bluuebunny/crossref_metadata_2025_split huggingface dataset:
Psychosocial outcomes among bereaved and non-bereaved parents of children with cancer.
Authors: Rosenberg Abby R. , Bradford Miranda , Shaffer Michele , Wolfe Joanne , Baker Kevin Scott 
Published: March 2020

9526 Background: Psychosocial outcomes among parents of children with cancer are not well characterized and may affect the well-being of cancer-survivors and other children in the home. In order to examine adverse psychosocial outcomes among bereaved (BR) and non-bereaved (NBR) parents, we conducted a cross-sectional, survey-based study. Methods: Enrolled parents completed the “Resilience in Pediatric Cancer Assessment” (RPCA) at least 6 months after their child completed therapy or died from cancer. The RPCA is comprised of validated instruments to assess resilience, emotional distress, social function, health-related quality of life, and financial hardship. Descriptive statistics were used to characterize groups. Differences between groups were assessed with t or Fisher’s exact tests. Differences between the combined sample and population norms were assessed with one-sample t or binomial tests. Results: 120 (78%) of invited parents completed the RPCA (24 BR; 96 NBR). Compared to the general population, parents had lower levels of self-perceived resilience and higher levels of psychological distress. They were more likely to meet criteria for serious, debilitating psychological distress, or Post-Traumatic Stress Disorder (PTSD). All parents (100%) endorsed at least some PTSD symptoms. Parents also reported less marital satisfaction and family cohesion, and more sleep disturbance and binge drinking than population norms. Conversely, enrolled parents reported higher levels of social support and family adaptability, and were less likely to smoke cigarettes (all p<0.05). Compared to parents of survivors, BR parents were less likely to report appreciation for life, an ability to cope, or deal with stress. They had higher levels of psychological distress, more sleep difficulties, and greater financial hardship (all p<0.05). There were no differences between BR and NBR parents with respect to marital satisfaction, family function, or perceived general health. Conclusions: Parents of children with cancer are at high risk for poor psychosocial outcomes. Compared to parents of survivors, bereaved parents are at additional risk. Interventions aimed at improving resilience and other psychosocial outcomes are needed.
Effect of YOCAS yoga on insomnia and sleep medication usage among breast cancer patients receiving hormone therapy: A URCC CCOP randomized, controlled clinical trial.
Authors: Peppone Luke Joseph , Janelsins Michelle Christine , Peoples Anita Roselyn , Kamen Charles Stewart , Kirshner Jeffrey J. , Gaur Rakesh , Atkins James , Reddy Pavan S. , Mustian Karen Michelle 
Published: March 2020

9531 Background: Insomnia (INS) is a highly prevalent side effect of hormonal therapy for breast cancer. Patients often turn to Rx sleep meds, which may lead to negative interactions with cancer therapeutics, dependency, rebound impairment, and do not cure INS. We conducted a secondary data analysis of a multi-site, phase III RCT examining the efficacy of yoga for improving INS and decreasing sleep medication usage among breast cancer patients currently receiving hormone therapy through the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP). Methods: The original RCT randomized patients with any type of non-metastatic cancer without previous yoga participation into 2 arms: 1) standard care monitoring [controls] or 2) 4-week yoga intervention (2x/wk; 75 min/session) plus standard care. The yoga intervention utilized the UR Yoga for Cancer Survivors (YOCAS) program consisting of breathing exercises, 18 Hatha and Restorative yoga postures, and meditation. Only breast cancer patients currently receiving aromatase inhibitors (N = 95) or tamoxifen (N = 72) were included in this analysis. Changes in INS and sleep meds between the groups were assessed using ANCOVA with baseline values as covariates. Results: Despite using Rx sleep meds at baseline, INS, assessed by the Insomnia Severity Index, was worse for those women compared to women not taking any Rx sleep meds (Rx = 15.3 vs No Rx = 13.1; p<0.01). Yoga participants demonstrated greater improvements in INS compared to controls (CS=change score; Yoga CS = −3.3 vs Control CS = −0.5; p<0.01). In addition to improved INS, yoga participants significantly decreased Rx sleep med usage compared to controls (Yoga = −17.6% vs Control = −3.3%; p=0.04). There was also a trend toward lower combined Rx/Non-Rx sleep med use for the yoga group compared to controls (Yoga = −14.5% vs Control = −3.1%; p=0.09). Conclusions: YOCAS yoga is a safe intervention that significantly improves INS while concurrently reducing Rx sleep medication usage among breast cancer patients receiving hormone therapy. Funding: MRSG-13-001-01-CCE, NCI U10CA37420, K07CA120025 and OCCAM supplement. Clinical trial information: NCT00397930.
