bluuebunny/crossref_metadata_2025 huggingface dataset:
Pilot randomized trial of a telehealth intervention for women with advanced ovarian cancer and PARP inhibitor-related fatigue.
Authors: Wright Alexi A. , Poort Hanneke , Tavormina Anna , Schmiege Sarah , Matulonis Ursula A. , Campos Susana M , Liu Joyce F. , Slivjak Elizabeth , Gilmour Anna , Salinger Julia , Haggerty Ashley Ford , Arch Joanna J
Published: June 2023

e24122

Background: Poly(ADP-ribose) polymerase inhibitors (PARPi) have dramatically changed the treatment of advanced ovarian cancer and are increasingly used in other cancers. However, PARPi cause significant fatigue in nearly half of patients. Psychosocial interventions have shown promise for treating cancer-related fatigue, but there is limited evidence for use in patients with advanced cancers. Moreover, most fatigue interventions have been delivered in person over many sessions, limiting their accessibility and scalability. Methods: We conducted a pilot randomized trial of REVITALIZE, a 6-session telehealth intervention developed and refined by our group, compared with enhanced usual care among 35 fatigued patients with advanced or recurrent ovarian cancer on PARPi at two sites, Dana-Farber Cancer Institute and University of Pennsylvania. REVITALIZE was based on acceptance and commitment-based behavioral therapy and addressed modifiable contributors to PARPi-related fatigue. The trial tested the feasibility, acceptability, and preliminary efficacy of REVITALIZE through 3-month follow-up. Exit interviews were conducted with all REVITALIZE patients. Results: Among 35 participants (mean age=62.5 years, 83% stage III/IV disease, 46% first-line maintenance therapy), the trial met or exceeded its acceptability and feasibility goals. Exit interviews further indicated high acceptability. Relative to enhanced usual care, REVITALIZE significantly reduced fatigue interference at 12-week follow-up (Cohen’s d=.94, p=.008) and fatigue severity (d=.54, p=.049), while improving current fatigue levels (d=.62, p=0.04). REVITALIZE participants also reported improved fatigue self-efficacy, fatigue catastrophizing, depression, anxiety, and quality of life (ds=.60-.86). REVITALIZE participants were also numerically less likely to experience PARPi dose reductions compared with enhanced usual care (7% vs. 17%), and less likely to have dose delays (7% vs. 22%). Conclusions: Among fatigued adults with advanced ovarian cancer on PARPi, a brief telehealth intervention based on acceptance and commitment therapy showed strong feasibility, acceptability, and preliminary efficacy with improvements in fatigue, anxiety, depression, and quality of life outcomes. REVITALIZE is a novel, scalable telehealth intervention worthy of further investigation in patients with advanced cancers with PARPi-related fatigue. The study is supported by the National Comprehensive Cancer Network (NCCN) through a grant provided by AstraZeneca. Neither NCCN or AstraZeneca are the sponsors of this study. Clinical trial information: NCT04525183 .
Evaluating response to interventions for vasomotor symptoms in patients with breast cancer: A patient-centered approach.
Authors: Cole Katherine , McGee Sharon , Clemons Mark J. , Liu Michelle , MacDonald Fiona , Vandermeer Lisa , Ng Terry L. , Pond Gregory Russell , El Emam Khaled
Published: June 2023

e24126

Background: Vasomotor symptoms (VMS), such as hot flashes, are a common reason for early discontinuation of endocrine therapy for patients (pts) with breast cancer (BC). The optimal intervention for VMS remains unknown. Using a novel symptom change analysis and regression trees, we examined whether clinically important change in VMS severity depends on baseline symptomatology. Methods: In this prospective study, pts with BC experiencing VMS chose either a lifestyle (LS), or non-LS (i.e. complementary and alternative therapies [CAM], prescription medications [PM], or endocrine therapy modification [ETM]) intervention. The primary outcome was change in symptom severity using the 10-point Hot Flush Rating Scale (HFRS). Patients declining interventions were included as controls. At the end of the 6-week intervention, participants rated the effectiveness of their chosen intervention on a five-point Likert scale. A logistic sigmoid function and Bayesian optimization were used to weight the change in VMS score based on baseline VMS severity. A regression tree was trained to predict which intervention resulted in the greatest improvement in VMS at 6 weeks. Results: 100 baseline and follow-up questionnaires from 85 pts were included in an intention to treat analysis. The median baseline HFRS was 5.0 (IQR 3.33 ,7.00). Selected interventions included LS (27%), CAM (25%), PM (11%) and ETM (8%), with 29% declining interventions. After removal of missing data, 59 individuals provided responses for both the HFRS score and the effectiveness score. Higher baseline HFRS scores had greater impact on symptom change scores. The largest difference in VMS improvement was noted between the non-LS (median symptom change –0.82, IQR –2.00, –0.01) and LS/control groups (median symptom change – 0.38, IQR –1.46, 0.00) (Table 1). Of non-LS interventions, CAM had the greatest improvement in VMS severity. Pre-menopausal individuals who pursued LS interventions had the least improvement in VMS severity. Conclusions: Interventions for VMS were most impactful among pts with greater baseline symptoms. While LS interventions were the most commonly selected intervention, the resulting improvement in symptoms at 6 weeks was negligible, and alternative strategies should be encouraged. Future studies integrating pt preferences and accounting for baseline symptom severity are needed. [Table: see text]
The effect of touch on pain, anxiety, and the patient experience during bone marrow biopsies.
Authors: Dhawan Natasha , Schaal Anna , Pushee Jacob R. , Broglio Kathleen
Published: June 2023

