bluuebunny/crossref_metadata_2025_split huggingface dataset:
Implementing financial toxicity and health-related social risks screening and referral.
Authors: Thom Bridgette , Aviki Emeline Mariam , Chino Fumiko 
Published: June 2024

11006 Background: Financial toxicity (FT), or cancer-related economic hardship, is associated with delayed/skipped care, reduced quality of life, and worse mortality. Screening for FT and health-related social risks (HRSR) as part of assessment for social determinates of health is currently being integrated into clinical care, but there is limited research on outcomes after patients screen positive for FT or HRSR. Methods: We conducted FT and HRSR screening for patients receiving treatment for breast, gynecologic, gastrointestinal, or thoracic cancer at an urban comprehensive cancer center. Screening included the 11-item Comprehensive Score for Financial Toxicity (COST) tool (scored 0-44, lower scores = worse FT) and a HRSR checklist to identify food, housing, medicine, and transportation insecurity. A COST score ≤20 or any endorsed HRSR was considered a positive screen, and financial/assistance counseling referral was offered. Multivariable logistic regression assessed associations of accepting referral, after controlling for demographic and clinical characteristics. Data were collected 09/2022-08/2023. Results: 28,606 patients completed screening, of which 32% (n = 9106) screened positive. Median COST was 16.0. Identified HRSR were: 23% food, 25% housing, 21% medicine, and 24% transportation insecurity. Of positive screens, 51% (n = 4683) requested some form of financial counseling. Associations with accepted referral include: higher FT (β = 1.15, 95% CI: 1.13, 1.16), younger age (β = 1.01, 95% CI: 1.008, 1.02), more essential needs (β = 1.19, 95% CI: 1.13, 1.25), non-White race/ethnicity (β = 1.70, 95% CI: 1.49, 1.93), and stage 3 (β = 1.29, 95% CI: 1.08, 1.53) or stage 4 (β = 1.26, 95% CI: 1.07, 1.49) diagnoses (vs. stage 0/1). Needs of patients who requested counseling included concerns relating to out-of-pocket expenses (68%), non-medical expenses (39%), health insurance coverage (23%), and paying for prescription medication (18%; not mutually exclusive). Of financial counseling sessions with available dispositions (n = 2336/4683, 50%), outcomes (not mutually exclusive) included general counseling (29%), referral to specific assistance programs (e.g., copay assistance, reduced cost care program; 15%), and insurance navigation (15%). One-third of patients requesting counseling did not respond to contact attempts; 21% reported no longer being interested in counseling upon contact. Conclusions: Screening for FT and HRSR was feasible, and one-third of patients were identified as at risk for FT or having an unmet essential need. Patients known to have worse FT outcomes (those with later-stage disease, younger age, higher FT, minoritized groups) were more likely to accept financial counseling; however, only one-half of those at risk accepted help. Future work will focus on improving workflows to ensure assistance meets patient needs, including addressing patient stigma around requesting help.
Early integrated rehabilitation and vocational rehabilitation in 435 patients with breast cancer: A comparison between the intervention group and control group in a prospective study.
