bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized trial of dietary modification with exercise in women who are class 2 obese with non-metastatic breast cancer.
Authors: Feinstein Trevor , Bowman Isabelle , Hoffman Catherine , Wellons Allison , Smith Jackie , Latham Valarie 
Published: June 2024

e22542 Background: As overweight and obesity increases worldwide, associated risks of breast cancer parallel. A higher body mass index (BMI) has been linked with at least seventeen types of solid tumors, including 9% of all breast cancer cases. Weight gain post-diagnosis is associated with greater morbidity and may increase cancer recurrence risk by 30-40%. Exercise and diet modifications carry potential to lower risk of recurrence. Herein, we report a 6-month pilot study at Piedmont Fayette Hospital in women with nonmetastatic breast cancer with diet modification. Methods: Women with non-metastatic breast cancer, class 2 obesity were recruited to participate in a six-month pilot study at the Thomas F. Chapman Family Cancer Wellness Program at Piedmont Fayette Hospital. Following consent, participants were randomized into either: ARM 1- Dietary coaching including Caloric Counting/Food Tracking with Exercise Coaching ARM 2- Dietary coaching including Carbohydrate Cycling/Intermittent Fasting/Caloric Counting/Food Tracking with Exercise Coaching. The primary goal of this pilot study is to evaluate and compare the feasibility and preliminary efficacy of two weight loss interventions. Results: As of December 2023, 20 patients were enrolled in the dietary modification study. 11 patients completed 6 months of dietary modification. Of the 11 evaluable patients, 6 were randomized to arm 1 and 5 patients were randomized to arm two, table 1. There was not a substantial weight loss in arm 1 at 6 months. However, patients on arm 2 had a median 17-pound weight loss. Conclusions: Although this was a small pilot study performed at the community hospital, we were able to demonstrate dietary modification is feasible in women with nonmetastatic breast cancer and class II obesity. Furthermore, carbohydrate cycling, and intermittent fasting seemed to be a more effective method at weight loss over calorie restriction. We plan to further expand this pilot study to other Piedmont Wellness Centers. [Table: see text]
Perceptions of multi-cancer early detection (MCED) screening tests among underrepresented populations.
Authors: Cong Ze , Ross Melissa , Mulnick Sarah , Samuelson Ashley , Chung Karen 
Published: June 2024

e22546 Background: Cancer is the second leading cause of death, with higher death rates observed among racial and ethnic minorities and individuals of lower income. MCED tests detect a shared cancer signal in plasma cell-free DNA. Beyond clinical/direct economic benefits, MCED may offer additional benefits (emotional, social, and/or behavioral) associated with a no cancer signal detected (NCSD) result, which might differ depending on socioeconomic status. This study aimed to explore the value of a NCSD result from the perspective of underrepresented individuals from the US general population. Methods: Qualitative interviews informed a cross-sectional online survey administered to adults aged 40-80 years without a cancer diagnosis within the last 5 years and not on cancer treatment. Soft quotas ensured a sample representative of the US population by age, gender, race, and ethnicity. The survey asked about the perceived value of a NCSD result from a hypothetical MCED test and collected sociodemographic and clinical information. Results were summarized descriptively. Results: The 1073 participants were 53% female, mean age 58 years (SD = 11), 67% non-Hispanic white, 12% non-Hispanic Black/African American, 12% Hispanic, 9% other or multiple races, 32% retired and 42% had less than a college degree. Regardless of income or race/ethnicity, nearly all participants (96-98%) viewed a NCSD result as somewhat or very valuable and anticipated maintaining or improving health behaviors (98-100%) and the majority expected positive emotional impacts (66-74%). However, minority groups were more likely than white participants to anticipate making lifestyle changes after a NCSD result (44-58% vs. 28%), increasing behaviors such as: exercising (61-75% vs. 47%), seeking health-related educational material (39-52% vs. 26%), eating healthy (58-78% vs. 47%), receiving vaccines (44-49% vs. 35%), maintaining/increasing adherence to recommended cancer screenings (22-29% vs 33% / 68-74% vs. 66%), and attending doctor visits (43-65% vs. 40%). Minorities also reported being more certain they would increase these behaviors than white participants. Lower to middle household income ( < $120,000) was associated with more positive impacts to self-care and monitoring health, relief, and happiness, and less fear, concern, anxiety, and stress after a NCSD result versus those with an income ≥$120,000. Conclusions: Regardless of income level or race/ethnicity, a negative MCED test result provides additional value to the US general population beyond traditional clinical benefits, has positive impacts on psychological/emotional health, and could promote adherence to or increase preventive healthcare behaviors. Importantly, racial/ethnic minorities and those of low to mid income anticipated greater positive impacts, specifically to preventive health behaviors with a negative MCED result.