e24131

Background: Many patients report severe pain and anxiety during bone marrow biopsies (BMBx), but there is no formal consensus on the best approach to managing these symptoms during the procedure. The aims of this study were to evaluate the effect of simple foot touch on pain and anxiety during BMBx, and to describe the patients’ experience during the procedure. Methods: A single-center randomized control trial using permuted block randomization was conducted at a rural academic cancer center. Nursing assistants without specialized massage training performed simple foot touch on patients in the intervention arm, while the BMBx was performed by advanced practice registered nurses. The patients in the control arm received usual care. Patients rated pain and anxiety levels before and after BMBx using the Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI) scales, respectively. All participants completed a post-intervention survey about their experience. Results: 46 patients were enrolled in the study; 21 in the intervention arm (median age 64.1 years) and 25 in the control arm (median age 64.4 years). There was no difference in the use of anxiolytics (p = 0.51) or opioids (p = 0.48) during the procedure between the two arms. There were no statistically significant differences on the VAS (p = 0.37) or STAI (p = 0.40) between the intervention and control arms. Participants in the intervention arm reported more positive feedback and had fewer suggestions for improving the patient experience compared to the control arm (table 1). Conclusions: This is the first study to use an interprofessional team approach to evaluate the impact of touch on pain, anxiety, and the patient experience during BMBx. While the intervention did not impact pain or anxiety scores, it may be a feasible, minimal-risk, and no-cost intervention to improve patients’ overall experience during BMBx. Clinical trial information: NCT04935775 . [Table: see text]
Opiate use after total hip arthroplasty for metastatic bone disease.
Authors: Vijayakumar Gayathri , Vance Dylan , Colman Matthew W. , Gitelis Steven , Sweeney Kyle , Blank Alan T.
Published: June 2023

e24132

Background: Metastatic bone disease (MBD) commonly affects the hip and surgical intervention including total hip arthroplasty (THA) may be indicated for pain relief or to improve function. Following THA, patients are often prescribed short courses of opioids for postoperative pain relief. This study investigated postoperative opioid use following THA in MBD patients. Methods: This was a retrospective review of patients using opioids preoperatively who underwent THA for MBD at two institutions between 2009 and 2022. Preoperative and postoperative opioid usage at 6 weeks and 90 days were quantified through calculating daily morphine milligram equivalents (MME) and compared using the sign test. Results: Nineteen primary THA and 11 THA with complex acetabular reconstruction were included. At six weeks, 26 (86.7%) patients were utilizing opiates and at ninety days 23 (76.7%) patients were utilizing opiates. There was a statistically significant difference between median daily preoperative MME compared to daily MME at ninety days (p < 0.001). The only statistically significant association with opioid use at 90 days was opioid use at 6 weeks. Conclusions: To our knowledge, this is the first paper evaluating postoperative opioid use following primary THA in MBD patients. After THA in the setting of MBD, patients exhibit decreased postoperative opioid use.[Table: see text]
Effect of multimodal intervention care on cachexia in patients with advanced cancer compared to conventional management (MIRACLE): An open-label, parallel, randomized, phase 2 trial.
Authors: Kim Bo-Hyung , Maeng Chi Hoon , Chon Jinmann , Kang Won Sub , Kang Kyounglan , Woo Mihye , Hong Il Ki , Lee Junhee , Lee Kil Yeon
Published: June 2023

e24135

Background: Cancer Cachexia (CC) is a multi-factorial process characterized by progressive weight loss, muscle mass and fat tissue wasting, and adversely affecting their quality of life and survival in patients with advanced stage of cancer. We investigated the efficacy and safety of a multi-modal intervention including anti-inflammation, omega-3-fatty acids, nutritional supplement with counselling, physical exercise, psychiatric intervention as well as Bojungikki-tang which mediates immune-modulation and reverse chronic inflammation and wasting condition as a complementary and alternative medicine compared to patients receiving best supportive care. Methods: Eligible criteria included patients with advanced stage of gastrointestinal (gastric, colorectal and pancreaticobiliary) as well as lung cancer undergoing active palliative chemotherapy. Patients are randomized into experimental arm (Multi-modal intervention care: MIC) versus control arm (Conventional Palliative Care, CPC). MIC are comprised of daily oral medications; ibuprofen 400 mg three times a day, omega-3-fatty acid 1 g twice a day, Bojungikki-tang 3.75g twice a day, oral nutritional supplement (HAMONILAN SOLN) 200 ml twice a day, and weekly physical exercise (60 minutes per visit), psychiatric assessment on every other week, and nutritional counselling total four times during the study period. CPC included basic nutritional counselling for two times provided by National Health Insurance Service, and megestrol acetate as needed (ie, anorexia≥grade 2). All interventions were provided during 12 weeks per subject. Co-primary outcomes are total lean body mass changes and handgrip strength change from the baseline. Secondary outcomes included change of fat mass and total body mass, lean body mass, and quality of life assessment (KCT0004967, NCT 04907864). Results: A total of 112 patients was planned to be assigned to the two arms (56 in each group), however, the study was terminated due to low accrual rate and the expiration of the study approval period of the national research fund, after enrolling up to 56 subjects (28 in each group). Demographic findings were even distributed between arms. The difference of median changes of total lean body mass in MIC group after 12 weeks of intervention, was numerically increased without statistical significance compared to CPC group (MIC vs CPC, 91 vs. -295 g, p= 0.3863). There was no difference of median changes of handgrip strength between MIC and CPC groups (MIC vs CPC, 0.4 vs. 0.9, p= 0.2319). Other secondary outcomes showed no differences, either. Conclusions: Multimodal intervention in this study did not show clinical meaningful improvement. We have to further investigate another method to improve cachexia. Clinical trial information: NCT04907864 .
Mobile-based multimodal rehabilitation including exercise, nutritional, and psychological interventions in patients with abdominal cancer receiving concurrent chemoradiotherapy: Prospective, multicenter, randomized trial.
Authors: Yang Lei , Wen-bo Wang , Xiong Yudi , Cao Dedong , Dai Jing , Xu Hui , Wu Han , Peng Jin , Wang You , Su Jing , Chen Xin , Wang Qing-Yun , Jiang Huangang , Xia Ling , Chen Weidong , Xu Ximing , Zhou Fuxiang
Published: June 2023

