bluuebunny/crossref_metadata_2025 huggingface dataset:
Are there racial differences in colorectal cancer care timeliness among users of the Veterans Affairs Healthcare System?
Authors: Zullig Leah L. , Jackson George L. , Weinberger Morris , Provenzale Dawn T. , Reeve Bryce B. , Carpenter William Ruffin
Published: March 2020

6555

Background: The Veterans Affairs (VA) healthcare system is the largest integrated healthcare system in the United States. While the quality of VA colorectal cancer (CRC) care is well chronicled, there is a paucity of literature describing racial differences in timeliness of VA CRC care. The objective of this analysis was to examine potential racial differences in CRC care timeliness. Methods: Data were from the VA External Peer Review Program (EPRP), a nationwide VA quality-monitoring program. Included patients must have been Caucasian or African American, diagnosed with non-metastatic CRC between 2003 and 2006, and received definitive CRC surgery. We examined 3 timeliness metrics – time from: 1) surgery to initiation of adjuvant chemotherapy (Stage II-III), 2) surgery to surveillance colonoscopy (Stage I-III), and 3) surgery to death (Stage I-III). Unadjusted analyses used Log-rank and Wilcoxon tests. Adjusted analyses used Cox proportional hazard models. Results: In adjusted Cox regression there were no racial differences in time to initiation of chemotherapy (HR 0.82, p=0.61) or surgery to death (HR 0.94, p=0.0.49). In adjusted Cox regression, Caucasian race was protective, with shorter time to first surveillance colonoscopy (HR 0.63, p=0.02). The median time to colonoscopy was 367 and 383 days for Caucasian and African American patients respectively. Conclusions: Caucasian patients receive follow-up colonoscopies slightly sooner than African American patients in VA; the difference between median times by race is only 16 days. Though statistically significant, this difference is not clinically meaningful since no scientific evidence suggests differing benefits of surveillance colonoscopy in a small timeframe.
Predictors of care for early-stage breast cancer in Appalachia.
Authors: Kimmick Gretchen Genevieve , Camacho Fabian , Kern Teresa , Fleming Steven , Liao Jason , Matthews Stephen , Hwang Wenke , Mackley Heath B. , Lipscomb Joseph , Short Pamela , Moran John , Yao Nengliang , Anderson Roger T.
Published: March 2020

6558

Background: We studied care for early-stage breast cancer in Appalachia, a region with health infrastructure, socioeconomic (SES) and geographic disparities. Methods: Cases of stage I-III breast cancer diagnosed 2006-2008 were identified from cancer registries of KY, NC, OH, and PA and linked to Medicare data. Guideline concordance was studied in eligible groups, as follows: endocrine therapy for hormone receptor positive cancer (n=1429); and radiation (RT) use after breast conserving surgery (BCS) divided into two groups - age 70 years and older with ER/PR+, <2 cm, node negative tumors where it may have been acceptable to forgo RT (OptRT, n=1108) and all other cases (IndRT, n=1422). Multivariate (MV) and univariate analyses were performed. Covariates included age, state, Appalachian Regional Commission (ARC) economic status, Commission of Cancer (CoC) status, state, access to care, number of beds, surgery facility ownership, volume, and chemotherapy/radiation offered, provider graduation year and volume, Charlson comorbidity, diagnosis year, Medicaid/Medicare dual status, histology, tumor size, tumor sequence, positive lymph nodes, ER/PR status, stage, herceptin use, and BCS/mastectomy indicator. Results: Mean age was 74 years and 97% were white. Guideline-concordance was 76% for endocrine therapy, 83% for IndRT, and 77% for OptRT. Younger age predicted higher concordance in all groups. Endocrine therapy use was lower in NC vs PA (OR 0.60; 95% CI 0.41-0.88) and greater for cases whose provider graduated in years 1984-1988, vs. 1989+ (1.55; 1.06-2.29). In IndRT, provider volume in the 3rdquartile vs. highest quartile predicted increased radiation use (2.36; 1.46-3.81). In OptRT, less receipt of radiation was predicted by residence in NC vs. PA (0.26; 0.18-0.48), and competitive ARC class vs. transitional (0.60; 0.36-0.99). Conclusions: Within Appalachia, there are SES and provider characteristics that are associated with use of guideline concordant care.
Cultural competency training for health care providers in an urban cancer institute and impact on breast care.
Authors: Williams Erica H. , Whitaker Earlene , Zickafoose Barbara , Mete Mihriye , Swain Sandra M.
Published: March 2020

