Experiences of a Multiethnic Cohort of Patients Enrolled in a Financial Reimbursement Program for Cancer Clinical Trials.

PURPOSE: Financial reimbursement programs (FRPs) offset out-of-pocket (OOP) expenses from therapeutic clinical trial (TCT) participation. The study explores patients' experience in TCTs after enrollment in a FRP at two academic medical centers, including barriers and opportunities to improve trial participation. METHODS: From May 2019 to January 2020, adults diagnosed with cancer and eligible for TCTs and FRP were recruited from the Improving Patient Access to Cancer Clinical Trials randomized trial at the University of California San Francisco and University of Southern California. Patients with income ≤ 700% of national poverty guidelines were eligible. Semistructured interviews were conducted in patients' preferred language. Qualitative analysis was performed by site and preferred language by two independent coders. RESULTS: Of 65 trial patients, 53 participated (38%, University of California San Francisco; 62%, USC). The median age was 59 (IQR, 46-65) years, and 58% were female. Nearly half (49%) identified as Latinx/Hispanic compared with 32% non-Hispanic White, 10% Asian, 4% Black, 1% Native American, and 4% Others. A third were non-English speakers, 42% had college education or more, and 55% were retired/unemployed. Most common malignancies were gastrointestinal (42%), breast (19%), and genitourinary (13%), and 66% had metastatic disease. Patients experienced long travel time (1-4.5 hours) among 57% and financial toxicity from OOP costs (68%). High acceptability of the FRP was reported (81%). Although 30% of patients reported willingness to discuss finances of cancer treatment/trial with physicians, majority (87%) preferred discussion with social workers or TCT staff. Proposed modifications to TCTs included decentralization, recruitment strategies, voucher structure, and established rates for OOP expenses. CONCLUSION: Patients' experience with TCTs reveal financial and logistical stressors that may be lessened by the Improving Patient Access to Cancer Clinical Trial reimbursement program. FRPs may address inequities in clinical trial access among low-income and diverse populations.

Implementation of a Multisite Financial Reimbursement Program in Cancer Clinical Trials Integrated With Patient Navigation: A Pilot Randomized Clinical Trial.

PURPOSE: Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical Trials, a pilot feasibility study investigating the efficacy of offering a financial reimbursement program (FRP) during a therapeutic clinical trial discussion with or without additional outreach in improving patient enrollment. METHODS: Study participants for this study were recruited at two National Cancer Institute-designated comprehensive cancer centers (CCCs) from April 8, 2019, to September 19, 2019. Eligible participants were adults with a cancer diagnosis being approached to consider enrollment in a clinical trial. Participants were randomly assigned 1:1 to receive no follow-up (usual care) or a follow-up telephone call to facilitate FRP utilization stratified by study site. The target enrollment was 132 patients, with 66 patients in each study arm. The primary outcome was the consent rate to the multisite interventional study on the FRP among participants enrolling in clinical trials. RESULTS: The study had a 78% consent rate and enrolled a total of 132 participants, of whom 51% were non-White compared with 28% of CCC treatment clinical trial participants in 2019. No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms. The most common reason for not enrolling in a clinical trial was due to ineligibility determined through screening procedures (75%). CONCLUSION: The current study observed that implementation of FRP at CCCs is feasible and serves a diverse patient population. Future studies will measure the impact of programs on overall clinical trial accrual and among racial/ethnic minorities.

Mortalidad infantil por malformaciones congénitas en Chile: análisis temporal y espacial, 1997–2011 / Infant mortality from congenital malformations in Chile: temporal and spatial analysis, 1997–2011