e24138

Background: Concurrent chemoradiotherapy (CCRT) has several adverse toxicities such as fatigue, bone marrow suppression and malnutrition. We aimed to examine whether the mobile-based multimodal rehabilitation including exercise, nutritional and psychological interventions have an impact on clinical outcomes in abdominal cancer patients receiving concurrent chemoradiotherapy. Methods: A total of 90 eligible abdominal cancer patients were randomly assigned (1:1) to either the study (n = 47) or control (n = 43) group from February 2022 to November 2022. Multimodal rehabilitation was provided by a team of oncologists, rehabilitation physicians, nurses, clinical nutritionists and psychologists, while patients in the control group received only standard oncologic care. The study group received a wearable device and mobile app that provided an exercise program (at least 90 to 150 minutes of aerobic and resistance exercise per week for 5 weeks, depending on the patient's health status). Primary endpoints were changes in grip strength and body weight, with secondary endpoints including nutrition-related haematological indicators, toxicity and treatment completion rate. Results: Our study found that the body weight and grip strength of patients in the control group decreased significantly after CCRT, while those in the study group remained stable. The average weight loss (-0.19 ± 1.51 kg vs 1.28±1.90 kg, P = 0.016) and average grip strength loss (-0.95 ± 2.24 vs 1.26 ± 2.38 kg, P = 0.008) in the study group and control group after CCRT were significantly different. Meanwhile, patients in the study group showed less decline in haemoglobin levels (-1.96 ± 10.24 vs 12.05 ± 8.45 g/L, P = 0.000), serum albumin levels (0.65 ± 4.40 g/L vs 3.42 ± 2.87 g/L, P = 0.030) and lymphocyte count (0.74 ± 0.30 vs 1.16 ± 0.62 g/L, P = 0.010) contrast with control group. Conclusions: Multimodal rehabilitation based on mobile health could effectively maintain the body weight and nutritional status of patients undergoing concurrent chemoradiotherapy, which may be beneficial to improve the treatment tolerance of patients. Keywords: Abdominal cancer; Concurrent chemoradiotherapy; Multimodal rehabilitation; Mobile health; Grip strength. Clinical trial information: NCT05325554 .
Effectiveness of NEPA, an oral fixed-dose combination of netupitant and palonosetron in the prevention of chemotherapy induce nausea (CIN): A post-hoc analysis.
Authors: Pednekar Amullya , Gupta Sudeep , Biswas Ghanashyam , MV Chandrakanth , Dattatreya Palanki Satya , Thomas Boben , Gupta Sumant , Bhagat Sagar B , Patil Saiprasad , Barkate Hanmant V.
Published: June 2023

e24140

Background: Despite widespread use of antiemetics, chemotherapy-induced nausea is still reported by upto 70% of adult patients receiving moderately emetogenic chemotherapy(MEC) or highly emetogenic chemotherapy (HEC) agents. Control of nausea remains an important, unmet need among cancer patients. The current evidence suggests that, overall, no significant nausea is reported by upto 75% of the patients with the aprepitant based regimens. Here, we present a post-hoc analysis of an observational study on NEPA (NEtupitant 300mg and PAlonosetron 0.50 mg) in preventing nausea in patients receiving HEC/MEC in a real-world setting in India. Methods: An open-label, single-arm, prospective study among chemonaive patients was conducted across six centers from April 2019 to December 2021 after approval from each institutional ethics committee (CTRI/2020/02/023586). A post-hoc analysis was carried out to assess the effectiveness of NEPA in preventing CIN in patients. The parameters assessed included severity of nausea using a visual analogue scale (VAS) [No significant nausea (includes no/mild nausea) < 2.5cm on VAS scale, moderate nausea 2.5cm to 7.5cm, Severe nausea 7.5cm to 10cm], complete control (no nausea and complete response) and safety. Results: Of the 354 patients, 289 (81.64%) received the HEC regimen, and the remaining 65 (18.36%) received the MEC regimen. Anthracycline-Cyclophosphamide (36.16%) and FOLFOX (6.21%) were the most common HEC and MEC regimens, respectively. In the overall, acute, and delayed phases, no significant nausea was reported in 89.83%., 93.22% and 92.65% of the patients, respectively. Moderate and severe nausea was reported in 5.65%, and 1.13% of patients in the acute phase, 5.65%, and 1.69% in the delayed phase, and 8.19%, and 1.98% in the overall phase respectively. Among, those on HEC and MEC regimen, no significant nausea was reported in 93.42 % and 89.23 % respectively during the overall phase (Table 1). Complete control was achieved in 77.40% of patients in the overall phase, 82.77% in the acute phase, and 85.03% in the delayed phase. Adverse events were reported in 10 (3.4%) patients, with leg pain being the most common 3(0.8%). Conclusions: NEPA was found to be effective and well tolerated in preventing nausea in patients receiving HEC/MEC regimens, with almost 90% of patients reporting no significant nausea in real world Indian setting. Clinical trial information: CTRI/2020/02/023586 .[Table: see text]
Cancer-related fatigue and functional impairment: Retrospective study in patients with newly diagnosed solid-tumor cancer.
Authors: Beeler Dori Michelle , Boselli Danielle , Meadors Patrick L. , Walsh Declan
Published: June 2023

