bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparing nonverbal synchrony in racially concordant and racially discordant oncology interactions.
Authors: Hamel Lauren M. , Moulder Robert , Eggly Susan , Albrecht Terrance Lynn , Boker Steven , Dougherty David W. , Penner Louis 
Published: March 2020

11525 Background: Communication in racially discordant (Black patient, non-Black physician) oncology interactions, which constitute about 80% of Black patients’ interactions, is generally poorer than in racially concordant interactions, and likely contributes to treatment disparities. However, the nonverbal behaviors that contribute to this problem are largely unknown. We examined nonverbal synchrony, or the nonconscious coordination of movement, which can reflect relationship quality. We hypothesized that racially discordant interactions will have lower levels of nonverbal synchrony. Methods: Data include video recordings of 68 Black patients and 163 White patients discussing treatment with their non-Black oncologists. Recordings were submitted to motion detection software to measure nonverbal synchrony. This software measures global synchrony (all correlated motion), peak synchrony (all positively correlated motion), who is leading the interaction (similar to who is leading in ballroom dancing), and how much synchrony occurs based on who is leading the interaction. Using multi-level models, we investigated whether nonverbal synchrony differed in racially concordant and racially discordant dyads. Results: Findings showed greater levels of global synchrony (p < .05) and greater peak synchrony (p < .05) in racially discordant interactions compared to racially concordant interactions. Global synchrony was the same in racially concordant interactions regardless of who was leading, but greater global synchrony occurred in racially discordant interactions when the patient was leading (p < .05). Conclusions: This is the first study to use a dynamic jointly determined measure of behavior to assess oncology interactions. Contrary to our hypothesis, nonverbal synchrony was greater in racially discordant interactions than in racially concordant interactions. It appears patients are driving more of the synchrony in racially discordant interactions. This may suggest that patients in racially discordant interactions adapt to their physicians to bridge racial differences. Findings could contribute to physician training to enhance coordination and outcomes in oncology interactions.
ELAN-ONCOVAL (Elderly Head and Neck Cancer-Oncology Evaluation) study: Evaluation of the G8 screening tool and the ELAN geriatric evaluation (EGE) for elderly patients (pts) with head and neck squamous cell carcinomas (HNSCC).
Authors: Mertens Cécile , Le Caer Hervé , Ortholan Cécile , Blot Emmanuel , Even Caroline , Rousselot Hubert , Peyrade Frederic , Sire Christian , Cupissol Didier , Pointreau Yoann , Debourdeau Philippe , Rolland Frederic , Fayette Jerome , Capitain Olivier , Sun Xu Shan , Debbah Moufida , Boulahssass Rabia , Schwob Dominique , Auperin Anne , Guigay Joel 
Published: March 2020

11541 Background: About 47% and 10% of HNSCC occur in pts aged ≥65 or ≥80 respectively. This population being heterogeneous, balancing efficacy with toxicity is challenging. As the G8 screening tool includes 3 nutritional items, we need to evaluate its usefulness in HNSCC pts and to establish an adapted tool for HNSCC pts. Methods: ONCOVAL is the first step of the ELAN program for pts ≥70 with HNSCC not amenable to surgery. Pts were assessed for geriatric frailties before inclusion in appropriate trials (ELAN-RT, FIT, UNFIT) depending on curative or palliative setting and fit or unfit status. The aim was to evaluate the G8 tool and EGE usable by oncologists to classify pts as fit or unfit. The EGE was elaborated by the French GERICO group for HNSCC pts, evaluating functional status, comorbidity, cognition/mood, social status. To estimate sensitivity and specificity of G8 and EGE, we used comprehensive geriatric assessment (CGA) performed by geriatricians as gold standard. Results: From 06/2013 to 08/2018, 633 pts were included in 44 centers. Data are available for 613 pts. Median age 79 years (70-97) with 45% ≥ 80. 75% males. G8 score was ≤14, i.e. at risk of geriatric frailty, in 82% pts. Assessment by EGE was done by physicians (64%), nurses (11%), ELAN staff (21%) in 20 minutes of median time. After EGE, oncologists classified 71% pts as unfit. 49% of pts were assessed by CGA. The G8 score with cut-off ≤ 14 has sensitivity 91% and specificity 30%. Lowering cut-off to 12 increased specificity to 56% but decreased sensitivity to 75%. Sensitivity of EGE was 95% and specificity 60%. Multidisciplinary interventions were more frequently implemented in pts assessed by geriatricians than in others (71% vs 47%), even after adjusting for frailty. 58% of pts included in ONCOVAL were further included in ELAN therapeutic trials. Assessment by geriatricians did not modify the rate of inclusion in trials. Conclusions: The G8 screening tool is not appropriate for HNSCC pts. The EGE was feasible and had better sensitivity and specificity. Oncologists and geriatricians must continue such collaboration to propose tailored treatments. Clinical trial information: NCT03614936.
Associations of uncertainty with psychological status and quality of life (QoL) among 527 older patients with advanced cancer.
Authors: Babu Dilip Sankar , Loh Kah Poh , Bautista Javier , Xu Huiwen , Culakova Eva , Canin Beverly E. , Conlin Alison Katherine , Bearden James , Berenberg Jeffrey L. , Zhang Yingzi , Wells Megan , Epstein Ronald M. , Dale William , Duberstein Paul , Mohile Supriya Gupta , Tejani Mohamedtaki Abdulaziz 
Published: March 2020

