bluuebunny/crossref_metadata_2025 huggingface dataset:
Change in telomere length and cardiovascular risk in testicular cancer survivors.
Authors: Volders Ellen L.D. , Meijer Coby , Steeneken Lotte S. , Lubberts Sjoukje , Zwart Nynke , van Roon Arie M. , Lefrandt Joop D. , de Jong Igle Jan , Demaria Marco , Nuver Janine , Gietema Jourik A.
Published: June 2022

12079

Background: Testicular cancer (TC) survivors cured with chemotherapy (CT) are prone to develop cardiovascular events, as part of an early aging phenotype. Telomere shortening could be a mechanism contributing to these events and their risk factors. Methods: In a prospectively followed cohort of patients with disseminated TC who received cisplatin containing CT (Lubberts et al., Eur J Cancer 2016), mean absolute leukocyte telomere length (TL) was measured using qPCR before and one year after start of cisplatin containing CT. Cardiovascular risk factors, including development of the metabolic syndrome (according to the NCEP ATP III definition) and hypogonadism (LH >10 U/L or testosterone < 10 nmol/L or use of testosterone suppletion), were assessed before and up to 5 years after CT. Shortening of TL was defined as a decrease of >33% after one year compared to baseline; short TL was defined as <5 kilobase (kb) pair (=P25). Data are presented as median (range). For comparisons, a Mann-Whitney U or Chi-Square test was applied. Results: 55 out of 73 patients of the initial cohort were evaluable for this analysis. CT regimens consisted of 3xBEP (n=41), 4x BEP (n=11), 4xEP (n=3). At baseline, patients with a BMI > 30 kg/m2 (n=12) had a shorter TL (4.9 (2.2-13.4) vs. 6.3 kb (3.1-12.9), p=.045); there was no difference in age. For the whole group, TL did not change one year after CT compared to baseline (5.7 (2.2-13.4) vs. 5.8 kb (1.6-19.2), p=.335). Patients with TL shortening after 1 year (n=7) showed a significant increase in diastolic blood pressure (p=.007) and triglycerides (p=.003), compared to those with unchanged TL (table). TL shortening after 1 year or short TL at baseline (n=7+11) are not significant predictors for newly developed metabolic syndrome (25 vs. 21%; p=.777), nor hypogonadism (38 vs. 17%; p=.120) after 5 years, compared to the others. Conclusions: A small subset of TC patients treated with cisplatin containing CT showed shortening of TL 1 year after treatment. This shortening is associated with a rise in diastolic blood pressure and triglycerides. Short or shortening of telomeres are not predictive for development of the metabolic syndrome or hypogonadism. [Table: see text]
Adverse health outcomes (AHO) in testis cancer survivors (TCS) following high-dose chemotherapy (HDCT) and autologous stem cell transplant.
Authors: Miller Meagan Elizabeth , Ashkar Ryan , Althouse Sandra K. , Hanna Nasser H. , Abonour Rafat , Travis Lois B. , Einhorn Lawrence H. , Adra Nabil , Abu Zaid Mohammad Issam
Published: June 2022

12083

Background: Patients with relapsed/refractory germ cell tumors are often cured with tandem platinum-based HDCT followed by autologous stem cell transplant in the ≥2nd line treatment setting. A comprehensive assessment of long-term AHO (adverse health outcomes) in TCS cured with HDCT has not been previously described. Methods: Testis cancer survivors (TCS) at least 1 year after HDCT and treated at Indiana University were eligible. TCS were asked to complete a comprehensive, well validated survey regarding 19 different AHO. TCS demographics, disease characteristics, treatment received, and AHO were collected. Results: From 2/2021-1/2022, 118 eligible TCS were invited. 70 TCS completed the survey (59.3% completion rate). TCS received HDCT followed by autologous stem cell transplant in the 2nd (91.4%), 3rd (7.1%) or 4th line (1.4%) setting. At the time of survey completion, 93% of respondents were at least two years from HDCT (range 1.6-16.2 y) with a median age of 42 y (range 24.8-66.6 y). Median age at the time of original germ cell tumor diagnosis was 32 y (range 17.4-56.8 y). TCS reported a median of 3 AHO with 37% of participants reporting 5 or more AHO. 90% of participants reported tinnitus, 91% experienced hearing impairment, and 52% required the use of hearing aids. Additionally, 46% TCS noted peripheral neuropathy and 26% reported problems with balance/vertigo/dizziness. Prevalence of kidney disease was 10%, and 24% TCS experienced erectile dysfunction. In regards to physical activity, 47% of participants were not participating in vigorous physical activity (defined as > 6 mets/week). 16% TCS reported use of medications to treat anxiety and/or depression, and 19% required testosterone replacement therapy. The prevalence of hypertension, coronary artery disease, Raynaud phenomenon, hypercholesterolemia, diabetes, and thyroid disease were 13%, 1%, 17%, 12%, 4%, and 6% respectively. Conclusions: Despite the high cure rate of HDCT, TCS report a substantial burden of morbidity with the majority experiencing ototoxicity, and with half of the TCS requiring hearing aids. Special attention to these AHO and efforts to develop ototoxicity prevention approaches are urgently needed for this patient population.
Racial disparity in breast cancer survivorship: Results of a qualitative research study to identify themes from a series national healthcare provider live virtual forums.
Authors: Binkley Jill M. , Gabram Sheryl G. A. , McCullough Lauren E. , Finley Janae , Fowler Dawnovise , VanHoose Lisa
Published: June 2022

