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Abstract Background Although the diagnosis and treatment of a primary brain tumor present unique challenges to patients and their family caregivers, evidence-based supportive care interventions are generally lacking. The primary aim of this research protocol is to determine the feasibility of implementing a dyadic yoga (DY) versus a caregiver yoga (CY) intervention or a wait-list control (WLC) group using a randomized controlled trial design. Methods Seventy-five glioma patients undergoing radiotherapy and their family caregivers are randomized to the DY, CY, or a WLC group. Patient-caregiver dyads in the DY group and caregivers in the CY group receive 15 sessions (45 min each) over the course of patients’ standard radiotherapy (6 weeks). Patients and caregivers in all groups complete baseline assessments of symptoms, quality of life (QOL), and health utilization outcomes prior to randomization. Follow-up assessments are performed 6 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 50% of eligible dyads consent, ≥ 70% of enrolled dyads complete all assessments, and ≥ 50% of all practice sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., fatigue, overall QOL) and explore potential intervention moderators (e.g., performance status) to inform a larger future trial. Conclusion This trial will provide important information regarding the feasibility of a dyadic versus a caregiver yoga intervention regarding symptom, QOL, and health utilization outcomes in glioma patients and their caregivers. Trial registration ClinicalTrials.gov NCT02481349

Abstract Background Despite their significant distress, supportive care interventions for caregivers of glioma patients are generally lacking. And, whether caregivers are more likely to benefit from interventions targeting patient‐caregiver dyads or caregivers individually is unknown. This pilot randomized controlled trial compared the feasibility and preliminary efficacy of a dyadic yoga (DY) versus an individual caregiver yoga (CY) intervention as a supportive care strategy for family caregivers. Methods Patient‐caregiver dyads were randomized to a DY, CY or usual care (UC) arm. DY and CY interventions were delivered over 15 sessions. Caregivers completed assessments of their depressive symptoms, quality of life (QOL), and caregiving reactions at baseline, 6 weeks, and 12 weeks, and a subset completed qualitative interviews at 12 weeks. Results With a consent rate of 63%, 67 dyads were randomized. Attendance in the DY was higher than in the CY group (session means, DY = 12.23, CY = 9.00; p = 0.06). Caregivers (79% female; 78% non‐Hispanic White; mean age, 53 years) reported significantly more subjective benefit in the CY arm than in the DY arm (d = 2.1; p

Abstract Background African Americans (AAs) have had lower colorectal cancer (CRC) screening rates, higher incidence rate, and earlier mean age at onset. The 2017 U.S. Multi‐Society Task Force (MSTF) recommended initiating CRC screening at age 45 for AAs and age 50 for non‐AAs. Objective To investigate the impact of the 2017 MSTF's race‐specific guidelines on CRC screening rate among young AAs. Design, setting, and participants We used the 2015 and 2018 National Health Interview Survey to provide nationally representative estimates. The study sample included adults aged between 45 and 75 without a history of CRC, excluding screening recipients for diagnosis or surveillance purposes. Main measures The outcome is a binary variable of CRC screening. Primary independent variables were age and race category (non‐AAs aged 45–49, AAs 45–49, non‐AAs 50–75, AAs 50–75), a binary variable indicating before or after the 2017 MSTF guideline (2015 vs. 2018), and their interaction terms. We employed a multivariable logistic model, adjusting for individual characteristics, and accounting for complex survey design. Key results Among the total sample (n = 21,735), CRC screening rate increased from 54.6% in 2015 to 58.5% in 2018 (p

