Longitudinal Progression of Patients with Long COVID Treated in a Post-COVID Clinic: A Cross-Sectional Survey.

BACKGROUND: In addition to the morbidity and mortality associated with acute infection, COVID-19 has been associated with persistent symptoms (>30 days), often referred to as Long COVID (LC). LC symptoms often cluster into phenotypes, resembling conditions such as fibromyalgia, postural orthostatic tachycardiac syndrome (POTS), and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). LC clinics have been established to best address the needs of LC patients and continuity of care. We developed a cross-sectional survey to assess treatment response through our LC Clinic (LCC). METHODS: A 25-question survey (1-10 Likert scale) was expert- and content-validated by LCC clinicians, patients, and patient advocates. The survey assessed LC symptoms and the helpfulness of different interventions, including medications and supplements. A total of 852 LCC patients were asked to complete the survey, with 536 (62.9%) responding. RESULTS: The mean time from associated COVID-19 infection to survey completion was 23.2 ± 6.4 months. The mean age of responders was 52.3 ± 14.1 (63% females). Self-reported symptoms were all significantly improved (P < .001) from the initial visit to the LCC (baseline) to the time of the follow-up survey. However, only 4.5% (24/536) of patients rated all symptoms low (1-2) at the time of the survey, indicating low levels of full recovery in our cohort. The patients rated numerous interventions as being helpful, including low-dose naltrexone (45/77; 58%), vagal nerve stimulation (18/34; 53%), and fisetin (28/44; 64%). CONCLUSIONS: Patients report general improvements in symptoms following the initial LCC visit, but complete recovery rates remain low at 23.2 ± 6.4 months.

Pro Inflammatory Cytokines Profiles of Patients With Long COVID Differ Between Variant Epochs.

BACKGROUND: Over 30% of patients with COVID-19 have persistent symptoms that last beyond 30 days and referred to as Long COVID. Long COVID has been associated with a persistent elevation in peripheral cytokines including interleukin-6, interleukin-1ß, and tumor necrosis factor-α. This study reports cytokine profiles of patients in our clinic across SARS-COV-2 variant epochs. METHODS: The clinical cytokine panel was analyzed in patients with Long COVID during periods that were stratified according to variant epoch. The 4 variant epochs were defined as: (1) wild-type through alpha, (2) alpha/beta/gamma, (3) delta, and (4) omicron variants. RESULTS: A total of 390 patients had the clinical cytokine panel performed; the median age was 48 years (IQR 38-59) and 62% were female. Distribution by variant was wild-type and alpha, 50% (n = 196); alpha/beta/gamma, 7.9% (n = 31); delta, 18% (n = 72); and omicron, 23% (n = 91). Time to cytokine panel testing was significantly longer for the earlier epochs. Tumor necrosis factor-α (P < .001) and interleukin 1ß (P < .001) were significantly more elevated in the earlier epochs (median of 558 days in wild-type through Alpha epoch vs 263 days in omicron epoch, P < .001)). Nucleocapsid antibodies were consistently detected across epochs. DISCUSSION: When stratified by variant epoch, patients with early epoch Long COVID had persistently elevated peripheral pro-inflammatory cytokine levels when compared to later epoch Long COVID. Patients with Long COVID have similar clusters of symptoms across epochs, suggesting that the underlying pathology is independent of the peripheral cytokine signature.

Relationship of Weight Concerns to Body Mass Index in a Tobacco Treatment Program.

