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Background: Hormone receptor-positive (HR +) breast cancer is the most common type of breast cancer in the USA but has excellent long-term outcomes in recent decades, in part due to effective oral endocrine therapy (ET). ET medications are typically prescribed for 5 to 10 years, depending on the risk of recurrence, and must be taken daily. One limiting factor to ET efficacy is nonadherence, with high-risk groups for nonadherence including younger women and Black women., Methods: The Alliance for Clinical Trials in Oncology (Alliance) trial A191901 is an ongoing, four-arm (text message reminder (TMR), motivational interviewing (MI), TMR plus MI, or enhanced usual care) randomized clinical trial that tests the efficacy and effect of two interventions (TMR and/or MI) on improved ET adherence, patient-reported outcomes (PROs), and resource use requirements among HR + breast cancer survivors. Participants are randomized in a 1:1:1:1 ratio to the four arms. With an assumed loss to follow-up of approximately 11%, we plan to recruit 1180 participants. Randomization is stratified based on age and race to ensure balance between the arms, and we oversample younger and Black women, with each group representing 30% of the study population. Participants randomized to an intervention will actively participate in the intervention for 9 months, and all participants will be followed for adherence data and PRO endpoints, through the use of the Pillsy cap medication event monitoring system and Alliance ePRO survey app (i.e., Patient Cloud). The primary analysis will compare Pillsy-measured ET adherence among study arms at 12 months., Discussion: This multisite study will not only define strategies to improve adherence to breast cancer oral therapies, but it will also potentially support strategies in large cooperative research groups that can increase delivery and tolerability of ET, involve diverse patient populations in clinical research, and engage patients effectively in interventional studies, using remote and cost-effective delivery methods., Trial Registration: Clinicaltrials.gov NCT04379570 . Registered on 7 May 2020., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objective: There are potentially deleterious sequelae of the physiologic response to surgical intervention. Some inflammatory cytokines can act as tumor growth factors, angiogenic and metastatic promoters, or both. Modulation of negative effects could improve outcomes from surgical intervention. The effects of surgical intervention on gene expression have not been fully elucidated. We assayed gene expression changes in an animal model of thoracotomy versus a sham operation and evaluated the ability of a cyclooxygenase inhibitor, celecoxib, to mediate these changes., Methods: Sixty adult male BALB/c mice were randomized into one of 3 experimental groups: sham operation with anesthesia only, thoracotomy incision, and thoracotomy incision with perioperative celecoxib administration. Six hours after surgical intervention, the animals were killed, and blood was collected. RNA pools from each group were labeled and hybridized to Mouse Whole Genome Microarrays. Gene expression profiles were analyzed to determine the effect of both surgical intervention and celecoxib treatment., Results: Surgical intervention initiated a robust gene expression response. We identified 867 transcripts that were found to be statistically significant (corrected P < .05) and differentially expressed at least 2-fold in response to surgical intervention. Celecoxib had a profound effect on this response, preserving close to baseline levels of expression for most of those genes., Conclusions: Surgical intervention has a dramatic effect on the expression of genes related to the inflammatory response. Perioperative treatment with a cyclooxygenase 2 inhibitor abated many of these changes and might counteract many of the negative effects of the response to surgical intervention., (2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)