BackgroundThe prevalence of smoking remains high in many low- and middle-income countries (LMICs), including the Southeast Asian nation of Cambodia. Smoking is especially hazardous for people with HIV. In Cambodia, approximately 43%-65% of men with HIV and 3%-5% of women with HIV smoke cigarettes. Thus, there is a critical need for cost-effective smoking cessation interventions for Cambodian people with HIV. This paper describes the design, methods, and data analysis plans for a randomized controlled trial assessing the efficacy of a theory-based mobile health smoking cessation intervention in Cambodian people with HIV. ObjectiveThis 2-group randomized controlled trial compares the efficacy of a mobile health–based automated messaging (AM) intervention versus standard care (SC) in facilitating smoking cessation among Cambodian people with HIV. MethodsCambodian people with HIV who currently smoke and are receiving antiretroviral treatment (target, N=800) will be randomized to (1) SC or (2) the AM intervention. SC participants will receive brief advice to quit smoking, written self-help materials, nicotine patches, and will complete weekly app-delivered dietary assessments for 26 weeks. AM participants will receive all SC components (but will complete smoking-related weekly assessments instead of dietary assessments), in addition to a fully automated tailored messaging program driven by the weekly assessments to facilitate smoking cessation. In the Phase-Based Model of smoking cessation, the cessation process is partitioned into 4 phases: motivation, preparation (precessation), cessation (quit date to 2 weeks post quit), and maintenance (up to 6 months post quit). Our AM program targets processes within these phases, including increasing motivation to quit, enhancing self-efficacy, obtaining social support, skills to cope with nicotine withdrawal symptoms and stress, and skills to maintain abstinence. All participants will complete baseline and 3-, 6-, and 12-month in-person follow-up assessments. The primary outcome is biochemically confirmed abstinence at 12 months, with 3- and 6-month abstinence as secondary outcomes. Potential mediators and moderators underlying treatment effects will be explored, and cost-effectiveness will be assessed. ResultsThis study was approved by all relevant domestic and international institutional and ethical review boards. Participant recruitment commenced in January 2023. Data collection is expected to conclude by the end of 2025. ConclusionsBy demonstrating the greater efficacy and cost-effectiveness of AM relative to SC, this study has the potential to transform HIV care in Cambodia and prevent tobacco-related diseases. Furthermore, it may be adapted for use in other Cambodian populations and in other low- and middle-income countries. Ultimately, the AM approach to smoking cessation could greatly improve public health in the developing world and beyond. Trial RegistrationClinicalTrials.gov NCT05746442; https://clinicaltrials.gov/ct2/show/NCT05746442 International Registered Report Identifier (IRRID)PRR1-10.2196/48923

Purpose: In patients treated with chemoradiation for esophageal cancer (EC), randomized trial data demonstrate that proton beam therapy (PBT) reduces toxicities and postoperative complications (POCs) compared with intensity-modulated radiation therapy (IMRT). However, whether radiation therapy modality affects postoperative health care resource utilization remains unknown. Materials and Methods: We examined 287 patients with EC who received chemoradiation (prescribed 50.4 Gy/GyE) followed by esophagectomy, including a real-world observational cohort of 237 consecutive patients treated from 2007 to 2013 with PBT (n = 81) versus IMRT (n = 156); and an independent, contemporary comparison cohort of 50 patients from a randomized trial treated from 2012 to 2019 with PBT (n = 21) versus IMRT (n = 29). Postoperative complications were abstracted from medical records. Health care charges were obtained from institutional claims and adjusted for inflation (2021 dollars). Charge differences (Δ = $PBT − $IMRT) were compared by treatment using adjusted generalized linear models with the gamma distribution. Results: Baseline PBT versus IMRT characteristics were not significantly different. In the observational cohort, during the neoadjuvant chemoradiation phase, health care charges were higher for PBT versus IMRT (Δ =+ $71,959; 95% confidence interval [CI], $62,274–$82,138; P < .001). There was no difference in surgical charges (Δ =−$2234; 95% CI, −$6003 to $1695; P = .26). However, during postoperative hospitalization following esophagectomy, health care charges were lower for PBT versus IMRT (Δ = −$25,115; 95% CI, −$37,625 to −$9776; P = .003). In the comparison cohort, findings were analogous: Charges were higher for PBT versus IMRT during chemoradiation (Δ =+$61,818; 95% CI, $49,435–$75,069; P < .001), not different for surgery (Δ = −$4784; 95% CI, −$6439 to $3487; P = .25), and lower for PBT postoperatively (Δ = −$27,048; 95% CI, −$41,974 to −$5300; P = .02). Lower postoperative charges for PBT were especially seen among patients with any POCs in the contemporary comparison (Δ =−$176,448; 95% CI, −$209,782 to −$78,813; P = .02). Conclusion: Higher up-front chemoradiation resource utilization for PBT in patients with EC was partially offset postoperatively, moderated by reduction in POC risks. Results extend existing clinical evidence of toxicity reduction with PBT.

