bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient-reported hope, prognostic understanding, quality of life, symptom burden, coping mechanisms, and financial wellbeing in early phase clinical trial participants.
Authors: Lundquist Debra , Durbin Sienna , Pelletier Andrea , Petrillo Laura A , Bame Viola , Turbini Victoria , Heldreth Hope , Lynch Kaitlyn , Silva Jenipher , McIntyre Casandra , Juric Dejan , Ferrell Betty R. , Jimenez Rachel , Nipp Ryan David 
Published: June 2023

12109 Background: Early phase clinical trials (EP-CTs) investigate novel treatment options in oncology, with recent advances in personalized therapy leading to improved outcomes and offering hope to patients with cancer. However, little research has sought to understand hope in EP-CT participants, thus we sought to study associations of patient-reported hope with prognostic understanding, quality of life (QOL), symptom burden, coping mechanisms, and financial wellbeing in EP-CT participants. Methods: We prospectively enrolled consecutive adults with cancer participating in EP-CTs at Massachusetts General Hospital from 04/2021-01/2023. Participants completed baseline surveys prior to treatment initiation that assessed hope (Herth Hope Index [HHI], higher scores indicate greater hope), prognostic awareness (Prognosis and Treatment Perceptions Questionnaire [PTPQ], QOL (Functional Assessment of Cancer Therapy-General), symptom burden (physical: Edmonton Symptom Assessment System [ESAS]; psychological: Patient Health Questionaire-4 [PHQ4]), coping mechanisms (Brief COPE), and financial wellbeing (Comprehensive Score for Financial Toxicity [COST]). We used descriptive statistics and regression models to explore associations of hope with patient characteristics as well as patient-reported prognostic awareness, QOL, symptom burden, coping, and financial wellbeing. Results: Of 221 eligible patients, we enrolled 204 (enrollment rate 92.3%, median age = 63.4 years [range 54.8-70.5]; 56.9% female, and 94.0% metastatic cancer). Most common cancer types were gastrointestinal (34.8%), breast (19.6%), and head and neck (10.3%). Patients had a mean HHI score of 27.2 (range 12.0-36.0), with 27.1% reporting their cancer is curable (mean hope scores were higher for those reporting curable vs incurable on the PTPQ: 28.8 vs 26.7, p = 0.016). Higher hope scores were associated with better QOL (B = 0.21, p < 0.001), lower symptom burden (ESAS-physical: B = -0.10, p < 0.001; PHQ4-depression: B = -2.10 p = < 0.001; PHQ4-anxiety: B = -0.99, p < 0.001), more adaptive coping strategies (self-blame [B = -1.34, p < 0.001]; acceptance [B = 1.30, p < 0.001], denial [B = -1.31, p < 0.001], support [B = 1.03, p < 0.001], active [B = 0.97. p < 0.001], disengage [B = -2.69, p < 0.001], religion [B = 0.63, p < 0.001]), and greater financial wellbeing (B = 0.10, p = 0.013). Conclusions: In this prospective cohort study, we found novel associations of higher hope scores with prognostic understanding, better QOL, lower symptom burden, more adaptive coping mechanisms, and greater financial wellbeing. Future studies should measure patient-reported hope and explore its role as a potential moderator of other outcomes in EP-CT participants.
Rose geranium in sesame oil nasal spray to improve symptoms of nasal vestibulitis: A phase III double blinded randomized controlled trial.
Authors: Cathcart-Rake Elizabeth Jane , Novotny Paul J. , Smith Deanne R. , Lewis-Peters Susan E. , Giridhar Karthik , Steinert Kimberly O. , Dauer Darcie , O'Connor Amanda K. , Thome Stephan , Register Terra A. , Erickson Marsha K. , Friday Bret Edward Buckley , Loprinzi Charles L. 
