CancerI-ACCESSNCT07664436
Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS)
A study testing Financial counseling and navigation in people with Cancer and Financial Burden, run by UNC Lineberger Comprehensive Cancer Center at 4 sites in United States.
Trial summary
Screening and referral program to proactively identify financial hardship in adult patients with cancer and connect those at-risk with education, counseling, and resources. Patients with cancer will be screened as part of routine care and referred to available resources at their institution, following the referral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Financial Burden, Financial Toxicity
- What is being tested?
- Financial counseling and navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2027to 1 Sep 2029
- 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: Treatment for cancer at study site, over age 18 years, speak/read English or Spanish; Caregivers: Identified caregiver of a patient with cancer offered financial hardship screening, over age 18 years, speak/read English or Spanish; Staff/Clinicians: Involvement with I-ACCESS pilot implementation; over age 18 years, speak/read English or Spanish
Who cannot join
- Unable to read of speak English or Spanish
- Under the age of 18 years old
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Cone Health Alamance Regional
Burlington, North Carolina, 27215
Brianna Connelly, 919-964-2343, brianna_connelly@med.unc.edu
Bridgette Thom, 646-221-6953, Bridgette.Thom@unc.edu
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
UNC Health Pardee
Hendersonville, North Carolina, 28791
Brianna Connelly, 919-964-2343, brianna_connelly@med.unc.edu
Bridgette Thom, 646-221-6953, Bridgette.Thom@unc.edu
Perlmutter Cancer Center
New York, New York, 10016
Brianna Connelly, 919-964-2343, brianna_connelly@med.unc.edu
Bridgette, 646-221-6953, Bridgette.Thom@unc.edu
About this study
Screening and referral program to proactively identify financial hardship in adult patients with cancer and connect those at-risk with education, counseling, and resources. Patients with cancer will be screened as part of routine care and referred to available resources at their institution, following the referral processes developed and mapped in Aim 1.
Read the detailed description
In Aim 1, we will interview up to 30 clinical leaders and front-line staff across the two healthcare systems and community-based practices to understand workflows and opportunities for I-ACCESS integration. Assessment constructs will focus on understanding structural characteristics (including information technology infrastructure), available resources, culture, compatibility, relational connections, communications, and access to knowledge. These data will inform the creation of tailored process maps to outline processes and procedures to prepare each site for I-ACCESS implementation and elucidate when, how, and by whom I-ACCESS screening should be done.
In Aim 2, we will implement I-ACCESS as part of routine clinical practice for eight months at each site. Using a pre-/post-approach, we will examine whether I-ACCESS screening increases the number of financial counseling and oncology social work referrals (primary outcome). We will also examine counseling dispositions, receipt of services among those referred to financial support, and the predictive accuracy of the screening tool (secondary outcomes).
In Aim 3, we will analyze approximately 225 patient and 25 clinician surveys, informed by the Practical, Robust, Implementation and Sustainability Model, to gather feedback on I-ACCESS delivery, procedures, and barriers/facilitators to implementation. Based upon survey findings, we will then focus on key implementation determinants and outcomes through in-depth, semi-structured interviews with up to 40 stakeholders. Stakeholders will include patients, caregivers, healthcare providers, financial counselors, clinical support staff, and hospital administration at participating clinical sites.
- Conditions
- Cancer, Financial Burden, Financial Toxicity, Screening Tool
- Being tested
- Financial counseling and navigation
- 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 counseling and navigationBehavioural
Patients who screen positive for financial toxicity on the 2-question screener tool, will be referred to available counseling or navigation resources available at each site.
| Study group | Role | What they receive |
|---|---|---|
| Financial Screener | Other | Determine the effectiveness of the I-ACCESS screening tool in facilitating patient referrals for financial hardship counseling across diverse clinical practice settings. Patients who meet inclusion criteria will be screened for financial toxicity for financial toxicity using a 2-question screener tool developed from the COST ( a financial toxicity screening measure). Patients who screen positive for financial toxicity will be appropriately referred to available counseling resources. Receives: Behavioral: Financial counseling and navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening completion
Ratio of the number of completed screens to the number of eligible patients
Measured: From enrollment to the end of the intervention at 8 months.
Rate of referral assistance
Ratio of the number of patients referred to counseling to the number of patients screened positive for financial distress
Measured: From enrollment to the end of the intervention at 8 months.
Secondary outcomes (8)
Type of referral
Count/percent of reason for referral (out-of-pocket costs, non-medical expense, benefit counseling, medication cost, other)
Measured: From enrollment to the end of the intervention at 8 months.
Counseling content
Count/percent of counseling disposition (general, insurance, external referral, other)
Measured: From enrollment to the end of the intervention at 8 months.
Applications for assistance
Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)
Measured: From enrollment to the end of the intervention at 8 months.
Referrals to external resources
Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)
Measured: From enrollment to the end of the intervention at 8 months.