e24143

Background: Functional impairment (FI) and debilitating cancer-related fatigue (CRF) occur across all cancers with negative impact on quality of life (QoL). The nature of the association between CRF and FIs is unknown. We conducted a retrospective, single institutional study to investigate the association between CRF and FIs prior to treatment in newly diagnosed solid tumors within Levine Cancer Institute (LCI), a regional, multi-site cancer system. Methods: Electronic Distress Screening (EDS) and Cancer Registry databases from Jan 2017 to Jan 2022 were sourced. CRF was defined as fatigue (0-10 scale) ≥4. FIs were assessed using three EDS questions with a two-week recall: (1) how well have you been able to manage your day-to-day life? (PM); (2) has your physical health kept you from doing things like household chores or climbing stairs? (PHL); and (3) do you have limited movement (LM) in any of the following [body parts]? These are proxies for activities of daily living and instrumental activities of daily living. LCI patients aged ≥18 years with one cancer diagnosis within 10 years, completed EDS ±2 weeks of diagnosis, and before treatment were included. Proportions were compared using Fisher’s Exact test; multivariable logistic regression models evaluated the prognostic value of FIs on CRF. Results: 3439 unique patients were identified with strong associations between CRF and FIs. Median age was 62 years (18 to 97); 68% female and 78% White. The largest diagnostic groups were breast (30%), upper GI (17%), and gynecologic (16%); and 21% had stage IV disease. High CRF was reported by 57% (N = 1946) patients. FIs included: poor PM of day-to-day life, PHL, and ≥1 one body area of LM which were reported by 18% (N = 613), 19% (N = 648), and 29% (N = 982) respectively. More patients with FIs indicated CRF: PM 92% v. no PM 49% (P < .01), PHL 92% v. no PHL 48% (P < .01), and LM 75% v. no LM 49% (P < .01). In multivariable modeling, all FIs were significantly associated with CRF. The Table outlines that all lower bounds of estimated 95% confidence intervals ratios associated with odds ratios were greater than 1.66 when adjusted for age at diagnosis, sex, race, diagnostic group, and advanced disease, highlighting that all are independently associated with CRF. Conclusions: FIs are highly associated with CRF prior to treatment for solid tumors in a large cohort of patients. Pre-diagnosis FI screening identifies patients at risk for significant CRF. Early CRF management is essential to reduce negative QoL impacts.[Table: see text]
Factors affecting administration of palliative care in primary central nervous system tumors: An NCDB analysis.
Authors: Spalinski Daniel , Nguyen Daniel , Hoenack Michael , Memon Ali , Zineldine Sherif , Silberstein Peter T.
Published: June 2023