12091

Background: Significant disparity exists in the diagnosis, treatment, and survivorship outcomes among Black breast cancer (BC) survivors. Unmet physical and emotional needs in BC survivors are well documented, but there is mounting evidence that Black BC survivors have more significant survivorship issues and a greater burden of illness than White counterparts. Barriers to rehabilitation and recovery care exist for all BC survivors; however, they are magnified in Black BC survivors due to systemic racism, healthcare provider bias and discrimination, lack of culturally relevant care models, and socio-economic barriers. There is limited literature on lived personal and professional experiences of racial disparity in BC survivorship. Methods: The purpose of this qualitative research was to document patient, clinician and researchers’ perceptions surrounding contributing factors, lived experiences, and potential solutions to racial disparity in BC survivorship against the contextual background of reported inequities. A narrative approach was utilized to identify themes from a series of four virtual healthcare provider forums that explored lived personal and professional experiences, issues and potential solutions surrounding racial disparity in BC survivorship from October 2020-September 2021. The forums included perspectives of patients, healthcare providers, researchers, and stakeholders in the BC field. The total live and online views for all four forums was 2,093. An independent thematic analysis was performed by the investigators, all of whom have emic perspectives with respect to race and/or breast cancer. Results: Three main themes were independently identified by study investigators: 1. societal and cultural contributing factors contributing to racial disparity in BC survivorship, 2. contribution of healthcare providers and systems to racial disparity in BC survivorship and 3. models of care and research considerations that would reduce racial disparity. These themes were widely echoed by forum participants throughout the series. With respect to solutions, widespread implementation of navigation models and the Prospective Model of Rehabilitation for Women with Breast Cancer that address physical and psychosocial treatment side effects would reduce disparity. The importance of the inclusion of voices of Black BC survivors in community-based participatory research aimed at reducing survivorship disparity is critical. Conclusions: The findings provide compelling documentation of lived personal and professional experiences of racial disparity in BC survivorship. These issues have been described in the literature for nearly two decades. Potential solutions exist and must be enacted immediately to ensure equitable survivorship outcomes for Black individuals following a BC diagnosis.
Associations between diet quality and chronic health conditions (CHCs) in adult survivors of childhood cancer in the St. Jude Lifetime Cohort Study (SJLIFE).
Authors: Finch Emily R , Foley Elizabeth , Hyun Geehong , Goodenough Chelsea Goodliffe , Zhang Fang Fang , Krull Kevin R. , Bhakta Nickhill , Park Yikyung , Ehrhardt Matthew J. , Brinkman Tara M. , Lanctot Jennifer Q. , Robison Leslie L. , Hudson Melissa M. , Ness Kirsten K.
Published: June 2022

12095

Background: Survivors of childhood cancer are at increased risk for early development of CHCs, including metabolic syndrome (MetS), low bone mineral density (LBMD), and gastrointestinal (GI) disease. Dietary modification is often recommended for prevention and/or treatment of these CHCs in non-cancer populations. However, associations between diet quality and severity of CHCs in adult survivors of childhood cancer are not well known. Methods: Adult survivors (≥10 years post-diagnosis) of childhood cancer who completed a clinical evaluation and Block Food Frequency Questionnaire were included. Diet quality was estimated using the Mediterranean diet score (aMED), with scores ranging from 0 to 9 (increased scores represent higher adherence to diet). CHCs were graded (modified CTCAE) and classified as “low” (grade ≤1 for LBMD and GI; grade ≤2 for MetS) or “high” (grade 2-4 for LBMD and GI; grade 3-4 for MetS). A multivariable linear regression model was used to estimate the mean aMED score by “low” or “high” disease category, with adjustment for age at evaluation, sex, race, education, total energy intake, adjusted BMI, physical activity, smoking, and alcohol consumption. Results: 2,822 survivors of childhood cancer (52.4% male, 83.1% non-Hispanic white) were included. The most prevalent diagnosis was acute lymphoblastic leukemia (34.1%). Time from primary diagnosis was 24.2±8.5 years and age at recruitment was 32.5±8.7 years. Lower adherence to aMED diet was associated with “high” MetS and LBMD, but not GI disease. See the Table for aMED multivariate-adjusted diet quality scores by CHC. Conclusions: In this cross-sectional analysis, MetS and LBMD were associated with poor adherence to the aMED diet. Although longitudinal investigation of associations between diet quality and CHCs in survivors of childhood cancer are needed to determine causal association between diet quality and CHCs in childhood cancer survivors, dietary interventions in early or late cancer survivors may help prevent development or progression of specific treatment related chronic conditions. [Table: see text]
Implementation of electronic patient-reported outcomes in head and neck oncology at a comprehensive cancer center.
Authors: McCleary Nadine Jackson , Sethi Rosh K , Uppaluri Ravindra , Whittaker Sarah , Cleveland Jessica , Black Brittany , Zhang Sunyi , Hassett Michael J. , Goguen Laura A.
Published: June 2022