6561

Background: The purpose was to improve the cultural competence of healthcare providers at an urban cancer institute and to assess its impact on breast screening and diagnostic benchmarks. Methods: A web-based learning module was developed to address breast cancer disparities in African American women, identifying common barriers to care and highlighting functions of patient-provider education. The module, a pre-and post-test were administered to providers including physicians, nurses, non-clinical employees, diagnostic technicians and medical office assistants (MOA) of MedStar’s Washington Cancer Institute (WCI) and Breast Imaging Center (BIC). Cultural competency discussions began with providers in BIC in April 2011. The module was available to BIC providers in October 2011 and to WCI providers in December 2011. To increase the cancer knowledge-base, a breast education class was offered to 40 MOAs. Statistical analysis was conducted using SAS v.9.1. Results: October 2011-March 2012, 133 providers were offered the module. Seven providers helped create the module, were removed from analyses. Of the 126, 29 did not complete all parts or complete in proper order and were not used in analyses. Overall, providers (n=97) demonstrated an increase in average pre/post test scores (119 vs. 123; P<.01). All providers, except diagnostic technicians, increased cultural competency scores post module. Physician’s average pre/post test scores showed the greatest increase with 11 points (P<.01). From Nov 2011- April 2012, BIC experienced a 59% decrease in number of patients lost to follow up after a screening mammogram, a 11% decrease in lost to follow up for diagnostic patients as well as a decrease of 1 days in average number of days patients return for diagnostic imaging after a mammogram. There was a 32% increase in employee satisfaction within in BIC. Conclusions: This suggests that our learning module had a positive impact on patient-provider communication. The decrease in screening and diagnostic lost to follow up rates illustrates the learning module’s potential for staff motivation in reducing breast cancer disparities. Supported by Susan G. Komen for the Cure NR-11-33340.
Current status of the implementation of gene expression testing in breast cancer management in the United States.
Authors: Lynch Julie Ann , Fiore Louis , Kelley Michael J. , Borzecki Ann , Lathan Christopher S. , Hassett Michael , Rugo Hope S. , Khoury Muin J , Freedman Andrew N
Published: March 2020

6562

Background: Data on implementation of genetic diagnostic (GDx) tests are lacking yet are crucial to evaluate population differences in access and outcomes. Previous studies identified substantial underuse of GDx tests. Greater access existed in states with NCI cancer centers. This pattern of diffusion may exacerbate disparities. Since 2008, the 21-gene recurrence score (21-gene RS), which assesses the 10-year risk of breast cancer (BC) recurrence in ER+, node-negative, early-stage disease, has been recommended by ASCO/NCCN to guide chemotherapy decisions. This study examines regional and site-of-care differences in use. We report national implementation rate and state-level differences in utilization. Methods: Hospital level data on 2011 orders for the test were provided by Genomic Health. We aggregated this dataset at the state-level and linked it to public datasets (Census and CDC State Cancer Profiles). Using Surveillance Epidemiology End Results (SEER) data, we estimated number of guideline-directed BC cases. The outcome variable, state utilization ratio, was calculated by dividing the number of tests ordered by guideline-directed BC cases. For some states utilization ratios may be higher than 1 because patients may have crossed state boundaries to obtain care. Results: Of approximately 101,702 guideline-directed BC cases nationally, 59,053 patients had the test; a utilization ratio of 0.58. Utilization ratio by state ranged from 0.21 to 1.71 (25th/75thpercentile range 0.48-0.64). The District of Columbia had the highest utilization ratio at 1.71 (8 institutions ordered 367 tests on an estimated 213 patients); Iowa had the lowest at 0.21 (39 institutions, 458 tests, 2094 patients). Only 7 states had utilization ratios <0.45. Conclusions: In contrast to other GDx tests, 21-gene RS has achieved notable market penetration. Overall, utilization across states is remarkably consistent, especially considering potential variations in age, comorbidities, stage, and incidence of ER+ BC. Despite widespread use, there are likely county-level and site-of-care differences in use. Hospital level analysis is ongoing and will be presented at the meeting.
Cancer risks, beliefs, and health care access among the underprivileged.
Authors: Morere Jean F. , Viguier Jérôme , Pivot Xavier B. , Blay Jean-Yves , Coscas Yvan , Lhomel Christine , Eisinger François
Published: March 2020

6563

Background: One goal of the current French National Cancer Plan is to reduce health inequities in cancer control. In the present work, an underprivileged population was explored to analyze exposure to cancer risk factors and cancer screening attendance in order to highlight ways to improve cancer control. Methods: Within the nationwide observational study EDIFICE 3, conducted by phone interviews among a representative sample of 1603 subjects aged between 40 and 75 years old, we used the “EPICES” validated questionnaire to examine the association of underserved status with cancer risk factors, beliefs, and health care access. Results: Based on EPICES score, underserved subjects represent 33% of the sample. These subjects subjectively perceive a higher risk of cancer compared to non-underserved subjects (21% vs 14% respectively, p<0.01). They more often consider that the cancer always has an external cause (18% vs 12%, p<0.01), rely less on information from the general practitioner (48% vs 56%, p<0.01) and lay press (28% vs 37%, p<0.05). They trust the national health system less (average score from 1 to 10; 6.0 vs 6.3, p <0.05). They also have more cancer risk factors: BMI (26.0 vs 24.8, p<0.01), active smoking (38% vs 23%, p<0.01) and less practicing sport (42% vs 77%, p<0.01). They have more comorbidities: average (2.2 vs 1.8, p<0.01), at least one (76% vs 65%, p<0.01), anxiety (27% vs 12%, p<0.01), hypertension (24% vs 19%, p<0.05) and cardiovascular disease (13% vs 9%, p<0.05). Among persons with a cancer, underserved subjects have a higher rate of lung cancer (10% of cancers vs 1%, p<0.05). However, no difference in cancer screening attendance was observed between underserved and non-underserved subjects: colorectal cancer (60% vs 60%); breast cancer (94% vs 97%) and prostate cancer (46% vs 52%). Access to healthcare is not an issue (consultations with a general practitioner more frequent for underserved group: 5.4 vs 3.7 per year, p<0.01). Conclusions: To reduce inequities in cancer control, as screening attendance is not discriminating, the effort for upstream interventions should be focused on prevention. Cancer risk factors such as smoking, overweight and a sedentary life style are appropriate targets for communication campaigns.
Minority accrual on a prospective study targeting a diverse U.S. breast cancer population: An analysis of Wake Forest CCOP research base protocol 97609.
Authors: Urbanic James John , Case Doug , Naughton Michelle Joy , Hu Jennifer J. , Enevold Gina , Beech Bettina , Weaver Kathryn E , Danhauer Suzanne , Rapp Steve , Sheidler Vivian , Vitolins Mara , Lesser Glenn , Shaw Edward G.
Published: March 2020

