Project Summary

Financial hardship is a critical healthcare delivery problem because it leads to impaired health-related quality of life (HRQoL) and increased symptom burden, financial worry and mortality, likely due to cost-related treatment nonadherence. Recent therapeutic advances have lengthened the life expectancy of people living with advanced/metastatic cancer, prolonging the duration of high out-of-pocket costs and reduced earnings due to work impairments. 

Not surprisingly, the prevalence of financial hardship in patients with advanced cancer is high; up to 71 percent of patients with health insurance experience financial hardship within a year of diagnosis. The risk is even higher for low-income patients, exacerbating related disparities. Therefore, there is a crucial need for an effective and scalable intervention to prevent and manage financial hardship in patients with advanced cancer. 

Prior studies have shown that financial navigation may be an effective strategy to attenuate the impact of financial hardship. However, patients and clinicians have identified communication as a key barrier that prevents patients from being connected to sources of financial assistance. The Centers for Medicare & Medicaid Services has recommended that patients be screened for health-related social needs as part of a new voluntary value-based payment model for cancer care (the Enhancing Oncology Model), but they have not provided guidance on how this screening should be implemented. The research team previously reported preliminary evidence that monthly screening via an electronic survey that alerts the care team when patients are experiencing financial hardship improves communication about financial hardship and prevents worsening financial difficulties in patients treated for advanced cancer.

That finding was based on a substudy of a larger PCORI-funded national digital health project, the PRO-TECT trial. However, the PRO-TECT trial did not: 

  • Measure the impact of screening on downstream patient-centered outcomes 
  • Characterize the mechanism whereby screening conferred benefits 
  • Test financial hardship screening independently of remote symptom monitoring 
  • Include a minimum set of standards for post-screen financial navigation 

To address the critical gap in management of financial hardship among patients treated for advanced cancer, the research team designed AFiNICO (Addressing Financial Needs to Improve Cancer Outcomes), a standalone financial screening intervention based on the intervention tested in PRO-TECT. In this trial, patient-facing staff at 10 community oncology practices nationwide will receive standardized financial navigation training. The team will then compare the impact of systematic screening to enhanced usual care. Specifically, using AFiNICO, patients will complete a brief monthly screen via a centralized, user-friendly platform, either online or using interactive voice response. Practice staff will receive automated alerts when patients “screen in,” and they will then contact patients to offer resources, identified and implemented at the local level.

Patients randomized to the control arm will receive enhanced usual care (site staff will have received financial navigation training prior to the start of the trial, and they will have access to informational resources they may share with any patients). The research team may hypothesize that by connecting patients who are experiencing financial hardship with financial navigation resources, AFiNICO will lead to improved patient-centered outcomes identified by the study Patient Investigator Committee. 

This study aims to: 

  • Determine whether monthly remote digital financial hardship screening among adults who are undergoing systemic therapy for advanced/metastatic cancer improves HRQoL, symptom burden, financial worry, treatment adherence and survival 
  • Evaluate how screening affects patient outcomes by identifying mediators (e.g., financial worry, treatment adherence, financial support received) and moderators (e.g., race or ethnicity, younger age, baseline level of financial worry, magnitude of out-of-pocket costs) of the effect of financial hardship screening on outcomes
  • Identify barriers and facilitators to implementing AFiNICO and assess acceptability using surveys and interviews of patients, clinical care teams, site financial assistance personnel and practice leadership 

Comparing AFiNICO to enhanced usual care will allow the research team to understand the impact of financial hardship screening, through a scalable, efficient, generalizable and individually tailored intervention to attenuate a potentially catastrophic toxicity of cancer treatment for which, to date, there is no large-scale solution.

Project Information

Victoria Blinder, M.D., M.S.
Alliance NCTN Foundation
$10,479,575 *

Key Dates

60 months *
April 2024

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.


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Last updated: April 23, 2024