Published: June 2023

12114 Background: A retrospective study suggested a potential benefit from rose geranium in sesame oil nasal spray for alleviating nasal vestibulitis symptoms in patients (pts) undergoing chemotherapy. Methods: Pts undergoing active chemotherapy who reported moderate or worse nasal symptoms were randomized 1:1 to receive a rose geranium in sesame oil nasal spray (RG) or an isotonic saline nasal spray (IS), administered twice daily for two weeks. Consenting pts completed nasal symptom questionnaires at baseline and then weekly while on treatment. The number and percentage of pts experiencing improvements in their nasal symptoms 2 weeks after initiating the nasal spray, defined as symptoms moderately (2) or very much (3) better on a 7-point global impression of change score (ranging from scores of -3: very much worse, to 3: very much better), was estimated within and then between each randomized arm, using Fisher’s exact test (5% significance level). The estimated odds ratio was determined (95% confidence interval). After 2 weeks, pts initially randomized to IS were allowed to cross-over to RG and completed weekly surveys. Results: 106 pts consented to this study; 43 pts in the RG arm and 41 in the IS arm were evaluable for the primary endpoint. Pts had a mean age of 57.8 (SD 13.9). Demographic characteristics and baseline nasal symptoms were similar between arms. The most prominent baseline nasal symptoms were dryness (36%) and bleeding (35%). Of the 43 evaluable pts who received RG, 67.4% reported improved nasal symptoms, compared with 36.6% of the 41 pts who received IS (p=0.009; Table). On the global impression of change score, pts who received RG had a mean score of 1.93 (SD 1.16), compared to a mean score of 0.98 (SD 1.41) among pts who received IS. Adjusting for potential confounding factors, pts who received RG had a 4.56 odds of responding to the nasal spray, compared with those who received IS (p=0.005). There were no significant differences between pt responses based upon type of nasal symptoms, age, allergies, or gender. Adverse events were sparse and did not differ between arms. 34 pts crossed over to RG after week 2. Among the 29 pts who completed final surveys, 37% reported a response on IS, 79% reported a response on RG. Conclusions: Rose geranium in sesame oil nasal spray significantly improves nasal vestibulitis symptoms among patients undergoing chemotherapy. Clinical trial information: NCT04620369 . [Table: see text]
Patient-controlled subcutaneous analgesia with hydromorphone versus oral oxycodone for opioid titration of cancer pain: A prospective multicenter randomized trial.
Authors: Xiao Xiaoguang , Chu Qian , Chen Yuan 
Published: June 2023

12124 Background: Studies have shown that oral oxycodone sustained-release (SR) tablets can be used for opioid titration. The European Society for Medical Oncology (ESMO) guidelines for adult cancer pain recommend opioid titration through the parenteral route, usually the intravenous or subcutaneous route. Patient-controlled subcutaneous analgesia (PCSA) with hydromorphone needs further evaluation for opioid titration. This prospective multicenter study was designed to compare the efficacy and safety of hydromorphone PCSA with oral oxycodone SR tablets for opioid titration of cancer pain. Methods: Eligible patients with cancer pain were randomly assigned in a 1:1 ratio to the PCSA group or the oxycontin group for dose titration. Different titration methods were given in both groups depending on whether the patient had an opioid tolerance. The primary endpoint of this study was time to successful titration (TST). Results: A total of 256 patients completed this study. The PCSA group had a significantly lower TST compared with the oxycontin group (median [95% confidence interval (CI)], 5.5 [95%CI: 2.5-11.5] hours vs. 16.0 [95%CI: 11.5-22.5] hours; p< 0.001). PCSA reduced the frequency of breakthrough pain (Btp), especially in patients with opioid tolerance. The number of Btp was 121±28 times and 186±31 times in the PCSA and oxycontin groups, respectively ( p< 0.001). The 12-hour numeric rating scale (NRS) score was significantly lower in the PCSA group than that in the oxycontin group (median [95%CI], 2.5 [95%CI: 1.4-2.9] vs. 4.4[95%CI: 3.2-5.8]) ( p< 0.001). Similar equivalent morphine consumption and significantly improved quality of life were observed in the two groups. No between-group difference in the incidence of opioid-related adverse effects was observed. Conclusions: Compared with oral oxycodone SR tablet, the use of PCSA with hydromorphone achieved faster pain relief and a shorter titration duration for patients with cancer pain without increasing adverse events. Clinical trial information: ChiCTR2000037845 .
A phase III, double-blind, non-inferiority, randomized controlled trial of antiemetic prophylaxis for highly emetogenic chemotherapy without dexamethasone: CINV POD study.