6564

Background: Clinical trial accrual rates are lower among minority patients. Wake Forest CCOP RB protocol 97609 designed to accrue 400 non-Hispanic White (NHW) and 600 minority patients to a study evaluating potential genomic single nucleotide polymorphisms as markers for breast radiosensitivty. Methods: Accrual data evaluated from 24 participating CCOPs and numerous CTSU sites. Race / ethnicity self-reported by participants (NHW, non-Hispanic Black, Hispanic/Latino, Asian /Pacific Islander, or American Indian/Alaskan Native) based on ACS reporting criteria. Results: 752 participants accrued in 14.5 mths (11/11-1/13); 402 NHW and 350 minorities. NHW accrual goal reached, 5.9 months (period 1; avg 68.4 participants /month) compared with 54 minority participants (period 1; avg 9.2 participants / month). This 7.4 ratio NHW to minority accrual is higher than expected given incidence. During 8.6 months following closure NHW enrollment (period 2), 296 minority participants accrued (avg 34.3 participants/month). An almost 4-fold increase in minority accrual raises question of accrual disparity. 19 CCOPs open in period 1 and 24 CCOPs in period 2. CTSU contributed both periods, more CTSU sites were added during period 2. Excluding all CTSU sites and five CCOPs open only in period 2, the avg minority accrual:6.8 patients / month period 1 and 10.6 patients / month period 2. The average time of accrual was 4.0 months period 1 and 8.6 months period 2 due to variable opening dates at sites. Taking time into account, the avg minority accrual rate was 0.60 patients / month / site in period 1 and 0.56 patients / site / month in period 2. CCOP minority accrual rates in period 1 vs. 2 increased 11 / 19 sites, decreased 6 / 19, and remained the same in 2 / 19, p = .33. Conclusions: Despite closure of enrollment of NHWs into this study with a specific goal to accrue a large minority population, there was no increase in the rate of minority accrual. The initial appearance of an accrual bias can be attributed to the addition of sites and variable lengths of accrual time at sites. It is unknown whether overall lower minority accrual rate compared to NHWs is participant-, provider-, or population-based. Clinical trial information: NCT01407770.
Patterns of disparities in breast cancer care.
Authors: Hassett Michael J. , Schrag Deborah , Chen Kun , Roohan Patrick R. , Boscoe Francis P. , Schymura Maria J.
Published: March 2020

6565

Background: Studies have documented disparities in breast cancer care for decades, but disparities in outcomes have not improved. Previous disparity investigations included relatively small, potentially biased samples of disadvantaged populations, or focused only on selected aspects of care. We sought to describe the relative importance of race/ethnicity versus Medicaid insurance status as determinants of suboptimal quality across the spectrum of care using two population-based samples of women with non-metastatic breast cancer. Methods: From two state registry datasets (NY and CA), we identified adult women diagnosed with stage 0-III breast cancer from 2004-2009. To these data, we merged enrollment and claims files from Medicaid and Medicare. Quality was assessed relative to 35 underuse and overuse measures derived from clinical practice guidelines. We compared measures across race/ethnic and Medicaid enrollment groups, and used logistic regression models to assess the relationships between race/ethnicity, Medicaid status, and quality relative to surgery, chemotherapy, radiation, and endocrine measures. Analyses were conducted in parallel for NY and CA, and for women <65 and ≥65 years old. Results: The sample, which comprised 80,079 from NY and 121,098 from CA, included 14%/6% blacks, 8%/15% Hispanics, 5%/12% API’s, and 19%/14% Medicaid enrollees, respectively from NY/CA. There was moderate-high correlation in measure performance across states and race/ethnic groups. Multivariable models demonstrated that blacks had lower odds of receiving recommended surgery versus whites, and whites had lower odds of receiving chemotherapy, whether recommended or not, versus other race/ethnic groups. Medicaid status was associated with lower odds of receiving recommended surgery, radiation therapy, and anti-estrogen therapy, but not chemotherapy, for patients <65 and ≥65. Conclusions: Medicaid status, a surrogate for socio-economic status, was associated with lower odds of receiving recommended care across a broad spectrum of breast cancer treatments. Understanding patterns of disparities will facilitate efforts to design and disseminate real world solutions that foster improvements in outcomes for the most disadvantaged populations.
Survival rates of male breast cancer compared to female: A Surveillance, Epidemiology, and End Results (SEER) database analysis.
Authors: Mushtaq Rao , Shaik Mohammed , Mistry Shams , Alkharabsheh Omar Abed , Shaqfeh Mahmoud , Afsharimani Seyedamirhossein , Ahmad Delshad , Habte-Gabr Eyassu , Katato Khalil , Tamkus Deimante
Published: March 2020