11544 Background: Older patients with advanced cancer face considerable uncertainty related to their disease and treatment. The aim of our study was to evaluate the associations of uncertainty with psychological status and QoL. Methods: This is a secondary analysis of baseline data from a national geriatric assessment (GA) cluster randomized trial (URCC 13070; PI: Mohile). Patients aged ≥70 years with ≥1 GA domain impairment (e.g., function, cognition) and advanced cancer who were considering or receiving any line of cancer treatment were enrolled (n=541). Uncertainty was measured using the modified 9-item Mishel Uncertainty in Illness (MUIS), where respondents with higher scores perceive more uncertainty (range 9-45). QoL and psychological measures consisted of Functional Assessment of Cancer Therapy-General (FACT-G), emotional wellbeing (EWB; FACT-G subscale), distress (distress thermometer), anxiety (Generalized Anxiety Disorder-7), and depression (Geriatric Depression Scale-15). Multiple linear regressions were used to evaluate the associations of MUIS scores with each measure, adjusted for demographics, cancer type, and number of impaired GA domains. Results: Mean age was 77 years (SD 5, range 70-96); 26% had gastrointestinal cancer and 26% had lung cancer. Mean number of GA domain impairments was 4 (SD 1, range 1-7). Mean MUIS score was 20 (SD 5, range 9-37). On multivariate analyses, higher MUIS score was associated with lower QoL (β=-1.08, SE=0.11) and EWB (β=-0.29, SE=0.03), as well as higher distress (β=0.12, SE=0.02), anxiety (β=0.11, SE=0.04), and depression (β=0.09, SE=0.03; all P<0.01). Conclusions: Distress associated with uncertainty was common in a vulnerable population of frail older patients with advanced cancer and ≥1 GA domain impairment. A higher degree of uncertainty was associated with poorer psychological health and QoL. Our results underscore the important role that uncertainty plays in older patients' psychological status. Previous tested uncertainty management interventions (mainly including information and coping strategies) could be revised, tailored and tested to meet the unique needs of older patients with cancer. Clinical trial information: NCT02107443.
High temporal variability of clinical side effects with and without adjuvant chemotherapy in 4,684 early breast cancer patients in the CANTO trial.
Authors: Cottu Paul H. , Tanguy Marie-Laure , Laas Enora , Tredan Olivier , Giacchetti Sylvie , Guillermet Sophie , Ferrero Jean-Marc , Rigal Olivier , Tarpin Carole , Campone Mario , Levy Christelle , Soulie Patrick , Vanlemmens Laurence , Fournié Marion , Jouannaud Christelle , Everhard Sibille , Lemonnier Jerome , Arveux Patrick , Luis Ines Maria Vaz Duarte , Andre Fabrice 
Published: March 2020

