tbuckley/cabot-search huggingface dataset:
Efficacy of eSyM: Acute care utilization among patients with cancer who do versus do not report ePROs.
Authors: Michael J. Hassett, Hajime Uno, Angela Tramontano, Christine Cronin, Jessica J Bian, Don S. Dizon, Hannah W. Hazard-Jenkins, Raymond U. Osarogiagbon, Sandra L. Wong, Deb Schrag
Journal: Journal of Clinical Oncology (2024)

11001 Background: Patients (pts) receiving cancer treatment frequently experience burdensome symptoms that compromise outcomes and necessitate acute care. Prior clinical trials have demonstrated that electronic patient-reported outcome (ePRO)-based symptom management programs improve outcomes in controlled settings. Deploying these programs in routine care settings remains challenging. With funding from the Cancer Moonshot IMPACT Consortium, we created eSyM – an ePRO-based, EHR-integrated symptom management program – to facilitate the widespread adoption of active symptom management efforts. Methods: eSyM was deployed across six health systems from September 2019-August 2022 via a modified stepped-wedge cluster randomized pragmatic trial. Pts starting chemotherapy (CHEM) or undergoing surgery (SURG) for a suspected or confirmed thoracic, gastrointestinal, or gynecologic cancer were prompted to complete symptom questionnaires regularly; those reporting symptoms were offered additional supports. To assess eSyM efficacy, we studied pts who were eligible to use the program – comparing those who completed at least one symptom questionnaire to those who did not. Outcomes included emergency department (ED) visits and inpatient encounters (INPT) at 30 and 90-days. Odds ratios with 95% CIs were derived after adjusting to account for the propensity to report ePROs as a function of age, sex, race/ethnicity, employment, marital status, poverty, rurality, insurance, comorbidity, cancer, treatment goal, institution, and calendar time. Results: Among eSyM-eligible pts, 51% (N = 10,454/20,471) completed at least one symptom questionnaire (median 4 reports/patient) – 47% (3815/8187) for CHEM and 54% (6639/12,293) for SURG. Comparing symptom reporters to non-reporters, the proportion of CHEM+SURG pts experiencing an ED event was 5.3% vs. 7.1% at 30 days and 10.0% vs. 12.9% at 90 days; and the proportion experiencing an INPT event was 6.7% vs. 11.3% at 30 days and 14.0% vs. 19.5% at 90 days ( p&lt; 0.001 for all). Adjusted ORs appear in the. Conclusions: After accounting for propensity to report symptoms, completing at least one symptom questionnaire was associated with lower odds of experiencing an ED or INPT encounter among CHEM and SURG pts across six diverse health systems. eSyM engagement reduced acute care utilization. This EHR-integrated symptom management solution is broadly available to health systems that use Epic. Clinical trial information: NCT03850912 . [Table: see text]
Analysis of diagnosis patterns and implications on cancer stage in patients with lung cancer: A single-institution experience.