12115

Background: Monitoring electronic patient reported outcomes (ePROs) has demonstrated impact on quality of life and survival in oncology. Maintaining high response rates to ePRO measures is critical in routine care. We evaluate the routine care implementation of head and neck oncology (HNO)-focused ePROs and the impact of patient demographics and assignment method on response rate. Methods: Since October 2021, patients diagnosed with head and neck cancer (PHN) at Dana-Farber Cancer Institute (DFCI) have had the opportunity to respond to the EHR-integrated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ- H&N43) at clinic visits, not to exceed every 30 days. PHN are also prompted at 7 and 14 days postoperative, regardless of clinic visit. HNO clinicians selected EORTC QLQ- H&N43 because of its actionable scores and limited overlap with cross-cutting ePRO tools at DFCI. Reviewed by Patient and Family Advisory Council members, PHN can respond to the questionnaire in English or Spanish via any internet-enabled device or tablet provided in clinic. Tablet assignment rates are sent via automated report to the HNO clinic manager. Results: Between October 2021 and January 2022, PHN responded to 64% of questionnaires for eligible clinic visits (1618/2535). Post-operatively, 65% of PHN responded to EORTC QLQ- H&N43 at least once within 28 days of surgery. Prompted at 7 and 14 days, PHN responded to 44% (133/300) of all post-operative questionnaires. Overall, PHN responded on their own device 50% of the time and on tablets in clinic 50% of the time. Response rates significantly associated with race, primary language, and age at clinic, but not post-operatively due to low sample size. PHN with a primary language other than English, older PHN, and PHN with races other than white responded less frequently, with the exception of Asian PHN in clinic who had the highest response rates. Clinician champions, EHR-integration, and a timely feedback loop to clinic managers facilitated response rates. Conclusions: Successful implementation of HNO ePROs is aided by clinical engagement and availability of real-time response rate data. ePRO response rate in HNO was found to be associated with race, primary language, age, and assignment method. Further work to focus on improving disparities within response rates and linking automatic interventions to scores is needed. [Table: see text]
Self-reported efficacy and usage of cannabis among patients with cancer within the Minnesota Cannabis Program.
Authors: Zylla Dylan M. , Parsons Helen , Ziegenfuss Jeanette Y , Lindgren Bruce , Park Susan , Blaes Anne Hudson
Published: June 2022

12122

Background: Patients with cancer are increasingly using cannabis to alleviate symptoms of pain, nausea, insomnia, and appetite loss. Despite the increased popularity of cannabis, little is known about the patterns of use in the cancer population, efficacy in treating symptoms outside of small clinical studies, and out-of-pocket expenses. We assessed self-reported efficacy and patterns of cannabis use from patients with cancer registered with the Minnesota Cannabis Program (MCP). Methods: We conducted an anonymous survey from December 2021-January 2022 of 797 individuals with cancer-associated pain, nausea/vomiting and/or anorexia currently enrolled in the MCP who had purchased a cannabis related product in the preceding three months. The mailed survey included questions about cancer history, cannabis use, and changes in symptoms. We conducted a descriptive analysis to describe patterns of use. Results: 225 individuals responded to the survey after a single mailing for a 28% response rate. 70% reported using cannabis at least once prior to cancer diagnosis. Respondents had diverse cancer diagnoses (breast (24%), lung (14%), colorectal (10%), prostate (9%)) and were more often female (52%), married, (71%), white (95%), and retired (40%) with a median age of 62.0. Most respondents (46%) had stage IV disease with the remaining 34% stage 1-3 (20% unknown). Household income varied across respondents with 10% reporting annual income <$20,000, 39% between $50-100k, and 33% with incomes ≥100k. 88% purchased at least one product with THC:CBD (tetrahydrocannabinol/cannabidiol) composition >1. Respondents reported that oral products were preferred to vaporizers (81% vs 45%) and 75% reported at least daily use. 27% reported monthly average out of pocket expenses for cannabis of $100-200; with 31% spending ≥$200/mo. The Table outlines perceived change in symptoms amongst users. Conclusions: Patients with cancer in the MCP with recent cannabis purchases predominantly use high THC:CBD products delivered via oral or vaporizer route on daily basis. While out of pocket costs for these products can be significant, many respondents report significant improvements in cancer related symptoms.[Table: see text]
Major stressful events and risk of developing head/neck and pancreatic cancer.
Authors: Sridhar Arthi , Nguyen Chandler H. , Abushalha Kamelah , Saghir Iqra , Tahanan Amirali , Rahbar Mohammad Hossein , Jafri Syed Hasan Raza
Published: June 2022