11566 Background: CANTO (CANcer TOxicities - NCT01993498) is a French multicenter prospective longitudinal study dedicated to the quantification and characterization of side effects after treatment for patients with stage I-III breast cancer, and to the development of predictors of toxicities. Methods: The CANTO study has included > 12,000 patients, assessed at diagnosis, and 3-6 months (T0), 15 months (T12), and year 3 and 5 after treatment completion. In the current report, we focus on key toxicities at T0 and T12 according to chemotherapy (CT) administration. For each side effect, 4 populations were defined according to its occurrence at T0 and/or T12 (no/no, no/yes, yes/no, yes/yes). Results: We analyzed 4684 patients with T0 and T12 consolidated data. Median age at diagnosis was 57y (22-89). Patients (pts) had HR+/HER2-, HER2+ or triple negative tumors in 78.9%, 12.4% and 8.7% of cases, respectively. Overall, 2516 pts (53.7%) received CT. Most CT pts (81%) received a sequential anthracyclines– taxanes schedule. As an example, a high proportion of patients presented neurological symptoms including cognitive symptoms, sensory or motor neuropathy, paresthesia, headache, etc (all grades) at either T0 or T12. Overall, CT was strongly associated with neurotoxicity at all times (OR = 2.27, p < 0.0001). However, proportions of patients with neurological side effects changed between T0 and T12. The table shows the proportions of the 4 categories of pts in the CT and no CT groups. Furthermore, at T12, neurological symptoms remained more frequent in the CT group, whether pts had symptoms at T0 (CT vs no CT, 81% vs 77%, p = 0.007) or not (CT vs no CT, 41% vs 36%, p = 0.03). Similar temporal trends were observed (with specific percentages for each considered side effect) for detailed neurological toxicities, pain and joint/bone toxicity (stratified on endocrine therapy), gastro-intestinal, pulmonary and cardiac toxicities. Conclusions: Overall, symptoms burden is extremely high at T0 and T12 after treatment, and much higher in pts receiving CT. A high temporal variability was observed in all subsets, including a clinically meaningful delayed onset of e.g. neurological side effects. Clinical trial information: NCT01993498. [Table: see text]
Single-fraction stereotactic versus standard conventional multifraction radiation for predominantly non-spine bone metastases: A randomized phase II trial.
Authors: Nguyen Quynh , Chow Edward , Chun Stephen G. , Liao Zhongxing X. , Fnu Rensi , Welsh James William , Hahn Stephen , Fuller Clifton David , Moon Bryan , Bird Justin E. , Satcher Robert L. , Lin Patrick P. , Jeter Melenda , O'Reilly Michael , Lewis Valerae O. 
Published: March 2020

11578 Background: There lacks a consensus as to the optimal radiotherapy dose and fractionation schedule for treating bone metastases. We assessed the relative efficacy of single high-dose stereotactic radiation therapy (SBRT) versus standard multifraction radiation therapy (MFRT) for alleviation of pain in patients with mostly non-spine bone metastases. Methods: This prospective, randomized, single-institution phase II non-inferiority trial enrolled patients with radiologically confirmed painful bone metastases from September 2014 through June 2018. Patients were randomly assigned in a 1:1 ratio to receive either single-fraction SBRT (12 Gy for ≥4-cm lesions or 16 Gy for < 4-cm lesions) versus MFRT to 30 Gy in 10 fractions. Results: The primary endpoint was pain response, defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose [MED]). Failure of pain response was defined as worsening pain score (≥2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of ≥50%; re-irradiation; or pathologic fracture. Among evaluable patients who received treatment per protocol, the single-fraction SBRT group had more pain responders (CR+PR) at 2 weeks (62% vs. 36% MFRT, P= 0.01), at 1 month (62% vs 36%, P= 0.01), at 3 months (72% vs. 49% MFRT, P= 0.03), and at 9 months (77% vs. 12% MFRT, P= 0.03). No differences were found in treatment-related toxicity or quality of life scores after SBRT versus MFRT; local control rates at 1 year were higher in patients receiving single-fraction SBRT. Conclusions: Delivering high-dose single-fraction SBRT is an effective, convenient treatment option for patients with painful bone metastases. Among evaluable patients, SBRT led to higher rates of pain response (CR+PR) than did MFRT and thus should be considered for patients expected to have relatively long survival. Clinical trial information: ClinicalTrials.gov ID NCT02163226.
Correlates of distress for cancer patients: Results from multi-institution use of holistic patient-reported screening tool.
Authors: Weldon Christine B. , Gerhart James I. , Penedo Frank J. , Khosla Paramjeet , Roggenkamp Betty , Pasquinelli Mary , Martin Joanna , Lillis Teresa , Lo Shelly S. , Feldman Lawrence Eric , Deamant Catherine , Berardi Rosa , Miranda Harry , Newsom Carol , Bowman Anne , Trosman Julia Rachel 
Published: March 2020

