Clinical features of prostate cancer by polygenic risk score.

Genome-wide association studies have identified more than 290 single nucleotide variants (SNVs) associated with prostate cancer. These SNVs can be combined to generate a Polygenic Risk Score (PRS), which estimates an individual's risk to develop prostate cancer. Identifying individuals at higher risk for prostate cancer using PRS could allow for personalized screening recommendations, improve current screening tools, and potentially result in improved survival rates, but more research is needed before incorporating them into clinical use. Our study aimed to investigate associations between PRS and clinical factors in affected individuals, including age of diagnosis, metastases, histology, International Society of Urological Pathology (ISUP) Grade Group (GG) and family history of prostate cancer, while taking into account germline genetic testing in known prostate cancer related genes. To evaluate the relationship between these clinical factors and PRS, a quantitative retrospective chart review of 250 individuals of European ancestry diagnosed with prostate cancer who received genetic counseling services at The Ohio State University's Genitourinary Cancer Genetics Clinic and a 72-SNV PRS through Ambry Genetics, was performed. We found significant associations between higher PRS and younger age of diagnosis (p = 0.002), lower frequency of metastases (p = 0.006), and having a first-degree relative diagnosed with prostate cancer (p = 0.024). We did not observe significant associations between PRS and ISUP GG, histology or a having a second-degree relative with prostate cancer. These findings provide insights into features associated with higher PRS, but larger multi-ancestral studies using PRS that are informative across populations are needed to understand its clinical utility.

Mindfulness-based Interventions Across the Cancer Continuum in the United States: A Scoping Review.

OBJECTIVE: To review mindfulness-based interventions (MBIs) tested in randomized controlled trials (RCT) across the cancer continuum. DATA SOURCE: Articles identified in PubMed, CINAHL, Web of Science, PsycINFO, and Embase. STUDY INCLUSION AND EXCLUSION CRITERIA: Two independent reviewers screened articles for: (1) topic relevance; (2) RCT study design; (3) mindfulness activity; (4) text availability; (5) country (United States); and (6) mindfulness as the primary intervention component. DATA EXTRACTION: Twenty-eight RCTs met the inclusion criteria. Data was extracted on the following variables: publication year, population, study arms, cancer site, stage of cancer continuum, participant demographic characteristics, mindfulness definition, mindfulness measures, mindfulness delivery, and behavioral theory. DATA SYNTHESIS: We used descriptive statistics and preliminary content analysis to characterize the data and identify emerging themes. RESULTS: A definition of mindfulness was reported in 46% of studies and 43% measured mindfulness. Almost all MBIs were tested in survivorship (50%) or treatment (46%) stages of the cancer continuum. Breast cancer was the focus of 73% of cancer-site specific studies, and most participants were non-Hispanic white females. CONCLUSION: The scoping review identified 5 themes: (1) inconsistency in defining mindfulness; (2) differences in measuring mindfulness; (3) underrepresentation of racial/ethnic minorities; (4) underrepresentation of males and cancer sites other than breast; and (5) the lack of behavioral theory in the design, implementation, and evaluation of the MBI.

A study to assess the efficacy of enasidenib and risk-adapted addition of azacitidine in newly diagnosed IDH2-mutant AML.

ABSTRACT: Enasidenib (ENA) is an inhibitor of isocitrate dehydrogenase 2 (IDH2) approved for the treatment of patients with IDH2-mutant relapsed/refractory acute myeloid leukemia (AML). In this phase 2/1b Beat AML substudy, we applied a risk-adapted approach to assess the efficacy of ENA monotherapy for patients aged ≥60 years with newly diagnosed IDH2-mutant AML in whom genomic profiling demonstrated that mutant IDH2 was in the dominant leukemic clone. Patients for whom ENA monotherapy did not induce a complete remission (CR) or CR with incomplete blood count recovery (CRi) enrolled in a phase 1b cohort with the addition of azacitidine. The phase 2 portion assessing the overall response to ENA alone demonstrated efficacy, with a composite complete response (cCR) rate (CR/CRi) of 46% in 60 evaluable patients. Seventeen patients subsequently transitioned to phase 1b combination therapy, with a cCR rate of 41% and 1 dose-limiting toxicity. Correlative studies highlight mechanisms of clonal elimination with differentiation therapy as well as therapeutic resistance. This study demonstrates both efficacy of ENA monotherapy in the upfront setting and feasibility and applicability of a risk-adapted approach to the upfront treatment of IDH2-mutant AML. This trial is registered at www.clinicaltrials.gov as #NCT03013998.