12128

Background: Major stressful life events have been shown to be associated with an increased risk of lung cancer, breast cancer and the development of various chronic illnesses. The stress response generated by our body results in a variety of physiological and metabolic changes which can affect the immune system, endocrine system and metabolism which has been shown to be associated with tumor progression. There is an indication that stress may need to be considered as a risk factor for malignancies. Methods: This is a matched case control study. The objective of this study was to determine if major stressful life events are associated with the incidence of head, neck, and pancreatic cancer (HNPC). Cases (CA) were HNPC patients diagnosed within the previous 12 months. Controls (CO) were patients without a prior history of malignancy and were matched with the cases by age and smoking status. Basic demographic data and medical information were collected from the patient’s medical records. Data on major stressful life events were collected using the modified Holmes-Rahe stress scale, and the following variables: death of a spouse, death of a child/immediate family member, serious personal illness, divorce/separation, loss of a job, caring for ill family member, financial difficulties, relocation, stress at work, detention/incarceration and retirement. A total sample of 300 was needed (100 cases, 200 controls) to achieve at least 80% power to detect odds ratios (OR) of 2.00 or higher at 5% level of significance. Results: From January 2018 to August 2021, 278 patients were enrolled (CA = 77, CO = 201) matched for mean age (years) (CA = 63, CO = 64), median smoking exposure (years) (CA = 36, CO = 38). About 65% of patients in CA group and 49% of CO group were male and 54% and 46% of the CA and CO groups respectively were of white race. In a multivariable logistic regression analysis after controlling for potential confounding variables (including sex, age, race, education, marital status, smoking history), there was no difference in lifetime incidence of major stressful event between the cases and controls. However, patients with HNPC were significantly more likely to report a major stressful life event within past 5 years when compared to CO [OR = 2.59 (1.24, 5.44), p = 0.012]. Conclusions: Patients with head, neck and pancreatic cancers are significantly associated with having a major stressful life event within 5 years of their diagnosis. This study highlights the potential need to recognize stressful life events as risk factors for developing malignancies and consider incorporating early rehabilitative efforts for major life stressful events.
Association between unmet needs and utilization of emergency services among cancer survivors in Canada.
Authors: Delisle Megan E , Srikanthan Amirrtha , Wang Ying , Fitch Margaret I
Published: June 2022

12131

Background: In 2016, the Canadian Partnership Against Cancer distributed surveys to over 40,000 cancer survivors to understand their experiences transitioning from primary cancer treatment to follow-up cancer care. Previously reported results of this survey identified that cancer survivors had high rates of unmet physical, emotional and practical needs. This study describes the association between these unmet needs and emergency services (ES) utilization within the first three years after cancer treatment. Methods: 13,319 respondents returned the survey (response rate 33%). Respondents in this study have non-metastatic breast, hematologic, colorectal, melanoma or prostate cancer. The association between self-reported unmet needs and ES utilization was assessed using multivariable logistic regression. High ES utilization was defined as accessing ES more than three times per year during the first three years after active cancer treatment. Results: 8,911 participants are included in this analysis; 80.5% reported at least one unmet practical, physical, and emotional need (n=7169, Table). A total of 3.9% (n=344) reported high ES utilization. Unmet needs were a significant predictor of high ES utilization (OR 1.75 95% CI 1.14-2.68 p=0.01). Other significant predictors of high ES utilization on the multivariable analysis included: not being able to identify a healthcare provider in charge of follow-up cancer care (OR 2.73 95% CI 1.32-5.65 p=0.01), high oncologist utilization (OR 3.08 95% CI 2.28-4.15 p<0.01), high primary care provider utilization (OR 2.3 95% CI 1.76-3.0 p<0.01), having a chronic condition (OR 1.6 95% CI 1.19-2.07 p<0.01), having colorectal cancer (OR 2.12 95% CI 1.31-3.44 p<0.01), being enrolled in a clinical trial (OR 1.54 95% CI 1.11-2.16 p=0.01), and rating follow-up cancer care coordination as fair or poor (OR 1.39 95% CI 1.03-1.86 p=0.03). Conclusions: Unmet needs are associated with high ES utilization in the first three years after cancer treatment. A better understanding of the reasons for this association is required to develop approaches to reduce potentially preventable ES utilization and improve perceived care needs among cancer survivors. [Table: see text]
Understanding barriers and facilitators to clinical trial participation among Black patients with multiple myeloma.
Authors: Saxton Claire , Cutforth Asia , Gonzalo Maria Belen , Nichosl Helen , Fearnley Kirstin
Published: June 2022

12137

Background: Currently, Black patients make up 20% of people living with multiple myeloma, yet they represent only 6% of participants in clinical trials.1 The underrepresentation of Black patients in clinical trials can contribute to outcome disparities thereby negatively impacting health equity in cancer treatment and outcomes.2 This project examined attitudes towards clinical trials among Black multiple myeloma patients and caregivers. Findings will inform the development of programs aimed at increasing clinical trial participation in this population. Methods: In 2021, the Cancer Support Community conducted an online survey to gain insights on barriers, facilitators, and perceptions of clinical trials among Black multiple myeloma patients and caregivers/care partners. Survey questions were informed by insights from prior focus groups. 94 patients and 101 caregivers were surveyed. Results: Most participants were male (62%) and African American (90%). 5% identified as African Caribbean and 5% as Black and Hispanic. The average age was 46 years. Just over half (51%) currently or previously participated in clinical trials. Of those who chose not to participate in a trial, the most common reasons were fear of side effects (46%) and fear of receiving a placebo (38%). Another barrier to participation reported was discomfort with being randomly assigned to a treatment (56%). Participants reported a significant level of distrust in medical research and doctors, saying that it was “very or somewhat likely” that doctors provide treatment as part of an experiment without patient consent (41%) and that they might be used as a “guinea pig” (25%). Of note, 57% of respondents said COVID had changed their attitude towards participating in clinical trials. 14 of 16 factors mentioned in our focus groups were affirmed by more than half of respondents as facilitating participation in a clinical trial. The top factors were: Understanding potential side effects (66%) My health care team speaks to me about trials (65%) Compensation offered for transportation, childcare, or time off work (62%) My family/community support my decision (61%). Conclusions: These findings are consistent with previous research which found that cancer patients reported the biggest attitudinal barriers to clinical trial participation were fear of side effects, distrust in medical research, and random assignment to clinical trial groups.3 Our study highlights that Blacks and African Americans living with multiple myeloma value multifactorial efforts to increase clinical trial participation: logistical and financial interventions, patient/provider communication, and culturally sensitive support and education programs. These programs can also work to improve health equity by reducing barriers to overall care and encouraging Blacks and African Americans living with multiple myeloma to be active members of their health care team.
Changes in cancer mortality by race and ethnicity following the Affordable Care Act implementation in California.
Authors: Martinez Elena , Gomez Scarlett Lin , Canchola Alison J. , Oh Debora , Murphy James Don , Mehtsun Winta Tsegay , Yabroff K. Robin , Banegas Matthew P.
Published: June 2022

