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NCT Number: NCT07664436

Improving Affordability in Cancer Care Through Economic Screening and Support (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.

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Key information

Conditions

Cancer Behavior Behavioral Symptoms Financial Burden Financial Stress Financial Toxicity Neoplasms Screening Tool Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perlmutter Cancer Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Financial counseling and navigation

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Type of referral

    Time frame: From enrollment to the end of the intervention at 8 months.

    Count/percent of reason for referral (out-of-pocket costs, non-medical expense, benefit counseling, medication cost, other)

  2. Counseling content

    Time frame: From enrollment to the end of the intervention at 8 months.

    Count/percent of counseling disposition (general, insurance, external referral, other)

  3. Applications for assistance

    Time frame: From enrollment to the end of the intervention at 8 months.

    Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)

  4. Referrals to external resources

    Time frame: From enrollment to the end of the intervention at 8 months.

    Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)

  5. Predictive accuracy of tool

    Time frame: From enrollment through the end of data analysis at 12 months

    Sensitivity, specificity, positive predictive value, and negative predictive value of tool vs. documented bill-paying challenges

  6. Acceptability of Intervention Measure

    Time frame: 4-6 months after implementation of I-ACCESS

    Patient and clinician perception of intervention acceptability

  7. Intervention Appropriateness Measure

    Time frame: 4-6 months after implementation of I-ACCESS

    Patient and clinician perception of intervention appropriateness

  8. Feasibility of Intervention Measure

    Time frame: 4-6 months after intervention completion

    Patient and clinician perception of intervention feasibility

Study contacts

Contact information is provided by the study sponsor or research team.

Brianna Connelly

CONTACT

[email protected]

919-964-2343

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Acronym: I-ACCESS

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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