Video brochures in a mailed fecal immunochemical test outreach program provide cancer screening information in a user-friendly format for rural Appalachian community members.

PURPOSE: Colorectal cancer (CRC) screening is recommended for average-risk adults, yet many adults are not up-to-date with screening. One recommended CRC screening approach is the annual completion of a fecal immunochemical test (FIT). However, usually, fewer than half of mailed FIT tests are returned. METHODS: To address barriers to FIT return, a video brochure was developed providing targeted CRC screening information and step-by-step FIT instructions as a component in a mailed FIT program. This pilot study occurred in 2021-2022 and partnered with a federally qualified health center in Appalachian Ohio to send a FIT to patients who were 50-64 years old, of average risk, and not up-to-date on CRC screening. Patients were randomly assigned to 1 of 3 groups that differed on materials sent with the FIT: usual care (manufacturer's instructions), a video brochure (video instructions, disposable gloves, disposable stool collection device), or an audio brochure (audio instructions, disposable gloves, disposable stool collection device). FINDINGS: Overall, 16 of 94 patients (17%) returned the FIT, and return was higher among those sent the video brochure (28%) compared to the other 2 groups (OR: 3.1; 95% CI: 1.02, 9.2; P = .046). Two patients had positive tests and were referred for colonoscopy. Patients sent the video brochure reported the content was important, relevant, and made them think about completing the FIT. CONCLUSIONS: Using a video brochure to provide understandable information in a mailed FIT kit is a promising strategy to improve CRC screening outreach programs in rural regions.

Maternal hepatitis C virus infection and three adverse maternal outcomes in the United States.

BACKGROUND: Hepatitis Virus C (HCV) infection rates have trended upwards among pregnant people in the USA since 2009. Existing evidence about HCV infections and maternal outcomes is limited; therefore, we used birth certificate data to investigate the association between HCV infection and maternal health outcomes. METHODS: We used the 2017 US birth certificate dataset (a cross-section of 1.4 million birth records) to assess the association between prevalent HCV infection and gestational diabetes, gestational hypertension, and eclampsia. Potential confounding variables included prenatal care, age, education, smoking, presence of sexually transmitted infections (STIs), body mass index (BMI), and weight gain during pregnancy. We restricted our analysis to only women with a first singleton pregnancy. Odds ratios were estimated by logistic regression models and separate models were tested for white and Black women. RESULTS: Only 0.31% of the women in our sample were infected with HCV (n = 4412). In an unadjusted model, we observed a modest significant protective association between HCV infection and gestational diabetes (Odds ratio [OR]: 0.83; 95% CI: 0.76-0.96); but this was attenuated with adjustment for confounding variables (Adjusted odds ratio [AOR]: 0.88; 95% CI: 0.76, 1.02). There was no association between HCV and gestational hypertension (AOR: 1.03; 95% CI: 0.91, 1.16) or eclampsia (AOR: 1.15; 95% CI: 0.69, 1.93). Results from the race stratified models were similar to the non-stratified summary models. CONCLUSION: We observed no statistically significant associations between maternal HCV infection with maternal health outcomes. Although, our analysis did indicate that HCV may lower the risk of gestational diabetes, this may be attributable to confounding. Studies utilizing more accurately measured HCV infection including those collecting type and timing of testing, and timing of infection are warranted to ensure HCV does not adversely impact maternal and/or fetal health. Particularly in the absence of recommended therapy for HCV during pregnancy.

Differences in obesity-related health behaviors and health outcomes by rural and Appalachian residency.