Objectives: Our aim was to examine the relationship between weight concerns (WC) and smoking cessation. Methods: WC was assessed before smoking cessation treatment in 671 adult patients who completed a 12-month follow-up visit at the Centre for Tobacco-Dependent, Prague, Czech Republic, from 2013 through 2019. We evaluated the abstinence rate at 12-month follow-up. Results: Among 669 patients with baseline WC (mean age, 43.4 years), 47% were women (145/306) and 21% were men (78/363). No association existed between WC and abstinence at 12 months. Smokers with obesity had increased fear of gaining weight (34% versus 24% of overweight and 23% of healthy-weight smokers) (p=.034) and were less confident in their ability to maintain their current weight (36% versus 55% of overweight smokers and 59% of healthy- weight smokers) (p<.001). Conclusions: Many smokers are concerned about gaining weight after stopping smoking, but in this cohort of patients, having WC was not associated with 12-month abstinence, but obesity or overweight was related to being afraid of postcessation weight-gain and low confidence for maintaining weight. Practitioners should be aware of the prevalence of WC in those stopping smoking and should address concerns, such as poor motivation and low confidence about managing their weight.

Post-discharge early assessment with remote video link (PEARL) initiative for patients discharged from hospital medicine services.

OBJECTIVES: The COVID-19 pandemic impacted the availability and accessibility of outpatient care following hospital discharge. Hospitalists (physicians) and hospital medicine advanced practice providers (HM-APPs) coordinate discharge care of hospitalized patients; however, it is unknown if they can deliver post-discharge virtual care and overcome barriers to outpatient care. The objective was to develop and provide post-discharge virtual care for patients discharged from hospital medicine services. METHODS: We developed the Post-discharge Early Assessment with Remote video Link (PEARL) initiative for HM-APPs to conduct a post-discharge video visit (to review recommendations) and telephone follow-up (to evaluate adherence) with patients 2-6 days following hospital discharge. Participants included patients discharged from hospital medicine services at an institution's hospitals in Rochester (May 2020-August 2020) and Austin (November 2020-February 2021) in Minnesota, US. HM-APPs also interviewed patients about their experience with the video visit and completed a survey on their experience with PEARL. RESULTS: Of 386 eligible patients, 61.4% were enrolled (n = 237/386) including 48.1% women (n = 114/237). In patients with complete video visit and telephone follow-up (n = 141/237), most were prescribed new medications (83.7%) and took them as prescribed (93.2%). Among five classes of chronic medications, patient-reported adherence ranged from 59.2% (narcotics) to 91.5% (anti-hypertensives). Patient-reported self-management of 12 discharge recommendations ranged from 40% (smoking cessation) to 100% (checking rashes). Patients reported benefit from the video visit (agree: 77.3%) with an equivocal preference for video visits over clinic visits. Among HM-APPs who responded to the survey (88.2%; n = 15/17), 73.3% reported benefit from visual contact with patients but were uncertain if video visits would reduce emergency department visits. CONCLUSION: In this novel initiative, HM-APPs used video visits to provide care beyond their hospital role, reinforce discharge recommendations for patients, and reduce barriers to outpatient care. The effect of this initiative is under evaluation in a randomized controlled trial.

Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial.

Objective: To evaluate the safety and effectiveness of combination varenicline with lorcaserin in preventing post-cessation weight gain. Participants and Methods: We conducted a randomized (varenicline for 12 weeks + lorcaserin for 24 weeks vs varenicline for 12 weeks + placebo for 24 weeks) phase II clinical study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing post-cessation weight gain in overweight and obese smokers. Eighty-four overweight and obese (body mass index [BMI], 27-40 kg/m2) cigarette smokers were randomized before study termination (lorcaserin: n=40; placebo: n=44). The primary outcomes were weight and waist circumference (WC) changes at 12 and 24 weeks in smokers meeting criteria for prolonged smoking abstinence. Results: Thirty-nine participants met criteria for prolonged smoking abstinence at 12 weeks (46%) and 21 at 24 weeks (25%). No significant treatment effect was observed at 12 weeks with lorcaserin compared with placebo (weight difference, -0.7 kg; 90% CI, -2.6 to 1.1 kg; P=.51; WC difference, -1.9 cm; 90% CI, -4.2 to 0.5 cm; P=.18; or BMI difference, -0.4 kg/m2; 90% CI, -1.1 to 0.3 kg/m2; P=.33). No significant treatment effect was observed between lorcaserin at 24 weeks compared with placebo (weight, 1.4 kg; 90% CI, -3.8 to 6.7 kg; P=.65; WC, -0.9 cm; 90% CI, -5.8 to 4.0 cm; P=.75; or BMI 0.29 kg/m2; 90% CI, -1.5 to 2.12 kg/m2; P=.79). Conclusion: Weight gain and WC increases after prolonged smoking abstinence were not reduced using combination varenicline and lorcaserin. The results do not support further research in the obese and weight-concerned smoking population using lorcaserin or similar drugs. Trial Registration: clinicaltrials.gov Identifier: NCT02412631.