6567

Background: Breast cancer (BC) is rare in males (M) compared to females (F). There were 2,190 new cases of MBC out of total 226,870 BC cases diagnosed in 2012. Recently, the incidence of MBC is rising but mortality is decreasing in both MBC and FBC. Therefore we want to evaluate survival difference between MBC and FBC. Methods: Using SEER database we analyzed 4,192 MBC compared to 591,268 FBC diagnosed between 1983-2009. Data including age, sex, tumor size, grade, stage, and ER/PR status was used in analysis. Overall five year survival (OS) and Disease specific survival (DSS) rates were calculated using Kaplan-Meier (KM). We further analyzed the data based on race (Black vs White) and calculated 5yr-OS and 5yr-DSS using KM. Results: The majority of MBC were diagnosed at later stages (49.2% vs 35.3%), with greater number of +veLN (44% vs33.5%), and higher percentage of positive ER/PR(95% vs79%) compared to FBC. When analyzed stage-by-stage, males had significantly lower 5-yrOS in all stages except in the stage with distant metastasis (mets) (Table1a). There was no significant difference in 5-yr DSS survival in both sex. Based on race, black males had worse 5-yrOS and 5yr-DSS, followed by white males, black females, and white females (p= 0.0001)(Table1b). Conclusions: Even though MBC presents with advanced disease at diagnosis, our analysis shows there is no difference in DSS when analyzed stage-by-stage. White females had better prognosis compared to others, and black males had worse prognosis. Prospective studies needed to be done to evaluate the prognosis of male breast cancer. [Table: see text] [Table: see text]
Racial disparity in diffuse large B-cell lymphoma survival.
Authors: Han Xuesong , Jemal Ahmedin , Ward Elizabeth M.
Published: March 2020

6569

Background: Although blacks have a lower risk of non-Hodgkin lymphoma (NHL) compared to whites, black non-Hodgkin lymphoma (NHL) patients experience worse survival than white patients. This study aims to examine in patients with diffuse large B-cell lymphoma (DLBCL), the most common subtype of NHL, how much of the racial disparity in survival can be explained by differences in certain demographic (age, sex and area-level education) and access-to-care-related (stage, treatment, health insurance status) factors. Methods: Our cohort included 3716 non-Hispanic white or black DLBCL patients aged 18-64, diagnosed in 2004-2005 from the National Cancer Database (NCDB), a nationwide, hospital-based cancer registry. The analysis included only HIV/AIDS-negative patients. Kaplan-Meier survival curves were drawn for blacks and whites. Cox proportional hazards model was fitted to estimate hazard ratios (HR) and the 95% confidence intervals (CI) for race with and without controlling for demographic factors (age, sex and area-level education), stage, treatment and health insurance status. Results: Black patients had a worse survival than white patients (5-year survival rate 66.6% in blacks vs. 73.3% in whites, log-rank test p-value = 0.0006). Without adjusting for other factors, blacks had a 34% higher risk of death compared to whites (crude HR=1.34, 95% CI =1.13-1.58). After adjusting for demographic factors including age, sex and area-level education, the HR reduced to 1.27 (95% CI=1.06-1.51). After further adjustment for stage, treatment and insurance status, the association disappeared (HR=1.03, 95% CI= 0.86-1.23). Conclusions: Demographic factors and access-to-care-related factors including stage, treatment and health insurance status fully explained the black-white racial disparity in DLBCL survival in this cohort. Our findings suggest that improvements towards timely diagnosis, appropriate treatment and other adequate access to health care measures could potentially eliminate the survival disparity between black and white DLBCL patients.
A new design for phase II single-arm clinical trials: Bayesian predictive sample size selection design.
Authors: Teramukai Satoshi , Daimon Takashi , Zohar Sarah
Published: March 2020

6576

Background: The aim of phase II trials is to determine if a new treatment is promising for further testing in confirmatory clinical trials. Most phase II clinical trials are designed as single-arm trials using a binary outcome with or without interim monitoring for early stopping. In this context, we propose a Bayesian adaptive design denoted as PSSD, predictive sample size selection design (Statistics in Medicine 2012;31:4243-4254). Methods: The design allows for sample size selection followed by any planned interim analyses for early stopping of a trial, together with sample size determination before starting the trial. In the PSSD, we determined the sample size using the predictive probability criterion with two kinds of prior distributions, that is, an ‘analysis prior’ used to compute posterior probabilities and a ‘design prior’ used to obtain prior predictive distributions. In the sample size determination, we provide two sample sizes, that is, N and Nmax, using two types of design priors. At each interim analysis, we calculate the predictive probability of achieving a successful result at the end of the trial using analysis prior in order to stop the trial in case of low or high efficacy, and we select an optimal sample size, that is, either N or Nmax as needed, on the basis of the predictive probabilities. Results: We investigated the operating characteristics through simulation studies, and the PSSD retrospectively applies to a lung cancer clinical trial. As the number of interim looks increases, the probability of type I errors slightly decreases, and that of type II errors increases. The type I error probabilities of the probabilities of the proposed PSSD are almost similar to those of the non-adaptive design. The type II error probabilities in the PSSD are between those of the two fixed sample size (N or Nmax) designs. Conclusions: From a practical standpoint, the proposed design could be useful in phase II single-arm clinical trials with a binary endpoint. In the near future, this approach will be implemented in actual clinical trials to assess its usefulness and to extend it to more complicated clinical trials.
The importance of early treatment to decrease therapy-related complications in Burkitt lymphoma (BL), Burkitt-like leukemia/lymphoma (BLL), and acute lymphocytic leukemia (ALL) treated with disease-specific systemic therapy.
Authors: Muslimani Alaa , Fawole Adewale , Daw Hamed , Spiro Timothy Peter , Ye Hong , Jaiyesimi Ishmael A.
Published: March 2020

