Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Financial counseling and navigation.
- Who it may be relevant to
- Registry conditions: Cancer, Financial Burden, Financial Toxicity, Screening Tool. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Screening completion [Time frame: From enrollment to the end of the intervention at 8 months.]
- Rate of referral assistance [Time frame: From enrollment to the end of the intervention at 8 months.]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 4 centers
- Perlmutter Cancer Center — New York
- Cone Health Alamance Regional — Burlington
- University of North Carolina at Chapel Hill — Chapel Hill
- UNC Health Pardee — Hendersonville
Identifiers
NCT: NCT07664436 · 25-1413