1500

Background: Implementation of the Affordable Care Act (ACA) has resulted in improvements in cancer outcomes but the extent to which these apply to specific racial and ethnic populations is unknown. We examined changes in health insurance distributions pre- and post-ACA and assessed cancer-specific mortality rates by race and ethnicity. Methods: The population included 167,181 newly diagnosed breast (n = 117,738), colorectal (n = 38,334), and cervix cancer (n = 11,109) patients younger than 65 years and 141,026 patients 65 years or older in the California Cancer Registry. Hazard rate ratios (HRRs) and 95% confidence intervals (CIs) were calculated using multivariable Cox regression to estimate associations with risk of 5-year cancer-specific death for each cancer site pre- (2007-2010) and post-ACA (2014-2017), and by race and ethnicity (American Indian/Alaska Natives, AIAN; Asian Americans; Hispanics; Native Hawaiian/Pacific Islanders, NHPI; non-Hispanic Blacks, NHB; and non-Hispanic whites, NHW). Difference-in-difference analysis was conducted to compare changes over time between younger (< 65 years) and older (65 years and older) patients. Results: Cancer-specific mortality for patients age < 65 was significantly lower post- vs. pre-ACA for colorectal cancer among Hispanic (HRR = 0.83; 95% CI: 0.74-0.93), NHB (HRR = 0.69; 95% CI: 0.58-0.81), and NHW (HRR = 0.90 95% CI: 0.84-0.97) but not Asian American (HRR = 0.95; 95% CI: 0.82-1.10) patients. The HRR for younger NHB colorectal cancer patients was significantly lower than that for patients 65 years of and older (HRR = 1.09; 95% CI, 0.95-1.25, p-interaction < 0.0001). A significantly lower risk of dying from cervix cancer was observed in the post- vs. pre-ACA period among younger NHB women (HRR = 0.68; 95% CI: 0.47-0.99), but this was not significantly different than that for older women (HRR = 0.41; 95% CI, 0.16-1.01, p-interaction = 0.30). No significant differences in breast cancer-specific mortality were observed for any racial or ethnic group. Conclusions: Findings show decreases in cancer-specific mortality for colorectal and cervix cancers for some racial and ethnic groups following ACA implementation in California. These results shed light on ongoing discussions as additional states consider Medicaid expansion. Future studies should assess shifts between health insurance plans resulting from the economic impact of the 2019 novel coronavirus (COVID-19) pandemic.
Operational metrics for the ELAINE II study combining a traditional approach with a just-in-time model.
Authors: Blau Sibel , Peguero Julio Antonio , Moore Halle C. F. , Anderson Ian Churchill , Barve Minal A. , Cherian Mathew Amprayil , Elkhanany Ahmed , O'Sullivan Ciara Catherine Maria , Moreno-Aspitia Alvaro , Plourde Paul , Gleich Lyon L. , Riesen Kendra , Ezzati Ross , Degele Meghan , Shulman Megan , Stempf Stephanie , Cooney Matthew M. , Damodaran Senthil
Published: June 2022