6577

Background: BL, BLL and ALL are highly aggressive malignancies. We conducted a study to determine the relationship between the time to start of disease-specific systemic therapy and the frequency of various complications during treatment. Methods: A multi-center chart review was conducted for a total of 175 patients (pts) from Cleveland Clinic and Beaumont Health System, who received thearapy between Jan 2000 and Oct 2012. Pts were classified into two groups based on time to start of disease-specific systemic therapy. The first group started therapy within 1 week of the presenting symptoms and the second group started therapy in ≥ 1 week. Pts characteristics, stage of disease, incidence of acute renal failure (ARF) [Am J Med. 1983;74(2):243], Tumor lysis syndrome (TLS) [Cairo-Bishop definition], major bleeding [requiring transfusion, drop in hemoglobin > 2 g/dL, or bleeding in critical sites], venous thrombotic events (VTEs) [documented by imaging], neutropenic fever (NF) [Clin Infect Dis. 2011;52(4):e56], and mortality rate were retrieved from the records. Results: Of 175 pts (66 BL, 13 BLL, 96 ALL), 67 % were males, 92.6 % had stages III or IV disease. Chi-Square test analysis showed pts treated with disease specific systemic therapy within 1 week as compared to those whose treatment began ≥ 1 week after symptoms onset had less incidence of ARF (16.7% vs 38.5% p=0.001), less TLS (3.6% vs 16.5% p=0.006), less VTEs (8.3% vs 16.6% p=0.007), less NF (3.6% vs 24.2% p=0.001) and most importantly had a lower mortality rate during the therapy (1.2% vs 8.8% p=0.036). Further analysis of the data showed no significant difference in the incidence of major bleeding between the two groups (9.5% vs 17.8 p=0.129), although there was a trend toward fewer episodes in pts started on therapy within 1 week. Conclusions: This study confirmed an increased risk of therapy related complications including higher mortality in pts with BL, BLL and ALL when the therapy was initiated ≥ 1 week after symptoms onset. These findings indicate that clinicians should start disease specific therapy within 1 week.
Prognosis, diagnostic delay, and patient characteristics associated with diagnostic delay among Kaposi sarcoma (KS) patients in Uganda.
Authors: De Boer Christopher , Niyonzima Nixon , Orem Jackson , Bartlett John , Zafar Yousuf
Published: March 2020

6578

Background: The incidence and mortality of KS remain high in sub-Saharan Africa. Delaying treatment might explain poor outcomes, but no study has measured the association between delay, characteristics associated with delay, and prognosis for KS patients in low- and middle-income countries. Methods: This is a prospective, cross-sectional study conducted from June-October 2012 at the Uganda Cancer Institute (UCI) in Kampala, Uganda among HIV-infected adults with histologically confirmed KS. The aim was to measure the association between delay and overall KS stage risk at diagnosis. Standardized interviews were conducted in English or Luganda to measure delay, and medical records were abstracted to obtain KS stage at admission to UCI. Multivariable logistic regression was used to assess the relationship between diagnostic delay and poor-risk stage at diagnosis. Results: 161 patients were enrolled; 68.9% were men, mean age was 34.0 years (SD 7.7), 58.1% had income < $2 per day, and 49.4% had ≥primary education. 25.8% had been seen in an HIV clinic within 3 months, 71.6% were on antiretroviral therapy (ART), and 25.5% had visited a traditional healer prior to being seen at UCI. 45.3% delayed seeking care at UCI for ≥3 months from onset of symptoms. Among those who delayed, 35.6% waited 6 months, and 24.7% waited 12 months. The most common reasons for delay were lack of pain (47.9%), no money (31.5%), and distance to UCI (8.2%). In adjusted analysis patients who experienced diagnostic delay were more likely to have poor-risk stage compared to those who did not delay (OR 3.41, p=0.002, 95%CI: 1.46-7.45). After adjusting for patient characteristics, HIV clinic attendance, and ability to pay out-of-pocket costs, visiting a traditional healer was the only characteristic associated with greater likelihood of delay (OR 2.69, p=0.020, 95%CI: 1.17-6.17). Conclusions: Diagnostic delay was independently associated with poor-risk stage at diagnosis, and visiting a traditional healer was the only patient characteristic independently associated with delay. The relationship between traditional and Western medicine presents a critical point of intervention to improve KS outcomes in Uganda.
Integration of patient-reported adverse events into a phase II chemotherapy treatment trial.
Authors: Basch Ethan M. , Pietanza Maria Catherine , Kris Mark G. , Shaw Mary , Sima Camelia S. , Rogak Lauren J. , Schrag Deborah
Published: March 2020