e24146

Background: Primary central nervous system (CNS) tumors are a diverse group of neoplasms that can vary greatly in terms of their cellular origin, histological features, clinical behavior, and prognosis. Many diagnoses leave patients with a poor prognosis and an impaired quality of life. Palliative care (PC) has long been used as a means to improve quality of life and symptoms associated with debilitating malignancies; however, its use in CNS tumors is not well characterized. Yet, the plethora of life-altering symptoms such as gait impairment, cognitive decline, motor deficits, and seizures provide a need for further multidisciplinary approaches to integrating PC with primary CNS tumor diagnoses. We aim to assess factors that influence the receipt of PC in the current data on central nervous system tumor patients and assess differences in overall survival. Methods: This study retrospectively evaluated the use of PC in patients with single primary malignant central nervous system tumors (gliomas, neuroepitheliomatous neoplasms, and meningiomas) diagnosed and recorded in the National Cancer Database (NCDB) between 2004 and 2020. Patients were identified by ICD-O-3 coding and patients with other malignancies were excluded. Multivariable logistic regression was performed to evaluate associations between patient characteristics and the use of PC, and Kaplan-Meier curves with log-rank analysis were used to determine survival for each group. Results: After excluding patients without information on utilization of PC, a total of 9295 patients with primary CNS tumors were considered in the final analysis. Overall, 1.31% received palliative care. From patients receiving palliative care, 81.1-93.4% received non-curative treatment with surgery, radiation, chemotherapy, or a combination of one or more of these modalities with additional pain management. Odds of receiving palliative care were decreased in black patients, patients who received non-palliative surgical treatment, patients with a primary tumor site at the optic chiasm, patients with unilateral tumors, and patients with private, medicaid, other government, or unknown insurance status. Odds of receiving palliative care were increased with increased Charlson-Deyo Score, in patients receiving non-palliative systemic or radiation treatment, and patients with a primary site at the spinal dura. Utilization of PC was associated with a decreased 1-year and 5-year overall survival. Conclusions: PC use in CNS tumors was influenced by tumor location, treatment type, insurance status, patient race, and comorbidity index. This study demonstrates the areas in which use of PC utilization is still lacking across a diverse set of CNS tumors and patients. Further exploration is needed into the integration of palliative care broadly across these malignancies as it still remains low despite the abundance of quality-of-life altering symptoms.
METASNCore: A new tool for palliative whole brain radiotherapy (WBRT) assessment in the era of targeted therapies.
Authors: Flores Paco Pablo , Vargas Alicia , Guevara Maria Geraldina , Lopera Ignacio , Rodríguez Ruiz Lucía , María López-Herrero , Camús Juan Adrián , López-González Javier , Inga-Saavedra Elizabeth , Montero Marina , Barneto Isidoro , Gomez Maria Auxiliadora , Ruiz Estela , Ruza Marta , Tudela María Luz , Palacios Amalia , De La Haba Juan , Aranda Enrique
Published: June 2023

e24154

Background: Palliative WBRT has been the main treatment for multiple brain metastases (BM). Recent studies report no benefit in survival or quality of life of WBRT compared to palliative supportive care in patients (pts) with poor prognosis. Several scores have been developed to support decision-making for selection of patients; despite this, the scales implemented so far do not consider the substantial impact of new developments in recent years. The purpose of this study was to develop and statistically validate a prognostic score in palliative pts with BMs who underwent WBRT. Methods: 239 pts with BM who received palliative WBRT between 2013-2022 in our center were analyzed retrospectively. Relevant clinicopathological features and their association with overall survival (OS) were measured using univariate and multivariate Cox regression models. The score was designed according to the value of the β coefficient of each variable with statistical significance (p < 0.05) in the multivariate model. Extra 0.5 points were added to all variables with a statistical significance of p < 0.001. Once the score was established, a comparison was performed according to Kaplan-Meier and the survival curves were analyzed with the log-rank test. Results: 149 pts (62.3%) were male and median age was 60 years. 139 (58,2%) were lung cancer (22,8% small cells), 35 (14,6%) breast cancer (53% luminal). 124 pts had ECOG 0-1 (52,1%) and 114 (47,9%) ECOG 2-3, 169 (70,7%) had extracranial disease and the most common symptom was headache (24,3%). All patients received 30Gys in 10 sessions. 37 pts (15,5%) had a specific target mutation and 15 (6,3%) received targeted therapy after WBRT. Median OS was 3,74 months (95% CI 3,28-4,20). After the multivariate analysis: ECOG, gastrointestinal (GI) or urothelial cancer, previous RT, protein C reactive (PCR), target drug treatment and chemotherapy after WBRT were shown to have independent prognostic value for the OS. Our score found 16% to 33% higher risk of the event taking place before per each point in the score. (HR (CI 95%): 1.243 (1.164 - 1.329). p < 0.001) (table 1). We found that 48 pts were in group 0-4 points with mOS 6,89ms (CI 95% 3,18-10,62), 80 in group 4-7 points with mOS 4,01ms (CI 95% 3,40-4,62) and 90 pts in group > 7 points with mOS 2,72ms (CI 95% 1,93-3,52). Conclusions: Some items in our cohort like ECOG, primary tumor site, PCR or post-WBRT systemic treatment (specially target treatment) are associated with OS and they could be useful in a score to select palliative pts to receive WBRT. More prospective and multicenter studies are necessary to corroborate our findings.[Table: see text]
Extracranial palliative radiotherapy for metastatic renal cell carcinoma.
Authors: Kwon Young Suk , Hsu Eric , Stein Maggie , Christie Alana , Garant Aurelie , Wang Andrew Zhuang , Yang Daniel X. , Yen Allen , Miljanic Mihailo , Courtney Kevin Dale , Hammers Hans J. , Zhang Tian , Arafat Waddah , Qin Qian , Cole Suzanne , Brugarolas James , Timmerman Robert D. , Hannan Raquibul
Published: June 2023