1504

Background: Trial recruitment that requires specific actionable mutations based on next-generation sequencing (NGS) is challenging. Barriers can include competing studies, physician study awareness, site proximity, mutation incidence, among other concerns. Methods: This study (NCT04432454) opened clinical sites using two methods during the COVID-19 pandemic. The “Traditional” approach included site selection, IRB and contract approval, and trial activation prior to a patient being identified for enrollment. The second approach used the Tempus “TIME” Trials network that would only open a site after identifying a patient with a mutation of interest and eligible for the trial. Results: The first patient enrolled was on 10/12/20 and the last patient was on 6/24/21. A total of 16 sites (6 Traditional and 10 TIME) participated. All Traditional sites, and none of the TIME sites, were affiliated with major academic institutions. Duration for full CTA execution for Traditional sites averaged 200.5 days (range 142 to 257) and for TIME sites averaged 7.6 days (range 2 to 14). IRB approval time average for Traditional sites was 27.5 days (range 12 to 71) and TIME sites was 3.0 days (range 1 to 12 days). Days from site selection to activation letter for Traditional sites was on average 250.0 days (range 187 to 281) and for TIME sites was 131.6 days (range 22 to 248). Time from study activation to first consent was 33.3 days (range 18 to 58) for Traditional sites and 8.8 days (range 1 to 35) for TIME sites. The first patient on-study was at a TIME site 115 days prior to a Traditional site and the first 7 patients enrolled were at TIME sites. Traditional sites consented 23 and enrolled 16 patients while the TIME sites consented 16 and enrolled 13. The trial enrolled all 29 patients in 8 months with the anticipated enrollment duration being 12 to 18 months. Conclusions: Although the Traditional and TIME programs had different operational models, they both contributed a significant number of patients and reduced the projected enrollment timeline. TIME sites enrolled the initial patients. These results demonstrate that the “Just-in-Time model,” in conjunction with a Traditional model, can reduce projected overall time to enrollment in biomarker-driven studies. [Table: see text]
Improving supportive care for patients with thoracic cancer.
Authors: Banks Lakedia Charman , Kapphahn Kris , Das Millie , Wujcik Debra , Stricker Carrie Tompkins , Shanbhag Lucinda , Lin Stephanie , Zhu Ge , Patel Manali I.
Published: June 2022

1520

Background: Improving lung cancer care among Veterans is a priority within the Veterans Affairs due to higher rates of lung cancer incidence, morbidity, and mortality among Veterans compared to non-veterans. Unaddressed symptom burden is common due to many factors including complex comorbidities, psychosocial challenges, smoking history and limited social support networks. Additionally, complications from social determinants of health can obstruct successful discussions of symptom-burden between Veterans and their clinical care teams which can limit compliance with recommended symptom management strategies. To overcome these barriers, we conducted a randomized controlled trial to test the effectiveness of a lay volunteer-led proactive symptom assessment and symptom intervention. The objective was to determine if the intervention improved clinician documentation from baseline to 6-months post-enrollment compared to usual care. Secondary outcomes included change in patient activation, health-related quality of life (HrQOL), and symptom-burden. Methods: Patients were randomized into the lay volunteer proactive symptom assessment intervention plus usual cancer care (intervention group) or usual cancer care alone (control group). We conducted electronic health record review to assess primary cancer-clinician symptom documentation of Veterans’ symptoms identified as moderate-to-severe at baseline and 6-months using the Edmonton Symptom Assessment Scale. Patient surveys with validated assessments were used to assess patient activation, HrQOL and symptom burden at baseline (time of enrollment) and 6-months post-enrollment. We used regression models to evaluate differences in our primary and secondary outcomes. Results: 60 Veterans were consented and randomized into the study (29 control; 31 intervention). There were no differences in demographic or clinical factors across groups. The median age was 70 years (range 56-85), 95% were male, 70% identified their race as White, 53% were married and 48% had a 2-year or 4-year college degree. The majority had at least 3 comorbidities (54%), diagnosed with stage 3 or 4 (62%) and received systemic treatment with chemotherapy and/or radiation (77%). At 6-months post-enrollment as compared to baseline, the intervention group had greater improvements in symptom documentation (56% from 12.5% vs. 29% from 43%, p = 0.01), greater improvements in patient activation (p<0.001), HrQOL (<0.001), and lower symptom burden (p<0.001) than the control group. Conclusions: Integration of proactive symptom assessment by lay volunteers has a significant and meaningful effect on symptom documentation, patient activation, quality of life, and reducing symptom burden among Veterans with lung cancer. Clinical trial information: NCT03216109.
Impact of proactive symptom monitoring on quality of life (QoL) and treatment toxicity in patients with cancer receiving chemotherapy: A meta-analysis of randomized clinical trials.
Authors: Tamimi Faris , Stajer Sabrina , Savill Jacqueline , Mittal Abhenil , Molto Consolacion , Di Iorio Massimo , Amir Eitan
Published: June 2022

1545

Background: Early recognition and management of symptoms can improve outcomes in cancer patients receiving treatment. A number of randomized trials have investigated the effects of adding proactive symptom monitoring to usual care (UC). These include web-based, application-based, or telephone-based assessments. Results have been variable, and the impact of proactive symptom monitoring on QoL, treatment toxicity and utilization of unscheduled acute care remains unclear. Methods: A systematic search of MEDLINE identified prospective, randomized trials that studied the effect of proactive monitoring and intervention versus UC in cancer patients receiving chemotherapy. The difference between proactive symptom monitoring and UC on the mean and SD for QoL using validated scales was collected for each study and pooled in a meta-analysis. Analysis was performed using the standardized mean difference (SMD) using random-effects modeling. The effect size was reported as the Hedges’ adjusted g. We also calculated the odds ratios (OR) for the occurrence of several common symptoms of any grade in the individual trials and pooled them in a meta-analysis. Statistical significance was defined as P < 0.05. Quantitative significance was defined as a difference in QoL score exceeding the minimal clinically important difference (MCID) based on previous studies for each QoL framework. Results: Of the 17 trials which met eligibility criteria, FACT-G and EORTC QLQ C30 were the most consistently utilized QoL tools. The mean difference in score between intervention and control at the last evaluation visits was 2.82 (95% CI -0.57 to 6.21; P = 0.10) in FACT-G and 2.33 (95% CI -0.29 to 4.96; P = 0.08) in EORTC QLQ C30, neither of which met quantitative or statistical significance. There was a statistically significant reduction in fatigue (OR 0.67, 95% CI 0.46 to 0.97; P = 0.04), but no difference in constipation (OR 0.63, 95% CI 0.34 to 1.17; P = 0.15), nausea (OR 1.03, 95% CI 0.72 to 1.47; P = 0.89), pain (OR 0.83, 95% CI 0.62 to 1.10; P = 0.19), or diarrhea (OR 1.41, 95% CI 0.40 to 5.01; P = 0.60). SMD for symptom severity was calculated for fatigue, diarrhea, and nausea. Severity of fatigue was statistically lower with proactive symptom monitoring (SMD -0.45, 95% CI -0.69 to -0.22; I² = 0%, P < 0.001), however, magnitude of effect was modest. Conclusions: Proactive symptom monitoring in cancer patients receiving treatment is not associated with significant or meaningful QoL improvement. Similarly, there is limited impact on individual toxicity.
Machine learning application to find patients with lower-risk myelodysplastic syndrome from real-world data.
Authors: Johanson Colden , Huang Hu T. , Idryo Danny , Broome Ronda , Rioth Matthew J. , Matsuno Rayna K.
Published: June 2022