6583

Background: It has been shown that patient reporting of symptomatic adverse events (AEs) is feasible during routine chemotherapy, and that patients report AEs that clinicians otherwise miss. It is not known if this approach is feasible in a treatment trial; whether clinicians will agree or disagree with patent-reported AE grades; or if clinicians will take actions based on patients' AE reports. Methods: Patients with advanced non-small cell lung cancer enrolling in a single-arm phase 2 trial of paclitaxel, pemetrexed, and bevacizumab at Memorial Sloan-Kettering Cancer Center (NCT00807573) reported 13 validated plain language questions adapted from the NCI's Common Terminology Criteria for Adverse Events (CTCAE), via iPads in waiting areas before each visit. Patients’ grades were transmitted to an investigator web page via which clinicians could agree or reassign each of the CTCAE grades, which were then transmitted to the institutional database as the official reported AEs for the trial. The proportion of patients and clinicians reporting AEs at each visit was tabulated with an a priori average compliance threshold set at 75% to conclude feasibility of the approach. The rate of clinician agreement with patient grades was computed. The frequency of clinical actions in response to patient-reported grade 3/4 AEs was calculated (ie, chemotherapy dose modification, ER referral, supportive medication). Results: 44 patients were enrolled between 1/09-9/11 (mean age 59; 50% female; 93% white), encompassing 721 total clinic visits (median 10; range 1-65). Patients reported AEs at visits 99.6% of the time and clinicians 98.7% of the time. Median time between patient self-reports and clinician reviews was 1 hour (range 0.2-18). Across symptoms, clinicians agreed with patients 93% of the time (weighted kappas .83 to .92), increasing the grade 5% of the time and decreasing it 2%. Clinical actions were taken in response to 67% of patient-reported grade 3/4 AEs. 71% of clinicians stated patient reporting informed their toxicity grading. Conclusions: Collection of patient-reported AEs at clinic visits via computer is feasible in a chemotherapy trial. Clinicians agree with patients’ self-reported AE grades and act on this information.
One-year survival and physical functioning with surgery compared to no surgery in early-stage lung cancer.
Authors: Walker Paul R. , Cykert Sam , McGuire Franklin , Edwards Lloyd , Dilworth-Anderson Peggye
Published: March 2020

6584

Background: Medical co-morbidities in patients with lung cancer frequently impact a treatment decision out of fear of doing harm without a benefit. A prospective study looking at racial disparity factors associated with surgery decisions in early lung cancer identified > 2 co-morbidities with an Odds Ratio (OR) of 0.04 of going to surgery for African Americans (AA) patients, yet a 10-fold higher likelihood of Caucasians (C) going to surgery with an OR 0.45. (Cykert et al JAMA 2010: 303: 2368). Methods: 386 out of the original437 patients with early stage lung cancer and no absolute contraindications to surgery were evaluated at multiple institutions for relative co-morbidities and with an initial Short Form 12 (SF-12) to assess physical functional status at enrollment and one year after enrollment. One year mortality and physical functional status was assessed. Results: 66% of C underwent surgery compared to 55% of AA (p = .048). One year mortality was not different between the AA (15%) and C (15.4%) populations (p=0.9); however not powered for a survival difference between surgery and no surgery. One year mortality in the overall surgical group was 10.8% compared to 22.8% in the non-surgical group; OR 0.50 (p<0.001). Patients with > 2 co-morbidities at diagnosis had a 27.5% one year mortality compared to 13.5% with < 2 co-morbidities; OR 1.7 (p=0.01). Combined analysis of co-morbidities and surgery revealed those with < 2 co-morbidities having surgery experienced a 10% one year mortality and those with > 2 co-morbidities 19%; without surgery one year mortality was 20% and 31% respectively. Despite > 2 co-morbidities, there was a 12% absolute mortality reduction with surgery. Regression analysis controlling for age and co-morbidities identified no physical functioning decline with surgery compared to the non-surgical group. Conclusions: One year mortality was doubled in patients with early lung cancer who declined surgery compared to those treated with surgery. There was no increased physical functioning decline in patients treated with surgery compared to no surgery. Treatment decisions in early lung cancer should be based on the survival benefit and not a perceived concern of physical functioning decline.
Validation of a cancer-specific Oncological-Multidimensional Prognostic Index (Onco-MPI) for mortality prediction in older cancer patients.
Authors: Brunello Antonella , Fontana Andrea , Zafferri Valeria , Chiarini Ramona , Fiduccia Pasquale , Basso Umberto , Copetti Massimiliano , Lonardi Sara , Falci Cristina , Monfardini Silvio , Pilotto Alberto , Zagonel Vittorina
Published: March 2020

6593

Background: Recently, a Multidimensional Prognostic Index (MPI) based on a Comprehensive Geriatric Assessment (CGA) was developed and validated in independent cohorts of older patients (pts) demonstrating good accuracy in predicting 1-year mortality. Aim of the study was to validate a cancer-specific modified MPI (Onco-MPI) for mortality prediction in older cancer pts. Methods: 658 consecutive new cancer pts aged ≥70 years (mean age 77,1 years, 433 females, 65.8%) referred to the Geriatric Oncology Program from Sep 2004 to June 2011 were included. MPI was calculated according to a previously validated algorithm (derived from multivariate Cox regressions) as a weighted linear combination of the CGA domains: age, sex, basal and instrumental activities of daily living (ADL, IADL), Performance Status, Mini Mental State Examination, Body Mass Index, comorbidity by Cumulative Illness Rating Scale, number of drugs and presence of caregiver. To develop the Onco-MPI, cancer sites (breast 46.5%, colorectal 21.3%, lung 6.4%, prostate 5.5%, urinary tract 5.0%, other 15.3%) and cancer stages (I 37%, II 22%, III 19%, IV 22%) were also included in the model. Pts were followed for a median of 2,5 years and mortality was recorded. Three grades of severity of the onco-MPI (low 0.0-0.46, medium 0.47-0.63, high-risk 0.64-1.0 score) were calculated on the basis of estimated recursive partition and amalgamation method (RECPAM) cut-offs. Discriminatory power and calibration were further assessed. Results: Overall 1-year mortality incidence rate (events/person-years) was 17.4%. A significant difference in mortality rates was observed for Onco-MPI low-risk compared to medium- and high- risk pts (2.1% vs 17.7% vs 80.8%, p<0.0001). The discriminatory power of 1-year mortality prediction of the Onco-MPI was very good (survival C index 0.86, 95%CI 0.83-0.89). The Onco-MPI was well calibrated showing < 10% differences between predicted and observed mortality. Conclusions: The Onco-MPI is an accurate and well-calibrated predictive tool for 1-year mortality in older cancer pts and can be useful for clinical decision making in geriatric oncology.
Patient perceptions about potential side effects and benefits from chemotherapy agents.
Authors: Kuchuk Iryna , Bouganim Nathaniel , Beusterien Kathy , Grinspan Jessica , Vandermeer Lisa , Mazzarello Sasha , Crawly Freya , Gertler Stan Z. , Dent Susan Faye , Song Xinni , Segal Roanne , Dranitsaris George , Clemons Mark J.
Published: March 2020