Authors: Maha Zafar, Muhammad Arnous, Nkolika Nwankwo, Aswanth Reddy
Journal: Journal of Clinical Oncology (2024)

e22508 Background: Lung cancer is the most common cause of cancer-related death in the US. Patients are often diagnosed at advanced stages, challenging treatment and improving life expectancy. There has been tremendous progress in developing newer treatments; however, it is crucial to emphasize low-dose CT (LDCT) screening as it may improve earlier diagnosis and ultimately lead to better outcomes. Research Question What is the utilization of LDCT for lung cancer screening in newly diagnosed lung cancer patients? Do patients with lung cancer diagnosed after LDCT have earlier-stage disease when compared to patients who did not have LDCT? Methods: We conducted an observational cohort study on all new lung cancer patients seen in our clinic from January 2022 to July 2023 (18 months). Data collected included the age, type of lung cancer (NSCLC/SCLC), reason and method of initial identification of lung mass/nodule, methodology of biopsy, cancer stage, and if the patient was eligible for LDCT. Results: Over the study duration, 143 newly diagnosed lung cancer patients were seen in our oncology clinic. Of these, only 12% (18) patients had LDCT before diagnosis. Amongst these 18 patients, 44% (8) were diagnosed with stage I, two patients were diagnosed with stage II, and 44% (4+4) were diagnosed with stages III and IV. A total of 56% of patients (combined stage I/II) were eligible for curative treatment in this group. The remaining 82% of patients were diagnosed with lung cancer after imaging for other reasons (non-LDCT group). In this group, the most common stage at diagnosis was stage IV, constituting 39% (56) of the patients, followed by patients diagnosed at stage III with 24% (34). Only 37% (combined stage I/II) were eligible for curative treatment in this group. Conclusions: The USPSTF recommends annual lung cancer screening with LDCT for adults aged 50 to 80 years who have a 20-pack-year smoking history and are current smokers or have quit within the past 15 years. In an observational study conducted in 2021 from our institution, we identified a lower utilization of LDCT in eligible patients. We improved the screening rates by more than 50% from baseline with lung navigation intervention. In this study, we show that patients are getting diagnosed with lung cancer from X-rays and CTs performed for reasons including but not limited to chest pain, shortness of breath, workup for pulmonary embolism, and preoperative X-rays. Most patients diagnosed after LDCT (44%) had stage I disease compared to only 18% of patients in the non-LDCT group. We also observed that a significantly higher percentage (56% vs 37%) of patients are eligible for curative treatment (stage I/II) when diagnosed with LDCT. We highlight the importance of LDCT screening potentially offering a curable treatment in patients with lung cancer.
The science of getting published: Key factors influencing publication in pediatric oncology.
Authors: Shushan Hovsepyan, Karen Bedirian, Ruzanna Papyan, Julieta Hoveyan, Amalya Sargsyan, Elen Baloyan, Samvel Bardakhchyan, Gevorg Tamamyan
Journal: Journal of Clinical Oncology (2024)

11024 Background: Childhood cancer is rare, with an annual global incidence of 400,000 cases. Research articles play a crucial role in disseminating significant advancements in this rare field; however, it often experiences delays. We investigated the key factors influencing the transition from abstracts presented at the American Society of Clinical Oncology (ASCO) Annual Meetings to publication of articles in the pediatric oncology field. Methods: We analyzed oral (OA), poster (PA), and publication-only abstracts (PO) presented during pediatric oncology sessions at ASCO Annual Meetings from 2017 to 2023. We cross-referenced abstract titles and authors with PubMed-indexed journals. Each predictor was assessed for its correlation with the publication status using the chi-square test. Additionally, logistic regression was performed to understand the influence of each predictor while controlling for other variables. Results: A total of 521 abstracts were identified. Among these, 93 were OA, 270 were PA, and 158 were PO. Of these, 67%, 60%, and 32% were eventually published, respectively. The mean time to publication was 21.3 months for OA, 17.15 months for PA, and 23.4 months for PO. Female authors comprised 56% of the first authors. Funding was provided for 96% of OA, 87.7% of PA, and 63% of PO. Only 7% of all abstracts were from low-middle-income countries (LMICs). A significant correlation was found between the likelihood of publication and the income level of the authors' country of affiliation (p&lt;0.0001), the number of authors (p=0.001), presentation type (p&lt;0.0001), availability of funding (p&lt;0.0001), and the number of institutions involved (p=0.0001). The gender of the first author was not a significant predictor of publication (p=0.46). However, according to the logistic regression model, only the availability of funding and presentation type had a significant impact on the likelihood of publication (p&lt;0.05), while the other variables were found to be insignificant. Conclusions: Our study underscores the critical role of funding as a driver in the publication process. Researchers from LMICs are less likely to publish, likely due to a lack of funding. Furthermore, we observed a delay in publication, with an average time exceeding a year and a half. These findings emphasize the importance of equitable funding access and enhanced publication processes to improve research dissemination.
Recruitment strategies in a lung cancer screening program for Asian women with no smoking history.
