13 research outputs found
655MO Quality of life in patients with p16+ oropharyngeal cancer receiving accelerated radiotherapy (RT) with either cisplatin or cetuximab in NRG/RTOG 1016
Background: This phase 3 randomized non-inferiority de-escalation trial compared cetuximab (cetux) vs cisplatin (cis), concurrent with accelerated RT 70 Gy/6 weeks, in p16+ oropharyngeal cancer (OPC). Quality of life (QOL) was an important secondary endpoint.
Methods: EORTC QLQ-C30/HN35 was completed at baseline, end of treatment, 3, 6, and 12 months post. The substudy aimed for 400 eligible patients. We report completion rates and compare by arm for change from baseline in each domain (0.05 two-sided alpha and MID of 10 points) using linear mixed models.
Results: Consent was 91% (381/419 offered substudy); 6 protocol deviations excluded (n=375). No significant differences in patient/tumor characteristics were found by participation status. Completion rates (%) at the 5 times did not differ by arm (cis/cetux): 92/94, 74/77, 76/81, 76/81, and 73/74. The swallowing domain of HN35 (previously reported) did not differ significantly by arm. No significant difference was seen by arm for the 6-mo change from baseline on any domain. At end of RT (only), dry mouth was significantly worse for RT+cetux. At end of treatment, all domains showed statistically and clinically significant mean worsening across both arms except Emotional Functioning, Dyspnea, Diarrhea, and Teeth. Most domains returned within 10 points of baseline by 6 mo, with the following maintaining significant impairment: Senses (taste/smell), Social Eating, Opening Mouth, Dry Mouth, Sticky Saliva. At 12 mo post-treatment, worsening from baseline persisted for Senses, Dry Mouth, Sticky Saliva, and Weight Gain. Pain Killer use improved significantly from baseline to 3, 6, and 12 mo.
Conclusions: Although replacing RT+cis with RT+cetux did not benefit QOL, this study has confirmed the responsiveness of EORTC QLQ-C30/HN35 to the effects of concurrent systemic/RT for OPC. Dry Mouth, Sticky Saliva, and Senses showed large, significant, and persistent impairments, and remain worthwhile targets for future de-escalation efforts. Domains related to eating (Swallowing, Appetite, Nutritional Supplements, Social Eating, Weight Loss) did not show sustained significant impairment on this instrument in this study.
Clinical trial identification: NCT01302834
RTOG/NRG 1115 Quality of Life of Phase III Dose Escalated Radiation Therapy (RT) and Standard Androgen Deprivation Therapy (ADT) with GnRH Agonist vs. Dose Escalated RT and ADT with GnRH Agonist and Orteronel (TAK-700) for Men with High-Risk Prostate
Purpose/Objective(s): Quality of life (QOL) was assessed with the hypothesis that QOL and fatigue scores would not differ significantly between the ADT + RT (Arm A) and the experimental group receiving ADT + RT + oreteronel (Arm B).
Materials/Methods: In both arms, ADT with GnRH agonist was given for 24 mos, and dose escalated RT started 8-10 wks after initiation of ADT. In Arm B, oreteronel was given BID for 24 mos. QOL was measured with Expanded Prostate Cancer Index Composite (EPIC) and EQ-5D global QOL assessment. EPIC has 4 domains: bowel, urinary, sexual, and hormonal. EQ-5D index score was calculated using health states obtained from 5 dimensions, and a visual analog score (VAS). For EPIC, EQ-5D index and VAS, higher scores indicate better QOL. Fatigue was measured by the 7-item Patient-Reported Outcome Measurement Information System (PROMIS) short form. Total score is standardized into a T-score with mean of 50 and standard deviation of 10 with higher score representing more fatigue. Change scores, calculated as follow-up minus baseline, were compared between arms. Longitudinal analysis using repeated measures mixed effects models was conducted (prior to ADT [baseline], one wk prior to starting RT, last wk of RT, and 1 and 2.5 yrs after initiation of therapy).
Results: Of 231 eligible patients, 196 consented to QOL, 102 on Arm A and 94 on Arm B. Compliance prior to start of RT and end of RT was 83%. At 1 and 2.5 yrs, 80% and 62% of pts, respectively, completed the EPIC. There were no differences between any EPIC domain between arms from the start of RT through the end of follow-up. Men on oreteronel had a significantly greater decline in bowel score prior to starting RT then control patients (-6.12, 95% confidence interval [CI]: -9.24, -3.01 vs. -1.93, 95% CI: -4.48, 0.63, respectively, p=0.038). Arm B patients also had a statistically significant and clinically meaningful worse change in urinary score vs control from baseline to pre-RT (-2.33, 95% CI: -5.02, 0.36 vs. 1.38, 95% CI: -1.07, 3.83, respectively, p=0.043). No other timepoints were significant. The only sig. between arm difference in EPIC sexual and hormonal scores was also at pre-RT in favor of Arm A over Arm B; p=0.024 and p=0.0024 respectively). Fatigue was also greater in the oreteronel patients prior to starting RT (3.81, 95% CI: 1.88, 5.74 vs. 1.18, 95% CI: -0.23, 2.60, p=0.028).