Background: The Medicare Part D medication therapy management (MTM) program has positive effects on medication and health service utilization. However, little is known about its utilization, much less so about the use among racial and ethnic minorities. Objective: To examine MTM service utilization among older Medicare beneficiaries and to identify any racial and ethnic disparity patterns. Methods: A retrospective cross-sectional analysis of 2017 Medicare administrative data, linked to the Area Health Resources Files. Fourteen outcomes related to MTM service nature, initiation, quantity, and delivery were examined using logistic, negative binomial, and Cox proportional hazards regression models. Results: Racial and ethnic disparities were found with varying patterns across outcomes. For example, compared with White patients, the odds of opting out of MTM were 8% higher for Black patients (odds ratio [OR] = 1.08, 95% confidence interval [CI] = 1.03–1.14), 57% higher for Hispanic patients (OR = 1.57, 95% CI = 1.42–1.72), and 57% higher for Asian patients (OR = 1.57, 95% CI = 1.33–1.85). The odds of continuing MTM from the previous years were 12% lower for Black patients (OR = 0.88, 95% CI = 0.86–0.90) and 3% lower for other patients (OR = 0.97, 95% CI = 0.95–0.99). In addition, the probability of being offered a comprehensive medication review (CMR) after MTM enrollment was 9% lower for Hispanic patients (hazard ratio [HR] = 0.91, 95% CI = 0.85–0.97), 9% lower for Asian patients (HR = 0.91, 95% CI = 0.87–0.94), and 3% lower for other patients (HR = 0.97, 95% CI = 0.95–0.99). Hispanic and Asian patients were more likely to have someone other than themselves receive a CMR. Conclusions: Racial and ethnic disparities in MTM service utilization were identified. Although the disparities in specific utilization outcomes vary across racial/ethnic groups, it is evident that these disparities exist and may result in vulnerable communities not fully benefiting from the MTM services. Causes of the disparities should be explored to inform future reform of the Medicare Part D MTM program.

Abstract Background Smoking is the leading cause of preventable morbidity and mortality in the United States. Individuals with low socioeconomic status have disproportionately high smoking rates and greater difficulty quitting smoking. Efficiently connecting underserved smokers to effective tobacco cessation programs is crucial for disease prevention and the elimination of health disparities. Smartphone-based interventions have the potential to enhance the reach and efficacy of smoking cessation treatments targeting underserved smokers, but there is little efficacy data for these interventions. In this study, we will partner with a large, local hunger-relief organization to evaluate the efficacy and economic impact of a theoretically-based, fully-automated, and interactive smartphone-based smoking cessation intervention. Methods This study will consist of a 2-group randomized controlled trial. Participants (N = 500) will be recruited from a network of food distribution centers in West Central Florida and randomized to receive either Standard Treatment (ST, n = 250) or Automated Treatment (AT, n = 250). ST participants will be connected to the Florida Quitline for telephone-based treatment and will receive a 10-week supply of nicotine replacement therapy (NRT; transdermal patches and lozenges). AT participants will receive 10 weeks of NRT and a fully-automated smartphone-based intervention consisting of interactive messaging, images, and audiovisual clips. The AT intervention period will span 26 weeks, with 12 weeks of proactive content and 26 weeks of on-demand access. ST and AT participants will complete weekly 4-item assessments for 26 weeks and 3-, 6-, and 12-month follow-up assessments. Our primary aim is to evaluate the efficacy of AT in facilitating smoking abstinence. As secondary aims, we will explore potential mediators and conduct economic evaluations to assess the cost and/or cost-effectiveness of ST vs. AT. Discussion The overall goal of this project is to determine if AT is better at facilitating long-term smoking abstinence than ST, the more resource-intensive approach. If efficacy is established, the AT approach will be relatively easy to disseminate and for community-based organizations to scale and implement, thus helping to reduce tobacco-related health disparities. Trial registration Clinical Trials Registry NCT05004662 . Registered August 13, 2021.

