Financial hardship from cancer is prevalent among people with cancer and related to several adverse intermediate and health outcomes, including quality of life, treatment adherence, and survival. Communication about out of pocket costs early in the treatment trajectory could help to prevent or lessen financial hardship. CAF is a randomized trial with step wedge design to test the novel CAF (Cancer Financial Experience) intervention. The intervention is based on the research team's prior studies, informed by a conceptual framework of how patient-centered communication can improve health, and designed with clinic team members and patients using human-centered design methods.
Our aims are:
Aim 1 : Compare self-reported financial hardship and between patients receiving the CAF intervention versus a comparison group at 12-month follow up.
Aim 1 a: Compare self-reported health-related quality of life between patients receiving the CAF intervention versus a comparison group at 12-month follow up.
Aim 2 : Compare health service use between patients receiving the CAF intervention versus a comparison group at 12-month follow up.
Aim 3 : Assess patient-level factors influencing variability in dose of the CAF intervention. Newly diagnosed cancer patients (n=750) will be randomized to receive either (a) a resource sheet listing financial support resources or (b) a financial navigator-based intervention that will include 6 months of personalized outreach and assistance with cost concerns, including coordination with the oncology team, provision of out of pocket cost estimates to support shared clinical decision-making, patient planning and budgeting, and referral to financial assistance resources as needed. Oncology clinics in two integrated health systems in the Pacific Northwest (Kaiser Permanente Washington and Kaiser Permanente Northwest) will be the setting for the study. Our primary outcome of interest is financial distress at 12-month follow-up. Secondary outcomes include health-related quality of life, financial hardship due to cancer, patient assessment of communication experiences, and time to initiation of treatment. The CAF study represents one of the first trials of an intervention focused on mitigating patient financial hardship. It is theory-informed and clinic-based, aligned with patient preferences, and has been developed following extensive stakeholder input. By design, it will provide high quality prospective evidence on the potential benefits of cost of care communication on patient-relevant cancer outcomes.
The CAF study (Cancer Financial Experience) is among the first trials to assess the impact of financial navigation in preventing financial hardship in people with cancer. We developed this novel, theory-informed intervention building on pilot work and human-centered design methods in partnership with the participating oncology clinic staff and leadership. Using a randomized trial with step wedge design, we will assess the impact of the CAF intervention on financial hardship (primary outcome) and health-related quality of life, cancer-related material and psychological financial hardship, patient-centered communication experiences, and time to initiation of treatment (secondary outcomes), as well as a mixed-methods evaluation of factors influencing variability in dose received by intervention participants.
