, Deal AM, Rosenstein DL. Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings. Trials. 2022 Oct 3;23(1):839. doi: 10.1186/s13063-022-06745-4.
PubMed 36192802Planey AM, Spees LP, Biddell CB, Waters A, Jones EP, Hecht HK, Rosenstein D, Wheeler SB. The intersection of travel burdens and financial hardship in cancer care: a scoping review. JNCI Cancer Spectr. 2024 Sep 2;8(5):pkae093. doi: 10.1093/jncics/pkae093.
PubMed 39361410Wheeler SB, Thom B, Waters AR, Shankaran V. Interventions to Address Cancer-Related Financial Hardship: A Scoping Review and Call to Action. JCO Oncol Pract. 2025 Jan;21(1):29-40. doi: 10.1200/OP.24.00375. Epub 2025 Jan 10.
PubMed 39793544Wheeler SB, Manning ML, Gellin M, Padilla N, Spees LP, Biddell CB, Petermann V, Deal A, Rogers C, Rodriguez-O'Donnell J, Samuel-Ryals C, Reeder-Hayes K, Rosenstein DL. Impact of a Comprehensive Financial Navigation Intervention to Reduce Cancer-Related Financial Toxicity. J Natl Compr Canc Netw. 2024 Oct;22(8):557-562. doi: 10.6004/jnccn.2024.7030.
PubMed 39413831Wheeler SB, Birken SA, Wagi CR, Manning ML, Gellin M, Padilla N, Rogers C, Rodriguez J, Biddell CB, Strom C, Bell RA, Rosenstein DL. Core functions of a financial navigation intervention: An in-depth assessment of the Lessening the Impact of Financial Toxicity (LIFT) intervention to inform adaptation and scale-up in diverse oncology care settings. Front Health Serv. 2022 Nov 9;2:958831. doi: 10.3389/frhs.2022.958831. eCollection 2022.
PubMed 36925862Petermann VM, Biddell CB, Planey AM, Spees LP, Rosenstein DL, Manning M, Gellin M, Padilla N, Samuel-Ryals CA, Birken SA, Reeder-Hayes K, Deal AM, Cabarrus K, Bell RA, Strom C, Young TH, King S, Leutner B, Vestal D, Wheeler SB. Assessing the pre-implementation context for financial navigation in rural and non-rural oncology clinics. Front Health Serv. 2023 Oct 23;3:1148887. doi: 10.3389/frhs.2023.1148887. eCollection 2023.
PubMed 37941608Biddell CB, Spees LP, Petermann V, Rosenstein DL, Manning M, Gellin M, Padilla N, Samuel-Ryals CA, Birken SA, Reeder-Hayes K, Deal AM, Cabarrus K, Bell RA, Strom C, DeAntonio PA, Young TH, King S, Leutner B, Vestal D, Wheeler SB. Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. JCO Oncol Pract. 2022 Sep;18(9):e1392-e1406. doi: 10.1200/OP.21.00894. Epub 2022 May 12.
PubMed 35549521Waters AR, Thom B, Deal AM, Murray CR, Pignone K, Manning ML, Gellin M, Padilla NR, Spees LP, Planey AM, Reeder-Hayes KE, Rosenstein DL, Wheeler SB. Improvements in Health-Related Quality of Life After Financial Navigation Among Cancer Survivors. Psychooncology. 2026 Sep;35(9):e70605. doi: 10.1002/pon.70605.
PubMed 42770487
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Cancer-Related Financial Toxicity in Rural and Non-Rural North Carolina Oncology Care Settings
- ClinicalTrials.gov ID
- NCT04931251
- Acronym / sponsor ID
- LCCC1941
- Keywords
- Financial Toxicity, Cancer, Financial Navigation, Carcinoma, Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 7 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 4 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.
Detailed description
The objective of this study was to evaluate changes in financial toxicity, as measured by the COmprehensive Score for financial Toxicity (FACIT-COST) from baseline to follow-up after participation in a financial navigation program among rural and non-rural cancer patients in North Carolina with moderate to severe financial toxicity.
After providing informed consent, participants completed the FACIT-COST measure (score range: 0-44, with lower scores indicating greater financial toxicity). Participants with a score of 22 or lower, indicating moderate to severe financial toxicity, were eligible to enroll in the financial navigation intervention. Those with scores of 23 or higher were not eligible.
This implementation study was conducted across eight oncology practices in North Carolina (four rural and four non-rural). Eligible participants completed baseline questionnaires assessing health-related quality of life before meeting with a financial navigator for a comprehensive assessment of financial needs and identification of available financial assistance resources. Participants continued to work with the financial navigator until all appropriate assistance options had been explored and applications, benefits, or referrals were completed.