Authors: Besic Nikola , Kurir Borovcic Mateja , Mavric Zlatka , Mozetic Anamarija , Zagar Tina , Homar Vesna , Kopcavar Gucek Nena , Skufca Smrdel Andreja Cirila , Kozjek Nada Rotovnik , Hadzic Vedran , Kos Natasa , Pelhan Bojan , Sremec Marko , Rozman Tina , Borstnar Simona 
Published: June 2024

11007 Background: Return to work is beneficial both for breast cancer (BC) patients and for society. This study explored the impact of early integrated and vocational rehabilitation on sick leave and disability one year after the start of cancer treatment in BC patients. Methods: The subjects of our prospective study were 435 employed female BC patients (26-65 (mean 52) years of age), who participated in the pilot study on the individualized integrated rehabilitation in 2019-2022 and were followed for at least one year. There were 211 patients in the control group and 224 in the intervention group. The patients completed three questionnaires (EORTC QLQ - C30, B23, and NCCN): before, half and one year after the start of cancer treatment. The control group received the standard rehabilitation programme, offered to all BC patients before the start of the study. The multidisciplinary rehabilitation team reviewed the documentation of the patients from the intervention group before, half and one year after the start of treatment and recommended appropriate interventions according to the patient's needs in compliance with the institute’s new clinical pathway (psychologist, general practitioner, nutritional treatment, physical rehabilitation, kinesiologist-guided online exercises, gynaecologist, analgesia, vocational rehabilitation). Data on the patients’ demographics and needs reported in questionnaires, the extent of the disease and cancer treatment were collected. These data and the frequency of sick leave and disability retirement one year after the start of treatment in both groups of patients were analysed using the chi-square and ANOVA test. Results: The patients from the intervention group had 50 calendar days shorter sick leave compared to the control group (p = 0.002). Patients without metastatic disease from the intervention group had 52 calendar days shorter sick leave compared to the control group (p = 0.002). The intervention group treated with chemotherapy had 43 calendar days shorter sick leave compared to the control group (p = 0.029). The difference in sick leave of the group of patients who did not receive chemotherapy was statistically borderline significant (50 calendar days, p = 0.053). The patients in the intervention group had a better work ability (p < 0.001) and less disability (p < 0.001) than the patients in the control group one year after the start of treatment. Conclusions: One year after the beginning of cancer treatment, patients from the intervention group had shorter sick leave, better work ability, and a lower proportion of disability compared to the control group.
Association of higher baseline stress and pain with clinical outcomes: Secondary analysis from Alliance A011502.
Authors: Gandhi Shipra , Ballman Karla V. , Holmes Michelle D. , Visvanathan Kala , Symington Banu , Carvan Margaret , Matyka Carol , Weiss Anna , Winer Eric P. , Razaq Wajeeha , Carey Lisa A. , Partridge Ann H. , Chen Wendy Y. 
Published: June 2024

11016 Background: A011502 is a phase 3 randomized double-blind clinical trial that enrolled high-risk nonmetastatic breast cancer (BC) patients (pts) and randomized pts to aspirin 300 mg daily vs. placebo. There was no significant difference in invasive disease-free survival (iDFS) between the two arms. A secondary objective was to determine the association of inflammation-affiliated factors (stress, depression, poor sleep quality and pain) with iDFS and overall survival (OS). We hypothesized that these baseline factors are associated with worse clinical outcomes. Methods: At baseline, 2735, 2720, 2422 and 2610 pts completed Perceived Stress Scale (PSS), Brief Pain Inventory (BPI), Pittsburgh Sleep Quality Index (PSQI) and Center for Epidemiologic Studies Depression Scale Revised (CESD-R) respectively. Stress was categorized with PSS scores: low (0-13), moderate (14-26) or high stress (27-40). Pain was categorized with BPI scores: none/mild (0-3) or moderate/severe (≥4). Sleep quality was categorized with PSQI scores: good (0-5) or poor ( > 5).Depression was categorized with CESD-R scores: no depression (0-15) or depression (≥16). Associations between the measures of interest and outcomes were performed with multivariable Cox models controlling for age, body mass index, time since diagnosis, race, ethnicity, hormone receptor status and treatment arm. Results: Median follow up was 35 months. The associations from multivariable Cox model are shown in Table 1. Pts who reported high PSS had significantly worse iDFS and (non-significant) worse OS. Moderate/severe average (avg) pain was significantly associated with worse iDFS and OS. Poor sleep quality and depression were associated with worse iDFS and OS but not statistically significant. Conclusions: Pts reporting higher stress and pain at baseline had worse outcomes. We acknowledge that both pain and stress may be related to other non-cancer issues (chronic comorbidities). Our study highlights the need for clinical trials to consider including questionnaires to assess pt-reported outcomes. Future studies are warranted to determine if measures to decrease pain and stress would improve BC outcomes. U10CA180821, U10CA180882, UG1CA233196; https://acknowledgments.alliancefound.org . NCT02927249: Clinical trial information: NCT02927249 . [Table: see text]
Impact of the COVID-19 pandemic mitigation strategies on cancer treatment trials: A meta-analysis of industry and NCI studies.