PURPOSE: Obesity and health behaviors are the major modifiable contributors to cancer and health disparities. We examined the differences in obesity-related health behaviors, and health outcomes by rural and Appalachian residency in Ohio. METHODS: Cross-sectional survey data from the 2011-2019 Behavioral Risk Factor Surveillance System were obtained from the Ohio Department of Health. County-level identifiers were used to classify urban non-Appalachian, urban Appalachian, rural non-Appalachian, and rural Appalachian residency. Self-reported weight, height, health behaviors, and health conditions were used. Logistic regression was used to assess the difference in health behaviors and health outcomes by rural and Appalachian residency. All analyses incorporated with sample weights. RESULTS: Among Ohio residents, compared to urban non-Appalachian residents, urban Appalachian and rural Appalachian residents had a higher prevalence of obesity, hypertension, high cholesterol, and cardiovascular diseases, as well as lower rates of healthy diet and physical activity. No difference was found in trends of obesity and obesity-related health outcomes in 2011-2019 by rural and Appalachian residency. However, rural Appalachian residents had a greater increase in obesity, hypertension, and diabetes, whereas rural non-Appalachian had favorable changes in obesity-related health behaviors. Additionally, associations between health behaviors and obesity-related health outcomes differed by rural and Appalachian residency. CONCLUSIONS: Findings underscore the importance of distinguishing between urban non-Appalachian, urban Appalachian, rural non-Appalachian, and rural Appalachian populations when assessing health disparities. While the trends of obesity and obesity-related health outcomes did not differ, the association between health behaviors and obesity-related outcomes differed by rural and Appalachian residency.

Maternal Hepatitis C Virus Infection and Adverse Newborn Outcomes in the US.

OBJECTIVES: We investigated the relationship between maternal hepatitis C virus (HCV) infection and infant health. Furthermore, we evaluated racial disparities with these associations. METHODS: Using 2017 US birth certificate data, we investigated the association between maternal HCV infection and infant birthweight, preterm birth, and Apgar score. We used unadjusted and adjusted linear regression and logistic regression models. Models were adjusted for use of prenatal care, maternal age, maternal education, maternal smoking status, and the presence of other sexually transmitted infections. We stratified the models by race to describe the experiences of White and Black women separately. RESULTS: Maternal HCV infection was associated with reduced infant birthweight on average by 42.0 g (95% CI: -58.81, -25.30) for women of all races, 64.6 g (95% CI: -81.91, -47.26) for White women and 80.3 g (95% CI: -162.48, 1.93) for Black women. Women with maternal HCV infection had increased odds of having a preterm birth of 1.06 (95% CI: 0.96, 1.17) for women of all races, 1.06 (95% CI: 0.96, 1.18) for White women and 1.35 (95% CI: 0.93, 1.97) for Black women. Overall, women with maternal HCV infection had increased odds 1.26 (95% CI: 1.03, 1.55) of having a low/intermediate Apgar score; White and Black women with HCV infection had similarly increased odds of an infant with low/intermediate Apgar score in a stratified analysis: 1.23 (95% CI: 0.98, 1.53) for White women and 1.24 (95% CI: 0.51, 3.02) for Black women. CONCLUSIONS: Maternal HCV infection was associated with lower infant birthweight and higher odds of having a low/intermediate Apgar score. Given the potential for residual confounding, these results should be interpreted with caution.

Entospletinib with decitabine in acute myeloid leukemia with mutant TP53 or complex karyotype: A phase 2 substudy of the Beat AML Master Trial.

BACKGROUND: Patients with acute myeloid leukemia (AML) who have tumor protein p53 (TP53) mutations or a complex karyotype have a poor prognosis, and hypomethylating agents are often used. The authors evaluated the efficacy of entospletinib, an oral inhibitor of spleen tyrosine kinase, combined with decitabine in this patient population. METHODS: This was a multicenter, open-label, phase 2 substudy of the Beat AML Master Trial (ClinicalTrials.gov identifier NCT03013998) using a Simon two-stage design. Eligible patients aged 60 years or older who had newly diagnosed AML with mutations in TP53 with or without a complex karyotype (cohort A; n = 45) or had a complex karyotype without TP53 mutation (cohort B; n = 13) received entospletinib 400 mg twice daily with decitabine 20 mg/m2 on days 1-10 every 28 days for up to three induction cycles, followed by up to 11 consolidation cycles, in which decitabine was reduced to days 1-5. Entospletinib maintenance was given for up to 2 years. The primary end point was complete remission (CR) and CR with hematologic improvement by up to six cycles of therapy. RESULTS: The composite CR rates for cohorts A and B were 13.3% (95% confidence interval, 5.1%-26.8%) and 30.8% (95% confidence interval, 9.1%-61.4%), respectively. The median duration of response was 7.6 and 8.2 months, respectively, and the median overall survival was 6.5 and 11.5 months, respectively. The study was stopped because the futility boundary was crossed in both cohorts. CONCLUSIONS: The combination of entospletinib and decitabine demonstrated activity and was acceptably tolerated in this patient population; however, the CR rates were low, and overall survival was short. Novel treatment strategies for older patients with TP53 mutations and complex karyotype remain an urgent need.