Postacute Sequelae of SARS-CoV-2 Infection-Lessons Learned From a Coordinated Health System Response.

Objective: To outline a consensus-designed process for triaging and managing patients with post-coronavirus disease (COVID-19) syndrome at Mayo Clinic. Patients and Methods: We convened a central multidisciplinary team including members from the departments of general internal medicine, occupational medicine, physical medicine and rehabilitation, psychology, allergy and immunology, infectious disease, pulmonology, neurology, cardiology, and pediatrics and otorhinolaryngology with membership from all Mayo Clinic sites in Arizona, Florida, Iowa, Minnesota, and Wisconsin. Results: Consensus recommendations were made for the best practice guidelines on triaging and managing patients. Several innovations were agreed upon, including a postacute sequelae of COVID-19-specific appointment request form for data collection, a bioregistry, a biorepository, and a postacute sequelae of COVID-19-specific treatment program. Conclusion: Given that each clinical site had individual clinical practices, these recommendations were implemented using different models, which may provide broad applicability to other clinical settings.

Use of Complementary and Integrative Medicine Among Patients With Glioblastoma Multiforme Seen at a Tertiary Care Center.

Background: Glioblastoma multiforme (GBM) is among the most aggressive and lethal tumors, with a median survival of 12-15 months. Many patients use complementary and integrative medicine (CIM) therapies to supplement their cancer treatment. Objective: To determine the prevalence of CIM use and identify the most frequently used types of CIM in a cohort of patients with GBM seen at a tertiary care medical center in the United States. Methods: An anonymous survey was mailed through the US Postal Service from August 1, 2019, through February 21, 2020, to patients with GBM. Results: A total of 346 surveys were mailed, and 146 responses (42%) were received. The median age of respondents was 61 years (range, 52-68 years), and 85 (58%) were male. Most patients had undergone surgery (90%), chemotherapy (96%), and radiotherapy (95%). The median time from diagnosis of GBM to survey participation was 18 months (range, 12-31 months). Most respondents (81%) used some form of CIM, most frequently meditation (22%), relaxation and other stress management techniques (19%), chiropractic therapy (16%), and acupuncture (12%). Compared with men, women more commonly meditated (32% vs 16%; P = .046) and practiced yoga (20% vs 6%; P = .04). We observed age-based differences, with younger patients more commonly meditating, practicing relaxation and stress management techniques, and receiving chiropractic therapy (P < .05 for all). Conclusions: Providers should encourage patients with GBM to discuss their interest in CIM therapies and guide them to evidence-based treatments that may help improve their quality of life.

Symptoms COVID 19 Positive Vapers Compared to COVID 19 Positive Non-vapers.