11587 Background: The Commission on Cancer (CoC) Standard 3.2 requires distress screening and indicated action for cancer patients. NCCN and ASCO supportive care and age-related guidelines include patient reported concerns beyond distress. This study compares PHQ4 scores to other patient reported concerns. Methods: The Coleman Supportive Oncology Collaborative aggregated “best of” screening tools to assess patient reported needs and concerns aligned with CoC, NCCN and ASCO guidance. This supportive care screening tool was implemented at 8 sites from July 2015 thru July 2018. Analysis used chi squared test. Results: Most patients, 86% (10,635/12,295), reported one plus concerns and/or above threshold scores on PHQ4, PROMIS Pain, Fatigue or Physical Function. A chi squared comparison of patients with at least mild distress on PHQ4 to patients with no distress resulted in p values < .0001 for every screening category. Conclusions: Patients with a PHQ4 distress score of mild, moderate or severe also reported statistically significant levels of practical, family, physical, nutrition and treatment concerns. These patients also scored threshold levels for PROMIS Pain, Fatigue, and Physical Function. Screening only for distress without screening for other patient concerns may direct patients to services that do not address or focus on the underlying cause of the distress. [Table: see text]
Survival and safety of monosialotetrahexosylganglioside in GI cancer patients with oxaliplatin-induced peripheral neurotoxicity-result from TJMUCH-GI-001 trial.
Authors: Likun Zhou , Huang Dingzhi , Liu Rui , Li Hongli , Ning Tao , Zhang Le , Ge Shaohua , Bai Ming , Wang Xia , Han Rubing , Yang Yuchong , Wang XinYi , Chen Xinyun , Gao Zhiying , Niu Kaijun , Luo Laizhi , Wu Xi , Deng Ting , Yang Yuanquan , Ba Yi 
Published: March 2020

11596 Background: TJMUCH-GI-001 Trial was a randomized, double-blind, placebo-controlled phase III trial to study the efficacy of Monosialotetrahexosylganglioside (GM1) for oxaliplatin-induced peripheral neurotoxicity (OIPN) in GI cancer patients. Majority patients (> 80%) in both arms continued receiving oxaliplatin on the trial. The results showed GM1 effectively reduced OIPN in GI cancer patients. Here we report the survival and safety results of this trial. Methods: Patients were randomized in a 1:1 ratio to receive GM1 or placebo. Patients with OIPN > = G2 by CTCAE 4.03 persisting during or after oxaliplatin-based chemotherapy were eligible. The patients who remained on oxaliplatin after enrollment, received concurrent placebo or GM1 x 7 days with each chemotherapy cycle. The patients who stopped taking oxaliplatin, were treated with placebo or GM1 x 14 days every 3 weeks. GM1 was dosed at 60mg daily for every 3-week or 40mg daily for every 2-week schedule. Trial was continued until modified EORTC QLQ-CIPN20 ( MCIPN) increased by 30% or stayed unchanged after two more treatments beyond completion of oxaliplatin. Survival data for the treatment arms were compared using a log-rank test and Chi-square tests were used for safety analysis. Results: From May 2015 to Dec 2017, 73 patients were enrolled in GM1 and 72 in placebo arm. The median follow-up was 16.6 months (0.8-43.1 months) as of Dec.2018. Four patients lost to follow up. There was no deleterious impact of GM1 on survival. As a matter of fact, receiving GM1 was associated with a trend toward improved PFS and OS (HR=0.74,95%CI, 0.469 - 1.156 for PFS and HR=0.76, 95%CI0.469 - 1.156 for OS). The most frequent Grade 3 or 4 adverse events included neutropenia (8 patients in GM1 group VS. 4 in placebo group) and hypoleukemia (4 patients in GM1 group VS. 1 in placebo group). Other 3 or 4 adverse events (all less than 3 patients) included anorexia, hypercalcemia, nausea, vomiting, proteinuria, hyperbilirubinemia, hypokalemia, hypertension and appendicitis. All the 3 or 4 adverse events were related to chemotherapy, not to GM1. Conclusion: In this placebo-controlled phase III trial, GM1 showed acceptable toxicity with trends favorable PFS and OS in GI cancer patients. Clinical trial information: NCT02486198.
Phase 2 trial of Symptom screening with Targeted Early Palliative care (STEP) for patients with advanced cancer.
Authors: Zimmermann Camilla , Hannon Breffni , Krzyzanowska Monika K. , Li Madeline , Rodin Gary , Pope Ashley , Swami Nadia , Giruparajah Mohana , Howell Doris , Oza Amit M. , Warr David , Knox Jennifer J. , Leighl Natasha B. , Sridhar Srikala S. , Prince Rebecca M. , Lheureux Stephanie , Hansen Aaron Richard , Booth Christopher M. , Dudgeon Deborah Jane , Le Lisa W ,   STEP Trial Group
Published: March 2020