The Role of Cigarillo Flavor in the Co-Use of Cigarillos and Cannabis among Young Adults.

Background: Research suggests flavor facilitates cigarillo use, but it is unknown if flavor impacts patterns of co-use of cigarillos and cannabis ("co-use"), which is common among young adult smokers. This study's aim was to determine the role of the cigarillo flavor in co-use among young adults. Methods: Data were collected (2020-2021) in a cross-sectional online survey administered to young adults who smoked ≥2 cigarillos/week (N = 361), recruited from 15 urban areas in the United States. A structural equation model was used to assess the relationship between flavored cigarillo use and past 30-day cannabis use (flavored cigarillo perceived appeal and harm as parallel mediators), including several social-contextual covariates (e.g., flavor and cannabis policies). Results: Most participants reported usually using flavored cigarillos (81.8%) and cannabis use in the past 30 days ("co-use") (64.1%). Flavored cigarillo use was not directly associated with co-use (p = 0.90). Perceived cigarillo harm (ß = 0.18, 95% CI = 0.06, 0.29), number of tobacco users in the household (ß = 0.22, 95% CI = 0.10, 0.33), and past 30-day use of other tobacco products (ß = 0.23, 95% CI = 0.15, 0.32) were significantly positively associated with co-use. Living in an area with a ban on flavored cigarillos was significantly negatively associated with co-use (ß = -0.12, 95% CI = -0.21, -0.02). Conclusions: Use of flavored cigarillos was not associated with co-use; however, exposure to a flavored cigarillo ban was negatively associated with co-use. Cigar product flavor bans may reduce co-use among young adults or have a neutral impact. Further research is needed to explore the interaction between tobacco and cannabis policy and use of these products.

The feasibility of a telephone-based weight loss intervention in rural Ohio: A pilot study.

BACKGROUND: Weight loss through lifestyle modification can produce health benefits and may reduce cancer risk. The goal of this study was to examine the feasibility of and adherence to a 15-week telephone-based weight loss intervention in rural Ohio, an area with high rates of obesity. METHODS: This pilot 2-arm randomized controlled study was designed for rural Ohio residents who were overweight or obese. Eligible participants were 2:1 randomly assigned to either a 15-week weight loss intervention group or active control group. The weight loss intervention group received weekly telephone sessions to improve healthy diet and increase physical activity. The active control group received education brochures with information on physical activity and dietary guidelines. Feasibility was defined as at least 80% of participants completing the follow-up surveys, and acceptable adherence was defined as the percentage of participants in the weight loss group who attend ≥75% of weekly telephone sessions. RESULTS: A total of 423 individuals entered the online screening survey, 215 (50.8%) completed the survey, and 98 (45.6%) of those were eligible. Forty eligible individuals were enrolled and randomly assigned to the weight loss group (n = 27) or active control group (n = 13). The average age of the weight loss group was 49 (SD = 10) years, and 89% were female. The average age of the active control group was 51 (SD = 9) years, and 92% were female. Feasibility was demonstrated: 90% of participants completed the online follow-up surveys at 15-weeks. Among participants in the weight loss group, 22 out of 27 (81.5%) completed the 15-week intervention, the average number of sessions attended was 9.7 (64.9%). Adherence to the intervention was rated as acceptable among almost half of the group (48.1%). CONCLUSIONS: Feasibility of a 15-week telephone-based weight loss study among rural residents with overweight/obesity were determined. A future study will test this intervention for weight loss efficacy.

Efficacy of the Outsmart HPV Intervention: A Randomized Controlled Trial to Increase HPV Vaccination among Young Gay, Bisexual, and Other Men Who Have Sex with Men.