Pattern of chemotherapy use at end-of-life (EOL) in patients with solid tumors (ST).
Authors: Burke Thomas W. , DeJesus Yvette A , Cheng Lee , Buzdar Aman , Rodriguez Maria Alma 
Published: March 2020

9539 Background: Quality performance measures for cancer care, including use of chemotherapy in the last two-weeks of life, will be required for reporting. In this study, we evaluated the pattern and frequency of chemotherapy use for ST patients in the last two-weeks of life, and whether such treatment included standard or investigational drugs. Methods: We conducted a retrospective study of 5,607 adult cancer patients (≥18 years) who received their care at The University of Texas MD Anderson Cancer Center and died between December 01, 2010 through May 31, 2012. Data on patients’ demographics, and chemotherapy agents dispensed (excluded: hormones) were obtained from the institution’s administrative databases. Type of treatment (research versus standard) was obtained from our chemotherapy dispensed database. Chi-square test and Fisher's exact test were used to determine the association between categorical variables.All statistically significant levels were determined with P values < 0.05. Results: Only 3.9% (216/5,607) of ST patients who died had received chemotherapy within 14 days EOL. For those 216 patients who received chemothapy: median age 64 years; 48% female; 89% metastatic disease. The distribution by chemotherapy treatment route: intravenous (IV) 85%; IV plus oral 6%; oral 6%; other 3%. The distribution of patients by number of chemotherapy agents: one 56%; two 31%, and three or more 13%. Among those who received chemotherapy, 98.6% (213/216) of the chemotherapy administered were standard agents. There were no differences in frequency distribution for chemotherapy treatment route (p>0.05), number of chemotherapy agents (p>0.05) between patients with metastatic and non-metastatic disease, or between men and women (p>0.05). Conclusions: Our results indicate EOL chemotherapy use was infrequent in our patients with STs, and most of those treated received standard chemotherapy, with simple one or two drug regimens. We need more research to determine factors that influence chemotherapy use at EOL, and if it palliates physical symptoms and/or emotional distress in advanced stages of disease.
Impact of bladder cancer (BC) on health-related quality of life (HRQL) in 1,476 older Americans.