Authors: Unger Joseph M. , Andrews Hillary , Levit Laura A. , McKelvey Brittany Avin , Stewart Mark , Dressler Emily Van Meter , Flaherty Keith T. , Fredette Peter , Jones Lee , Miller Therica , Onitilo Adedayo A. , Patel Timil , Bruinooge Suanna Steeby , Garrett-Mayer Elizabeth , Schenkel Caroline 
Published: June 2024

11021 Background: ASCO and Friends of Cancer Research established a task force to evaluate trial mitigation strategies allowed by US regulators during the COVID-19 pandemic, including the use of telemedicine and remote monitoring. We report the results of a meta-analysis quantifying the impact of these strategies on quality metrics and the recovery time to pre-COVID levels. Methods: We invited 41 sponsors with active US cancer treatment trials from January 2015-May 2022 to contribute deidentified trial-level aggregate data on major protocol deviations (PDs), dropouts, severe or worse toxicity (CTCAE Grade 3-5), and enrollment. We examined outcomes as proportions of participants at-risk during the pre-COVID, initial wave (IW), initial recovery (IR), and secondary recovery (SR) assessment times (Table). Multi-level beta-regression analyses were adjusted for trial phase (“early”, phases I, II, or I/II, vs. “late”, phase III) with study and sponsor as random effects. Indicator variables were used for post-COVID time periods with pre-COVID as the reference. Results: Ten sponsors (9 industry and 1 NCI Cooperative Group) contributed 82 evaluable studies: 63 early and 19 late phase trials. Among the 15,679 participants, enrollment odds decreased 64% in the IW and 45% in the IR but recovered to approximately pre-COVID levels by the SR (Table). Major PDs, dropouts, and severe or worse toxicity all had lower incidence in the IW compared to pre-COVID; these outcomes were also less frequent in IR (p<.05 for each), but not in the SR (p>.05 for each) compared to pre-COVID. Conclusions: Large declines in enrollment rates during the IW rebounded to pre-COVID levels by 2021-2022. We found steep reductions in the rates of reported occurrence of major PDs, dropouts, and severe or worse toxicity during the initial outbreak, which also recovered to pre-COVID levels by 2021-2022. Findings suggest pandemic-related procedural flexibility did not lead to increased reporting of PDs or dropouts and highlight how use of mitigation strategies likely corresponded with the temporary disruption to trial conduct during the pandemic’s peak. Sponsors could consider broader adaptation of trial flexibilities moving forward. [Table: see text]
Project Facilitate: An analysis of the increased utilization in the oncology single patient expanded access pathway.
Authors: Chan Mitchell , Wilson Cameron , Boehmer Jessica , Kim Tamy , Pazdur Richard 
Published: June 2024

11029 Background: FDA Oncology Center of Excellence’s (OCE) Project Facilitate (PF) was launched in June 2019 in response to perceived barriers providers face when accessing Expanded Access (EA). PF staff provide step-by-step support to oncology healthcare providers requesting use of investigational drugs to treat their patients with cancer. Since launch, PF has received an increased number of oncology single patient EA applications each calendar year. An analysis of single patient investigational new drug applications (IND) received was performed over each calendar year, starting June 1, 2020. Methods: Data was extracted from PF’s central database between June 1, 2020 and December 31, 2023. Data collected included IND receipt date, granting date, status, application type, indication, drug name, address of requestor, and patient demographics. The starting date of June 1, 2020 was chosen since it was when PF staff officially started performing clinical review of applications. Results: Of the 2791 oncology single patient expanded access applications extracted, there were 681 (24.4%) emergency INDs (eIND) and 2110 (75.6%) non-emergency single patient INDs (SPI). Applications received by calendar year increased since June 1, 2020 to December 31, 2020 (397, 14.2%), 2021 (682, 24.4%), 2022 (822, 29.5%), and 2023 (890, 31.9%). The top-3 disease areas requested include high grade glioma (262, 9.4%), multiple myeloma (213, 7.6%), and melanoma (186, 6.7%). The top-3 disease areas requested in pediatric patients < 17 years of age (568, 20.4%) include AML (88, 15.5%), high grade glioma (85, 15%), and ALL (47, 8.3%). Race and ethnicity information was provided in 32 applications containing white/Caucasian (24, 75%), Black or African American (4, 12.5%), Asian (2, 6.25%), and Hispanic or Latino (2, 6.25%). Applications were received from 46 states and 1 US territory, Puerto Rico. The top 3 states requestors resided in were CA (346, 12.4%), NY (317, 11.4%), and TX (276, 9.9%). Although rare, 22 (0.79%) applications were denied or placed on clinical hold most commonly due to curative or established therapies being available. Conclusions: Project Facilitate saw a 20.4% increase in oncology single patient expanded access requests received from calendar year 2021 compared to 2022 and an 8.3% increase from 2022 to 2023, equaling a 30.4% increase in 2023 compared to 2021. [Table: see text]
Caregivers and legal barriers: Navigating care of a family member diagnosed with cancer.