Conclusion: The addition of oreteronel to RT and ADT resulted in greater declines in QOL prior to the start of RT but did not result in significant differences at any other time points. Although oreteronel development has been halted, the QOL results are encouraging for other drugs in this class that remain under investigation. In ongoing prospective trials, QOL impacts should be measured in conjunction with changes in clinical outcome and survival. This project was supported by grants UG1CA189867, U10CA180868, U10CA180822 from the National Cancer Institute and Takeda Pharmaceutical
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Who Supports Her? The Conditions of Gender Specific Voting
The purpose of this dissertation is to increase our understanding of the conditions under which Americansâand particularly men and womenâvote for women candidates in primary and nonpartisan elections. I theorize that a cause for personal identification with feminism among men and women is primarily one or some combination of what I call âempathetic catalystsâ which all relate to real-world, lived experiences. I argue here that there are certain intense empathy inducing events (empathetic catalysts) like formal learning, experiencing certain forms of discrimination, and having a daughter that cause a shift in identity and subsequently, increase the likelihood of voting for a woman running for political office. I use data from the American National Election Study (ANES) 2016 and 2020, the Ask Every Student (AES) survey, the Cooperative Congressional Election Study (CES) 2020, the Party at the Mailbox Study (PATM) 2020, a 2019 study run by the UCR Politics & Gender Lab, as well as original data collected via MTurk to test the relationships between these catalysts, empathy, feminist identification, and voting for women running for office. I find that these catalysts are positively related to levels of feminism and support for women candidates. However, the strength of these relationships vary by gender
Reducing mask resistance among white evangelical christians with value-consistent messages
Public health experts have advocated for wearing protective face masks to combat the COVID-19 pandemic, yet some populations are resistant. Can certain messages shift attitudes toward masks? We investigate the effect of value-consistent messages within a mask-skeptical population: White evangelicals in the United States. An experiment within a national survey of White evangelicals (n = 1,212) assigned respondents to one of three conditions: One group was given a religious message equating mask use with loving your neighbor, another was given a message by Donald Trump saying mask use is patriotic, and a control group received no message. Those exposed to the religious message were more likely to see mask use as important and were more supportive of mask mandates. Republican evangelicals exposed to the patriotism message had similar responses. These findings show that messages that align with individualsâ core valuesâin this case, religious tenets and patriotismâcan shift certain views on mask use and government mask policies to combat COVID-19, even among a comparatively mask-resistant group
Female Empowerment and the Politics of Language: Evidence Using Gender-Neutral Amendments to Subnational Constitutions
Study of Thermionic Electrons in an Inertial Electrostatic Confinement Device Using a Novel âChordwireâ Diagnostic
Sustained Organizational Influence: American Legislative Exchange Council and the Diffusion of AntiâSanctuary Policy
Body composition and mortality in men receiving prostate radiotherapy: A pooled analysis of NRG/RTOG 9406 and NRG/RTOG 0126
PurposeTo validate the association between body composition and mortality in men treated with radiation for localized prostate cancer (PCa). Secondarily, to integrate body composition as a factor to classify patients by risk of all-cause mortality.Materials and MethodsParticipants of NRG/Radiation Therapy Oncology Group (RTOG) 9406 and NRG/RTOG 0126 with archived computed tomography were included. Muscle mass and muscle density were estimated by measuring the area and attenuation of the psoas muscles on a single slice at L4âL5. Bone density was estimated by measuring the attenuation of the vertebral body at mid-L5. Survival analyses, including Cox proportional hazards models, assessed the relationship between body composition and mortality. Recursive partitioning analysis (RPA) was used to create a classification tree to classify participants by risk of death.ResultsData from 2066 men were included in this study. In the final multivariable model, psoas area, comorbidity score, baseline prostate serum antigen, and age were significantly associated with survival. The RPA yielded a classification tree with four prognostic groups determined by age, comorbidity, and psoas area. Notably, the classification among older (â„70Â years) men into prognostic groups was determined by psoas area.ConclusionsThis study strongly supports that body composition is related to mortality in men with localized PCa. The inclusion of psoas area in the RPA classification tree suggests that body composition provides additive information to age and comorbidity status for mortality prediction, particularly among older men. More research is needed to determine the clinical impact of body composition on prognostic models in men with PCa.This study strongly supports that body composition is related to mortality in men with localized prostate cancer. The inclusion of psoas area in the recursive partitioning analysis classification tree suggests that body composition provides additive information to age and comorbidity status for mortality prediction, particularly among older men.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/175907/1/cncr34596_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/175907/2/cncr34596.pd