Influence of family caregivers on clinical trial decisions: Results from a qualitative study.
Authors: Blackstone Eric , Loue Sana , Daly Barbara J. , Dorth Jennifer Anne , Brandt Patricia T. , Mazanec Susan R. 
Published: June 2024

e23023 Background: Family caregivers are key stakeholders in cancer clinical trial decisions who have been overlooked in previous research. Caregivers play a critical role in supporting patients during clinical trial participation, yet there is little consensus regarding how they should be included in informed consent. Clinical trial staff communicate regularly with patients and caregivers during consent and throughout trial participation, making their perspectives vital to understanding the role caregivers play in these decisions. Methods: This qualitative study identifies the roles caregivers play in cancer trial decision-making, influential factors from the caregiver perspective, and practices of clinical trial staff regarding caregiver inclusion in consent. Patients who were offered a clinical trial at a midwestern comprehensive cancer center were asked to identify a caregiver to participate. Clinical trial staff were recruited via email invitation. We conducted focus groups with caregivers and trial staff, followed by semi-structured interviews with caregivers. Caregivers were asked about attitudes towards research, experiences with trial consent, and their role in decision-making. Trial staff were asked how they included caregivers in consent and attitudes towards their involvement. Transcripts were coded, then analyzed with NVivo using content analysis. Results: Focus groups consisted of 9 caregivers and 10 clinical trial staff, then 15 caregivers completed interviews. Caregiver themes included promoting patient autonomy, influential factors, and burdens of trial participation. Trial staff themes were approaches to caregiver inclusion, navigating challenging situations, and the need for training. Caregivers viewed their role as supporting patient understanding and deferring to the patient as final decision-maker. Hope for therapeutic benefit, oncologist endorsement, and practical barriers (e.g. cost, distance) were influential. Trial staff viewed caregivers as highly influential and encouraged their involvement in consent despite occasional challenges such as family disagreement and undue influence. Conclusions: Early communication with caregivers when offering a trial is vital due to their influential role in decision-making. Clinical trial staff would benefit from training on best practices for inclusion of caregivers, including communication, managing emotions, mediating disagreement, and where to refer caregivers for support. Researchers should consider caregiver burden and potential sources of caregiver support during trial design to minimize barriers to participation.
Comparison of standard charges for complex proton therapy among Medicare Prospective Payment System (PPS) –exempt and –non-exempt cancer centers.