1555

Background: It is a challenge to identify patients with myelodysplastic syndrome (MDS) using structured data from electronic health records (EHRs). Current claims-based algorithms incorporating diagnosis codes, clinical labs, and procedures have not been validated against an expert reference standard. A machine learning-based approach was investigated to identify erythropoietin-stimulating agent (ESA)-treated, lower-risk (LR)-MDS patients from structured EHR data. Methods: A sample of 1,549 patients from the Syapse Learning Health Network (SLHN) was identified as potential ESA-treated LR-MDS patients by a team of clinicians and epidemiologists based on diagnosis and medication data from multiple health systems’ EHRs and cancer registries. Of these, 404 (25%) were confirmed as ESA-treated LR-MDS patients through a review of patient records by certified cancer registrars (CTRs). The sample was divided into training and validation sets at a ratio of 80/20, stratified by the outcome. Age, sex, diagnosis codes corresponding to MDS and chronic kidney disease, medication (ESA, luspatercept, lenalidomide), clinical lab tests (hemoglobin, absolute neutrophils, platelet, blast percentage), and evidence of bone marrow biopsy were included as the predictive variables for the models. Gradient boosting machines with a nested cross-validation scheme were adopted to build the optimal model on the training set. Model acceptance was evaluated based on precision and recall on the validation set. The optimal model was then applied to the remaining unscreened SLHN patient population. Results: The optimal model identified an additional cohort of 157 patients based on the predicted likelihood. Among these, 69 (44%) were CTR-confirmed ESA-treated LR-MDS patients, all of whom were previously missed by the initial expert-determined selection criteria, as shown in the table. Conclusions: The application of machine learning methods increased the rate of ESA-treated MDS patient identification even after the expertly-determined population was depleted. This suggests the application of machine learning models using EHR data may improve the efficiency of MDS patient identification and screening efforts for research, quality improvement, and clinical care. [Table: see text]
Natural language processing-optimized case selection for real-world evidence studies.
Authors: Koskimaki Jacob , Hu Jenny , Zhang Yiduo , Mena Jose , Jones Nehanda , Lipschultz Elizabeth , Vaidya Vivek Prabhakar , Altay Gabriel , Erese Vance Andrei , Swaminathan Krishna Kumar , Mendonca Emma , Dutt Tarun , Singh Kuldeep , King Tian , Lakkimsetty Vinay Phani Santosh , Al-Olimat Hussein , Manning Brittany , Komatsoulis George Anthony , Chu Simon , Ottens Jeff
Published: June 2022

1556

Background: Much information describing a patient’s cancer treatment remains in unstructured text in electronic health records and is not recorded in discrete data fields. Accurate data completeness is essential for quality care improvement and research studies on de-identified patient records. Accessing this high-value content often requires manual and extensive curation review. Methods: AstraZeneca, CancerLinQ, ConcertAI, and Tempus have developed a natural language processing (NLP)-assisted process to improve clinical cohort selection for targeted curation efforts. Hybrid, machine-learning model development included text classification, named entity recognition, relation extraction and false positive removal. A subset of nearly 60,000 lung cancer cases were included from the CancerLinQ database, comprised of multiple source EHR systems. NLP models extracted EGFR status, stage, histology, radiation therapy, surgical resection and oral medications. Based on the results, cases were selected for additional manual curation, where curators confirmed findings of the NLP-processed data. Results: NLP methods improved cohort identification. Successfully returned cases using the NLP method ranged from 75.2% to 96.5% over more general case selection criteria based on limited structured data. For all cohorts combined, 84.2% of the cases sent out for NLP curation were returned with curated content (Table). Each cohort contained a range of NLP-derived elements for curators to further review. In comparison, more general case selection criteria yielded a total of 3,878 cases returned out of 41,186 lung cancer cases sent for curation, for a success rate of only 9.6%. Conclusions: NLP-driven case selection of six distinct, complex lung cohorts resulted in an order of magnitude improvement in eligibility over candidate selection using structured EHR data alone. This study demonstrates NLP-assisted approaches can significantly improve efficiency in curating unstructured health data. [Table: see text]
Natural language processing of Veterans’ electronic health records to confirm diagnoses of monoclonal gammopathy of undetermined significance.
Authors: Wang Mei , Yu Yao-Chi , Liu Lawrence , Schoen Martin W. , Thomas Theodore Seth , Colditz Graham A. , Chang Su-Hsin
Published: June 2022