Authors: Fung Chunkit , Pandya Chintan , Noyes Katia , Scosyrev Emelian , Sahasrabudhe Deepak M. , Messing Edward M. , Mohile Supriya Gupta 
Published: March 2020

9549 Background: The impact of BC on HRQL is poorly understood. To our knowledge, this is the first and largest cross-sectional study that compares HRQL of patients before and after BC diagnosis (DX). Methods: Our sample included 1,476 BC patients (≥ age 65) within the SEER-Medicare Health Outcomes Survey linkage database (1998-2007). We assessed differences in HRQL as measured by SF-36 physical (PCS) and mental (MCS) summary scores in patients who had a survey >1 yr before BC DX (n=620) and those who had a survey after BC DX (n=856). We compared groups by year from BC DX using regression analyses and results were adjusted for cancer stage, race, gender, age at BC DX, marital status, education, income, smoking status, activity of daily living (ADLs), and non-cancer comorbidities. Results: Patients who had a survey after BC DX were diagnosed with BC at an older age than those with a survey before BC DX (55.9% at age ≥75 yr vs. 36.8%; P<0.01). Other baseline demographic and socioeconomic characteristics were similar. Baseline HRQL were poor in patients before DX (PCS mean=40.1; MCS mean=51.1) with 50.6% and 31.9% of them having comorbidity score ≥2 and impairment of ≥1 ADLs, respectively. After BC DX, significant decreases in PCS (-2.7; 95% CI -3.8,-1.7) and MCS (-1.4; 95% CI -2.6, -0.3) were observed, with HRQL being lowest in those who had BC DX within 1 yr (PCS mean= 36.6; MCS mean=49.7). Declines in PCS during the <1, 1-3, 3-5, 5-10, and 10+ yr periods after BC DX compared to before BC DX were -3.8 (P<0.01), -2.5 (P<0.01), -2.2 (P=0.01), -1.1 (P=0.19) and -0.8 (P=0.57) whereas decreases in MCS were -2.0 (P=0.01), -2.2 (P<0.01), -1.2 (P=0.21), -0.1 (P=0.92), -0.8 (P=0.62) respectively. More advanced BC, lower educational level, higher comorbidity score, and impaired ADLs were significantly associated with both worse PCS and MCS after BC DX (P<0.05). Lower income and older age at BC DX showed significant association with low PCS (P<0.05). Conclusions: Older BC patients are a vulnerable population with poor baseline HRQL. HRQL of patients after BC DX is significantly worse than HRQL of patients before DX, possibly due to therapy and/or disease progression. Future research that evaluates interventions to improve HRQL in older patients with BC is critical.
Safety and tolerability in patients over age 75 included in phase I: The Institut Gustave Roussy experience.
Authors: Helissey Carole , Roquet Florian , Lanoy Emilie , Varga Andrea , Massard Christophe , Gazzah Anas , Ribrag Vincent , Bahleda Rastislav , Angevin Eric , Deutsch Eric , Soria Jean-Charles , Hollebecque Antoine 
Published: March 2020

9556 Background: Safety and tolerability of anti-cancer therapy in elderly people (>=75 years, EP) is of major interest since they represent 31% of US patients diagnosed with cancer. However proportion of EP recruited is only 9% in clinical trials and probably less in phase I trials, which aim to determine the recommended phase II dose. Our objective was to evaluate the safety of phase I trials in EP. Methods: Patients treated from 2007 to 2012 at Institut Gustave Roussy in phase I trials, in which patients aged over 75 years had been included. Population was divided into two groups: EP or patients aged < 75 years (YP). Time to occurrence of first high toxicity (any grade 3-4 adverse event (AE) or dose-limiting toxicity DLT) and overall survival were estimated using Kaplan-Meier method. Conditional Cox proportional hazards model was used to compare occurrence of AE in a sub population of patients aged >= 75 years matched with patients aged <75 years of same Royal Marsden Hospital (RMH) score (Albumin, LDH, Number of metastatic site) and protocol. Results: In the 33 EP and the 161 YP, 20(60%) and 100(62%) grade 3-4 AEs and 1(3%) and 18(11%) DLTs occurred. The median time to occurrence of high toxicity were 2 months (95%CI=1-4) and 2 months (95%CI=1-2). The median overall survival were 22 months (95%CI=11-non estimable) (EP) and 13 months (95%CI =10-16) (YP). Twenty-seven patients aged >=75 years could be matched: age over 75 years was not associated with higher risk of neither high toxicity (HR=0.85, 95%CI=[0.45 ; 1.61], p=.62) nor death (HR=1.03, 95%CI=[0.47;2.24], p=.94). Conclusions: No impact of age over 75 years on occurrence of neither high toxicity nor death was identified. Patients above 75 years are good candidates for phase I trials.
Epoetin biosimilars in the management of anemia secondary to chemotherapy in patients with solid tumors, lymphomas, and myelomas: The ORHEO study.