Authors: Cargill Kasey , Feder Noah Maxwell , Wilhite Tyler , Skinner Heath Devin , Wilke Christopher , Mowery Yvonne Marie 
Published: June 2024

e23039 Background: Proton therapy is one of the most expensive treatment modalities offered to cancer patients, and only 44 proton therapy centers are operational in the U.S. Of those, 5 are Medicare Prospective Payment System (PPS)-exempt and are reimbursed based on their reported costs rather than predetermined prices. These PPS-exempt cancer centers set their adjusted payment rates to reflect the expense required for providing specialized care. We hypothesized that PPS-exempt centers would have higher rates for complex proton therapy delivery compared to non-exempt centers. Methods: We obtained online standard charge files for 44 proton therapy centers in the U.S. We used the CPT code 77525, the per fraction technical charge billed for complex proton treatment delivery, to extract the gross price (base charge for service), de-identified minimum and maximum negotiated price (lowest/highest charge negotiated with third-party payers), and cash price (charge for cash payment of service) per fraction of complex proton therapy. Prices were compared between PPS-exempt and non-exempt proton therapy centers using Wilcoxon/Kruskal Wallis test with a p-value < 0.05 considered significant. Results: Of the 44 proton therapy centers, 39 (88.6%) had publicly available standard charge files, and 5 (11.4%) are private practice not required to provide a standard charge file. Five of the 39 (12.8%) centers are PPS-exempt, and the remaining 34 (87.2%) are PPS non-exempt. Four (80%) PPS-exempt centers had their gross price, minimum and maximum negotiated price, and cash price available in their standard charge file for CPT 77525, while 23 (67.6%) PPS non-exempt centers had their gross price and cash price listed and 19 (55.9%) had the minimum and maximum price available. The median gross charge per fraction for complex proton treatment delivery was $8,035.25 (IQR $7,022.00-$9,427.50) at PPS-exempt versus $6,434.00 (IQR $5,213.00-$12,350.00) at PPS non-exempt centers. The median minimum price was $656.47 (IQR $178.04-$1,353.23) at PPS-exempt versus $1,294.70 (IQR $734.20-$2,267.46) at PPS non-exempt centers. The median maximum price was $8,120.10 (IQR $5,576.40-$11,529.86) at PPS-exempt versus $5,814.00 (IQR $4,830.00-$9,524.70) at PPS non-exempt centers. The median cash price was $5,360.65 (IQR $2,979.51-$6,897.08) at PPS-exempt versus $4,170.40 (IQR $2,828.00-$5,640.00) at PPS non-exempt centers. Conclusions: In summary, 80% of PPS-exempt and 67.6% of PPS non-exempt centers had publicly available standard charge files. Median charges for PPS-exempt centers are higher for gross charge, maximum price, and cash price, however did not meet statistical significance. [Table: see text]
The single center experience with the war-related Ukrainian patients with various cancer diagnoses treated in clinical trials between 2022-2024.
Authors: Gudewicz Izabela 
Published: June 2024

e23040 Background: According to the WHO, 32% of active combat areas residents have been unable to obtain essential medicines since the beginning of the war in Ukraine. Clinical trials conducted in Poland have proven to assist oncological patients greatly. Many Ukrainian residents have Polish ancestors and are fluent in the Polish language. We decided to check whether the highest ethical standards of clinical trials make the ordinary intention to include a patient from Ukraine insufficient. Conducting a complete risk-benefit analysis allows choosing the best interest and safety of the clinical trial participant. Methods: The study aimed to evaluate the most frequent standards of oncological treatment of Ukrainian patients. We retrospectively verified the number of patients of Ukrainian nationality, in the age above 18 years treated at our center since the start of the invasion of Ukraine in February 2022 compared to the Polish patients. Results: Based on the National Health Fund data, Polish cancer centers in 2022 treated overall 994,767 patients including 8,000 patients from Ukraine. In the Pomeranian region, 3,815 patients received oncological therapies (data from the Central Statistical Office - of national). At our center in Gdansk between 01.01.2022 and 31.12.2023, therapy received 38,574 patients, including 34 Ukrainians. Clinical trials participants included 3,968 Polish and four Ukrainian patients (2 cases of malignant melanoma, one breast cancer, one lung cancer). Ukrainian patients represented 28.5%, 10%, and 8% of all patients included, respectively. Conclusions: Not prepared for the rapid influx of migrants Polish healthcare system encountered many problems like the language barrier, the need for a translator or approved documents by the Bioethics Committee, and the legal side of the informed consent form (ICF). At our center, all Ukrainian patients signed ICF in Polish. Regarding clinical trials participation, our study shows the unmet need of Ukrainian patients. The decision to include a patient has to be mutual (sponsor and investigator) and as soon as possible to ensure the required safety of each patient.