Objetivo. Analizar la distribución espacial y temporal (1997–2011) de la mortalidad infantile por malformaciones congénitas (MC) en Chile. Métodos. Los datos de nacimientos y muertes en menores de 1 año de edad codificados con la CIE-10 se obtuvieron del Instituto Nacional de Estadísticas. Para las regiones administrativas y las naturales (Norte Grande, Norte Chico, Central, Austral y Sur), sistemas (nervioso, cardiovascular, digestivo, genitourinario, musculo esquelético, anomalías cromosómicas) y 28 malformaciones específicas, se estimaron el porcentaje de muertes por MC (PM-MC) y la tasa de mortalidad infantil por MC (TMI-MC) en 3 períodos (1997–2001, 2002–2009, 2007–2011). La tendencia secular y la variación del riesgo de muerte se estimaron con un modelo de regression de Poisson. Resultados. Para todo Chile, la tendencia secular de la TMI-MC y el PM-MC fueron negative y positiva, respectivamente (P < 0,01). La TMI-MC y el PM-MC exhibieron una heterogeneidad espacial discreta en las regiones administrativas y naturales. La región natural que más se acercó al patrón nacional fue la Central. La tendencia secular de la TMI-MC de los sistemas nervioso y cardíaco y de algunas MC específicas (anencefalia, espina bífida, y comunicaciones interauricular e interventricular) fue negativa. El patrón de mortalidad infantil por MC para todo Chile se caracteriza por presentar en el período 1997–2011 un descenso de la TMI-MC y un aumento del PM-MC. Conclusiones. Los resultados indican que Chile se encuentra en un estadio avanzado de la transición epidemiológica de las causas de mortalidad infantil. Sin embargo, se observan disparidades interregionales de estos indicadores, más notorias en el sur del país.

Objective. To analyze the spatial and temporal distribution (1997–2011) of infant mortality resulting from congenital malformations (CM) in Chile. Methods. Data on births and deaths among infants aged less than one year using ICD-10 coding were obtained from the National Statistics Institute. The percentage of deaths from CM (PD-CM) and the infant mortality rate from CM (IMR-CM) during three different periods (1997–2001, 2002–2009, 2007–2011) were estimated for Chile’s administrative and natural regions (Norte Grande, Norte Chico, Central, Austral, and Sur), broken down by systems (nervous, cardiovascular, digestive, genitourinary, musculoskeletal, and chromosomal abnormalities) and by 28 specific malformations. The secular trend and the variation in the risk of death were estimated using a Poisson regression model. Results. For the whole of Chile, the secular trend for the IMR-CM was negative, and the secular trend for the PD-CM was positive (P < 0,01). The IMR-CM and the PD-CM both showed mild spatial heterogeneity in all administrative and natural regions. The Central region was the natural region that came closest to showing the pattern observed nationwide. The IMR-CM involving the nervous and cardiovascular systems and specific types of CM (anencephaly, spina bifida, and atrial and ventricular septal defects) showed a negative secular trend. For Chile as a whole, the pattern of infant mortality from CM is marked by a drop in the IMR-CM and by an increase in the PD-CM over the period from 1997 to 2011. Conclusion. The findings suggest that Chile is in the latter stages of the epidemiological transition with respect to the causes of infant mortality. However, these indicators show disparities between regions, more pronounced in the south of the country.

Mortalidad infantil por malformaciones congénitas en Chile: análisis temporal y espacial, 1997-2011 / Infant mortality from congenital malformations in Chile: temporal and spatial analysis, 1997-2011

OBJETIVO:Analizar la distribución espacial y temporal (1997-2011) de la mortalidad infantil por malformaciones congénitas (MC) en Chile. MÉTODOS: Los datos de nacimientos y muertes en menores de 1 año de edad codificados con la CIE-10 se obtuvieron del Instituto Nacional de Estadísticas. Para las regiones administrativas y las naturales (Norte Grande, Norte Chico, Central, Austral y Sur), sistemas (nervioso, cardiovascular, digestivo, genitourinario, musculo esquelético, anomalías cromosómicas) y 28 malformaciones específicas, se estimaron el porcentaje de muertes por MC (PM-MC) y la tasa de mortalidad infantil por MC (TMI-MC) en 3 períodos (1997-2001, 2002-2009, 2007-2011). La tendencia secular y la variación del riesgo de muerte se estimaron con un modelo de regresión de Poisson. RESULTADOS: Para todo Chile, la tendencia secular de la TMI-MC y el PM-MC fueron negativa y positiva, respectivamente (P < 0,01). La TMI-MC y el PM-MC exhibieron una heterogeneidad espacial discreta en las regiones administrativas y naturales. La región natural que más se acercó al patrón nacional fue la Central. La tendencia secular de la TMI-MC de los sistemas nervioso y cardíaco y de algunas MC específicas (anencefalia, espina bífida, y comunicaciones interauricular e interventricular) fue negativa. El patrón de mortalidad infantil por MC para todo Chile se caracteriza por presentar en el período 1997-2011 un descenso de la TMI-MC y un aumento del PM-MC. CONCLUSIONES: Los resultados indican que Chile se encuentra en un estadio avanzado de la transición epidemiológica de las causas de mortalidad infantil. Sin embargo, se observan disparidades interregionales de estos indicadores, más notorias en el sur del país.