OBJECTIVES: The purpose of the present study was to assess and describe the severity of symptoms reported by Covid-19 positive patients who vaped (smoked e-cigarettes) when compared to those who did not vape or smoke at the time of the diagnosis of Covid-19. METHODS: Patients from this study are from a well-characterized patient cohort collected at Mayo Clinic between March 1, 2020 and February 28, 2021; with confirmed COVID-19 diagnosis defined as a positive result on reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assays from nasopharyngeal swab specimens. Among the 1734 eligible patients, 289 patients reported current vaping. The cohort of vapers (N = 289) was age and gender matched to 1445 covid-19 positive patients who did not vape. The data analyzed included: date of birth, gender, ethnicity, race, marital status, as well as lifestyle history such as vaping and smoking and reported covid-19 symptoms experienced. RESULTS: A logistic regression analysis was performed separately for each symptom using generalized estimating equations (GEE) with robust variance estimates in order to account for the 1:5 age, sex, and race matched set study design. Patients who vaped and developed Covid-19 infection were more likely to have chest pain or tightness (16% vs 10%, vapers vs non vapers, P = .005), chills (25% vs 19%, vapers vs non vapers, P = .0016), myalgia (39% vs 32%, vapers vs non vapers, P = .004), headaches (49% vs 41% vapers vs non vapers, P = .026), anosmia/dysgeusia (37% vs 30%, vapers vs non vapers, P = .009), nausea/vomiting/abdominal pain (16% vs 10%, vapers vs non vapers, P = .003), diarrhea (16% vs 10%, vapers vs non vapers, P = .004), and non-severe light-headedness (16% vs 9%, vapers vs non vapers, P < .001). CONCLUSION: Vapers experience higher frequency of covid-19 related symptoms when compared with age and gender matched non-vapers. Further work should examine the impact vaping has on post-covid symptom experience.

Central Sensitization Phenotypes in Post Acute Sequelae of SARS-CoV-2 Infection (PASC): Defining the Post COVID Syndrome.

OBJECTIVE: To develop and implement criteria for description of post COVID syndrome based on analysis of patients presenting for evaluation at Mayo Clinic Rochester between November 2019 and August 2020. METHODS: A total of 465 patients with a history of testing positive for COVID-19 were identified and their medical records reviewed. After a thorough review, utilizing the DELPHI methods by an expert panel, 42 (9%) cases were identified with persistent central sensitization (CS) symptoms persisting after the resolution of acute COVID-19, herein referred to as Post COVID syndrome (PoCoS). In this report we describe the baseline characteristics of these PoCoS patients. RESULTS: Among these 42 PoCoS patients, the mean age was 46.2 years (median age was 46.5 years). Pain (90%), fatigue (74%), dyspnea (43%), and orthostatic intolerance (38%) were the most common symptoms. The characteristics of an initial 14 patients were utilized for the development of clinical criteria via a modified Delphi Method by a panel of experts in central sensitization disorders. These criteria were subsequently applied in the identification of 28 additional cases of suspected PoCoS. A 2-reviewer system was used to analyze agreement with using the criteria, with all 28 cases determined to be either probable or possible cases by the reviewers. Inter-reviewer agreement using these proposed defining criteria was high with a Cohen's alpha of .88. CONCLUSIONS: Here we present what we believe to be the first definitional criteria for Post COVID syndrome. These may be useful in clinical phenotyping of these patients for targeted treatment and future research.

The Association of Current Tobacco Status With Pain and Symptom Severity in Fibromyalgia Patients.