Clinical trial diversity (CTD) scorecards.
Authors: Horton Sara L. , Lewis Stanley , Olmstead Kay , Fassberg Elizabeth , Komelasky Chris , Fitzsimmons Bill 
Published: June 2024

e23042 Background: To ensure safety and efficacy, oncology clinical trials must include adequate participation by age, gender, race, and ethnicity subgroups. In November 2020, the US FDA issued Guidance for Industry to increase clinical trial diversity in pivotal clinical trial programs. CARER Group developed the CTD Scorecard to evaluate demographic diversity in registration trial programs for new drugs. Methods: Based on publicly available data, CTD Scorecard assigns each drug a letter grade (A, B, C, D, F) for demographic subgroups-age, race and ethnicity, as well as an overall grade. Scoring includes percentage of subgroup enrolled relative to US population, number of subgroup receiving study drug, and prevalence of disease in each subgroup. Results: From January 2022 to December 2023, US FDA approved 26 new oncology drugs. In this period, 8 trial programs were rated Grade B, 18 received Grade C. Notably, elderly, and female participation was better represented with 23 (88%) and 19 (90%) with Grade A or B respectively. Two trial programs each received Grade C for these subgroups. Asian representation was high, with 54% of programs scoring Grades A or B. Only one drug received Grade D for this demographic and no programs received Graded F. In contrast, Black and Hispanic populations showed significant underrepresentation. Fourteen (54%) of trial programs for Black and thirteen (50%) for Hispanic populations received Grades D or F. Notably, 20 (77% ) of trial programs had ≤10 Black participants receive study drug, with 6 programs having no Black participants receive study drug. Similarly, 14 (54%) of trial programs included ≤ 10 Hispanic participants receiving study drug, and 3 (12%) programs with no Hispanics receiving study drug. During this time, FDA issued Post-Market Requirements or Commitments (PMR/PMC) for 9(35% ) of oncology drugs due to premarket trial diversity shortfalls. However, by CTDs, 20 (77%) of the 26 approved drugs lacked adequate representation, yet did not receive Post-Marketing Requirements or Commitments. Conclusions: Oncology drug safety and efficacy can vary by age, race, sex, and ethnicity, necessitating diverse demographic participation in clinical trials. Alongside US FDA industry guidance, entities like the National Academy of Sciences, Engineering and Medicine and the GAO Report emphasize the need for trial diversity, bolstered by Federal Clinical Diversity Provision H.R. 2617 enacted in 2022. CARER’s scoring system evaluates clinical diversity age, sex, race and ethnicity, based on FDA data since January 2022. Age ≥65, female gender, and Asian race subgroups were generally well represented in clinical trial programs. Black and Hispanic groups show the lowest representation. Consistent use of PMC and PMR to new drugs may improve demographic inclusivity in trials lacking initial diversity.
Hematologic parameters as predictors of overall survival in metastatic solid tumor and aggressive lymphoma.
Authors: Morgenstern Kaplan Dan , Trabolsi Asaad , Plate Thomas , Hevroni Gil , Campoverde Leticia , Kronenfeld Rachel , Mercadel Alyssa , Zhao Wei , Soff Gerald A. 