e24156

Background: Radiation therapy (RT) is routinely used for the palliation of metastatic renal cell carcinoma (mRCC) symptoms despite a paucity of literature on RT’s efficacy. Since RCC is considered radioresistant to conventionally fractionated RT, we retrospectively evaluated factors influencing effective symptom palliation with RT for mRCC. Methods: A retrospective review of patients with mRCC between 2011 and 2022 at a high-volume academic radiation center was performed to identify patients with symptomatic extracranial metastatic sites managed with RT. Radiation therapy techniques included three-dimensional conformal RT, intensity-modulated RT, and stereotactic body RT. Symptomatic indications for RT were categorized as pain, neurologic (weakness and numbness), respiratory (hemoptysis and cough), gastrointestinal/genitourinary (GI/GU) bleeding, or multiple. Symptom relief was evaluated from chart reviews at subsequent on-treatment visits or follow-up encounters. Time to symptom alleviation (days) was measured from the RT start date. Descriptive analyses were performed. Results: Of 243 patients included in the study cohort, there were 617 irradiated sites. 560 out of 617 (91.0%) patients were treated for pain, and the other symptoms included neurologic (6.8%), respiratory (3.9%), and GI/GU bleeding (1.5%). The most common RT regimen was 20Gy in 5 fractions (122 lesions; 19.8%) followed by 30Gy in 10 fractions (35 lesions; 5.7%). Symptom relief was observed in 84.9% (95%CI 81.4, 88.1) of patients for pain, 90.8% (95%CI 78.2, 97.6) for neurologic, and 69.9% (95%CI 49.3, 88.0) for respiratory symptoms. The overall proportion of symptom relief was 103/131 (79%) for 20 Gy in 5 fractions versus 27/38 (71%) for 30 Gy in 10 fractions (chi-square P = 0.3). Conclusions: RT is effective for symptom palliation of mRCC. Further studies are required to fully delineate the impact of dose-fractionation and RT modality. [Table: see text]
Introduction and validation of the RONIN open assessment framework: A modular system for assessing patient-reported outcomes (PRO) in clinical practice and research.
Authors: Sidey-Gibbons Chris , Brown Grace , Elrick Ashley , Tang Yiqing , Williams Melanie , Harrison Conrad , Swisher Christine
Published: June 2023

e24158

Background: Despite their potential to improve patient quality of life and survival, PRO-based symptom assessments are not routinely used in clinical cancer care. Barriers to use include cost, availability to for-profit users, and data sharing mandates as well as restrictions to any modification or translation to mobile devices. A trustworthy, open, and flexible approach to PRO-based symptom assessment may create new opportunities to reduce patient burden, increase clinical insight, and maximize measurement quality. Methods: We conducted expert interviews with oncology care staff, patients, and psychometricians to develop a flexible framework for symptom assessment that could be used to provide clinical insight and, uniquely, provide unidimensional measurements supported by item response theory. We developed a scalable framework to create symptom assessments using four interchangeable components, recall period, construct (e.g., severity, frequency, control), symptom (e.g., nausea, fatigue, pain), and an optional qualifier (e.g., at its worst, on average, in your lower back) In its first iteration, we tested 18 questions measuring presence as well as the severity, frequency, and impairment related to 9 symptoms occurring over the previous 7 days. We assessed construct validity by comparing scores to the PRO-CTCAE and assessed scalability and dimensionality using Mokken analysis. We recruited cancer patients receiving therapy in the United States to complete the nascent assessment alongside the PRO-CTCAE. Results: We recruited 10 patients and 13 clinical and psychometric domain experts for the expert interviews to develop the framework. For validation, we recruited 251 patients. Fatigue (65%) was the most common symptom and vomiting (32%) the least. All items correlated with the PRO-CTCAE equivalents (r = 0.46 - 0.72, all P < 0.05). Mokken analysis confirmed the scalability and dimensionality of all symptom scales with multiple items ( Ho = 0.59 - 0.72) as well as their constituent items ( Ho = 0.49 - 0.66). Conclusions: We created a flexible framework using exemplar PRO-based symptom assessments that can flexibly provide clinical insights and robust research measurements depending on stakeholder need. In the future, we plan to share access and encourage its use and expansion. Further work is planned to increase the number of symptoms and number of questions per symptom available within the framework.
A whole-food, plant-based dietary intervention and cognitive function in women with metastatic breast cancer.
Authors: McGuire Jeremy , Campbell Thomas , Gilmore Nikesha , Culakova Eva , Mattick Lindsey Jean , Janelsins Michelle Christine , Peppone Luke Joseph , Campbell Erin
Published: June 2023

e24160

Background: Disease-specific quality of life (QOL) is consistently regarded as one of the most important outcomes by women with metastatic breast cancer (mBC), and it predicts survival. Treatment-related symptoms such as cognitive impairment greatly impact QOL in women with mBC. Patients undergoing treatment for breast cancer are highly interested in diet and nutrition, but despite this high level of interest, very few trials have tested dietary interventions in women receiving systemic breast cancer therapy and; the majority of research has been conducted in survivors who have completed primary treatment. Given the limited treatment options for cognitive impairment we evaluated whether our results show a whole food plant based (WFPB) dietary intervention might improve perceived cognitive function (CF) in women undergoing treatment for metastatic breast cancer. Methods: Patients with stage 4 breast cancer receiving treatment were randomized 2:1 into 2 arms: 1) WFPB diet (n = 20) or 2) usual care (n = 10) for 8 weeks with assessments at baseline, and 8 weeks. Our WFPB diet consisted of an ad libitum whole-food, plant-based diet; 3 meals/day were provided, which included fruits, vegetables, whole grains, nuts/seeds and excluded meat, dairy, eggs, added oils, solid fats and most sugars. Patient reported outcomes for perceived CF were collected using FACT- COG and EORTC-QLQ-C30. Paired t-tests were used to assess within group changes from baseline to week 8. The between group difference (WFPB diet vs control) was assessed by ANCOVA model. Results: Patients on the WFPB diet began with a mean baseline score of 140.8 on the FACT-COG which significantly improved to 156.6 (p = 0.005) at 8-weeks post intervention. The reported minimally important difference (MID) between groups is (9.6) and we observed a clinically significant difference of 17.1 (p = 0.03). Similar results in CF were observed for EORTC-QLQ-C30. The baseline mean score of 73.3 was improved to 84.7 (p = 0.004) at 8-weeks post intervention. The reported MID between groups is (4) and we observed a clinically significant difference of 12.6 (p = 0.07), with no significant changes in perceived CF for the control group. Conclusions: Our 8-week WFPB diet resulted in clinically meaningful and statistically significant improvements in perceived cognitive function in women with metastatic breast cancer. A phase 3 clinical trial is needed to confirm the results of this novel intervention. Funding: 3UG1CA189961. Clinical trial information: NCT03045289 .[Table: see text]
Recruitment lessons learned from a cross-sectional study of quality of life experienced by people receiving treatments for hepatocellular carcinoma.
Authors: Woodrell Christopher D. , Watman Deborah , Perez Sasha , Lubetsky Sara , Chen Yingtong
Published: June 2023