Predictive accuracy of tool
Sensitivity, specificity, positive predictive value, and negative predictive value of tool vs. documented bill-paying challenges
Measured: From enrollment through the end of data analysis at 12 months
Acceptability of Intervention Measure
Patient and clinician perception of intervention acceptability
Measured: 4-6 months after implementation of I-ACCESS
Intervention Appropriateness Measure
Patient and clinician perception of intervention appropriateness
Measured: 4-6 months after implementation of I-ACCESS
Feasibility of Intervention Measure
Patient and clinician perception of intervention feasibility
Measured: 4-6 months after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Sep 2027 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 screening and referral intervention
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664436
- Sponsor's protocol ID
- 25-1413
- Acronym
- I-ACCESS
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS)
- ClinicalTrials.gov ID
- NCT07664436
- Acronym / sponsor ID
- I-ACCESS / 25-1413
- Conditions
- Cancer, Financial Burden, Financial Toxicity, Screening Tool
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 24 Jun 2026 (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.
Screening and referral program to proactively identify financial hardship in adult patients with cancer and connect those at-risk with education, counseling, and resources. Patients with cancer will be screened as part of routine care and referred to available resources at their institution, following the referral processes developed and mapped in Aim 1.
Detailed description
In Aim 1, we will interview up to 30 clinical leaders and front-line staff across the two healthcare systems and community-based practices to understand workflows and opportunities for I-ACCESS integration. Assessment constructs will focus on understanding structural characteristics (including information technology infrastructure), available resources, culture, compatibility, relational connections, communications, and access to knowledge. These data will inform the creation of tailored process maps to outline processes and procedures to prepare each site for I-ACCESS implementation and elucidate when, how, and by whom I-ACCESS screening should be done.
In Aim 2, we will implement I-ACCESS as part of routine clinical practice for eight months at each site. Using a pre-/post-approach, we will examine whether I-ACCESS screening increases the number of financial counseling and oncology social work referrals (primary outcome). We will also examine counseling dispositions, receipt of services among those referred to financial support, and the predictive accuracy of the screening tool (secondary outcomes).
In Aim 3, we will analyze approximately 225 patient and 25 clinician surveys, informed by the Practical, Robust, Implementation and Sustainability Model, to gather feedback on I-ACCESS delivery, procedures, and barriers/facilitators to implementation. Based upon survey findings, we will then focus on key implementation determinants and outcomes through in-depth, semi-structured interviews with up to 40 stakeholders. Stakeholders will include patients, caregivers, healthcare providers, financial counselors, clinical support staff, and hospital administration at participating clinical sites.
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 screening and referral intervention
| Arm | Type | Receives |
|---|---|---|
| Financial Screener | Other | Behavioral: Financial counseling and navigationDetermine the effectiveness of the I-ACCESS screening tool in facilitating patient referrals for financial hardship counseling across diverse clinical practice settings. Patients who meet inclusion criteria will be screened for financial toxicity for financial toxicity using a 2-question screener tool developed from the COST ( a financial toxicity screening measure). Patients who screen positive for financial toxicity will be appropriately referred to available counseling resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients: Treatment for cancer at study site, over age 18 years, speak/read English or Spanish; Caregivers: Identified caregiver of a patient with cancer offered financial hardship screening, over age 18 years, speak/read English or Spanish; Staff/Clinicians: Involvement with I-ACCESS pilot implementation; over age 18 years, speak/read English or Spanish
Key exclusion criteria (2 listed)
- Unable to read of speak English or Spanish
- Under the age of 18 years old
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 counseling and navigationPatients who screen positive for financial toxicity on the 2-question screener tool, will be referred to available counseling or navigation resources available at each site. | Behavioural | Financial Screener |
Primary outcome
Screening completion
Time frame: From enrollment to the end of the intervention at 8 months.
Ratio of the number of completed screens to the number of eligible patients
Rate of referral assistance
Time frame: From enrollment to the end of the intervention at 8 months.
Ratio of the number of patients referred to counseling to the number of patients screened positive for financial distress
8 secondary outcomes
Type of referral
Time frame: From enrollment to the end of the intervention at 8 months.
Counseling content
Time frame: From enrollment to the end of the intervention at 8 months.
Applications for assistance
Time frame: From enrollment to the end of the intervention at 8 months.
Referrals to external resources
Time frame: From enrollment to the end of the intervention at 8 months.
Predictive accuracy of tool
Time frame: From enrollment through the end of data analysis at 12 months
Acceptability of Intervention Measure
Time frame: 4-6 months after implementation of I-ACCESS
Intervention Appropriateness Measure
Time frame: 4-6 months after implementation of I-ACCESS
Feasibility of Intervention Measure
Time frame: 4-6 months after intervention completion
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 Jun 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial counseling and navigation in people with Cancer and Financial Burden, run by UNC Lineberger Comprehensive Cancer Center at 4 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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 Brianna Connelly (919-964-2343, brianna_connelly@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening completion (time frame: From enrollment to the end of the intervention at 8 months.). The study lists 2 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 Jun 2026.