Published: June 2024

e23053 Background: Aggressive cancer is associated with an increased rate of thrombosis. In addition to body mass index (BMI), the Khorana score has identified several hematologic parameters associated with an increased risk of thrombosis. In this study, we assessed the relationship of these parameters with overall survival. Methods: Using data from our tumor registry, we selected patients with aggressive lymphomas (AL), glioblastoma multiforme (GBM), metastatic prostate (MP), metastatic lung (ML), and metastatic colorectal (MCRC) cancer from 2018 to 2023. Laboratory data were extracted from our electronic medical record, with a timeframe of 90 days before and 30 days after first contact, but prior to initiating treatment. We analyzed the relationship of hemoglobin (Hgb), white blood cell (WBC) count, platelet (Plt) count, and body mass index (BMI), with overall survival (OS). Each cancer type was analyzed as a separate group and multivariable analysis was controlled by sex and age at diagnosis. Dichotomizing the variables from categories of the Khorana score, we evaluated the relationship of such variables and OS using Kaplan-Meier Analysis and Cox Proportional Hazards Models. Patients were censored at two years of follow-up. Data analysis was done using R (version 4.3). Results: Of 2,362 patients, 55% were male, and median age was 63 years. (Cancer types: 622 ML, 604 AL, 453 GBM, 281 MCRC, 203 MP, and 199 MB). An initial, pre-treatment Hgb < 10 g/dL was associated with a shorter OS in patients with ML, MCRC, MP, and AL patients. Plt ≥350 x 109/L was associated with a shorter OS in ML and MCRC patients. WBC > 11 x 109/L was associated with a shorter OS in ML, AL, and MCRC, and a BMI ≥35 was associated with a shorter OS only in GBM patients (Table). Conclusions: While not in all cancer types, the hematologic parameters of the Khorana score that predict thrombosis correlate with a reduced overall survival. This effect was significant for different parameters in different cancers. The increased hazard ratio is beyond that which would be expected from thrombosis-related mortality. Our study is limited to data from our single institution and the retrospective nature of the study. [Table: see text]
Inpatient outcomes of patients with new solid tumors admitted to a comprehensive cancer center.
Authors: Nguyen Son V. , Stephen Bobyna A. , Curry Shauna L. , Halm Josiah , Kheder Ed 
Published: June 2024

e23056 Background: Hospitalized cancer patients demonstrate multiple challenges including management of acute illnesses, establishment of the cancer diagnosis, creation of a goal concordant care plan, and post-hospital disposition. Yet, there has been limited research regarding characteristics and outcomes of new to hospital oncology patients. Methods: We performed a retrospective chart review of patients with suspicion or confirmed solid tumor cancer diagnosis who were admitted without an established MD Anderson Cancer Center oncologist. We assessed length of stay, ICU utilization, 30-day readmission rate, inpatient mortality, and discharge disposition. We compared the results to our group’s established oncology patients. Statistical analysis was performed using Chi-squared testing. Results: Between November 2022 and January 2023, 201 unique new patients were reviewed out of 1635 admissions. Of those 103 (51.2%) were males, median age of 60 (range: 22-79), White including Hispanics 118 (59%), African Americans 46 (23%), others 33 (18%). Of the study population, 88 (43.8%) did not have a confirmed cancer diagnosis, of which we established a cancer diagnosis in 68 (77.3%) and ruled out cancer in 8 (4%). Of the 113 (56.2%) diagnosed at outside facilities, 63 (55.8%) were treatment naive and 22 (19.4%) had their cancer diagnosis revised. Of 175 patients which had staging information, 150 (85.7%) were stage 4. During the index admission, 45 (22.4%) patients had cancer-directed therapy. The average and geometric mean length of stay (days) for new patients was 12.1 and 8.8, respectively, compared to the established group of 8.2 and 6.1 (p < 0.001). Inpatient mortality was higher in new patients (10.5% vs 6.8%, p < 0.001) and they were more likely to be referred to hospice services (17.4% vs 8.3%, p < 0.001). Furthermore, hospice referral was higher in the unestablished, previously treated group compared to treatment naive patients (28% vs 13.9%, p = 0.003), however inpatient mortality was similar (12% vs 9.9%, p = 0.63). ICU stay, 30-day readmission rate, discharge to home vs placement were similar in new and established patients (Table 1). Conclusions: Admitted new oncology patients typically present with advanced disease and had longer length of stay, mortality rates, and hospice referrals compared to established patients. Further research is needed to identify and improve care barriers to new inpatients, focusing on improving workflow process and timely goal concordant care discussions. [Table: see text]