BACKGROUND: Routine human papillomavirus (HPV) vaccination is recommended for young adults, yet many young gay, bisexual, and other men who have sex with men (YGBMSM) remain unvaccinated. We report the efficacy of Outsmart HPV, a web-based HPV vaccination intervention for YGBMSM. METHODS: From 2019 to 2021, we recruited YGBMSM in the United States who were ages 18-25 and unvaccinated against HPV (n = 1,227). Participants were randomized to receive either: (i) Outsmart HPV content online and monthly interactive text reminders (interactive group); (ii) Outsmart HPV content online and monthly unidirectional text reminders (unidirectional group); or (iii) standard information online about HPV vaccine (control group). Regression models compared study groups on HPV vaccination outcomes. RESULTS: Overall, 33% of participants reported initiating the HPV vaccine series and 7% reported series completion. Initiation was more common among participants in the interactive group compared with the control group [odds ratio (OR) = 1.47, 98.3% confidence interval (CI): 1.03-2.11]. Completion was more common among participants in both the interactive group (OR = 3.70, 98.3% CI: 1.75-7.83) and unidirectional group (OR = 2.26, 98.3% CI: 1.02-5.00) compared with the control group. Participants who received Outsmart HPV content reported higher levels of satisfaction with online content compared with the control group. CONCLUSIONS: Outsmart HPV is an efficacious and acceptable HPV vaccination intervention for YGBMSM. Future efforts are needed to determine how to optimize the intervention and disseminate it to settings that provide services to YGBMSM. IMPACT: Outsmart HPV is a promising tool for increasing HPV vaccination among YGBMSM with the potential for wide dissemination.

Postnatal Cytokine Trajectories in Very Preterm Infants.

Inflammation often accompanies preterm birth and contributes to poor neurodevelopment in preterm infants. The purpose of this study was to describe postnatal cytokine trajectories among non-infected very preterm infants during the first weeks of life. Blood samples for cytokine analysis were collected weekly from infants born between 28 and 31 weeks post-menstrual age. We used linear mixed models to calculate slopes for each cytokine and allowed the slopes to differ by infant biological sex and post-menstrual age at birth. Levels of interleukin-6, interleukin-8, and interleukin-1 receptor antagonist decreased, on average, during the neonatal period. Monocyte chemoattractant protein-1 levels increased over time, and tumor necrosis factor-alpha levels were stable. Interleukin-6 and interleukin-8 slopes differed by post-menstrual age at birth but were unaffected by infant sex. Knowledge of average cytokine trajectories may be useful in identifying infants with unresolving inflammation that increases their risk for poor neurodevelopment.

BRCAShare-Assessment of an animated digital message for intrafamilial communication of pathogenic variant positive test results: A feasibility study.

While genetic testing for hereditary breast and ovarian cancer syndrome (HBOC) is well-established in the field of medicine, family members' uptake of cascade genetic testing for known familial pathogenic variants remains low. Probands often become responsible for initiating familial communication about their testing results, and barriers to communication may include difficulty in conveying information to relatives and a lack of communication resources for probands' use. In this study, we tested a two-minute animated digital message (ADM) intervention guided by the Health Belief Model (HBM) in an unselected sample to determine hypothetical individual perceptions of susceptibility and severity and behavioral intention to act on the information provided in the ADM. We recruited genetic testing naïve adults from the United States with no personal history of cancer through Amazon Mechanical Turk to participate in this study. Participants were presented a hypothetical scenario describing a relative's recent HBOC diagnosis, viewed the ADM, and answered a questionnaire assessing participants' perception of the HBM constructs in relation to the hypothetical scenario and participants' intentions to pursue cascade genetic testing, talk to a healthcare professional, or talk to family members after ADM viewing. Participants (n = 373) largely perceived HBOC as serious and believed that they could benefit from the information provided by genetic testing; 76% hypothetically intended to pursue genetic testing at a cost of $100 or less, and 90% intended to either pursue testing or talk to a healthcare provider or family members. This feasibility study in an unaffected population could mimic the experience of distant/less-engaged relatives in HBOC families after receiving unexpected information about cascade genetic testing. Most participants demonstrated behavioral intention toward cascade testing, at a rate higher than literature would suggest is typical in high-risk families, indicating that a theory-supported, simple to use intervention may be useful in clinical practice.

Effects of a web-based HPV vaccination intervention on cognitive outcomes among young gay, bisexual, and other men who have sex with men.