e24162

Background: People with advanced-stage hepatocellular carcinoma (HCC) are living longer given improved treatment effectiveness, yet we know little of their unmet palliative and supportive care needs. Previous studies of palliative care in populations of people facing liver diseases and liver cancer have cited difficulty with recruitment. Methods: This is a cross-sectional study at a single academic medical center. Participants are recruited from a multi-specialty liver cancer practice that includes surgery, interventional radiology, and medical and radiation oncology. Treating physicians identify appropriate participants from a list of pre-screened eligible individuals generated by the study team. Once enrolled validated survey instruments are used to collect data at two time points separated by one month and a qualitative interview is conducted that focuses on the experience of living with HCC. PDSA framework was used to improve recruitment procedures to a rate of 3-4 per month. Results: During the first four months we identified 19 potential participants. Of these, ten were ineligible: four did not meet timing criteria (enrollment before treatment initiation); three lacked English proficiency; and three were identified by their physician as not appropriate for the study. Of the remaining nine potential participants, four were unable to be contacted by phone, two were uninterested (including one who specifically ended the call after hearing the term palliative care), one was lost to follow-up, and two were consented and enrolled. In response, the following modifications were made to the protocol: (1) Medical eligibility criteria were liberalized so that enrollment could occur at any time during treatment; (2) a protocol to involve trained interpreters (in-person when possible) was implemented and a study team member who can conduct qualitative interviews in Spanish was added; (3) the title of the study was changed to more accurately focus on understanding quality of life (from “Palliative Care for People Facing HCC”) to address patient and physician concern; and (4) recruitment efforts are now focused on in-person introduction of the study to develop rapport. Since implementation of these changes, enrollment doubled in just one month. Conclusions: We identified actionable protocol modifications to increase study enrollment. Liberalized inclusion criteria, language inclusivity, and careful attention to stigma around palliative care may be generalizable to similar studies about supportive care, palliative care, and hospice in the population of people facing liver cancer. Additionally, avoiding language-based exclusions for lack of resources (rather than scientific ones) increases inclusivity in research and will allow for a more meaningful and accurate description of all our participants’ needs.
Racial disparities in utilization of palliative care among inpatients admitted for lung cancer.
Authors: Bharathidasan Kavya , Ajitkumar Ashika , Mohan Gaurav , Rehman Shabnam
Published: June 2023

e24166

Background: Multiple national database-based studies have shown that Black and Hispanic patients are less likely to receive palliative care options at end-of-life (EOL) inpatient care leading to higher costs and poorer quality of life. To the best of our knowledge, there is no reported data specifically considering lung and pleural malignancies. Methods: We analyzed hospitalizations across the United States in 2019 from the National Inpatient Sample dataset, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality. We identified adult non-emergent hospitalizations with ‘malignant neoplasm of the lung and bronchus’ (including mesothelioma) listed as the principal reason for hospitalization using the International Classification of Diseases, 10th revision, clinical modification codes C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and their sub-branches. StataCorp Stata software was used to extract data and compute mortality and palliative care consult utilization among various demographic factors such as sex, age, race, and payer status. Results: Of 67,425 total hospitalizations, 9.4% resulted in mortality. Of these 6338 patients that died, 73.1% were White, 13% Black, 5.8% Hispanic, 3.9% Asians/Pacific Islanders, 0.6% Native Americans, and 3.3% were other races. Palliative care was consulted in 63% of the patients whose admission resulted in death. 64.9% of the White patients, 58.6% of the Black patients, 62.6% of Hispanic patients, 67.7% of Asians/Pacific Islanders, 60% Native Americans, and 59.6% of other races were offered palliative care prior to their death. The average age among the admissions which resulted in death was 69.03 years. Conclusions: While most admissions resulting in mortality were among the White population, there was still a clear discrepancy in the number of Black patients on whom palliative care was consulted. Possible reasons include poor healthcare literacy, physician mistrust, and cultural preferences. Clinicians should consider and suggest early palliative care consultation in the care of Black patients and other minority racial groups to improve the quality of EOL care.
Cancer pain in the emergency department: An EMR-based opioid dosing intervention and the effects on patient outcomes.
Authors: Coyne Christopher John , Miller Ryan , Dong Kelly , Shatsky Rebecca Arielle
Published: June 2023

