OncologyNCT07281287
Evaluating the Implementation and Impact of Standard-of-care Delivered Oncology Financial Navigation
A study testing Financial navigation in people with Oncology and Financial Toxicity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to understand the implementation and impact of a pragmatically-delivered oncology financial navigation program. The main questions it aims to answer are: 1. How did oncology financial navigation implementation strategies affect implementation outcomes? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Financial Toxicity, Counseling
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 who have received oncology financial navigation
- Providers (oncology financial navigators, social workers, nurse managers, oncologists) involved with the oncology financial navigation program
- Health system team members (billing specialists, cancer service line leadership) involved with the oncology financial navigation program
Who cannot join
- Aim 2:
- Inclusion criteria: This will be a secondary data analysis of patient-reported data routinely collected since 2020, which will include:
- Patients with cancer seen at the UAB Medical Oncology clinic
- Patients with non-missing patient-reported outcome data
- Aim 3:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Hayden Reeves, BS, 205-996-4109, haydenreeves@uabmc.edu
Courtney Williams, DrPH, 205-975-0462, courtneywilliams@uabmc.edu
About this study
The purpose of this study is to understand the implementation and impact of a pragmatically-delivered oncology financial navigation program. The main questions it aims to answer are:
- How did oncology financial navigation implementation strategies affect implementation outcomes?
- What is the impact of financial navigation on patient financial hardship, quality of life, and psychological distress?
- How were implementation strategies utilized to overcome barriers to oncology financial navigation?
Researchers will examine secondary, standard-of-care collected, patient-reported data, electronic medical record data, and qualitative interview data to answer these questions.
Read the detailed description
Guided by the RE-AIM Extension for Equitable Sustainability framework, the investigators will use a series of implementation and effectiveness aims to evaluate equitable implementation of oncology financial navigation into routine cancer care delivery. The investigators hypothesize the proposed assessment will identify potential areas to improve implementation of oncology financial navigation, which will result in better financial and clinical outcomes for patients with cancer. The investigators propose a pragmatic, hybrid effectiveness-implementation study to assess outcomes of oncology financial navigation delivered as routine cancer care and collect information on strategies to address implementation barriers. Outcomes will be assessed overall and for inequities by race, residence, and insurance status using the following specific aims:
Aim 1. Track oncology financial navigation implementation strategies and their effect on implementation outcomes
Aim 2. Evaluate oncology financial navigation effectiveness
Aim 3. Assess how implementation strategies were utilized to overcome barriers to oncology financial navigation
- Conditions
- Oncology, Financial Toxicity, Counseling
- Being tested
- Financial navigation
- Keywords
- Financial Navigation, Out of pocket cost, Oncology, oncology Financial hardship
- Medical subject headings
- Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial navigationBehavioural
Oncology financial navigation is an evidence-based intervention which helps patients prepare for out-of-pocket treatment costs, optimize health insurance, and access financial resources to reduce cancer-related financial hardship.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving standard-of-care-delivered financial navigation | Experimental | Not described Receives: Behavioral: Financial navigation |
| Historical control patients who did not receive financial navigation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in financial hardship
Change in patient-reported financial distress (COmprehensive Score for financial Toxicity)
Measured: 6 months post-initiation of systemic therapy
Change in financial difficulties
Change in patient-reported financial difficulties (trouble paying for basic needs, utilities, transportation or lodging for treatment, medications, medical supplies, upfront medical payments, insurance or medical bills, child or eldercare, and employment or disability issues)
Measured: 6 months post-initiation of systemic therapy
Change in quality of life
Change in patient-reported quality of life (PROMIS v1.1 Global Health)
Measured: 6 months post-initiation of systemic therapy
Change in psychological distress
Change in patient-reported psychological distress (National Comprehensive Cancer Network Distress Thermometer)
Measured: 6 months post-initiation of systemic therapy
Utilization of implementation strategies
Track oncology financial navigation implementation strategies using the Expert Recommendations for Implementing Change (ERIC) implementation strategy taxonomy and their effect on implementation outcomes of Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM)
Measured: Quarterly tracking of strategies with monthly assessment of implementation outcomes, through study completion, an average of 4 years
Patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies
Using qualitative interviews, we will assess patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies
Measured: Annually through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Feb 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This will be a secondary data analysis of patient-reported data routinely collected since 2020 for patients with cancer seen at the UAB Medical Oncology clinic. All patients with data will be included in the analysis, as this is an evaluation of oncology financial navigation integration into real-world clinical teams. Therefore, due to a lack of comparable controls during the oncology financial navigation intervention, we will use historical controls matched by sociodemographic and cancer characteristics for comparison.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Courtney Williams, University of Alabama at Birmingham
- Investigators
- Courtney Williams, DrPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281287
- Sponsor's protocol ID
- IRB-300012763
- Other IDs
- 1K01CA296932
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Implementation and Impact of Standard-of-care Delivered Oncology Financial Navigation
- ClinicalTrials.gov ID
- NCT07281287
- Acronym / sponsor ID
- IRB-300012763
- Conditions
- Oncology, Financial Toxicity, Counseling
- Keywords
- Financial Navigation, Out of pocket cost, Oncology, oncology Financial hardship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand the implementation and impact of a pragmatically-delivered oncology financial navigation program. The main questions it aims to answer are:
- How did oncology financial navigation implementation strategies affect implementation outcomes?