Cancer-related financial toxicity impacts head and neck cancer patients and survivors. With increasing use of proton therapy as a curative treatment for head and neck cancer, the multifaceted financial and economic implications of proton therapy—dimensions of “financial toxicity”—need to be addressed. Herein, we identify knowledge gaps and potential solutions related to the problem of financial toxicity. To date, while cost-effectiveness analysis has been used to assess the value of proton therapy for head and neck cancer, it may not fully incorporate empiric comparisons of patients’ and survivors’ lost productivity and disability after treatment. A cost-of-illness framework for evaluation could address this gap, thereby more comprehensively identifying the value of proton therapy and distinctly incorporating a measurable aspect of financial toxicity in evaluation. Overall, financial toxicity burdens remain understudied in head and neck cancer patients from a patient-centered perspective. Systematic, validated, and accurate measurement of financial toxicity in patients receiving proton therapy is needed, especially relative to conventional photon-based strategies. This will enrich the evidence base for optimal selection and rationale for payer coverage of available treatment options for head and neck cancer patients. In the setting of cancer care delivery, a combination of conducting proactive screening for financial toxicity in patients selected for proton therapy, initiating early financial navigation in vulnerable patients, engaging stakeholders, improving oncology provider team cost communication, expanding policies to promote price transparency, and expanding insurance coverage for proton therapy are critical practices to mitigate financial toxicity in head and neck cancer patients.

PurposeLeaders in the oncology community are sounding a clarion call to promote "value" in cancer care decisions. Value in cancer care considers the clinical effectiveness, along with the costs, when selecting a treatment. To discuss possible solutions to the current obstacles to achieving value in the use of advanced technologies in oncology, the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine held a workshop, "Appropriate Use of Advanced Technologies for Radiation Therapy and Surgery in Oncology" in July 2015. The present report summarizes the discussions related to radiation oncology.Methods and materialsThe workshop convened stakeholders, including oncologists, researchers, payers, policymakers, and patients. Speakers presented on key themes, including the rationale for a value discussion on advanced technology use in radiation oncology, the generation of scientific evidence for value of advanced radiation technologies, the effect of both scientific evidence and "marketplace" (or economic) factors on the adoption of technologies, and newer approaches to improving value in the practice of radiation oncology. The presentations were followed by a panel discussion with dialogue among the stakeholders.ResultsChallenges to generating evidence for the value of advanced technologies include obtaining contemporary, prospective, randomized, and representative comparative effectiveness data. Proposed solutions include the use of prospective registry data; integrating radiation oncology treatment, outcomes, and quality benchmark data; and encouraging insurance coverage with evidence development. Challenges to improving value in practice include the slow adoption of higher value and the de-adoption of lower value treatments. The proposed solutions focused on engaging stakeholders in iterative, collaborative, and evidence-based efforts to define value and promote change in radiation oncology practice. Recent examples of ongoing or successful responses to the discussed challenges were provided.ConclusionsDiscussions of "value" have increased as a priority in the radiation oncology community. Practitioners in the radiation oncology community can play a critical role in promoting a value-oriented framework to approach radiation oncology treatment.

