bluuebunny/crossref_metadata_2025_split huggingface dataset:
Protocol requirements and logistical intensity of early-phase clinical trials (EP-CTs).
Authors: Durbin Sienna , Lundquist Debra , Healy Megan , Lynch Kaitlyn , Bame Viola , Martin Tristan , Johnson Andrew , Turbini Victoria , Juric Dejan , Jimenez Rachel , Nipp Ryan David 
Published: June 2022

e18609 Background: EP-CTs are increasingly important options for patients with cancer and often involve intensive monitoring. Characterizing the time burden and logistical intensity of EP-CT protocols could help patients and clinicians make informed decisions about trial participation. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs at Massachusetts General Hospital from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), EP-CT investigational agent (immunomodulatory [IM], targeted inhibitor [TI], antibody drug conjugate [ADC]/chemotherapy prodrug), and logistical intensity (visit frequency required per protocol and presence of extended visits). We defined visit frequency as the number of visits required per protocol within the first 28 days on trial. We defined an extended visit as six or more hours required in clinic on at least one day during the first 28 days on study. We evaluated associations among patient characteristics, investigational agents, logistical intensity, and time spent on trial. Results: Among 421 patients (median age = 63.0 years, 56.9% female, 97.6% metastatic disease), 43.2% were enrolled in IM EP-CTs, 43.0% TI, and 13.8% ADC/chemotherapy prodrug investigational agents. Patients enrolled on ADC/prodrug trials had the highest burden of metastatic disease (mean sites: 2.8 [ADC] vs 2.4 [TI] vs 2.3 [IM], p = 0.007) and oldest age (mean years: 64.0 [ADC] vs 61.7 [IM] vs 58.5 [TI], p = 0.003). However, those on ADC trials had the most days spent on trial (mean days: 78.3 [TI] vs 102.2 [IM] vs 131.8 [ADC], p = 0.003). Patients enrolled on TI trials had the highest required visit frequency compared with those enrolled on other trials (mean visits: 5.5 [TI] vs 5.3 [ADC] vs 5.0 [IM], p = 0.027). Additionally, those on TI trials were most likely to have an extended visit (82.3% [TI] vs 58.2% [IM] vs 29.3% [ADC], p < 0.001) and least likely to receive first in human therapy (38.1% [TI] vs 74.1% [ADC] vs 74.2% [IM], p < 0.001). Conclusions: In this cohort of patients participating in EP-CTs, we found that those enrolled on TI trials had the highest per protocol visit frequency and greatest likelihood of required extended visits. Those on ADC trials spent the most days on trial despite having the highest average age and burden of metastatic disease. These data highlight the time burden and logistical intensity of EP-CTs, underscoring certain trials as especially time intensive, which may help inform trial selection and participation.
Navigation of patients with locally advanced head and neck squamous cell carcinoma during cisplatin-based chemoradiation: A cohort study.
Authors: de Castro Gilberto , de Souza Priscila Rangel , Nunes Lenira Corsi Ruggiero , Souza Rosilene Josefa , Dias Tamara Aparecida Vieira , dos Reis Nathalia , Goes Samira S , Moravia Renata Alvim , Moreira Paulo Thadeu Fantinato , Lopez Rossana Veronica Mendoza , da Silva Maria Rita 
Published: June 2022

e18613 Background: Cisplatin(DDP)-based chemoradiation (CCR) is currently used to treat locally advanced head and neck squamous cell carcinoma (LAHNSCC), either as an exclusive modality or in the adjuvant setting. Acute, treatment-related toxicities are frequent. In this prospective cohort study, we evaluated the impact of patient (pt) navigation in multidisciplinary care by nurses on adherence to consultations and procedures, number and duration of hospital admissions, admissions to the emergency department, and treatment-related toxicities. Methods: In this prospective, uni-institutional cohort study, pts diagnosed with LAHNSCC (oral cavity, oropharynx, hypopharynx, and larynx) were consecutively included at the beginning of CCR, after informed consent. The navigation program included: (1) referral to multidisciplinary care (Nutrition, Psychology, Social Work); (2) monitoring attendance at multidisciplinary clinical visits; (3) monitoring of possible hospital and emergency admissions; and (4) diagnosis and monitoring of treatment-related toxicities, graded according to CTCAE v5.0. To observe an effect size of 0.50 with a power of 80% and a type I error of 0.05, 64 pts would be needed. Here we present the analysis of the first 26 pts included, with outcomes compared to 130 LAHNSCC pts treated with CCR at the same institution in 2019. Accrual was stopped. Results: 26 pts were included between Mar/2021 and Sep/2021, with a median age of 57 years, being 77% men, with KPS ≥ 80% in 25 pts (96%), and with a primary tumor in the oral cavity or oropharynx in 18 patients (69%). CCR was administered in the adjuvant setting in 9 pts and as an exclusive treatment in 17 pts. 10 pts (39%) experienced DDP discontinuation (mainly for toxicity) in the navigation group, compared to 67% in the control group (p = 0.008); and the duration of radiotherapy was 48d and 49d, respectively (p = 0.483). No grade 4 adverse events were observed in navigated pts. The median number of absences (any visit or treatment) was 1.0 (control) and zero (navigation, p < 0.001). Admission to the emergency department occurred in 6 navigated pts (23%) as compared to 100 control pts (77%, p < 0.001), while hospitalizations occurred in 1 (3.8%) and 50 (38.5%, p < 0.001), respectively, lasting 4.9±9.7d and 1±0.39d (p = 0.001). Conclusions: The navigation program provided better outcomes in comparison to the control group, in terms of a lower number of missed appointments, a higher number of chemotherapy cycles administered, lower frequency of severe toxicities, lower frequency of attendance at emergency and hospitalization services, as well as reduced length of hospital stay.
Impact of neuroendocrine tumor diagnosis (NET) on quality of life.
Authors: Roy Arya Mariam , Kaur Jasmine , Iyer Renuka V. 
Published: June 2022

