BACKGROUND: Clinical trials offer novel treatments, which are essential to high quality cancer care. Patients living in rural areas are often underrepresented in clinical trials due to several factors. This study evaluated the association between rurality and interest in clinical trial participation, change in interest, and treatment decision-making style preference. METHODS: This cohort study included patients with cancer receiving oncology care at the University of Alabama at Birmingham from 2017 to 2019. Associations between treatment decisionmaking preference and the interaction between rurality and area deprivation were analyzed using multinomial logistic regression. Initial interest in clinical trial participation and change in interest were analyzed using modified Poisson regressions with robust standard errors. Initial interest model was stratified by Area Deprivation Index (ADI; higher vs. lower disadvantaged). RESULTS: In adjusted models, patients in rural versus urban areas had similar initial interest in clinical trials, both those in higher (40% vs. 50%) and lower disadvantaged settings (54% vs. 62%). Additionally, rural versus urban patients had similar change of clinical trial interest for both those who changed from uninterested-to-interested (31% vs. 26%) and interested-to-uninterested (47% vs. 42%). CONCLUSION: This study compares the interest in clinical trial participation among patients living in rural and urban settings. Lack of interest may be secondary to barriers that patients in rural areas face (e.g., transportation, financial, access). Most rural patients prefer a shared treatment decision-making style, which should be considered when identifying interventions to increase enrollment of underserved rural patients in clinical trials. Cancer 2022;128:3977-3984.
Purpose: 3-8% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines.Methods: This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004-2020. Exclusion criteria were abstracted using OnCore and ClinicalTrials.gov. Laboratory values included liver function tests and hematologic labs. Comorbid conditions included congestive heart failure, cardiovascular disease, central nervous system (CNS) metastases, and prior cancer history. Comorbid conditions were further analyzed by amount of time protocols required participants to be from diagnosis or exacerbation-free.Results: 102 protocols were eligible. Among liver laboratory values, bilirubin (78%) was included in most protocols ranging from institutional upper limit of normal (ULN) (9%) to 3xULN (2%), with 1.5xULN (56%) being most common. Similar variability was observed in alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count ranging from 500μL (1%) to 1,800μL (1%), with 1,500μL (64%) being most common. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%) and a prior cancer (66%). The allowable timeframe varied between protocols for cardiovascular disease and prior cancer.Conclusion: Substantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.
97 Background: Shared decision-making (SDM), a process where patients partner with their physician to incorporate personal preferences into treatment decisions, is a tenet of high-value healthcare. It is unknown if high-value care associated with SDM manifests in the form of decreased out-of-pocket costs. Therefore, this study analyzes the relationship between patient preference for SDM and financial toxicity in metastatic breast cancer (MBC). Methods: This cross-sectional study utilized surveys of women age ≥ 18 with MBC who received care at two academic hospitals in Alabama between 2017 and 2019. SDM preference and financial toxicity were measured using the Control Preferences Scale and the Comprehensive Score for Financial Toxicity (COST) tool (11-item scale from 0-44, with lower scores indicating worse FT), respectively. Patient demographic and clinical data were abstracted from the electronic medical record. Effect sizes were calculated using Cohen’s d or Cramer’s V. Differences in financial toxicity by SDM preference were estimated using mixed models clustered by site and treating medical oncologist. Results: In 79 women with MBC, 41% preferred SDM, 33% preferred provider-driven decision making, and 22% preferred patient-driven decision making. Patients preferring SDM were more often college educated (48% vs. 40%; V = .15), higher income (52% vs. 44%; V = .09), and privately insured (47% vs. 41%; V = .11). Overall median COST score was 23 (interquartile range 16-30), which varied modestly by SDM preference. After adjusting for patient demographic and clinical characteristics, similar financial toxicity levels were found in patients who preferred SDM (COST 22, 95% confidence interval [CI] 19-25), patient-driven decision making (COST 22, 95% CI 18-26), and provider-driven decision making (COST 24, 95% CI 20-27). Conclusions: Similar levels of financial toxicity were found in patients with differing decision–making preferences regarding their MBC treatment, which may be secondary to lack of discussions about cost. Further research is needed to determine if and how financial toxicity is being identified or included within decision-making.