Authors: Radhakrishnan Venkatraman , Venkatakrishnan Kritthivasan , Perumal Kalaiyarasi Jayachandran , Selvarajan Gangothri , Mahaboobasha Nizamudin , Vijaykumar Victor Paulson , Anbazhagan Malarvizhi , Sivanandam Deyva Manohari , Rajaraman Swaminathan 
Published: June 2023

12127 Background: Chemotherapy-induced nausea and vomiting (CINV) is a common side effect of highly emetogenic chemotherapy (HEC). Current guidelines recommend the use of dexamethasone (DEX) for prophylaxis, but the effectiveness and safety of a DEX-free regimen for CINV prophylaxis in HEC is not known. Methods: This was an investigator-initiated, double-blind, phase 3 RCT designed to show the non-inferiority of a DEX-free regimen (olanzapine, palonosetron, and fosaprepitant; OPF) compared to the NCCN recommended DEX-containing regimen (olanzapine, palonosetron, and dexamethasone; OPD). Chemotherapy-naive patients aged 18-80 years receiving single-day HEC were randomized 1:1 to receive either the OPD regimen (olanzapine 5 mg once a day on days 1-4, palonosetron 0.25 mg on day 1, and DEX 12 mg on day 1) or the OPF regimen (olanzapine and palonosetron as above, and fosaprepitant 150 mg on day 1). The primary endpoint was to compare complete response (CR) rates for vomiting (no vomiting and no rescue medication) during the overall phase (start of chemotherapy to 120 h). The secondary endpoints were CR for nausea (ESAS), toxicities (CTCAE), and patient reported outcome measures (PROM) using MDASI. Assuming CR for vomiting for the overall phase of 77% (power = 90%, 2-sided alpha = 5%, and non-inferiority margin [NI] = 15%), 175 patients in each arm were required (including 5% dropout). Results: Between May 2022-Dec 2022, 350 patients were randomized and 346 received the study interventions (OPD arm n = 174 and OPF arm n = 172). The most common chemotherapy used was adriamycin/cyclophosphamide (66%) followed by cisplatin (27%). CR rates for vomiting for the overall phase were 48.8% in the OPD arm and 79.6% in the OPF arm (P < 0.001), with an absolute difference of -30.8% and 2-sided 95% CI = (-40.31, -21.24) which was within the pre-defined NI margin of 15% and also showed superiority. The DEX-free arm also had significantly higher CR rates for nausea and total control (vomiting and nausea combined) (Table). There were no significant differences in any grade CTCAE toxicities. PROM for fatigue (P = 0.009) and drowsiness (P = 0.002) were more in the OPF arm in the acute phase, and insomnia (P < 0.001) in the OPD arm in the delayed phase. Conclusions: This study shows that a DEX-free OPF regimen is superior to the DEX-based OPD regimen and should be considered a standard option for CINV prophylaxis for HEC. Clinical trial information: CTRI/2022/03/040906 . [Table: see text]
Palliative care in hematopoietic stem cell transplant recipients and impact on survival: A nationwide analysis.
