Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS) (I-ACCESS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Financial Toxicity; Financial Burden; Screening Tool
• Intervention / Treatment: Behavioral: Financial counseling and navigation

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 Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brianna Connelly; Phone Number: 919-964-2343; Email: brianna_connelly@med.unc.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Perlmutter Cancer Center
      • Contact: Brianna Connelly; Phone Number: 919-964-2343; Email: brianna_connelly@med.unc.edu
      • Contact: Bridgette; Phone Number: 646-221-6953; Email: Bridgette.Thom@unc.edu
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Cone Health Alamance Regional
      • Contact: Brianna Connelly; Phone Number: 919-964-2343; Email: brianna_connelly@med.unc.edu
      • Contact: Bridgette Thom; Phone Number: 646-221-6953; Email: Bridgette.Thom@unc.edu
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Hendersonville, North Carolina, United States, 28791
      • UNC Health Pardee
      • Contact: Brianna Connelly; Phone Number: 919-964-2343; Email: brianna_connelly@med.unc.edu
      • Contact: Bridgette Thom; Phone Number: 646-221-6953; Email: Bridgette.Thom@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unable to read of speak English or Spanish
• Under the age of 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Financial Screener; 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.

Behavioral: Financial counseling and navigation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening completion	Ratio of the number of completed screens to the number of eligible patients	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	From enrollment to the end of the intervention at 8 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of referral	Count/percent of reason for referral (out-of-pocket costs, non-medical expense, benefit counseling, medication cost, other)	From enrollment to the end of the intervention at 8 months.
Counseling content	Count/percent of counseling disposition (general, insurance, external referral, other)	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)	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)	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	From enrollment through the end of data analysis at 12 months
Acceptability of Intervention Measure	Patient and clinician perception of intervention acceptability	4-6 months after implementation of I-ACCESS
Intervention Appropriateness Measure	Patient and clinician perception of intervention appropriateness	4-6 months after implementation of I-ACCESS
Feasibility of Intervention Measure	Patient and clinician perception of intervention feasibility	4-6 months after intervention completion

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Financial Stress; Neoplasms
• Other Study ID Numbers: 25-1413

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No