OBJECTIVE: To describe current tobacco use among patients with newly confirmed fibromyalgia and evaluate the association between tobacco use status and severity of reported pain and other fibromyalgia symptoms. PATIENTS AND METHODS: Participants in this study were adult patients (N=1068) with fibromyalgia who met American College of Rheumatology 2010/2011 clinical criteria for fibromyalgia at the time of initial presentation to a Midwest fibromyalgia clinic (June 1, 2018, through May 31, 2019). Multiple linear regression analyses were performed to assess the association of tobacco use status with the Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) scores. Covariates included in these analyses included age, sex, body mass index, depression, opioid medication use, and use of fibromyalgia-specific pharmacotherapy. RESULTS: The patients were largely women (87.0%; n=929), white (87.9%; n=939), and with an average ± SD age of 46.6±13.9 years. The WPI and SSS scores were significantly greater in current tobacco users compared with never tobacco users (WPI effect estimate [EE] = 1.03; 95% CI, 0.30 to 1.76; type III P=.020; SSS EE = 0.47; 95% CI, 0.11 to 0.84; type III P=.036). The WPI score was negatively associated with age (EE = -0.02 per year; 95% CI, -0.03 to -0.001 per year; P=.037) and no use of opioid medication (EE = -1.08; 95% CI, -1.59 to -0.57; P<.001) while positively associated with higher body mass index (EE = 0.03 per 1 kg/m2; 95% CI, 0.001 to 0.06 per kg/m2; P=.04) and higher Patient Health Questionnaire-9 score (EE = 0.12; 95% CI, 0.08 to 0.16; P<.001). CONCLUSION: The results of our study suggest that tobacco use is associated with greater pain and other symptom severity in patients with fibromyalgia. These findings have important clinical and research implications for patients with fibromyalgia who use tobacco and who may benefit from early identification and timely implementation of tobacco cessation treatment to decrease pain and improve overall quality of life.

Electronic Cigarette Use Is Not Associated with COVID-19 Diagnosis.

This analysis tested the hypothesis that current e-cigarette use was associated with an increased risk of SARS-CoV-2 infection in patients seeking medical care. E-cigarette and conventional cigarette use were ascertained using a novel electronic health record tool, and COVID-19 diagnosis was ascertained by a validated institutional registry. Logistic regression models were fit to assess whether current e-cigarette use was associated with an increased risk of COVID-19 diagnosis. A total of 69,264 patients who were over the age of 12 years, smoked cigarettes or vaped, and were sought medical care at Mayo Clinic between September 15, 2019 and November 30, 2020 were included. The average age was 51.5 years, 62.1% were females and 86.3% were white; 11.1% were currently smoking cigarettes or using e-cigarettes and 5.1% tested positive for SARS-CoV-2. Patients who used only e-cigarettes were not more likely to have a COVID-19 diagnosis (OR 0.93 [0.69-1.25], P = .628), whereas those who used only cigarettes had a decreased risk (OR 0.43 [0.35-0.53], P < .001). The OR for dual users fell between these 2 values (OR 0.67 [0.49-0.92], P = .013). Although e-cigarettes have the well-documented potential for harm, they do not appear to increase susceptibility to SARS-CoV-2 infection. This result suggests the hypothesis that any beneficial effects of conventional cigarette smoking on susceptibility are not mediated by nicotine.

Body Mass Index, Multi-Morbidity, and COVID-19 Risk Factors as Predictors of Severe COVID-19 Outcomes.

PURPOSE: The purpose of the present study was to investigate body mass index, multi-morbidity, and COVID-19 Risk Score as predictors of severe COVID-19 outcomes. PATIENTS: Patients from this study are from a well-characterized patient cohort collected at Mayo Clinic between January 1, 2020 and May 23, 2020; with confirmed COVID-19 diagnosis defined as a positive result on reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assays from nasopharyngeal swab specimens. MEASURES: Demographic and clinical data were extracted from the electronic medical record. The data included: date of birth, gender, ethnicity, race, marital status, medications (active COVID-19 agents), weight and height (from which the Body Mass Index (BMI) was calculated, history of smoking, and comorbid conditions to calculate the Charlson Comorbidity Index (CCI) and the U.S Department of Health and Human Services (DHHS) multi-morbidity score. An additional COVID-19 Risk Score was also included. Outcomes included hospital admission, ICU admission, and death. RESULTS: Cox proportional hazards models were used to determine the impact on mortality or hospital admission. Age, sex, and race (white/Latino, white/non-Latino, other, did not disclose) were adjusted for in the model. Patients with higher COVID-19 Risk Scores had a significantly higher likelihood of being at least admitted to the hospital (HR = 1.80; 95% CI = 1.30, 2.50; P < .001), or experiencing death or inpatient admission (includes ICU admissions) (HR = 1.20; 95% CI = 1.02, 1.42; P = .028). Age was the only statistically significant demographic predictor, but obesity was not a significant predictor of any of the outcomes. CONCLUSION: Age and COVID-19 Risk Scores were significant predictors of severe COVID-19 outcomes. Further work should examine the properties of the COVID-19 Risk Factors Scale.