- What is the impact of financial navigation on patient financial hardship, quality of life, and psychological distress?
- How were implementation strategies utilized to overcome barriers to oncology financial navigation?
Researchers will examine secondary, standard-of-care collected, patient-reported data, electronic medical record data, and qualitative interview data to answer these questions.
Detailed description
Guided by the RE-AIM Extension for Equitable Sustainability framework, the investigators will use a series of implementation and effectiveness aims to evaluate equitable implementation of oncology financial navigation into routine cancer care delivery. The investigators hypothesize the proposed assessment will identify potential areas to improve implementation of oncology financial navigation, which will result in better financial and clinical outcomes for patients with cancer. The investigators propose a pragmatic, hybrid effectiveness-implementation study to assess outcomes of oncology financial navigation delivered as routine cancer care and collect information on strategies to address implementation barriers. Outcomes will be assessed overall and for inequities by race, residence, and insurance status using the following specific aims:
Aim 1. Track oncology financial navigation implementation strategies and their effect on implementation outcomes
Aim 2. Evaluate oncology financial navigation effectiveness
Aim 3. Assess how implementation strategies were utilized to overcome barriers to oncology financial navigation
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a secondary data analysis of patient-reported data routinely collected since 2020 for patients with cancer seen at the UAB Medical Oncology clinic. All patients with data will be included in the analysis, as this is an evaluation of oncology financial navigation integration into real-world clinical teams. Therefore, due to a lack of comparable controls during the oncology financial navigation intervention, we will use historical controls matched by sociodemographic and cancer characteristics for comparison.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving standard-of-care-delivered financial navigation | Experimental | Behavioral: Financial navigation |
| Historical control patients who did not receive financial navigation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have received oncology financial navigation
- Providers (oncology financial navigators, social workers, nurse managers, oncologists) involved with the oncology financial navigation program
- Health system team members (billing specialists, cancer service line leadership) involved with the oncology financial navigation program
Key exclusion criteria (5 listed)
- Inclusion criteria: This will be a secondary data analysis of patient-reported data routinely collected since 2020, which will include:
- Patients with cancer seen at the UAB Medical Oncology clinic
- Patients with non-missing patient-reported outcome data
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 navigationOncology financial navigation is an evidence-based intervention which helps patients prepare for out-of-pocket treatment costs, optimize health insurance, and access financial resources to reduce cancer-related financial hardship. | Behavioural | Patients receiving standard-of-care-delivered financial navigation |
Primary outcome
Change in financial hardship
Time frame: 6 months post-initiation of systemic therapy
Change in patient-reported financial distress (COmprehensive Score for financial Toxicity)
Change in financial difficulties
Time frame: 6 months post-initiation of systemic therapy
Change in patient-reported financial difficulties (trouble paying for basic needs, utilities, transportation or lodging for treatment, medications, medical supplies, upfront medical payments, insurance or medical bills, child or eldercare, and employment or disability issues)
Change in quality of life
Time frame: 6 months post-initiation of systemic therapy
Change in patient-reported quality of life (PROMIS v1.1 Global Health)
Change in psychological distress
Time frame: 6 months post-initiation of systemic therapy
Change in patient-reported psychological distress (National Comprehensive Cancer Network Distress Thermometer)
Utilization of implementation strategies
Time frame: Quarterly tracking of strategies with monthly assessment of implementation outcomes, through study completion, an average of 4 years
Track oncology financial navigation implementation strategies using the Expert Recommendations for Implementing Change (ERIC) implementation strategy taxonomy and their effect on implementation outcomes of Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM)
Patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies
Time frame: Annually through study completion, an average of 4 years
Using qualitative interviews, we will assess patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Courtney Williams, DrPH principal investigator
University of Alabama at Birmingham
1 site 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 Oncology and Financial Toxicity, run by University of Alabama at Birmingham at 1 site 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayden Reeves, BS (205-996-4109, haydenreeves@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in financial hardship (time frame: 6 months post-initiation of systemic therapy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2026.