Tolerability of bevacizumab and chemotherapy in a phase 3 clinical trial with human epidermal growth factor receptor 2- negative breast cancer: A trajectory analysis of adverse events

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/171125/1/cncr33992_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/171125/2/cncr33992.pd

Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0]

Abstract Background Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings. Methods/design This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes. Discussion This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery. Trial registration ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020.http://deepblue.lib.umich.edu/bitstream/2027.42/173518/1/12889_2022_Article_13631.pd

A randomized study of genetic education versus usual care in tumor profiling for advanced cancer in the ECOG-ACRIN Cancer Research Group (EAQ152)

Background: Enthusiasm for precision oncology may obscure the psychosocial and ethical considerations associated with the implementation of tumor genetic sequencing. Methods: Patients with advanced cancer undergoing tumor-only genetic sequencing in the National Cancer Institute Molecular Analysis for Therapy Choice (MATCH) trial were randomized to a web-based genetic education intervention or usual care. The primary outcomes were knowledge, anxiety, depression, and cancer-specific distress collected at baseline (T0), posteducation (T1) and after results (T2). Two-sided, 2-sample t tests and univariate and multivariable generalized linear models were used. Results: Five hundred ninety-four patients (80% from NCI Community Oncology Research Program sites) were randomized to the web intervention (n = 293) or usual care (n = 301) before the receipt of results. Patients in the intervention arm had greater increases in knowledge (P for T1-T0 \u3c .0001; P for T2-T0 = .003), but there were no significant differences in distress outcomes. In unadjusted moderator analyses, there was a decrease in cancer-specific distress among women (T0-T1) in the intervention arm but not among men. Patients with lower health literacy in the intervention arm had greater increases in cancer-specific distress and less decline in general anxiety (T0-T1) and greater increases in depression (T0-T2) in comparison with those receiving usual care. Conclusions: Web-based genetic education before tumor-only sequencing results increases patient understanding and reduces distress in women. Refinements to the intervention could benefit low-literacy groups and men

Supplemental Table 1 from Cigarette and Alternative Tobacco Product Use among Adult Cancer Survivors Enrolled in 9 ECOG-ACRIN Clinical Trials

Supplemental Table 1 shows cancer types, patient accrual and survey completion rates for parent trials</p

Supplemental Table 2 from Cigarette and Alternative Tobacco Product Use among Adult Cancer Survivors Enrolled in 9 ECOG-ACRIN Clinical Trials

Supplemental Table 2 shows associations of baseline continuous participant characteristics with past 30-day tobacco product use</p

Evidence for B+ --> tau+ nu_tau decays using hadronic B tags

10 pages, 7 postscript figures, contributed to 35th International Conference on High Energy Physics, July 22-28, Paris (ICHEP 2010)We present a search for the decay B+ --> tau+ nu_tau using 467.8 x 10^6 B B-bar pairs collected at the Upsilon(4S) resonance with the BABAR detector at the SLAC PEP-II B-Factory. We select a sample of events with one completely reconstructed B- in an hadronic decay mode (B- --> D{(*)0}X- and B- --> J/psi X-). We examine the rest of the event to search for a B+ --> tau+ nu_tau decay. We identify the tau+ lepton in the following modes: tau+ --> e+ nu nu, tau+ --> mu+ nu nu, tau+ --> pi+ nu and tau+ --> rho nu. We find an excess of events with respect to expected background, which excludes the null signal hypothesis at the level of 3.3 sigma and can be converted to a branching fraction central value of B( B+ --> tau+ nu_tau )=( 1.80 +0.57 -0.54 (stat.) +-0.26 (syst.)) x 10^{-4}