NCT07664436

Brief 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 processes developed and mapped in Aim 1.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable cancer

Timeline
24mo left

Started Sep 2027

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2027

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

CancerFinancial BurdenFinancial ToxicityScreening Tool

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Type of referral

    From enrollment to the end of the intervention at 8 months.

  • Counseling content

    From enrollment to the end of the intervention at 8 months.

  • Applications for assistance

    From enrollment to the end of the intervention at 8 months.

  • Referrals to external resources

    From enrollment to the end of the intervention at 8 months.

  • Predictive accuracy of tool

    From enrollment through the end of data analysis at 12 months

  • +3 more secondary outcomes

Study Arms (1)

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.

Behavioral: Financial counseling and navigation

Interventions

Financial counseling and navigationBEHAVIORAL

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.

Financial Screener

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Cone Health Alamance Regional

Burlington, North Carolina, 27215, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

UNC Health Pardee

Hendersonville, North Carolina, 28791, United States

Location

MeSH Terms

Conditions

NeoplasmsFinancial Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Brianna Connelly

CONTACT

919-964-2343brianna_connelly@med.unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is a multi-site, single arm, financial screening and referral intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 24, 2026

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

June 24, 2026

Record last verified: 2026-06

Locations

US(4)