Authors: Chen Krista Y. , Blackford Amanda L. , Bryant Monica Fawzy , Doran Joanna F. , Hussaini S. M. Qasim 
Published: June 2024

11034 Background: Caregivers of patients with cancer are vital for coordinating care, but the extent to which they encounter social and legal barriers is unknown.We performed a nationwide analysis of a legal navigation program to assess caregiver utilization of services. Methods: This is a retrospective analysis of caregivers who used the Triage Cancer Legal & Financial Navigation Program for legal navigation services on behalf of a family member with cancer or for questions regarding caregiver responsibilities. Triage Cancer is a national nonprofit that provides free education on legal and practical issues impacting patients with cancer. We gathered demographic, financial, disease-site, and legal navigation data and implemented Poisson regression models to explore factors associated with each type of primary legal concern that prompted a call for assistance. Results: We examined calls from 553 caregivers between 2021-23 for family members with cancer who were 54% male, 44% aged 40-64y, 51% White, 26% employed, 32% on employer-sponsored insurance, and 42% with income <$50k. Most prevalent cancer types were hematologic (23%), CNS (14%), GI (10%), and breast (9%). A majority of caregivers sought assistance with 1 (51%) or 2 (35%) legal barriers. Most common primary issue was health insurance (34% - including issues related to insurance options, navigation, appeals), followed by financial (22% - financial assistance, housing), disability (15% - insurance applications, claim appeals), other (18% - estate planning, wills, advanced directives; life insurance; family law; education; COVID), and employment (10% - time off, working through treatment, returning to work, job loss, job search, unemployment benefits). Compared to reference groups, caregivers of Black patients (RR 2.2) were more likely to call for financial barriers, patients aged 40-64y (RR 3.4) for disability insurance, uninsured individuals (RR 5.6) for health insurance, and those with income between $50-100k (RR 3.1) or patient age 0-39 (RR 5.2) for employment-related difficulties. Conclusions: This study highlights the social and legal navigation undertaken by caregivers of patients with cancer. It underscores an urgent need for accessible legal navigation that considers the caregiver alongside the patient as one family unit undergoing care. [Table: see text]
Clinical applicability of guideline-recommended molecular targets and genome-targeted cancer therapies.
Authors: Tibau Ariadna , Hwang Thomas J. , Avorn Jerry , Kesselheim Aaron S. 