Authors: Premnath Naveen , Khan Adeel , Pandey Mohak , Pandey Urvashi , Hoff Fieke W , Chung Stephen , Ramakrishnan Geethakumari Praveen , Awan Farrukh Tauseef , Anderson, Jr Larry D. , Kaur Gurbakhash , Afrough Aimaz , Wolfe Heather , Yilmaz Elif , Collins Robert , Terauchi Stephanie , Paulk Elizabeth , Sweetenham John W. , Madanat Yazan F 
Published: June 2023

12129 Background: Palliative care benefits have been widely studied in solid tumors with early palliative care demonstrating prolonged survival in several malignancies including lung and esophageal cancer. There are limited data and guidelines for use of palliative care in hematopoietic stem cell transplants (HSCT). Methods: We used the National cancer database (NCDB) to identify HSCT recipients between 2004 to 2017 and retrospectively examined the outcomes based on receipt of palliative care. Chi-square and Wilcoxon tests were used to compare categorical and continuous variables respectively. Kaplan Meier analysis and a Cox multivariable proportional hazards model were used for survival analysis using R software. The NCDB is available as de-identified data. Hence, this study was exempt from a full IRB review. Results: We identified 17,464 eligible patients with hematologic malignancies who underwent HSCT during 2004-2017. The table below shows differences in baseline characteristics in patients who received palliative care vs no palliative care and shows an improved median survival in those receiving vs those not receiving (43.5 vs 31.6 months) (p = 0.0003). Patients with median household income in the lowest quartile as per 2016 survey data were taken as low-income group. A multivariable cox regression analysis that adjusted for age, sex, Charlson-Deyo Comorbidity Index, insurance status, income and Hispanic ethnicity found that integration of palliative care was associated with improved survival outcomes (HR 0.85, CI 0.77- 0.93, p = 0.0002). Conclusions: To our knowledge, this is the largest study demonstrating improved outcomes in HSCT recipients when palliative care was incorporated despite there beingmore economically challenged patients in the group that received palliative care. Although these data are retrospective and correlational, it underscores how palliative care should be incorporated as part of national society guidelines for HSCT recipients. [Table: see text]
Will we have a match? Observations from decision making conversations between hematologists and White and Black patients considering allogeneic stem cell transplant.
Authors: Thordardottir Thorunn Halldora , Rodenbach Rachel , Campbell Toby Christopher 
Published: June 2023

12133 Background: Allogeneic stem cell transplant (alloSCT) is the only treatment associated with cure for high-risk myelodysplastic syndrome (MDS), but carries substantial risks. One routinely mentioned concern is donor source. While white patients have an 80% chance of finding an unrelated fully matched donor, Black patients have among the lowest chance at 30%. The aim of this secondary analysis, from a telemedicine study assessing how hematologists engage in shared decision making with patients considering alloSCT, is to analyze how hematologists navigate discussions about donor concerns related to the apparent race of the patient. Methods: This is a qualitative analysis of transcribed video-recorded virtual encounters. We recruited US hematologists who perform alloSCT and randomized them to meet with a patient actor of Black or white race. The hematologists conducted a new patient encounter with the actors who were trained to portray the same 67 year old man with newly diagnosed high-risk MDS referred for specialty consultation to discuss treatment options. The patient character had multiple healthy siblings and children. Results: Transcripts from a total of 33 hematologists were available at the time of analysis (61% male, 30% non-white, mean age 46 +/- 11 years). Hematologists spent varying amounts of time discussing the concept of transplant donation. While some used complex language to describe matching and HLA tissue markers, others used simplified terms of finding a donor with “an immune system that’s similar to your own,” to eradicate foreign MDS cells and avoid attack on healthy cells. The majority emphasized searching for a donor among siblings, given the highest likelihood of matching. Conversations with the white actor included reassurance of finding a fully matched donor, whether through family or the international registry. Hematologists frequently disclosed the highest chance of success for people of European ancestry. While hematologists mentioned the registry in conversations with the Black actor, they rarely disclosed the lower chance of finding a fully matched unrelated donor. Instead they reassured that with better technology haploidentical match could be an option through donation from their child, “with as favorable outcomes.” Some gave the Black actor an overestimation of finding a fully matched donor through the registry. Non-white hematologists more frequently acknowledged the concept of race in stem cell donation. Conclusions: Hematologists use multiple strategies to help patients understand the donor process. They reveal to white patients the high likelihood of finding a fully matched donor while appearing to avoid discussing the lower odds for a Black patient.
Analysis of delivery of cancer survivorship education to community healthcare professionals.