Knowledge, attitudes, and beliefs are important antecedents to HPV vaccination, yet remain suboptimal among young gay, bisexual, and other men who have sex with men (YGBMSM). We report the effects of a theoretically-informed, web-based HPV vaccination intervention on these cognitive outcomes. From 2019-2021, we recruited a national sample of YGBMSM ages 18-25 in the United States who were unvaccinated against HPV (n = 1,227). Participants received either standard HPV vaccination information online (control) or population-targeted, individually-tailored content online (Outsmart HPV intervention). Mixed effects models determined if pre-post changes in cognitive outcomes differed between study groups. For five of seven knowledge items about HPV, there were larger pre-post increases among the intervention group than the control group in the percentage of participants who provided correct responses (all statistically significant at p = .05 after Holm's correction). There were also larger pre-post improvements among the intervention group than the control group for most attitudes and beliefs examined, including response efficacy of HPV vaccine (pre-post increases in means: 0.57 vs. 0.38); self-efficacy for the HPV vaccination process (pre-post increases in means: 0.23 vs. 0.10); and intention to get HPV vaccine (pre-post increases in means: 0.70 vs. 0.28) (all statistically significant at p = .05 after Holm's correction). Outsmart HPV is a promising tool for improving key cognitive antecedents to HPV vaccination among YGBMSM, supporting the use of theoretically-informed interventions to affect such outcomes. If efficacious in increasing HPV vaccine uptake in future analyses, this intervention could be utilized in clinical and other healthcare settings that provide services to YGBMSM.

Cigarillo Flavor and Motivation to Quit among Co-Users of Cigarillos and Cannabis: A Structural Equation Modeling Approach.

Flavored cigar restrictions have the potential to benefit public health. Flavor availability facilitates cigarillo use, but it is unknown if flavor impacts patterns of co-use of cigarillos and cannabis, an increasingly prevalent behavior among young adults. Data were collected (2020-2021) in a cross-sectional online survey administered to a convenience sample of young adults who smoked cigarillos from 15 areas with high cigar use prevalence. We assessed the relationship between flavored cigarillo use and motivation to quit cannabis and cigarillo use among past 30-day co-users (N = 218), as well as several covariates (e.g., cigarillo price and flavor/cannabis policy). Flavored cigarillo perceived appeal and harm were hypothesized parallel mediators. Most co-users reported usually using flavored cigarillos (79.5%), which was not significantly associated with motivation to quit cigarillos or cannabis. Perceived cigarillo harm (ß = 0.17, 95% CI = 0.00, 0.33), advertising exposure (ß = 0.12, 95% CI = 0.00, 0.24), and income (among racial/ethnic minorities; ß = -0.13, 95% CI = -0.25, -0.02) were significant predictors of motivation to quit cigarillos. There were no significant predictors of motivation to quit cannabis. Cigarillo flavor was not associated with motivation to quit, so findings could suggest that banning flavors in cigars may have a neutral impact on co-use with cannabis among young adults.

Tailored Mobile Messaging Intervention for Waterpipe Tobacco Cessation in Young Adults: A Randomized Trial.

Objectives. To test a tailored mobile health (i.e., mHealth) intervention for waterpipe tobacco cessation in young adults. Methods. From 2018 to 2020 at 2 US sites, we conducted a randomized trial with 349 waterpipe tobacco smokers aged 18 to 30 years randomized to control (no intervention), untailored, or tailored intervention arms. Intervention arms received a 6-week mHealth intervention conveying risks of waterpipe tobacco through text and images and strategies to enhance motivation and support quitting. The tailored intervention was personalized to baseline measures and intervention text message responses. Risk appraisals, motivation to quit, waterpipe smoking frequency, and cessation were assessed at 6 weeks, 3 months, and 6 months. Results. At 6 months, cessation was higher in the tailored (49%) than the control arm (29%; odds ratio = 2.4; 95% confidence interval = 1.3, 4.2) and smoking frequency was lower in the tailored (mean = 3.5 days) than the control arm (mean = 4.3 days; P = .006). At interim follow-ups, significant differences in other outcomes favored the tailored intervention. Conclusions. Tailored mobile messaging can help young adult waterpipe tobacco smokers quit. This scalable intervention is poised for population implementation.

Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial.