Abstract Objective We describe primary care providers’ current practice patterns related to smoking cessation counseling and lung cancer screening (LCS). Methods Family, internal medicine, and pulmonary medicine providers from two medical centers were asked to complete an electronic survey to report their practice patterns. Results Of 52 participating providers, most reported initiating three major components of a smoking cessation intervention often or very often: advise to quit (50, 96%), assess willingness to quit (47, 90%), and assist with counseling or pharmacotherapy (49, 94%). However, other components were less commonly initiated such as arranging follow‐ups (only 11 providers indicated recommending them often or very often, 21%) and less than half of providers reported that they often or very often recommend cessation counseling or pharmacotherapy of any type (except varenicline), though family medicine providers were more likely to recommend pharmacotherapy compared to the other specialists (p

BackgroundThe prevalence of smoking among cervical cancer survivors is strikingly high, yet no smoking cessation interventions to date have specifically targeted this population. This paper describes the study design, methods, and data analysis plans for a randomized clinical trial designed to evaluate the efficacy of a theoretically and empirically based Motivation And Problem Solving (MAPS) approach for promoting and facilitating smoking cessation among cervical cancer survivors. MAPS is a comprehensive, dynamic, and holistic intervention that incorporates empirically supported cognitive behavioral and social cognitive theory–based treatment strategies within an overarching motivational framework. MAPS is designed to be appropriate for all smokers regardless of their motivation to change and views motivation as dynamically fluctuating from moment to moment throughout the behavior change process. ObjectiveThis 2-group randomized controlled trial compares the efficacy of standard treatment to MAPS in facilitating smoking cessation among women with a history of high-grade cervical dysplasia or cervical cancer. MethodsParticipants (N=202) are current smokers with a history of high-grade cervical dysplasia or cervical cancer recruited nationally and randomly assigned to one of two treatment conditions: (1) standard treatment (ST) or (2) MAPS. ST consists of repeated letters referring participants to their state’s tobacco cessation quitline, standard self-help materials, and free nicotine replacement therapy when ready to quit. MAPS has all ST components along with 6 proactive telephone counseling sessions delivered over 12 months. The primary outcome is abstinence from tobacco at 18 months. Secondary outcomes include abstinence over time across all assessment points, abstinence at other individual assessment time points, quit attempts, cigarettes per day, and use of state quitlines. Hypothesized treatment mechanisms and cost-effectiveness will also be evaluated. ResultsThis study was approved by the institutional review boards at the University of Texas MD Anderson Cancer Center, the University of Oklahoma Health Sciences Center, and Moffitt Cancer Center. Participant enrollment concluded at Moffitt Cancer Center in January 2020, and follow-up data collection was completed in July 2021. Data analysis is ongoing. ConclusionsThis study will yield crucial information regarding the efficacy and cost-effectiveness of a MAPS approach for smoking cessation tailored to the specific needs of women with a history of high-grade cervical dysplasia or cervical cancer. Findings indicating that MAPS has substantially greater efficacy than existing evidence-based tobacco cessation treatments would have tremendous public health significance. Trial RegistrationClinicalTrials.gov NCT02157610; https://clinicaltrials.gov/ct2/show/NCT02157610 International Registered Report Identifier (IRRID)DERR1-10.2196/34502

BackgroundSmoking prevalence rates among people with HIV are nearly 3 times higher than those in the general population. Nevertheless, few smoking cessation trials targeting smokers with HIV have been reported in the literature. Efforts to develop and evaluate sustainable, low-cost, and evidence-based cessation interventions for people with HIV are needed. Given the widespread proliferation of mobile phones, the potential of using mobile health apps to improve the reach and efficacy of cessation interventions is promising, but evidence of efficacy is lacking, particularly among people with HIV. ObjectiveThis study will consist of a 2-group randomized controlled trial to evaluate a fully automated smartphone intervention for people with HIV seeking cessation treatment. MethodsParticipants (N=500) will be randomized to receive either standard treatment (ST; 250/500, 50%) or automated treatment (AT; 250/500, 50%). ST participants will be connected to the Florida Quitline and will receive nicotine replacement therapy in the form of transdermal patches and lozenges. This approach, referred to as Ask Advise Connect, was developed by our team and has been implemented in numerous health systems. ST will be compared with AT, a fully automated behavioral treatment approach. AT participants will receive nicotine replacement therapy and an interactive smartphone-based intervention that comprises individually tailored audiovisual and text content. The major goal is to determine whether AT performs better in terms of facilitating long-term smoking abstinence than the more resource-intensive ST approach. Our primary aim is to evaluate the efficacy of AT in facilitating smoking cessation among people with HIV. As a secondary aim, we will explore potential mediators and moderators and conduct economic evaluations to assess the cost and cost-effectiveness of AT compared with ST. ResultsThe intervention content has been developed and finalized. Recruitment and enrollment will begin in the fall of 2021. ConclusionsThere is a critical need for efficacious, cost-effective, and sustainable cessation treatments for people with HIV who smoke. The AT intervention was designed to help fill this need. If efficacy is established, the AT approach will be readily adoptable by HIV clinics and community-based organizations, and it will offer an efficient way to allocate limited public health resources to tobacco control interventions. Trial RegistrationClinicalTrials.gov NCT05014282; https://clinicaltrials.gov/ct2/show/NCT05014282 International Registered Report Identifier (IRRID)PRR1-10.2196/33183