e18614 Background: With longer median survival for NET patients, the impact of symptoms and treatments on QOL and financial well-being throughout the disease course need to be evaluated to understand the true burden of the disease on patients. Current HRQOL data are during active treatments and this prospective biobank was established to capture this information throughout the disease course. Methods: At Roswell Park Comprehensive Cancer Center, with Institutional Review Board (IRB) approval a NET biobank was established in April 2019 for collecting clinical tissue samples, patient demographics, treatment outcomes, access to care and self-reported HRQoL outcomes. Using previously developed HRQoL questionnaires, we examined the impact of the NET on the quality of life of NET patients and data of 144 patients enrolled to date in the biobank is presented here. Linear regression was used to assess the association of baseline characters with QoL variables. The analysis was done with STATA/IC 16.0. Results: A total of 144 patients are enrolled. Males were 27% (n = 39) and females were 73% (n = 105). The mean age of diagnosis was 54 +/- 0.79, with those between 45 to 65 (72%, n = 103). These patients were enrolled through support groups and social media from 30 different states in the US (135) and 9 pts from Canada. After the diagnosis, 27% of patients had to quit their job. Impact on major HRQoL variables are summarized in Table. Only 21% of patients reported that they feel knowledgeable about NET and got the majority of their support from their primary care (60%) and oncologist (57%). When asked about the most pressing need from their care team, 57% of patients requested their care team had more information about available clinical trials. Sex, age groups did not have statistically significant association on the impact of NETs on the HRQoL of patients. Conclusions: NET diagnosis affects the HRQoL of patients including their social, emotional, and financial well-being. A national biobank capturing data on various demographic, risk factors, treatment sequence, symptoms, HRQoL parameters, financial toxicity is a valuable resource to better understand the needs of this patient group.[Table: see text]
Systematic assessment of online health information related to drug therapy for non-small cell lung cancer.
Authors: Xu Yu-Hui , Zheng Yi-Fan , Yang Hui-Min , Chen Xiao , Tang Ke-Jing 
Published: June 2022

e18626 Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Patients increasingly use the internet for drug therapy information that may influence decision-making, drug adherence, and self-management. However, online drug therapy information is prone to quality and readability issues. We systemically assess online drug therapy information for patients with NSCLC in terms of quality, suitability, reliability and readability. Methods: NSCLC online drug therapy websites were searched with three terms using three major engines (Google, Yahoo and Bing). Validated tools were used to assess the content in terms of quality (DISCERN), suitability (Suitability Assessment of Materials [SAM]), reliability (Journal of the American Medical Association [JAMA] benchmarks and the Health on the Net [HON] code), readability (Flesch-Kincaid Grade Level). The scores were compared in drug therapy and affiliation subgroups. Results: A total of 52 websites were included. The median quality score was 48.8 (interquartile range [IQR], 39.5-57.0), or fair (39-50). The quality scores were not statistically significant between different subgroups. The median suitability score was 43.8% (40.6%-46.4%), or adequate (40%-69%). The commercial websites showed the highest median suitability score of 45.2%, which was significantly higher than that of non-profit websites ( P < 0.05). The average readability was at a grade of 10.6 level using the Flesch-Kincaid scale which was significantly higher than the traditionally recommended grade-six level ( P＜0.001). The median reliability scores of commercial websites were observably higher than non-profit websites ( P＜0.05). Around 40% of websites were HON code accredited. Conclusions: Most online resources for NSCLC have fair quality, adequate suitability, and poor readability. Reliability was of a moderate level. Therefore, healthcare providers should be cautious when referring patients to online health information and the online information for NSCLC has great room for improvement.[Table: see text]
Impact of readmission for patients with cancer in a public health system.
Authors: Hidalgo Filho Cassio Murilo Trovo , Lazar Neto Felippe , Da Rocha Joao Wilson , Bonadio Renata Colombo , Hoff Paulo Marcelo 
Published: June 2022