Authors: Wenyuan Li, Jaimie Bell, Elaine Shum
Journal: Journal of Clinical Oncology (2024)

e22514 Background: The Female Asian Nonsmoker Screening Study (FANSS) is a pilot study for eligible Asian women with no smoking history to provide low-dose CT (LDCT) Chest scans for lung cancer screening annually for 3 years. To recruit for the study, we took into consideration several factors including potential language barriers, low awareness of lung cancer incidence in non-smoking populations, and participant (pt) availability. Here we describe the use of various recruitment strategies to support enrollment to the FANSS study. Methods: Multimodal recruitment strategies for enrollment into FANSS were used. A dedicated phone line answered by receptionists able to speak English and several Chinese dialects was created. Research staff are bilingual or utilized telephonic interpretation services in all pt interactions. Informational flyers available in both English and Chinese were mailed to primary care physicians serving primarily Asian communities and posted in pharmacies and storefronts in NYC Chinatown. A website was developed for interested individuals to submit their contact information for further information. Working with our institutional Epic EMR, a list of all pts with active MyChart accounts was created with criteria “Asian,” “female,” “OK to contact for Research recruitment,” “age 40-74,” and excluded anyone with a smoking history and “Cancer” in the past 5 years. From this list, pts then were sent an IRB-approved recruitment message through MyChart from 3/2023-6/2023. Interested pts who reached out through the above methods were contacted by research staff to determine eligibility. All eligible pts who agreed to participate were consented either in-person or virtually to allow for schedule flexibility to review the consent. Results: From 3/5/21 to 1/27/24, 1518 women inquired about FANSS through our website, dedicated phone line or MyChart messages and were directly contacted by our team. After determination of eligibility, 760 pts had an informed consent discussion either virtually or in-person. From 3/5/21 to 3/2023, 247 pts underwent the consent process and 229 pts had a baseline LDCT. Following the intervention of directed MyChart messaging in 3/2023, 568 pts responded to the MyChart message indicating interest, however 102 pts were not eligible due to inaccurate info in their Epic medical record (i.e. ethnicity or smoking history). Overall, from 3/2023 to 1/27/24, 513 pts underwent the consent process. Among these, 90 subjects (18%) were recruited via MyChart. Conclusions: Recruitment to a lung cancer screening program in non-smokers is feasible, and specific considerations tailored to engage minority populations can improve enrollment such as bilingual staff and translated materials. The use of directed messaging through the Epic EMR is an important tool to identify potential pts which may be applied to aid in recruitment to other clinical trials or lung cancer screening programs.
A randomized trial of dietary modification with exercise in women who are class 2 obese with non-metastatic breast cancer.
Authors: Trevor Feinstein, Isabelle Bowman, Catherine Hoffman, Allison Wellons, Jackie Smith, Valarie Latham
Journal: Journal of Clinical Oncology (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]
Impact of the COVID-19 pandemic mitigation strategies on cancer treatment trials: A meta-analysis of industry and NCI studies.
Authors: Joseph M. Unger, Hillary Andrews, Laura A. Levit, Brittany Avin McKelvey, Mark Stewart, Emily Van Meter Dressler, Keith T. Flaherty, Peter Fredette, Lee Jones, Therica Miller, Adedayo A. Onitilo, Timil Patel, Suanna Steeby Bruinooge, Elizabeth Garrett-Mayer, Caroline Schenkel
Journal: Journal of Clinical Oncology (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&lt;.05 for each), but not in the SR (p&gt;.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]
Assessing patient engagement levels in clinical cancer research: Development of a novel evaluation tool and comparison between eastern and western countries.