Advances in genomic technologies and an increased understanding of the molecular pathogenesis of cancer have resulted in development of new effective, mutation-targeted therapies. In turn, these informed the development of Master Trial designs to test these therapies. The Beat Acute Myeloid Leukemia (BAML) Master Trial (Sponsor: The Leukemia & Lymphoma Society) tests several targeted therapies in patients aged ≥ 60 years with AML based on genomic profiling obtained within 7 days of study enrollment. We hypothesized that integrating operational strategies with new electronic technologies (e-technologies) might streamline the conduct and management of this Master Trial. BAML's 5 core operational strategies revolve around the guiding principle of "patients first." The e-technology platforms employed in BAML include: Clinical Oversight Platform: a central collaborative tool; e-Protocol/e-Source Upload/Electronic Data Capture Platform: digitizes the protocol, allows remote data monitoring, and collects/exports data in Study Data Tabulation Model format; and Data Review Platform: ingests data from different sources for clinical response and safety data reviews. The operational approaches, e-technologies and sponsor/contract research organization's (CRO) expertise together allow: the complexity and size of the BAML Master Trial to be better managed; near real-time study data oversight; better collaboration, communication and training; improved data collection, enhanced transmission and accessibility; data integration, review and generation of reports; while maintaining data privacy, and compliance. Initial e-technology challenges were overcome through training, learning, discipline and adjustment. In conclusion, to successfully manage Master Trials, significant time should be spent re-evaluating, improving and developing new operational approaches.Clinical Trial Registration: Clinical Trials.gov Identifier: NCT03013998. https://clinicaltrials.gov/ct2/show/NCT03013998 .

A Teachable Moment: Colorectal Cancer Screening Among Companions Waiting for Outpatients Undergoing a Colonoscopy.

To determine colorectal cancer (CRC) screening knowledge, attitudes, behaviors, and preferences for a future CRC screening educational intervention among adults (companions) waiting for outpatients undergoing a colonoscopy. We approached 384 companions at three endoscopy centers associated with one healthcare system to complete a survey from March to July 2017. The survey assessed CRC and CRC screening knowledge, attitudes, behaviors, and preferences for a future CRC screening educational intervention. There were 164 companions at average risk for CRC that completed a self-administered survey. Among average-risk companions, 23% were not within screening guidelines. Additionally, 74% of those not within guidelines reported that they had never completed a CRC screening test. The most frequently reported barriers to CRC screening were the perception of not needing screening because they were asymptomatic and lack of a provider recommendation for screening. Companions suggested that a future CRC screening intervention include a brochure and/or a brief video, featuring men and women from different races/ethnicities, a CRC survivor, and a healthcare professional. Almost one-fourth of average-risk companions waiting at endoscopy centers were not within CRC screening guidelines, providing a teachable moment to recruit companions to participate in an educational intervention to encourage screening. Companions provided suggestions (e.g., content and channel) for a future intervention to promote CRC screening in this population.

The impact of a cascade testing video on recipients' knowledge, cognitive message processing, and affective reactions: A formative evaluation.

Cascade genetic testing is essential to clarify cancer risk in families with hereditary breast and ovarian cancer syndrome (HBOC) due to pathogenic variants (PVs) in BRCA1 or BRCA2. To date, data suggest that family communication of genetic testing results, with or without the aid of clinical resources such as a provider-written family letter, is impacted by multiple barriers. These barriers eventually lead to sub-optimal uptake of cascade genetic testing. We designed a 2-min animated video that a proband can share with relatives to notify them that the proband has tested positive for a pathogenic variant in BRCA1 or BRCA2. We studied the video via hypothetical scenario in an unselected population to simulate the process by which a relative receives unsolicited genetics information about their family member. We assessed the impact of the video on three specific domains: knowledge, cognitive message processing, and affective reactions. A total of 399 participants recruited through Amazon Mechanical Turk completed the study, and 373 were analyzed. The video significantly improved content knowledge/recall (p < .0001) from pre- to post-video viewing, indicating effective message communication. Items used to measure cognitive processing showed preliminary tendencies toward systematic message processing, which could be desired in familial communication aimed at initiating a specific action-in this case, cascade genetic testing. A majority of participants (66%) reported positive affective reaction as they indicated that they would feel gratitude if they received the video message from a relative, and did not evidence a negative affective reaction to receiving the information. Our data suggest that a video message can effectively communicate information about cascade genetic testing to potential relatives with as little as two minutes of content. Our data suggest that video messaging to assist family communication is a reasonable approach that increases understanding and is unlikely to cause harm.