Assessing Biomarkers of Breast Cancer Risk in Underserved Women in a Midwestern County.

OBJECTIVE: The primary aim of this study was to evaluate the feasibility of collecting risk factor information and accessing digitized mammographic data in a medically marginalized population. A secondary aim was to examine the association between vitamin D status and mammographic density. METHODS: Breast-screening examinations were provided for age-appropriate patients, and a referral for no-cost screening mammography was offered. Study participants were asked to undergo 25-hydroxyvitamin D testing at mammography and 1-year follow-up. RESULTS: Of 62 women approached, 35 (56%) consented to participate. Of 32 participants who had baseline mammography, the median mammographic density measured by VolparaDensity (Volpara Solutions Limited) was 5.7%. After 1 year, 9 women obtained follow-up mammograms, with a median density of 5.7%. Vitamin D status was measured for 31 participants at baseline and 13 participants in the following year. Insufficient vitamin D status (<30 ng/mL) was noted in 77% at each time point. Mammographic density was not significantly correlated with vitamin D status (P = .06). CONCLUSIONS: On the basis of this small pilot study, vitamin D insufficiency is common in this study population. Owing to the small sample size, an association between vitamin D insufficiency and breast density was not clear. Additional unexpected findings included substantial barriers in initial access to care and longitudinal follow-up in this population. Further study of these issues is needed.

A Midwest COVID-19 Cohort for the Evaluation of Multimorbidity and Adverse Outcomes from COVID-19.

OBJECTIVE: To describe the process and outcome of creating a patient cohort in the early stages of the COVID-19 pandemic in order to better understand the process of and predict the outcomes of COVID-19. PATIENTS AND METHODS: A total of 1169 adults aged 18 years of age or older who tested positive in Mayo Clinic Rochester or the Mayo Clinic Midwest Health System between January 1 and May 23 of 2020. RESULTS: Patients were on average 43.9 years of age and 50.7% were female. Most patients were white (69.0%), and Blacks (23.4%) and Asians (5.8%) were also represented in larger numbers. Hispanics represented 16.3% of the sample. Just under half of patients were married (48.4%). Common comorbid conditions included: cardiovascular diseases (25.1%), dyslipidemia (16.0%), diabetes mellitus (11.2%), chronic obstructive pulmonary disease (6.6%), asthma (7.5%), and cancer (5.1%). All other comorbid conditions were less the 5% in prevalence. Data on 3 comorbidity indices are also available including the: DHHS multi-morbidity score, Charlson Comorbidity Index, and Mayo Clinic COVID-19 Risk Factor Score. CONCLUSION: In addition to managing the ever raging pandemic and growing death rates, it is equally important that we develop adequate resources for the investigation and understanding of COVID-19-related predictors and outcomes.

Understanding User Acceptance of Clinical Decision Support Systems to Promote Increased Cancer Screening Rates in a Primary Care Practice.