At the conclusion of the intervention, participants repeated the FACIT-COST measure and baseline questionnaires to assess changes in financial toxicity, health-related quality of life, and the acceptability of the financial navigation program. The intervention typically involved two to six visits with a financial navigator over approximately four months, although participation could extend longer depending on the complexity of the participant's financial needs.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-site, single arm, financial navigation intervention
| Arm | Type | Receives |
|---|---|---|
| Financial Navigation | Other | Behavioral: Financial Navigationincludes 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Navigationproviding financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer | Behavioural | Financial Navigation |
Primary outcome
COST (Comprehensive Score for Financial Toxicity) Measure
Time frame: 4-6 months
To evaluate changes in financial toxicity from baseline to follow-up, participants completed the 12-item Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) before and after the financial navigation intervention. FACIT-COST scores range from 0 to 44, with higher scores indicating lower financial toxicity (less financial distress) and lower scores indicating greater financial toxicity (more financial distress). Therefore, an increase in score reflects improvement, whereas a decrease reflects worsening financial toxicity.
1 secondary outcome
Health-Related Quality of Life (HrQoL) Measures
Time frame: 4-6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36192802Wheeler SB, Biddell CB, Manning ML, Gellin MS, Padilla NR, Spees LP, Rogers CD, Rodriguez-O'Donnell J, Samuel-Ryals C, Birken SA, Reeder-Hayes KE, Petermann VM, Deal AM, Rosenstein DL. Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings. Trials. 2022 Oct 3;23(1):839. doi: 10.1186/s13063-022-06745-4.
- Background: PubMed 39361410Planey AM, Spees LP, Biddell CB, Waters A, Jones EP, Hecht HK, Rosenstein D, Wheeler SB. The intersection of travel burdens and financial hardship in cancer care: a scoping review. JNCI Cancer Spectr. 2024 Sep 2;8(5):pkae093. doi: 10.1093/jncics/pkae093.
- Background: PubMed 39793544Wheeler SB, Thom B, Waters AR, Shankaran V. Interventions to Address Cancer-Related Financial Hardship: A Scoping Review and Call to Action. JCO Oncol Pract. 2025 Jan;21(1):29-40. doi: 10.1200/OP.24.00375. Epub 2025 Jan 10.
- Background: PubMed 39413831Wheeler SB, Manning ML, Gellin M, Padilla N, Spees LP, Biddell CB, Petermann V, Deal A, Rogers C, Rodriguez-O'Donnell J, Samuel-Ryals C, Reeder-Hayes K, Rosenstein DL. Impact of a Comprehensive Financial Navigation Intervention to Reduce Cancer-Related Financial Toxicity. J Natl Compr Canc Netw. 2024 Oct;22(8):557-562. doi: 10.6004/jnccn.2024.7030.
- Results publication: PubMed 36925862Wheeler SB, Birken SA, Wagi CR, Manning ML, Gellin M, Padilla N, Rogers C, Rodriguez J, Biddell CB, Strom C, Bell RA, Rosenstein DL. Core functions of a financial navigation intervention: An in-depth assessment of the Lessening the Impact of Financial Toxicity (LIFT) intervention to inform adaptation and scale-up in diverse oncology care settings. Front Health Serv. 2022 Nov 9;2:958831. doi: 10.3389/frhs.2022.958831. eCollection 2022.
- Results publication: PubMed 37941608Petermann VM, Biddell CB, Planey AM, Spees LP, Rosenstein DL, Manning M, Gellin M, Padilla N, Samuel-Ryals CA, Birken SA, Reeder-Hayes K, Deal AM, Cabarrus K, Bell RA, Strom C, Young TH, King S, Leutner B, Vestal D, Wheeler SB. Assessing the pre-implementation context for financial navigation in rural and non-rural oncology clinics. Front Health Serv. 2023 Oct 23;3:1148887. doi: 10.3389/frhs.2023.1148887. eCollection 2023.
- Results publication: PubMed 35549521Biddell CB, Spees LP, Petermann V, Rosenstein DL, Manning M, Gellin M, Padilla N, Samuel-Ryals CA, Birken SA, Reeder-Hayes K, Deal AM, Cabarrus K, Bell RA, Strom C, DeAntonio PA, Young TH, King S, Leutner B, Vestal D, Wheeler SB. Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. JCO Oncol Pract. 2022 Sep;18(9):e1392-e1406. doi: 10.1200/OP.21.00894. Epub 2022 May 12.
- Derived from this study: PubMed 42770487Waters AR, Thom B, Deal AM, Murray CR, Pignone K, Manning ML, Gellin M, Padilla NR, Spees LP, Planey AM, Reeder-Hayes KE, Rosenstein DL, Wheeler SB. Improvements in Health-Related Quality of Life After Financial Navigation Among Cancer Survivors. Psychooncology. 2026 Sep;35(9):e70605. doi: 10.1002/pon.70605.
- UNC Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data are available upon reasonable request by contacting the study authors and signing the study Data Use Agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Wheeler, PhD principal investigator
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Navigation in people with Neoplasms and Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COST (Comprehensive Score for Financial Toxicity) Measure (time frame: 4-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04931251, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.