e24167

Background: Pain is a common reason for patients with cancer to seek care in the Emergency Department (ED). Many of these patients are on chronic opioids and may have developed opioid tolerance, which makes appropriate dosing challenging for emergency physicians. Therefore, we designed an electronic medical record (EMR) based best practice advisory (BPA) intervention to recommend appropriate opioid dosing in the ED, based on a patient’s prescription opioid use. Methods: We conducted a retrospective cohort study to evaluate our cancer pain intervention at two academic EDs from May 2020 to May 2022. Our novel BPA algorithm identified ED cancer patients who were taking prescription opioids with an EMR-calculated morphine equivalent daily dose (MEDD) of at least 100. If an ED provider ordered an opioid for one of these patients, the BPA would fire and recommend an opioid dose based on the patient’s individual MEDD. The ED provider would then have the option of accepting or cancelling the BPA. We compared outcomes based on whether patients received BPA-guided increased opioid dosing. We utilized the chi-squared test with an alpha of < 0.05 to assess the relationship between BPA-guided increased opioid dosing and pain scores, hospital admission rates and ED bounce-back rates (return visit within 7 days). Results: We identified 399 patients who met our inclusion criteria, representing 705 BPA alerts. Those patients that received increased opioid dosing were similar to those that did not, with respect to age, sex, race/ethnicity and ECOG score. Patients who received BPA-guided increased opioid dosing experienced a greater improvement in pain (72.5% vs 65.1%, p = 0.03) and were admitted less frequently (58.5% vs 63.9%, p = 0.04). However, among discharged patients, those that received increased opioid dosing bounced back to the ED more frequently (16.2% vs 7.7%, p < .01). Conclusions: This EMR-based BPA intervention was associated with improved pain scores and decreased admission rates among cancer patients visiting the ED. The same intervention, however, was associated with increased ED return visits within 7 days, suggesting that pain management strategies may need to be implemented or modified upon ED discharge to assure that patients’ symptoms are adequately managed at home.
Efficacy and safety of PEG-rhG-CSF versus rhG-CSF in preventing granulocytopenia in sarcoma patients receiving doxorubicin combined with ifosfamide: A prospective, randomized, non-inferiority phase II study.
Authors: Fan Li , Ye Ting , Wang Zhongliang , Cao Rubo , Wang Bicheng , Peng Ling , Chen Jing
Published: June 2023

e24173

Background: Prophylactic use of rhG-CSF is routinely recommended in patients with a high risk of febrile neutropenia (FN) after chemotherapy. Currently, rhG-CSF is mostly used in clinical practice. However, PEG-rhG-CSF tends to be a substitute due to its convenience and long-acting effect. Regarding concerns about its efficacy and safety, whether PEG-rhG-CSF could be prophylactically used after these regimens with a high risk of FN is still in doubt. Doxorubicin combined with ifosfamide is commonly applied in sarcoma patients and is one of the most serious myelosuppressive chemotherapy regimens in solid tumors. We compared the efficacy and safety of PEG-rhG-CSF with rhG-CSF in the prevention of severe granulocytopenia and FN, in patients receiving this representative regimen. Methods: This was a single-center, prospective, randomized, crossover, non-inferiority phase II trial. Patients with sarcoma suitable for doxorubicin combined with ifosfamide treatment were enrolled. All patients received 2 cycles of chemotherapy and were randomly assigned to either the AOB group (PEG-rhG-CSF used in 1st cycle and rhG-CSF in 2nd cycle) or BOA group (rhG-CSF used in 1st cycle and PEG-rhG-CSF in 2nd cycle). Blood monitoring every other day until ANC ≥ 2×109/L in two consecutive tests. The primary endpoints were the frequency and duration of grade 4 granulocytopenia after prophylactic use of PEG-rhG-CSF and rhG-CSF respectively, the secondary endpoints were the frequency and duration of febrile neutropenia, and proportion of antibiotic use. Results: From Jan 1, 2018 to Aug 31, 2021, 70 patients were enrolled, 35 each in AOB and BOA. There were no statistical differences in the incidence and duration of grade 4 granulocytopenia (85.7% vs. 77.0%, p = 0.1; 1.34d vs. 1.41d, p = 0.70), the proportion and duration of febrile neutropenia (12.8% vs. 8.2%, p = 0.77; 0.6d vs. 0.8d, p = 0.74), and the proportion of antibiotics used (19.1% vs. 14.9%, p = 0.79) when comparing PEG-rhG-CSF vs. rhG-CSF in prophylactical use. The incidence of grade 4 granulocytopenia in both groups was comparable in 1st cycle (90.9% vs. 96.0%, p = 0.47), but in 2nd cycle it was significantly lower in AOB than that in BOA (54.5% vs. 88.0%, p = 0.01). The lowest value of ANC was higher in AOB in 2nd cycle (0.32G/L vs. 0.12G/L, p = 0.03). Conclusions: This study demonstrated PEG-rhG-CSF could prevent granulocytopenia and FN in sarcoma patients receiving doxorubicin combined with ifosfamide, with comparable efficacy and toxicities as rhG-CSF. Considering the convenience in use and patient compliance, PEG-rhG-CSF could be an effective and reasonable alternative to rhG-CSF. Clinical trial information: ChiCTR1900021945 .