OBJECTIVE: To analyze the spatial and temporal distribution (1997-2011) of infant mortality resulting from congenital malformations (CM) in Chile. METHODS: Data on births and deaths among infants aged less than one year using ICD-10 coding were obtained from the National Statistics Institute. The percentage of deaths from CM (PD-CM) and the infant mortality rate from CM (IMR-CM) during three different periods (1997-2001, 2002-2009, 2007-2011) were estimated for Chile's administrative and natural regions (Norte Grande, Norte Chico, Central, Austral, and Sur), broken down by systems (nervous, cardiovascular, digestive, genitourinary, musculoskeletal, and chromosomal abnormalities) and by 28 specific malformations. The secular trend and the variation in the risk of death were estimated using a Poisson regression model. RESULTS: For the whole of Chile, the secular trend for the IMR-CM was negative, and the secular trend for the PD-CM was positive (P < 0,01). The IMR-CM and the PD-CM both showed mild spatial heterogeneity in all administrative and natural regions. The Central region was the natural region that came closest to showing the pattern observed nationwide. The IMR-CM involving the nervous and cardiovascular systems and specific types of CM (anencephaly, spina bifida, and atrial and ventricular septal defects) showed a negative secular trend. For Chile as a whole, the pattern of infant mortality from CM is marked by a drop in the IMR-CM and by an increase in the PD-CM over the period from 1997 to 2011. CONCLUSION: The findings suggest that Chile is in the latter stages of the epidemiological transition with respect to the causes of infant mortality. However, these indicators show disparities between regions, more pronounced in the south of the country.

[Infant mortality from congenital malformations in Chile: temporal and spatial analysis, 1997-2011]. / Mortalidad infantil por malformaciones congénitas en Chile: análisis temporal y espacial, 1997-2011.

OBJECTIVE: To analyze the spatial and temporal distribution (1997-2011) of infant mortality resulting from congenital malformations (CM) in Chile. METHODS: Data on births and deaths among infants aged less than one year using ICD-10 coding were obtained from the National Statistics Institute. The percentage of deaths from CM (PD-CM) and the infant mortality rate from CM (IMR-CM) during three different periods (1997-2001, 2002-2009, 2007-2011) were estimated for Chile's administrative and natural regions (Norte Grande, Norte Chico, Central, Austral, and Sur), broken down by systems (nervous, cardiovascular, digestive, genitourinary, musculoskeletal, and chromosomal abnormalities) and by 28 specific malformations. The secular trend and the variation in the risk of death were estimated using a Poisson regression model. RESULTS: For the whole of Chile, the secular trend for the IMR-CM was negative, and the secular trend for the PD-CM was positive (P < 0,01). The IMR-CM and the PD-CM both showed mild spatial heterogeneity in all administrative and natural regions. The Central region was the natural region that came closest to showing the pattern observed nationwide. The IMR-CM involving the nervous and cardiovascular systems and specific types of CM (anencephaly, spina bifida, and atrial and ventricular septal defects) showed a negative secular trend. For Chile as a whole, the pattern of infant mortality from CM is marked by a drop in the IMR-CM and by an increase in the PD-CM over the period from 1997 to 2011. CONCLUSION: The findings suggest that Chile is in the latter stages of the epidemiological transition with respect to the causes of infant mortality. However, these indicators show disparities between regions, more pronounced in the south of the country.