Authors: Laureline Gatellier, Bertrand F. Tombal, Béatrice Serckx, Hadrien Charvat, Keiko Katsui, Yoshiyuki Majima, Jin Higashijima, Kazuyuki Suzuki, Ingrid Klingmann, Kenichi Nakamura, Tomohiro Matsuda
Journal: Journal of Clinical Oncology (2024)

11018 Background: Patient Public Involvement and Engagement (PPIE) is essential in healthcare and cancer research. Currently, there is no objective method to assess at which stage of a clinical trial PPIE is effectively implemented. In this study, we developed a simple method for objectively assessing PPIE with an international scale. Methods: A novel, simple scoring method was developed to evaluate the PPIE implementation in cancer research. It follows the EUPATI Patient Engagement Roadmap and assesses PPIE at eight steps: defining research priorities, fundraising, protocol, informed consent, ethical review, investigator meeting, study results reporting, and application. PPIE level was self-rated by investigators on a five-level engagement scale: no engagement, considered, informed, actively involved, and co-creation. It was submitted to 124 Japanese and 203 European principal investigators (PI) of non-commercial sponsor cancer research clinical trials, conducted between January 2018 and December 2022, identified from publicly available databases (EudraCT, UMIN, jRCT). Results: The questionnaire was answered by 66 (53.2%) and 45 (22.2%) of the Japanese and European PIs, respectively. Overall, the PPIE implementation was low in both regions, with a “no engagement” rate of 61.7% in Europe and even lower, 78.5%, in Japan. Forty percent of the European PIs actively engaged patients (“actively involved” and “co-creation”) in at least one research step, versus only 16.7% of the Japanese PIs. The percentage of PIs answering “no engagement” in all eight steps was 47.0% in Japan and 11.1% in Europe. PPIE was the highest for the informed consent domain, with 73.3% of the European and 20.3% of the Japanese PIs reporting some level of engagement. Similarly, 55.6% of the European and 18.8% of the Japanese PIs involved PPIE in the ethical review domain. PPIE was notably low in the earlier steps of the research. Conclusions: Our innovative PPIE scoring method allowed us to objectively assess PPIE in cancer clinical trials and compare its implementation among different countries. This 2018-2022 snapshot revealed low (EU) to very low PPIE (Japan) levels, especially in the research design. Future assessments should help to monitor the enhancement of PPIE in cancer research on an international scale.
An AI-assisted navigation approach for patients with radiographic suspicion of new pancreas cancer.
Authors: Kristen M. John, Joseph Tenner, Rolando Croocks, Cristina Valente, Bernadette Bingham, Amber N Habowski, Tara McEvoy, Tiffany Zavadsky, Kristen Beyer, Rita Mercieca, Sandeep Nadella, Anthony Carvino, Matthew Barish, Daniel King
Journal: Journal of Clinical Oncology (2024)

11002 Background: The traditional cancer care paradigm relies on passive referral streams, resulting in suboptimal care delivery. Here, we assessed the results of an AI-assisted navigation approach to proactively coordinate specialty cancer care services for patients with radiographically suspected pancreas cancer. Methods: A natural language processing (NLP) classifier was trained to identify radiology reports suspicious for pancreas cancer from imaging reports generated within Northwell Health. The daily workflow consists of the following: the NLP flags reports with suspicion of pancreas cancer, a coordinator validates the finding, a GI oncologist and navigator coordinates specialty oncology and tumor board referral, and a clinical research coordinator pre-screens for research studies. Patients determined to be hospice-bound or with non-PDAC malignancy are excluded. Care delivery metrics were compared by Mann-Whitney U tests. Results: Prior to implementation, patients with new suspicion of pancreas cancer at our institution experienced a mean of 22 days to biopsy, 32 days to oncology visit, and 56 days to treatment initiation from radiology report with 17% referred to pancreatic multidisciplinary clinic (PMDC). Per monthly average, 1.8 patients were approached for biospecimen studies, 1.5 were consented, and 0.9 were enrolled. In the month following implementation of the AI-assisted navigation pilot, reports from 1666 patients were flagged, resulting in 38 patients with new suspicion of pancreas cancer identified (Table). Of these, 53% underwent biopsy, 50% were seen by an outpatient oncologist, 29% were referred to PMDC, and 42% received treatment at our institution. From date of radiology report, these patients underwent biopsy at a mean of 7 days (p&lt;0.01), outpatient oncology visit at 15 days (p=0.285), and treatment initiation at 34 days (p=0.3479). A monthly average of 4 patients were approached for biospecimen studies, 4 were consented, and 3.2 were enrolled. Conclusions: An AI-guided navigation workflow identified patients earlier in the diagnostic timeline; reduced time to biopsy, follow-up, and treatment initiation; increased patient referrals to PMDC; and tripled participation in biospecimen studies at our institution. [Table: see text]