6595

Background: Little is known about how breast cancer patients (pts) perceive the relative side effects and benefits of different chemotherapy (CT) agents. The objective of this study was to better understand these preferences in pts receiving CT at a Canadian cancer center. Methods: Pts completed a Web survey. Grade I/II (mild to moderate) and III/IV (moderate to severe) descriptions of 9 common CT side effects were assigned preferences by: conjoint and standard gamble (SG). Conjoint involved making trade-offs among different risks of side effects, yielding preferences (utilities) for each side effect. SG involved choosing to stay in a selected side effect state or taking a gamble between full health (probability p) or being dead (1-p). For each side effect, p was varied until the patient was indifferent of the side effect. Pts were also asked to rate how much of detriment in quality of life they would endure for benefits in survival. Results: 102 women participated, mean age 54 + 11, stage 1 (21%), 2 (24%), 3 (38%) and 4 (18%). Among the grade I/II side effects, a 5% reduction in risk of sensory neuropathy, nausea, and motor neuropathy had the highest impact on preferences. Among grade III/IV side effects, motor neuropathy, nausea/vomiting, and mucositis made the most difference. SG preferences for side effects were lowest (i.e. least preferred) for grade III/IV nausea (0.624) followed by diarrhea (0.633), hand-foot syndrome (0.681), and highest for grade I/II sensory neuropathy (0.757), mucositis (0.756), and myalgia (0.750). Agree/disagree items revealed patients are willing to endure quality of life detriments for improvement in survival; this willingness increased as disease stage increased (p=0.01). Conclusions: Relatively small changes in the risks of some CT side effects may have substantial impacts on pt treatment preferences. Nevertheless, pts will endure significant toxicity for a potential gain in survival. The standard gamble utilities from this population may also be used to quality-adjust life expectancy in cost-effectiveness evaluations of breast cancer chemotherapies.
Barriers to patient adherence with adjuvant endocrine therapy.
Authors: Duff Jennifer Michelle , Yan Hui , Chang Myron , Rosenberg Eric , Daily Karen Colleen
Published: March 2020

6605

Background: Adjuvant endocrine therapy for hormone receptor positive breast cancer is essential to decreasing recurrence and improving survival. However, adherence to these drugs has been reported to be suboptimal, the impact of which on breast cancer outcomes is unknown. Multiple non-modifiable risk factors have been associated with nonadherence. Identifying patients’ self-reported reasons for not taking these drugs as prescribed may be crucial to improving adherence. Methods: We obtained data from 49 women prescribed tamoxifen, letrozole, anastrozole, or exemestane for stage I-III invasive breast cancer. Written surveys were provided during the patients’ medical oncology visits. Our study collected demographic data on patient characteristics associated with nonadherence. Patients were asked to report reasons for missing doses including forgetting to take the drug, side effects, cost, and barriers to refill. Patients described their degree of adherence by identifying how often they miss a dose as never, once per month, once per week, or more than once per week. We compared their self-reported adherence to pharmacy refill records. Results: More than half the women (26 of 49) report regularly missing doses of their drug over the last year. Of these, 22 miss once per month, 3 miss once per week, and 1 misses more than once per week. Despite this, pharmacy records verified consistent refills in all 26 less adherent patients over the past year. The most common reason identified for missed doses (21 of 26) was forgetting to take the drug, followed by barriers to refill and side effects. 57% of all patients favored receiving an electronic reminder via text messaging or email. Nonadherence was associated with polypharmacy and lower levels of education, income, and activity. Conclusions: Our study provides insight into patient reported reasons for nonadherence to adjuvant endocrine therapy. Our patients reported forgetting to take their drug as most problematic. Patients’ self-reported adherence was confirmed (96%) by pharmacy records. Most patients are interested in an electronic reminder system via e-mail or text messaging, even if they report complete adherence. This has potential to be a cost effective intervention.
The development of a financial toxicity patient-reported outcome instrument (PRO) in cancer.
Authors: De Souza Jonas A. , Yap Bonnie , Hlubocky Fay J. , Ratain Mark J. , Cella David , Daugherty Christopher
Published: March 2020

