Navigator-assisted hypofractionation (NAVAH) phase I clinical trial of breast cancer patients: Implications for assessing personal versus familial financial toxicity via the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) survey instrument.

Abstract

e23180 Background: The COST-FACIT survey has been used to objectively measure financial toxicity (FT). It consists of 11 questions related to FT of an individual and a 12th question (“My illness has been a financial hardship to my family and me”), providing a glimpse beyond individual FT into familial FT. This question (Q12), which doesn’t contribute to the score, has not been rigorously evaluated alongside the first 11 questions. We present findings from our ongoing phase I clinical trial (ClinicalTrials.gov ID: NCT05978232) to evaluate the correlation of familial FT to individual FT. Methods: This study included African-American adult (18+) breast cancer patients with pathologically confirmed breast cancer undergoing adjuvant radiation therapy (RT). Patients were guided by a patient navigator during and following treatment. COST-FACIT results were amalgamated to determine extent of FT in patients prior to initiation of RT. FT was categorized as Grade 0 (absent: scores 26-44), Grade 1 (mild: scores 14-25), Grade 2 (moderate: scores 1-13), and Grade 3 (severe: score 0). Input for Q12 ranges from 0-4, with a higher score indicating more familial distress. Mean Q12 scores were calculated for each grade of individual FT and 95% confidence intervals (CIs) were estimated using standard statistical techniques. Statistical significance was determined at a threshold of P < 0.0001. Results: There is strong correlation between individual and familial FT (r 2 = 0.5997, P < 0.0001). Of patients experiencing any level of individual financial hardship, 86% also perceive it in their family. For patients reporting Grade 3 individual FT, the mean Q12 score is 4 (95% CI [4]), indicating “very much” familial FT. For those reporting Grade 2 individual FT, the mean Q12 score is 2.86 (95% CI [1.684, 4.03]) corresponding to “quite a bit” of familial FT on average. Patients experiencing Grade 1 individual FT have a mean Q12 score of 2 (95% CI [1.394, 2.606]), representing “somewhat” familial FT. Those with no individual FT had a mean Q12 score of 0.27 (95% CI of [0, 0.56]), indicating no familial FT on average. Overall, patients with higher levels of individual FT indicate higher levels of familial FT while those with lower levels of individual FT indicate lower levels of familial FT. Conclusions: This FT analysis from an ongoing phase I clinical breast cancer trial reveals a strong correlation between individual FT (COST-FACIT questions 1-11) and familial FT (COST-FACIT Q12). Individuals experiencing FT are also likely to report familial FT, warranting further investigation into the interconnected impacts on patients and caregivers to better address financial toxicity in cancer care. Clinical trial information: NCT05978232 .