Background:. “Time burden” (time required during treatment) is relevant when choosing a local therapy option for early-stage breast cancer but has not been rigorously studied. We compared the time burden for three common local therapies for breast cancer: (1) lumpectomy plus whole-breast irradiation (Lump+WBI), (2) mastectomy without radiation or reconstruction (Mast alone), and (3) mastectomy without radiation but with reconstruction (Mast+Recon). Methods:. Using the MarketScan database, we identified 35,406 breast cancer patients treated from 2000 to 2011 with these local therapies. We quantified the total time burden as the sum of inpatient days (inpatient-days), outpatient days excluding radiation fractions (outpatient-days), and radiation fractions (radiation-days) in the first two years postdiagnosis. Multivariable regression evaluated the effect of local therapy on inpatient-days and outpatient-days adjusted for patient and treatment covariates. Results:. Adjusted mean number of inpatient-days was 1.0 for Lump+WBI, 2.0 for Mast alone, and 3.1 for Mast+Recon (P < 0.001). Adjusted mean number of outpatient-days was 42.9 for Lump+WBI, 42.2 for Mast alone, and 45.8 for Mast+Recon (P < 0.001). The mean number of radiation-days for Lump+WBI was 32.4. Compared with Mast+Recon (48.9 days), total adjusted time burden was 4.7 days shorter for Mast alone (44.2 days) and 27.4 days longer for Lump+WBI (76.3 days). However, use of a 15 fraction WBI regimen would reduce the time burden differential between Lump+WBI and Mast+Recon to just 10.0 days. Conclusions:. Although Mast+Recon confers the highest inpatient and outpatient time burden, Lump+WBI carries the highest total time burden. Increased use of hypofractionation will reduce the total time burden for Lump+WBI.

Background: There has been a lack of evidence on whether there are racial and ethnic disparities in medication nonadherence among individuals receiving comprehensive medication review (CMR), a required component of the Medicare Part D medication therapy management (MTM) services. Objectives: To explore racial/ethnic disparities in medication nonadherence among older MTM enrollees who received a CMR and to determine how much the identified disparities can be explained by observed characteristics. Methods: The retrospective study used 100% of the 2017 Medicare claims, including MTM data. Linked Area Health Resources Files provided community characteristics. Nonadherence was defined as proportion of days covered

Introduction. The Centers for Medicare & Medicaid Services requires a written order of shared decision making (SDM) visit in its coverage policy for low-dose computed tomography (LDCT) for lung cancer screening (LCS). With screening eligibility starting at age 55, private insurance plans will likely adopt this coverage policy. This study examined the implementation of SDM in the context of LCS among the privately insured. Methods. We constructed two study cohorts from MarketScan Commercial Claims and Encounters database 2016-2017: a LDCT cohort who received LDCT for LCS and an SDM cohort who had an LCS-related SDM visit. For the LDCT cohort, we examined the trend and factors associated with the receipt of SDM within 3 months prior to LDCT. For the SDM cohort, we studied the trend and factors associated with LDCT within 3 months after an SDM visit. Results. For privately insured adults aged