e18633 Background: Patients with cancer have high mortality during hospitalization and poor prognosis after discharge. However, most evidence comes from developed countries where early diagnosis is common and a higher number of treatment options are available. In addition, socioeconomic disparity is also known to impact on cancer prognosis. We aimed to investigate the impact of hospitalizations, early readmissions, and Human Development Index (HDI) among cancer patients in a public tertiary hospital in Brazil. Methods: A retrospective study was conducted including patients admitted at a Brazilian tertiary cancer center from February 1st to November 30th of 2021. Data was collected from patients' electronic health records. COVID-19 diagnosed patients were excluded. We evaluated 7-day and 30-day readmission rate, and post-discharge survival. We retrieved patients' home address region HDI from the latest Brazilian Census and investigated if it would affect hospitalization and post-discharge outcomes. Overall survival (OS) after discharge was compared between groups with log-rank test and categorical variables proportions with chi-square test. Results: A total of 3711 patients were included during the period. The median age was 64 years (IQR 53-72); nearly half were female (51%). The most common cancer diagnosis was breast cancer (538, 15%) followed by prostate (308, 8.4%), colon (298, 8.1%) and lung (269, 7.3%). The median hospitalization length was 6 days (IQR 4-11). The overall in-hospital mortality rate was 20% (n = 734). Patients initially admitted to the Intensive Care Unit (ICU) had a higher mortality compared to wards (44% vs 17%, p < 0.001). Of those discharged, 9.9% and 28% of the patients were readmitted within 7 and 30 days, respectively. The median overall survival (mOS) of the discharged patients was 182 days (95% CI 160-201 days). Early readmission within 7 and 30 days were associated with poorer overall survival after discharge (Table, p < 0.001). We have not found any association between the HDI and in-hospital mortality, rate of readmissions or overall survival after discharge. Conclusions: Early readmission is an important prognostic factor and should be taken into consideration when discussing post-discharge treatment objectives. HDI does not seem to affect neither hospitalization nor survival outcomes in a publicly funded cancer center.[Table: see text]
Medically integrated dispensing (MID) clinical and cost outcomes compared to specialty pharmacies (SP).
Authors: Leach Joseph W. , Eckwright David , Champaloux Steven W. , Forsberg Paul , Weiss Arno , Jorgensen Christopher , Gleason Patrick P. 
Published: June 2022

e18645 Background: Oral oncolytics MID offers potential care and cost advantages compared to a centralized SP model. A pharmacy benefit manger and 3 health plans created a pilot program to enable and encourage oncology practice MID with the goal of improving care, enhancing the provider and patient experience, and reducing drug waste. This study assesses clinical outcomes and drug waste differences between MID and central SP dispensing using real-world pharmacy claims data. Methods: The MID pilot program was implemented early 2021 within 3 oncology practices across 3 plans commercially insured lives. Members were required to have continuous enrollment for the adherence and discontinuation (d/c) measures. Adherence was measured using the CMS industry standard proportion of days covered with a > / = 80% cut point. D/c was measured in new initiators defined as no claim evidence of the drug in the previous 90 days with discontinuation defined as having a > / = 45-day therapy gap within the first 180 days. Dose changes were defined as a new unit strength being dispensed for a previously filled drug. Each measure used a unique drug list: 3 CDK4/6i for adherence; 10 highly utilized oral brand and generic oncolytics for d/c; and 26 oral oncology brand drugs having multiple strengths and labeled dose change directions for dose change waste. The adherence and waste measures assessment end date was Dec 31, 2021 and for d/c was Jan 28, 2022. Statistical testing: adherence- Fischer’s exact test; d/c- chi-square; and waste– t-test. Results: For adherence, individuals were followed for an average of 243 days, range 21-333 days, without a statistical difference between MID and SP follow-up. CDK4/6i adherence was 82% (9 of 11) for MID and 73% (421 of 574) for SP, p = 0.74. D/C was 29% (15 of 52) for MID and 48% (360 of 753) for SP, p = 0.01. Waste occurred in 29% (6 of 21) of MID dose changes and 50% (315 of 627) of SP dose changes, p = 0.05; resulting in an average cost of $937 and $2,733 per dose change at the MID and SP, respectively, for an SP average dose change additional cost of $1,796. Conclusions: MID demonstrated numerically higher adherence, significantly lower d/c rate with MID having a number need to treat of 5 to prevent one less d/c event, and significantly lower waste expense with an estimated savings of $1.1 million, if all 627 individuals with a dose change at SP had used a MID. These real-world findings have resulted in a national PBM network to encourage MID use.
A multiphase continuing education and quality improvement initiative to tailor treatment plans for patients with follicular lymphoma.
Authors: Kim Joseph , Fenske Timothy S. , Gracie-King Linda , Viens Marc David , Ocana Victor , Chandra Abhinav Binod , Penberthy David , McCurdy Tori 
Published: June 2022