1557

Background: The Veterans Health Administration (VHA) provides extensive electronic health records (EHRs) on Veterans nationwide. Our prior studies utilized VHA data to study the risk of progression from monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma. These studies relied on International Classification of Disease (ICD) codes and manual abstraction on clinical notes to both identify and verify MGUS patients. Diagnosis confirmation is necessary because many providers place a diagnosis on the clinical notes to order lab tests, which is often left in the EHR despite a negative test result. However, manual abstraction is labor intensive and time consuming. With the advancement in natural language processing (NLP), we developed a model to make MGUS confirmation more efficient. Methods: We randomly selected 700 patients within patients diagnosed with MGUS from 1999-2021 in the VHA identified via ICD codes. A random sample of 500 patients were selected and split into the training (80%) and the testing (20%) sets. The remainder (n = 200) served as the validation set. There were 32,708 unstructured hematology/oncology Text Integration Utility reports and 9,237 lab reports (including 2,322 discrete results and 6,915 unstructured comments). All reports were manually reviewed to confirm MGUS diagnoses and served as the reference standard. We compiled three lists of keywords suggestive of MGUS diagnosis, subtypes of immunoglobulins, and negation modifiers. We trained a symbolic NLP model to identify diagnoses using combinations of the lists along with M-protein levels from lab reports. The optimized combination that gave the highest recall and precision from the training set was used and evaluated on the testing and validation sets. Results: Among patients with ICD codes for MGUS, manual abstraction confirmed 84% MGUS diagnoses in the testing set and 80% in the validation set. Our NLP model in the training set confirmed 75% and achieved recall, precision, accuracy, and F1 score of 88.1, 98.7, 89.0, and 93.1%, respectively; in the validation set, our rule confirmed 76% patients and the recall, precision, accuracy, and F1 score were 89.4, 94.7, 87.5, and 92.0%, respectively. On average data abstraction took five minutes per patient (excluding data loading time), whereas NLP model completed 13 patients per minute. Conclusions: The developed NLP model to confirm MGUS diagnosis improves accuracy in diagnosis, compared to ICD codes alone. While the performance is similar to that of manual abstraction, our NLP model is an efficient and viable method in MGUS diagnosis confirmation. [Table: see text]
Impact of trial site selection on minority patient recruitment in prostate cancer trials.
Authors: Lagor Charles , Bhandari Sudip , Chawla Jitesh , Knight Margot , Mann Jeremy , Mueller Judith , Raska Paola , Southwick Steve , Whyte Warren
Published: June 2022

1558

Background: Historically, minority patients have been underrepresented in clinical cancer trials. Despite recognition of this problem, trials in the early 2000’s showed a decrease from 10.5% to 6.2% in African American trial participation when compared to trials from the early 1990’s. The drop in trial participation is also reflected in prostate cancer trials, although Black men have a 1.76 higher prostate cancer incidence rate than White men. Using prostate cancer as an example, we investigated the impact of trial site selection on potential minority patient recruitment; thus, overcoming a major system-level barrier to trial access. Methods: We created a prostate cancer cohort by filtering our real-world data sources (CancerLinQ, Electronic Medical Office Logistics) for adult male patients with ICD10 CM code C61* or ICD9 CM code 185 on 1/1/2015 or later (cohort #1). As a pre-requisite for computing site level prostate cancer patient counts, we used claims data to attribute missing site information. Finally, to identify the most promising sites for minority trial recruitment, we ranked sites by the proportion of Black patients and the overall cohort patient count. We repeated the above steps for a subset of cohort #1, which was based on the criteria for trial NCT00887198 investigating the prostate cancer drug abiraterone (cohort #2). Results: The prostate cancer cohort (#1) had 151,261 patients, of which 99,152 (65.6%) were attributed to sites. The percentage of Black patients being treated at the top ten sites ranged from 33.0% to 66.4%, with a median of 45.2% (see table). All ten sites had participated in an interventional cancer trial, and eight had participated in prostate cancer trials. Half of them were community, and half were academic sites. The abiraterone cohort (#2) had 1,267 patients, of which 1,174 (92.7%) were attributed to sites. Among the top ten sites the Black patient percentages ranged from 23.8% to 85.7%, with a median of 39.3%. Conclusions: In an analysis of 17 recent FDA drug registration trials for prostate cancer, Black trial participation ranged from only 1.4% to 6.2%, with a median of 3.0%. In contrast, Black patients being treated at the top sites in our data ranged from 33.0% to 66.4%, with a median of 45.2% (cohort #1). The percentages for the abiraterone cohort (#2) were similar, suggesting that even after applying trial criteria the Black patient percentages remain in the double-digits at top sites. Our results demonstrate that informed trial site selection could have a substantial positive impact on minority patient recruitment. [Table: see text]