Table 1 CAFÉ study endpoints
Objectives | Endpoints assessed at 12 months | Justification for endpoints |
|---|---|---|
Primary | ||
1. To compare self-reported financial hardship between patients receiving the CAFÉ intervention versus a comparison group at 12-month follow-up. | Financial distress [InCharge Financial Distress/Financial Well-Being Scale] [41] | Financial hardship is an established social determinant of health. |
1a: To compare self-reported health-related quality of life between patients receiving the CAFÉ intervention versus a comparison group at 12-month follow-up. | Health-related quality of life [cancer-specific: FACT-G7] [42] | Cancer-related financial hardship is directly associated with multiple adverse health outcomes (e.g., quality of life; pain, symptom burden, mortality). |
Secondary | ||
2. Compare health service use between patients receiving the CAFÉ intervention versus a comparison group at 12-month follow-up. | Survey: Material, behavioral, and psychological financial hardship Medical Expenditure Panel Survey (MEPS) items [43] Global quality of life PROMIS Global health [44,45,46,47] Patient-centered communication: Patient Assessment of cancer Communication Experiences (PACE) [48] (EHR) Delayed or foregone care assessed by treatment initiationa and time to treatment initiationa Use of KP medical financial assistance servicesa; total out-of-pocket expenditure; account delinquency | The CAFÉ intervention could facilitate early identification of patient affordability concerns and care plan adjustments; improve access to financial planning resources or payment plans; and by connection to referrals and resources for acute financial distress. |
3. Assess patient-level factors influencing variability in dose of the CAFÉ intervention. | Intervention dose received (Arm 2 vs Arm 3) | Estimation of ideal dose will be important for future implementation of the intervention. |
Exploratory/covariates | ||
Exploratory | Difficulty paying bills, ongoing financial stress, medication reduction due to cost, food insecurity [49, 50]; difficulty living on current income [51]; decisional regret; decision satisfaction | The CAFÉ intervention may directly impact these endpoints but analyses are exploratory. |
Covariates | Socioeconomic variables; clinical variables; existing financial burden; insurance characteristics (health insurance type; maximum out-of-pocket limit; deductible limit; co-Insurance or co-payment) | |