11604 Background: Routine early palliative care (EPC) by specialized teams improves quality of life for patients with advanced cancer, but may not be scalable. To plan for a larger randomized controlled trial, we conducted a phase 2 trial of STEP, a novel intervention of targeted EPC based on symptom screening. Methods: Participants with advanced cancer, ECOG 0-2, and clinical prognosis ≥6 months were recruited from lung, gastrointestinal, genitourinary, breast and gynecology outpatient clinics. Symptoms were screened at every outpatient visit using the Edmonton Symptom Assessment System-revised (ESAS-r). Moderate to severe symptom scores (≥4/10 for pain, nausea, dyspnea, depression, anxiety; ≥7/10 for fatigue, appetite, drowsiness, well-being) triggered an e-mail to a nurse, who called the patient, offering an EPC visit. Participants completed outcome measures at baseline, 2, 4 and 6 months (primary endpoint). Trial feasibility criteria were: i) ≥100 patients accrued in 12 months; ii) ≥70% complete screening for ≥70% of visits; iii) ≥60% of those for whom a call is triggered meet at least once with the EPC team; iv) ≥60% complete measures at each endpoint. Results: From 11/2016-1/2018, 116 patients were enrolled; 89/116 (77%) completed screening for ≥70% of visits and 59% (69/116) received a call triggered by symptoms. Of those receiving a call, 62% (43/69) received EPC; 3 further patients were referred by their oncologist. Measure completion was 79% (81/116) at 2, 61% (71/116) at 4, and 57% (66/116) at 6 months. By trial end (6 months), patients who received a call and accepted EPC involvement had better symptom control (ESAS-r-CS mean change in those receiving vs. deferring EPC: -0.07±16.9 vs 11.8±13.7, p = 0.02) and less deterioration in mood (PHQ-9: -0.4±3.4 vs 2.6±2.3, p = 0.003). There was no difference between those receiving versus deferring EPC in quality of life (FACIT-Sp: -4.7±13.6 vs -3.2±15.4, p = 0.75; QUAL-E: -2.6±8.4 vs -1.5±11.0, p = 0.62), or satisfaction with care (FAMCARE-P-16: -3.2±7.9 vs -3.5±6.1, p = 0.79). Conclusions: STEP is feasible in patients with advanced cancer. More than half of patients have moderate to severe symptoms, and acceptance of the triggered EPC visit should be encouraged.
Lower costs of care, improved discharge disposition, and improved survival of advanced cancer patients (ACP) receiving early inpatient palliative care (PC) compared to standard oncologic care (SOC).
Authors: Daugherty Christopher , Johnson Julie , Levine Stacie K. , Wroblewski Kristen , Lane Bradford , Dale William , Malec Monica , Hlubocky Fay J. 
Published: March 2020

11609 Background: Outpatient PC improves ACP symptom burdens, end-of-life care transitions, and mortality thereby enhancing quality of life. Yet, the financial implications, discharge disposition, and survival benefits of early, inpatient PC compared to SOC remains less understood. Methods: Retrospective cohort analysis of ACP receiving either PC or SOC between Jan 2015-Dec 2015 (N = 810). ACP cohorts were compared for demographics, costs, disposition, and survival. Financial costs collected included: fixed (overhead expenditures, facility maintenance, hospital property); variable (patient care supplies, diagnostic/therapeutic supplies, medications); operating (fixed, variable, breaking-even costs); direct (labor, materials, commissions, piece-rate wages, manufacturing supplies); indirect (production-supervision salaries, quality control, insurance, depreciation). Univariate and multivariate analyses were completed. Results: 468 were admitted to PC and 342 to SOC. Compared with SOC, PC were more likely to be: younger (61.1±13.2 v. 62.5±13.0, p = 0.02); African American (48% v. 36%, p = 0.0045); female (50% v. 40%, p = 0.005); and have shorter length of stay (5.7±4.9 v. 6.2±6.5, p = 0.01). PC had significantly less 30-day readmissions (16% v 23%, p = 0.03) and lower costs: direct ($9,478 v. $10,416, p = 0.01); indirect ($9,538 v. $10,999, p = 0.002); fixed ($10,308 v. $12,076, p = 0.001); variable ($8,709 v. $ 9,339, p = 0.02); operating ($19,017 v. $21,416, p = 0.003).Compared with SOC, ACP receiving PC were more likely to be discharged to: home (55% v.45%, p = 0.01); healthcare facilities (e.g. skilled nursing, inpatient rehabilitation) (36.1% v. 20%, p = 0.04); and hospice (home and inpatient) (7.7% v 5.8%, p = 0.02). PC had overall greater median survival from the time of discharge (106.8±99.95 v. 73.8±61.93, p = 0.03) compared to SOC. Conclusions: Early PC results in less financial strain, greater cost savings, and improved outcomes for younger and underserved inpatient ACP. Our results provide additional evidence for policies supporting that ACP access to routine PC must become a healthcare priority.