6612

Background: Considering patients' (pts) subjective experience is essential for optimal decision making and care. However, despite increasing recognition of the impact of costs on oncology care, there is no accepted and validated PRO that specifically describes the financial burdens cancer pts experience. Methods: A financial toxicity PRO in advanced cancer pts undergoing treatment was developed in 3 stages. Stage 1: literature review and semi-structured qualitative interviews with pts for item generation; items were classified into 5 theoretical domains (financial, resources, affect, coping and family); draft items were examined for redundancy. Stage 2: pts assessed the items for readability and importance to their quality of life via two Likert scales (0 – 3 scales) to generate an importance score; items were ranked by decreasing importance score until at least 3 items per theoretical domain had been retained. Stage 3: pilot-testing assessing inter-item (IIC) and item–total (ITC) correlations to identify redundancy (Spearman’s rho >0.7, p<0.05) and statistically unrelated content; items were formatted in accordance with the Functional Assessment of Cancer Therapy (FACT) quality of life measure, with a 7-day time window and a 5-point Likert scale. Subject data on tumor type, age, gender, race, income, insurance type and educational level were collected. Results: 132 pts (20 in stage 1, 45 in stage 2 and 67 in stage 3) were approached and 101 agreed to participate. Stage 1: literature review, 20 pts, and 6 investigators generated 98 items, which were reduced to 58 due to redundancy. Stage 2: 35 pts ranked the items for importance, and 30 items were retained. The mean importance score was 1.83 (range 1.04 – 2.11). Stage 3: 46 pts completed the 30-item instrument. Their mean age was 61 years; 59% were male and 53% had private or employer purchased insurance; 14 items were excluded due to high IIC and 3 were excluded due to non-significant ITC, resulting in a 13-item PRO. The mean IIC and ITC of the final items were 0.373 and 0.645, respectively. Conclusions: A 13-item financial toxicity PRO has been developed in 101 pts with advanced cancers. This instrument will undergo validation as a subscale of the FACT in a larger cohort of cancer pts.
An analysis of methodologic quality in survey research reported in the Journal of Clinical Oncology.
Authors: Tamarelli Carrie M , Howell David D.
Published: March 2020

6616

Background: Survey research (SR) has been increasing as a percentage of published manuscripts in medical journals. SR plays an important role in studies of quality of life and patient preferences in treatment. Appropriate quality of methodology in SR is critical both to assure reliability and validity of survey results as well as to derive sound generalizations for larger populations from the subsets surveyed. Surveys that have deficient methodological criteria may suffer from significant flaws. A complete description and discussion of quality survey methodology, analysis, and results is essential for a thorough understanding and evaluation of published SR. Methods: Between January 2006 and December 2010, 227 articles in JCO were identified to have either “survey” or “questionnaire” in either the title or abstract. The most recent 52 consecutive articles fulfilling criteria from that time period were reviewed for reporting of survey methodology. A modification of Bennett et al.’s checklist for reporting SR was used for this analysis (Bennett C., et al. Reporting guidelines for survey research: An analysis of published guidance and reporting practices. PLoS Med 8(8): e1001069, 2011.). 35 metrics were used to analyze each survey. These metrics were grouped in the following categories: 1) title and abstract, 2) introduction, 3) methods (research tool, sample selection, survey administration and analysis), 4) results, 5) discussion, and 6) ethical quality indicators. Results: Of the 52 survey articles reviewed, the top quartile reported greater than 72% of the analyzed metrics. Half of the articles contained 63% or more of the desired metrics, and half of the articles had between 42% and 62% of the desired metrics. Some metrics were usually reported, such as ethics board review (reported in 85% of articles), but others were not consistently reported, such as calculation or justification of sample size (neither were reported in 71% of articles). Conclusions: A substantial number of articles reviewed reporting on survey research in JCO did not report critical components of survey methodology. More rigorous quality recommendations should be offered to guide authors in the report of survey research results.
Comparison of yoga versus relaxation on chemotherapy-induced nausea and vomiting (CINV) outcomes a mechanism of action study.
Authors: Raghavendra Rao M. , Usharani Malur R. , Kavya Mahesh , Aishvarrya S , Nandini Pkl , Patil Shekhar , Ravi Diwakar B , Shashidhara H P , Satheesh C T , Radheshyam Nayak , Ajaikumar Basavalinga S
Published: March 2020

6624

Background: Chemotherapy induced nausea and vomiting is a common distressing symptom. In this study we evaluated the effects of Yoga vs. Jacobson’s relaxation training on CINV outcomes in chemotherapy naive patients undergoing moderately to highly emetogenic chemotherapy. Methods: One hundred and twenty patients who satisfied the selection criteria and gave written consent to participate were randomized to receive Yoga or Jacobson’s relaxation or serve as waitlist controls for first 4 cycles of chemotherapy. Assessments for nausea and emesis including functional living index emesis, nausea diary and cardiac autonomic function and electrogastrogram were carried out at baseline, six days after 1st cycle, after 2nd and 3rd cycle of chemotherapy. Assessments for mood states such as anxiety and depression using HADS, and perceived stress were carried out at baseline and after 3rd cycle of chemotherapy. Both interventions were for a duration of 25 minutes imparted by a trained instructor. Data were analysed using repeated measures ANOVA with post hoc Bonferroni tests. Results: There was a significant decrease in acute and delayed nausea severity in Yoga compared to control group (p=0.001) and Jacobson’s group (p=0.004) after 1st cycle of chemotherapy. There was a significant decrease in self reported anxiety and depression in Yoga (p=0.03) and Jacobson’s relaxation (p=0.004) compared to control group following 3rd cycle of chemotherapy.There was significant decrease in LF/HF ratio in Yoga group compared to control group (p=0.06) after 3rd cycle of chemotherapy. There was a significant decrease in bradygastria (p=0.002) and tachygastria percentage (p=0.03) in Yoga group compared to Jacobson’s and control group becoming more evident after 3rd cycle of chemotherapy. Conclusions: Both Yoga and Jacobson’s intervention conferred beneficial effects in reducing chemotherapy induced nausea and vomiting. Yoga helps normalise gastric motility and enhances cardiac and gastric parasympathetic activity in subjects undergoing chemotherapy. Clinical trial information: NCT01387841.