Authors: Luporsi-Gely Elisabeth , Soubeyran Pierre-Louis , Michallet Mauricette 
Published: March 2020

9564 Background: Chemotherapy may induce anemia with potentially severe consequences. The ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study examined the efficacy and safety of epoetin alfa biosimilars (EABs) for the treatment of chemotherapy-induced anemia (CIA) in the clinical setting. Methods: ORHEO was a multicenter, observational, prospective, post-marketing study conducted in France. Patients with CIA (Hb <110g/L) >18 years old, with solid tumors, lymphomas or myelomas and eligible for epoetin alfa treatment were included in the study; they received EAB as prescribed by their physician. Baseline patient characteristics and anemia-related data including baseline and target Hb level epoetin treatment, adverse events and any other concomitant treatments prescribed were recorded. The primary endpoint was the rate of responders (defined as an increase in Hb levels to 100 g/L or at least 10 g/L since inclusion visit, or reaching target Hb set at start of study, without any blood transfusions in the 3 weeks prior to measurement) at +3 months (M3). Other endpoints included rate of responders at +6 months (M6) and safety endpoints. Results: 2310 patients (51.43 % male, 48.57 % female) from 232 centers were included in this study. At baseline 79.6% had solid tumors, 13.0% lymphomas and 7.4% myelomas. Median age was 68 y (range: 18–93). Mean baseline Hb level was 96 g/L with a target Hb level of >= 120 g/L for 52.7% of patients. Almost all (99.9%) received the biosimilar epoetin zeta (median dose 30,000 IU/week) with 26.6% receiving additional iron supplementation. A total of 2056 and 1664 patients had at least one Hb level value at M3 and M6 respectively. The rate of response was 81.6% and 86.5% at M3 and M6, respectively. In total, 17.0% of treated patients reported clinically relevant adverse events (all grades), the most common being infections (5.0%) and thromboembolic events (3.5%). Transfusion rates were reported as 9.4% and 5.8% at M3 and M6, respectively. No EAB-related deaths were reported. Conclusions: EAB was effective and well-tolerated in the management of CIA. Clinical trial information: NCT01626547.
Practical assessment of psychosocial concerns associated with genetic testing in ovarian cancer patients using the MICRA questionnaire.
Authors: Bjørnslett Merete , Dahl Alv A. , Sørebø Øystein , Dørum Anne 
Published: March 2020

9569 Background: Ten to 15% of ovarian cancer patients are BRCA mutation carriers. By offering genetic testing, families at risk and healthy female mutation carriers will be identified and offered clinical follow-up. The MICRA questionnaire was developed as a brief, practical, and targeted assessment of concerns and psychosocial issues associated with genetic testing. This study evaluates the practical and psychometric properties of the MICRA (Norwegian translation) in tested ovarian cancer patient. Methods: Since 2002, ovarian cancer patients at Oslo University Hospital, Norwegian Radium Hospital are offered genetic counseling and testing. By the end of 2009, 1,032 were included. The 530 (51%) patients still alive, were mailed the MICRA and three other instruments relevant for mental distress. 354 (67%) patients responded. Among them 9% were BRCA mutation carriers, 7% had a personal history of breast cancer, 29% had a family history of breast and/or ovarian cancer, and 55% had no such family history. Results: In the BRCA mutation carrier group, the total MICRA score and its subscale scores of distress, uncertainty, and positive experiences were all significantly higher than in the other groups. Confirmatory factor analyses of the three subscales of MICRA showed inadequate fit indices, while a four factors solution including the new factor of Support from family (items #18 and #19), showed adequate fit. The Positive Experiences subscale showed a maximum of 4% explained variance in relation to the Hospital Anxiety and Depression Scale total score, the Impact of Event Avoidance and Intrusion scores, and the Eysenck’s Neuroticism score. The subscales of Distress and Uncertainty showed maximum 12% and 41% explained variance, respectively, while the total MICRA score showed 22% explained variance. Conclusions: Our study supports the feasibility of the MICRA in ovarian cancer patients. Frail women may be identified for closer follow-up by using MICRA. Discrimant, content and construct validities of the MICRA were supported, while the factor structure still is open to further investigation.