Published: June 2024

11049 Background: Genomic testing has expanded the possibilities of precision medicine, particularly for advanced, treatment-resistant cancer cases. However, the clinical relevance of most genetic alterations remains uncertain, which can lead physicians to overestimate the benefits of tailored therapies. The National Comprehensive Cancer Network (NCCN) guidelines are cancer-specific treatment recommendations that often determine insurance coverage. We assessed the evidence for clinical benefit and actionability of molecular targets for genome-targeted cancer drugs recommended by NCCN. Methods: We identified genome-targeted therapies for solid cancers from the most recent NCCN guidelines. Trial design characteristics were obtained from publications supporting the NCCN recommendations. Genome target actionability was assessed with the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of molecular Targets (ESCAT). This ranges from genome alternation-therapy combinations that lead to improved outcomes (Tier I) to treatments with potential clinical relevance (Tiers II or III) to those with undetermined relevance (Tiers IV to X). Clinical benefit was evaluated using the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS). Molecular targets at ESCAT Tier I in combination with a given treatment associated with studies demonstrating substantial clinical benefit by ESMO-MCBS (Grades 4-5) were designated as high-benefit, while those linked to studies achieving an ESMO-MCBS Grade of 3 were categorized as promising but unproven. Results: We extracted411 recommendations from NCCN supporting 74 genome-targeted drugs targeting 50 driver alterations. Most recommendations (346/411, 84%) referred to clinical trial data, while one-sixth (65/411, 16%) relied on case reports or preclinical studies. Clinical trials were mostly Phase I or Phase II (271/346, 78%), single arm (262/346, 76%), and evaluated overall response rate as the primary endpoint (271/346, 78%). Over half of target recommendations had Tier I target actionability (246/411, 60%), over one-third were Tier II or III (142/411, 35%), and the rest were undetermined (23/411, 6%). Among 267 scorable trials,12% (32/267) demonstrated substantial clinical benefit (ESMO-MCBS Grades 4-5) and 45% (121/267) were Grade 3. When combining both frameworks,12% (32/267) genomic-based cancer treatments were high-benefit and 33% (88/267) were promising-but-unproven. Conclusions: About one-eighth of genome-targeted cancer therapies recommended in NCCN guidelines received a high benefit rating, while one-third were identified as having a promising but unproven substantial benefit according to the ESCAT and ESMO-MCBS frameworks. Ensuring NCCN recommendations are aligned with well-documented clinical benefits is crucial for promoting informed, evidence-based genomic-guided treatment decisions.
Cancer care service use intensity in Medicare Advantage versus traditional Medicare.
Authors: Mitchell Aaron Philip , Kalidindi Yamini , Feldman Roger , Carlin Caroline , Song Ge , Jung Jeah 
Published: June 2024

11054 Background: Prior studies have found evidence of lower cost of care and preserved care quality among Medicare Advantage (MA) plans vs. traditional Medicare (TM). However, MA performance for patients with serious conditions such as cancer is yet to be explored. MA plans are incentivized to reduce expenditures, and the high financial cost (often with marginal clinical benefit) of chemotherapy might be an opportunity for savings. We compared service use intensity and quality between MA and TM cancer patients receiving systemic therapy. Methods: Medicare claims data and MA encounter records (including only MA contracts that had highly complete data), 2015-2019. We included patients with select major cancer types, and measured outcomes during a 6-month chemotherapy episode, defined by the date of systemic therapy initiation after a 1-year washout period. Service use intensity was measured in dollar terms using standardized Medicare prices. Quality measures included treatment-related emergency department (ED) visits and hospitalizations, avoidable ED visits, preventable hospitalizations, and overall survival. To estimate the association between MA enrollment and these outcomes, we used regression models with county-level fixed effects and inverse probability of treatment weighting to balance the MA and TM samples on patient demographics, cancer type, health-risk score, metastatic status, frailty, and area characteristics. We performed separate analyses by cancer type. Results: The study sample comprised 96,501 MA and 206,274 TM beneficiaries who had one of seven cancer types: breast cancer, chronic leukemia, colon cancer, lung cancer, lymphoma, multiple myeloma, and prostate cancer, and who initiated systemic therapy between 2016 and 2019. Estimated mean overall service use among MA enrollees was $62,599, compared to $71,317 for TM beneficiaries (-$8,718, p<0.01). A majority of the overall difference was accounted for by Part B-covered systemic therapy drugs ($20,691 in MA versus $25,723 in TM, difference -$5,032, p<0.01). Although MA enrollees received slightly cheaper drugs (-$277 per treatment day, p<0.01), the lower cost of systemic therapy was driven largely by a lower number of treatment days occurring per 6-month episode for MA enrollees (-1.06 days, p<0.01). MA enrollees had fewer treatment-related ED visits and hospitalizations (-2.5%, p<0.01 and -0.7%, p<0.01 respectively) but had more avoidable ED visits (+0.5%, p<0.01). There was no difference in survival or preventable hospitalizations. Results were similar within individual cancer types. Conclusions: MA enrollment is associated with reduced service utilization but not shorter survival among cancer patients receiving systemic therapy. Further research is needed into the mechanisms of these savings to identify areas where care may be delivered more cost-effectively without negatively impacting outcomes.