e18651 Background: Data support the need for increasing shared decision-making (SDM) conversations to align treatment decisions with patient values and preferences (Kehl KL et al. JAMA Oncol. 2015). Combining certified interprofessional continuing education and quality improvement (QI) methods may accelerate how cancer clinicians translate evidence into real-world clinical practice when diagnosing and treating patients with follicular lymphoma (FL). This initiative was supported by educational grants from Genentech, a member of the Roche Group and Bristol Myers Squibb and managed by AXIS Medical Education and Q Synthesis. Methods: The project collaborators invited three community hospital-based cancer centers to participate in this 18-month longitudinal, multiphase CME/CE and QI initiative. Each cancer center performed a baseline assessment by reviewing how their clinicians diagnosed and treated patients with FL. This process involved chart reviews, focus group discussions, and online surveys. Each cancer center developed problem statements, aim statements, and implemented improvement projects around prognostic scoring, the use of molecular diagnostics, SDM, and treatment planning. Clinicians also participated in two live virtual continuing education interventions, co-moderated by an academic clinician with a focus in lymphoma (T.F.), as well as the medical director of the activity (J.K.) and received reinforcement messages following those activities. Results: Members of the multidisciplinary cancer care team from three cancer centers in AZ, TN, and VA participated in this initiative. Across all three cancer centers, the following educational outcomes were observed: 61% increase in knowledge about the concept of POD24 (early disease progression within 24 months of initiating therapy); 50% increase in knowledge and practice skills regarding tailored treatment planning based on patient risk factors and prognostic scores; 33% increase in knowledge around the benefits of incorporating SDM when developing treatment plans, and an 18% increase in knowledge about risk-based treatment plans. The QI projects resulted in a 56% improvement in prognostic scoring (incorporating tumor grade and stage), a 25% increase in documenting tumor burden, and a 22% increase in the use of molecular diagnostics. Conclusions: This multiphase education and QI program enabled cancer clinicians to improve monitoring patients for POD24 and risk assessment, incorporate molecular testing, engage in SDM conversations with patients, and formulate tailored treatment plans for patients with FL.
Incorporating mediation-based interventions at an academic cancer center: A six-step process.
Authors: Jain Neha M , Schremp Emma , Spalluto Lucy , Osterman Travis John , Friedman Debra L. 
Published: June 2022

e18662 Background: A growing body of evidence, including NCCN guidelines for distress management in oncology, supports the use of meditation-based interventions (MBI) in cancer care. However, MBI are generally delivered outside of the cancer treatment setting, with no integration between meditation instructors and the oncology care team. Further, there have been no studies to evaluate implementation of this evidence-based practice into routine cancer care. We report on the implementation process for establishing an integrated MBI program at an NCI-designated comprehensive cancer center. Methods: Guided by the Consolidated Framework for Implementation Research (CFIR), we developed a discrete MBI program as a strategy to implement MBI in our cancer center. Program components included 1) identifying champions and key stakeholders; 2) engaging with patient navigators and patient advocates; 3) partnering with cancer center leadership to gain infrastructure support; 4) establishing a meditation-focused program to increase acceptability amongst providers and patients; 5) launching an IRB-approved study to measure study outcomes; 6) leveraging social media, patient newsletters, and other institutional communication modes to increase awareness. We used the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to define the outcome measures including reach (number of patients who attended an MBI session), adoption (number of providers who referred patients to MBI and number of patients who attended > 1 MBI session), and implementation (feasibility and acceptability). Results: An MBI program has been successfully established within an NCI-designated comprehensive cancer and has received enthusiastic support from oncology providers, research nurses, as well as patient advocate groups. The intervention is delivered three times a week in 30 min sessions via videoconferencing. At the end of each session patients are encouraged to complete a short online survey about their experience. The first class has been established and enrolment is ongoing. Conclusions: Given the high prevalence of psychosocial distress in a rapidly expanding global cancer population, implementation of strategies to integrate psychosocial interventions, such as meditation, into routine care is critical. Well-defined MBI programs such as this can overcome the misperception that MBIs are difficult to implement in cancer centers and support the successful implementation of MBIs within cancer programs. Adoption of this evidence-based strategy can positively impact patient psychological resilience.