Impact of functional outcomes on long-term quality of life after open retropubic radical prostectomy.
Authors: Loeppenberg Bjoern , von Bodman Christian , Brock Marko , Noldus Joachim , Palisaar Jueri 
Published: March 2020

9580 Background: Patients who underwent open retropubic radical prostatectomy (ORRP) for prostate-cancer (PCA) have excellent long-term survival. Besides oncologic safety, recovery of continence and erectile function are highly important, as adverse functional outcomes may have a detrimental effect on health-related quality of life (HRQOL). We report the long-term HRQOL of PCA survivors after ORRP using standardized tools. Methods: Men treated between August 2003 and December 2007 with ORRP for localized PCA at a single academic hospital received validated questionnaires (International consultation on incontinence questionnaire (ICIQ), International index of erectile function (IIEF-5), Erection hardness score (EHS), EORTC QLQ-C30) to assess functional outcomes and HRQOL. Results were correlated with the global-health score (GHS) of the EORTC QLQ-C30 to assess the impact of ORRP on HRQOL. Results: In the study period 1936 men underwent ORRP of whom 1156 (59.7%) received a nerve-sparing (NS) procedure. Questionnaire return-rate was 59% (n=1141) comprising the final study cohort. Median follow-up (FU) was 62 months. Mean age at surgery and FU was 63.7±6.2 and 69.2±6.2 years, respectively. Biochemical recurrence (BCR) occurred in 17.5% (n=200/1141) and 2% (n=40/1936) deceased. Mean GHS in the study population was 71.5±20.8. In the ICIQ 28% (n=320) scored 0 indicating complete continence and 9.9% (n=113) scored ≥11 indicating severe incontinence. The corresponding GHS was 78.1±19.5 and 55.4±21.8, respectively. 68.5% (n=782) of patients used no pads and 17.9% (n=204) ≥2 pads. Corresponding GHS scores were 74.9±19.8 and 58.9±20.7. Using the IIEF-5 in men who received NS, 24.1% (n=154) had no erectile dysfunction versus 50% (n=318) using the EHS. Corresponding GHS scores were 82.2±16.3 and 74.7±19.8, respectively. Patients with BCR had a GHS of 66.8±21.8 versus 72.5±20.5 for patients without. Men who achieved the Trifecta and Pentafecta criteria had a GHS of 83.1±15.1 and 83.3±15, respectively. Conclusions: Incontinence severely impacts the HRQOL of long-term survivors after ORRP while erectile dysfunction and BCR have a lesser effect. Every effort should be undertaken to maintain functional integrity.
Utility of standardized letters in assisting primary care providers (PCPs) with the care of cancer survivors (CS).
Authors: Moghaddamjou Ali , Speers Caroline , Cheung Winson Y. 