Authors: Pariser Ashley , Johns Kevin Nathaniel , Champion Dena , Roberts Andrea , Fugett Susan , Holley Erin , Schreiber Candice , Hock Karen , Todd Jalyn , Honeychuck Andrew , Hunt Katherine , Lu Yurong , Ramaswamy Bhuvaneswari , Brill Seuli Bose 
Published: June 2023

12136 Background: There are currently 18.1 million cancer survivors in the United States; anticipated to reach 26.0 million survivors by 2040. Educational opportunities for healthcare providers in survivorship care is needed to insure capacity for this rapidly growing population particularly in the community setting. This pilot study implemented a cancer survivorship Project ECHO model in two community hospitals within a larger community health system. Methods: Providers affiliated with the Mercy Health System were enrolled in one of two cohorts. Eligible participants included physicians, advanced practice providers, nurses, social workers, and dietitians. Six one-hour sessions were developed from a needs assessment and delivered over a 12-week period. Participants were invited to complete pre and post session surveys to evaluate the following 3 domains: professional improvement (PI), self-efficacy (SE), and knowledge (KN). A Likert scale was used with each survey item rated 1-5, where 1 represents lowest and 5 highest (agreement/confidence/knowledge). The average score for survey items within each domain was utilized to compare pre- and post-survey results. Results: Fourteen multidisciplinary providers were enrolled in both Cohort 1 and Cohort 2. Twenty-six completed the baseline survey and 22 completed the post-study survey. The mean change of each domain (PI, SE, KN) and mean overall change are summarized in the table. For cohort 1, the overall score significantly increased 0.94 (0.45,1.42) (P=0.0023). While the SE and KN domain scores increased significantly (1.1 (0.5,1.7), 1.03 (0.45,1.62) and p = 0.003, 0.0036, respectively), the PI did not change -0.09(p=0.726). For cohort 2, the overall score significantly increased 0.617 (0.042,1.193) (P=0.0378). While the SE and KN domain increased significantly (0.728(0.048,1.407), 0.665 (0.041,1.289) and p = 0.0379, 0.0387, respectively), the PI did not change (p=> 0.999). Conclusions: The Cancer Survivorship ECHO model may serve as a scalable strategy for building cancer survivorship care capacity in community-based oncology practices through equipping multidisciplinary teams to meet the needs of cancer survivors within their community. Further research is needed to assess implementation of this model into novel settings and evaluate its impact on patient outcomes. [Table: see text]
Childhood leukemia survival in the US-Mexico border: Building sustainable leukemia care using health systems strengthening models.
Authors: Aristizabal Paula , Rivera Gomez Rebeca , Ribeiro Raul Correa , Roberts William 
Published: June 2023

1502 Background: Pediatric leukemia outcomes are poor in most low-and middle-income countries (LMIC) and exacerbated by healthcare systems ill-equipped to manage cancer. Effective leukemia management in LMIC involves curating epidemiologic data; providing healthcare workforce specialty training; developing evidence-based treatments and supportive care; safeguarding access to medications and equipment; providing patient and family psychosocial and financial support; partnering with non-governmental organizations, and ensuring treatment adherence. Methods: We describe the implementation of a collaborative program to achieve sustainable high-quality care for children with leukemia in a unique border health setting. In 2013, in a partnership between North-American and Mexican institutions, we used the health systems strengthening model developed by the World Health Organization (WHO) Framework for Action with domains in Services delivery, Workforce, Information systems, Access to essential medicines, Financing, and Leadership and Governance to implement a sustainable program aimed at improving acute lymphoblastic leukemia (ALL) outcomes at a public, referral hospital in the US-Mexico border region. We evaluated program sustainability indicators, and prospectively assessed clinical features, risk classification, and survival outcomes in children with ALL at Hospital General in Tijuana, Mexico from 2008-2012 (pre-implementation) and from 2013-2017 (post-implementation). Results: Our approach led to a fully-staffed leukemia service, sustainable training programs, evidence-based, data-driven projects to improve clinical outcomes, and funding for medications, supplies and personnel through local partnerships. Pre-implementation and post-implementation 5-year overall survival for children with standard-risk and high-risk ALL improved from 52% to 82% (P = 0 ×023) and from 46% to 76% ( P = 0 ×031), respectively. All sustainability indicators significantly improved between 2013 and 2017. Conclusions: By using a health systems strengthening approach, we improved leukemia care and survival in a public Mexican hospital in the US-Mexico border region. The demonstrated increase in overall survival across a decade after the implementation of our program validates the use of the health systems strengthening models, as they are not only efficacious in improving clinical outcomes, but also serve as financially and organizationally means of building sustainable capacity. Our model serves as an example for future international partnerships aimed at sustainably improving cancer outcomes in LMIC. Future research should evaluate best practices in establishing global health collaborations with particular attention paid towards the individual circumstances that impact healthcare delivery locally in each unique community.