84 Background: Only 2-8% of adult patients with cancer participate in clinical trials, likely due to strict exclusion criteria as well as financial and access issues. The primary objective of this study is to understand the population of patients with breast cancer who are and are not offered a clinical trial and the impact of exclusion criteria on enrollment. Methods: Inclusion and exclusion criteria from study protocols housed in OnCore and ClinicalTrials.gov were obtained for breast cancer-specific, therapeutic clinical trials open at the University of Alabama at Birmingham (UAB) from 2016 to 2020. Patients with breast cancer receiving oncology services at UAB from 2016 to 2020 were identified from electronic health records. Race and ethnicity and address were abstracted. Address was utilized to characterize patients as living in areas of higher vs. lower deprivation (Area Deprivation Index) and rural communities (Rural-Urban Commuting Area). Chart abstraction was conducted to assess if patients were offered a trial, eligible for a trial, reason for ineligibility, and enrollment in trial vs standard of care treatment. Results: 518 patients were included; 387 were offered a trial and 131 were not. The median age of patients offered a trial was 57 years old, whereas the median age of patients who were not offered a trial was 61. The majority of patients offered a trial were more often White (72% vs. 24% African American), resided in areas of lower disadvantage (70% vs 17% most disadvantaged), and urban residents (75% vs 13% rural). Of the 387 patients offered a trial, 319 (82%) enrolled, 34 (9%) declined enrollment and chose standard of care, and the remaining 34 (9%) were interested in enrollment but later found to be ineligible. Reasons for ineligibility of the 34 patients who were offered a trial included comorbidities (n = 9), tumor size (n = 7), metastases (n = 5), and previous cancer history (n = 4). Additionally, 9 patients were ineligible for miscellaneous reasons (abnormal labs, age, prescription, trial closed to accrual, tumor characteristics). Of the 131 patients that were not offered a clinical trial, 77 (59%) were ineligible for enrollment. Reasons for ineligibility included: stage 1 disease (n = 35), tumor size and characteristics (n = 24), and comorbidities and abnormal labs (n = 18). The remaining 54 patients would have been eligible, but their provider did not offer a clinical trial. Conclusions: Most patients who are offered a clinical trial are willing to participate; physicians not offering a trial to patients appears to be a driver for low enrollment. Strict exclusion criteria related to comorbidities limit trial participation. Further work is needed to understand the relative importance of these eligibility criteria in relation to validity. Efforts should be made to include patients in clinical trials that reflect the diverse patient population that will receive the drug in the future.
106 Background: Costs for cancer patients are not all monetary. For patients with limited life expectancy, such as metastatic breast cancer (MBC) patients, time spent in the hospital or clinic setting can become burdensome. The goal was to evaluate time spent on healthcare among patients receiving treatment for MBC. Methods: This survey-based, cross-sectional study included women ≥18 years with MBC who received treatment at two academic medical centers in Alabama from 2017-2019. Questions regarding employment status, MBC-related hours missed from work, and time spent on healthcare-related activities were used to quantify lost productivity and time. Descriptive statistics included means and standard deviations (SD) or medians and interquartile ranges (IQR) for continuous variables and frequencies for categorical variables. Effect sizes were calculated using Cohen’s d or Cramer’s V. Results: We surveyed 83 female MBC patients with a median age of 59 years (IQR 50-66). Among all respondents, 34% were African American, 41% held a college degree, and 52% had a household income of < $40,000. Patients spent a median 60 minutes (IQR 30-110) traveling from their home to clinic and a median 120 minutes (IQR 60-180) receiving care at a clinic visit. Though not statistically significant, modest differences were found for patients with differing insurance types in travel time. Patients with Medicare had the shortest travel time (median 45 minutes [IQR 30-75]) compared to Medicaid (60 minutes [IQR 60-80]) and private insurance (60 minutes [IQR 30-120]; d = .06).). Patients spent a median 30 minutes (IQR 0-60) on cancer care related activities outside of a clinic visit. Most patients were retired (31%); however, 15% worked full-time, 6% worked part-time, and 20% were on disability. For working women, a median of 8 hours (IQR 1-11) were missed from work in the week. Conclusions: This study highlights productivity losses uncaptured by current patient healthcare cost calculations. Further work is needed to identify and minimize these additional patient costs related to lost productivity during cancer treatment.
82 Background: Clinical trials play an important role in advancing cancer treatments. Unfortunately, only about 3% of adults with cancer are enrolled in a clinical trial in the United States due to various barriers to enrollment. This includes restrictive eligibility criteria, which currently have no standard guidelines. The purpose of this study is to evaluate the variability of eligibility criteria. Methods: This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham (UAB) between 2004-2020. Exclusion criteria (e.g., laboratory values and comorbidities) were extracted from protocols using OnCore, an online dataset used to manage clinical trials, and ClinicalTrials.gov. Laboratory values or vital signs analyzed included liver function tests, hematologic labs, Eastern Cooperative Oncology Group (ECOG) performance status, and hypertension. Comorbid conditions included congestive heart failure, cardiovascular disease, presence of central nervous system (CNS) metastases, and history of prior cancer. Comorbid conditions were further analyzed by amount of time protocols required participants to be from initial diagnosis or exacerbation-free. Results: There were a total of 102 eligible protocols. Substantial heterogeneity was observed in exclusion criteria across liver/hematologic laboratory values and demographic/comorbidity variables. Among liver laboratory values, most protocols included an upper limit of acceptable for bilirubin (78%): 9% used the institutional upper limit of normal (ULN), 2% used 1.2xULN, 3% used 1.25xULN, 56% used 1.5xULN, 6% used 2xULN, and 2% used 3xULN. Similar variability was observed in protocols that included alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count: 1% 500mcL, 11% used 1,000mcL, 4% used 1,200mcL, 1% used 1,250mcL, 64% used 1,500mcL, and 1% used 1,800mcL. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%) and a prior cancer (66%). While most protocols included cardiovascular disease, the allowable timeframe varied between protocols: 4% did not allow an acute exacerbation within the previous 3 months, 32% did not allow within the previous 6 months, 5% did not allow within the previous 12 months, and 38 % did not specify a time frame. Protocols including history of a prior cancer as a criterion similarly had varied definitions based on timeline. Conclusions: Substantial heterogeneity was observed among clinical trial protocols. While exclusion criteria are necessary for patient safety, there is lack of evidence for current parameters. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.
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