Published: March 2020

9593 Background: Survivorship care plans have strong face validity, but individualizing plans to each patient’s needs can be resource intensive. At our institution, a 1-page standardized letter that outlines the essential components of follow-up care is mailed to PCPs at the time of a patient’s discharge. This letter highlights the recommended frequency and interval of tests and physician visits. Our study aims were to 1) characterize PCPs’ attitudes regarding these letters and 2) identify potential strategies to improve this channel of communication with PCPs. Methods: Self-administered surveys were mailed to high-volume PCPs in British Columbia, defined as those whose practices followed >/=5 breast or colorectal CS in the preceding year. The survey asked about practice characteristics and PCPs’ views towards the content and format of these standardized letters. Logistic regression models were constructed to delineate factors associated with follow-up preferences. Results: Among 787 PCPs, 507 (64%) responded: median year since graduation was 27 (range 1-62), 67% were men, 38% had a faculty appointment, 71% practiced in a group, and 92% were paid fee-for-service. When asked about their perspectives regarding the care of CS, 388 (77%) indicated they were comfortable providing follow-up with 299 (74%) reporting that the standardized letter contained adequate information. In regression models, PCPs who were comfortable with cancer surveillance and those who graduated greater than 30 years ago were more likely to view the standardized letter as useful (OR 2.50, 95% CI 1.41-4.43 and OR 2.31, 95% CI 1.24-4.33, respectively) and important (OR 4.07, 95% CI 1.80-9.19 and OR 3.14, 95% CI 1.01-9.74, respectively). Among 103 (26%) PCPs who found the letter to be insufficient, most wanted additional details about the cancer diagnosis (88%), specific information on the toxicities of therapy (88%), and the estimated risk of recurrence (84%). Conclusions: Most PCPS were satisfied with a simple, standardized letter that outlines the necessary components of cancer follow-up. PCPs with less familiarity with cancer surveillance may be a target group that benefits most from individualized survivorship care plans.
Aprepitant, granisetrone, and dexamethasone for prevention of CINV after high-dose melphalan in autologous transplantation: Results of a randomized, placebo-controlled phase III trial.
Authors: Schmitt Thomas , Goldschmidt Hartmut , Neben Kai , Freiberger Anja , Huesing Johannes , Gronkowski Martina , Thalheimer Markus , Pelzl Le Hang , Mikus Gerd , Burhenne Juergen , Ho Anthony D. , Egerer Gerlinde 
Published: March 2020

9612 Background: Aprepitant (A) is a NK1-antagonist approved for prevention of chemotherapy-induced nausea and vomiting (CINV). Though melphalan (M) is regarded only moderately emetogenic, CINV after high-dose M conditioning in autologous TPX can severely interfere with patients’ (pts) quality of life. Here we present the results of our monocentric, randomized (1:1), placebo-controlled, double-blind phase IIIb trial of A, granisetrone (G) and dexamethasone (D) in this setting. Methods: Pts were treated with A 125 mg po day 1, A 80 mg po days 2-4, G 2 mg po days 1-4 and D 4 mg po day 1, D 2 mg po days 2-3 (arm A) or placebo (P) days 1-4, G 2 mg po days 1-4 and D 8 mg day 1, D 4 mg days 2-3 (arm B). Melphalan 100 mg/m² iv was administered days 1-2. Episodes of emesis, modified functional living index – emesis questionnaire (FLIE) and intensity of nausea by visual analogue scale (VAS) were recorded between days 1-6. Primary endpoint was defined as no episode of vomiting and no additional antiemetic therapy within 120h of M administration. Results: Between 07/05 and 01/12 a total of 362 pts were randomized. 361 subjects (arm A=180; arm B=181; male n=229; female n=132; median age arm A=59.5 years; median age arm B=58 years) were available for the efficacy analysis. There were no significant differences in gender distribution and previous experience of CINV. Significantly less pts receiving A failed the primary endpoint (42% vs. 59%, OR=0.53 [0.34; 0.82], p=.0046). This effect was stressed in women (57% vs. 82%, OR=0.30) and patients with previous CINV (48% vs. 71%, OR=0.38). Emesis within 120h occurred in 22% of pts receiving A and 35% receiving P (OR=0.5 [0.31; 0.80], p=.0036). Though differences in overall nausea (16% vs. 22%, OR=0.65 [0.83; 1.10], p=.11) did not reach statistical significance, major nausea (VAS >25mm) was reduced (6% vs. 12%, OR=0.42 [0.19; 0.92], p=.026). Difference in FLIE score was -8.2 (p=.0007). Study medication was well tolerated. PK analyses showed no interaction between M and A. Conclusions: The combination therapy with A resulted in significantly less CINV compared to placebo. This effect was pronounced in women and pts with previous CINV. Clinical trial information: NCT00571168.