OBJECTIVE: Clinical decision support systems (CDDSs) in the electronic medical record (EMR) have been implemented in primary care settings to identify patients due for cancer screening tests, while functioning as a real time reminder system. There is little known about primary care providers (PCPs) perspective or user acceptance of CDSS. The purpose of this study was to investigate primary care provider perceptions of utilizing CDSS alerts in the EMR to promote increased screening rates for breast cancer, cervical cancer, and colorectal cancer. METHODS: An electronic survey was administered to PCPs in a Midwest Health Institution community internal medicine practice from September 25, 2019 through November 27, 2019. RESULTS: Among 37 participants (9 NP/Pas and 28 MD/DOs), the NP/PA group was more likely to agree that alerts were helpful (50%; P-value = .0335) and the number of alerts (89%; P = .0227) in the EMR was appropriate. The NP/PA group also was more likely to find alerts straightforward to use (78%, P = .0239). Both groups agreed about feeling comfortable using the health maintenance alerts (MD/DO = 79%; NP/PA = 100%). CONCLUSION: CDSSs can promote and facilitate ordering of cancer screening tests. The use of technology can promptly identify patients due for a test and act as a reminder to the PCP. PCPs identify these alerts to be a beneficial tool in the EMR when they do not interrupt workflow and provide value to patient care. More work is needed to identify factors that could optimize alerts to be even more helpful, particularly to MD/DO groups.

Massage Compared with Massage Plus Acupuncture for Breast Cancer Patients Undergoing Reconstructive Surgery.

Objectives: Integrative therapies have been incorporated increasingly into health and wellness in the United States in recent decades. Their potential benefits are under evaluation in various situations, including pain and symptom relief for cancer patients and survivors. This pilot study evaluated whether combining two integrative complementary approaches augments a patient's benefit by reducing postoperative stress, pain, anxiety, muscle tension, and fatigue compared with one integrative complementary approach alone. Design: Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative complementary alternative therapies for three consecutive days. All participants were observed for up to 3 months. Subjects: Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Interventions: Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Outcome measures: Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated. Results: Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment (p = 0.03 and p = 0.04). After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes (p = 0.49). Conclusion: No additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.

Wellness Coaching: An Intervention to Increase Healthy Behavior in Breast Cancer Survivors.

BACKGROUND: Regular physical activity after breast cancer diagnosis improves survival rates and quality of life (QOL). However, breast cancer survivors rarely meet guidelines for recommended levels of physical activity. Wellness coaching interventions (WCIs) have improved exercise and health behaviors in other patient populations. OBJECTIVES: This study assessed the feasibility and effectiveness of WCIs for increasing physical activity in breast cancer survivors; secondary measures included changes in dietary habits, weight, and QOL. METHODS: 20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment were recruited into a single-arm, 12-week WCI pilot feasibility study. The intervention was comprised of one in-person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations. FINDINGS: Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL. Forty percent of participants achieved the 3% postintervention weight-loss goal, but this was not sustained at 30 weeks.

Use of a Wearable EEG Headband as a Meditation Device for Women With Newly Diagnosed Breast Cancer: A Randomized Controlled Trial.

Background: Breast cancer diagnosis and treatment affect quality of life and stress and are associated with fatigue. Meditation interventions are effective strategies for patients with breast cancer but are often limited by poor access, high cost, substantial time commitment, and poor adherence. In this feasibility study, we investigated the use of a portable, wearable, electroencephalographic device for guided meditation practices by breast cancer patients during the period from breast cancer diagnosis until 3 months after surgical treatment. Methods: We enrolled women (age = 20-75 years) who had received a recent diagnosis of breast cancer and planned to undergo surgical treatment. Participants were randomly assigned to perform guided meditation with the device (intervention group) or receive CD-based stress-reduction education (control group). Surveys were used to measure stress, quality of life, and fatigue at baseline, within 4 days before surgery, up to 14 days after surgery, and at 3 months after surgery. Results: In the intervention group, 15 of 17 participants (88.2%) completed the study; in the control group, 13 of 13 participants completed the study (100%). Participants in both groups had less fatigue and stress and improved quality of life at 2 weeks and 3 months after surgery compared with baseline, but there were no significant intergroup differences at any time point. Conclusion: The use of this wearable electroencephalographic device for meditation is a feasible strategy for patients with breast cancer.

Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial.

BACKGROUND: Each year, human papillomavirus (HPV) causes 30,000 cancers in the USA despite the availability of effective and safe vaccines. Uptake of HPV vaccine has been low and lags behind other adolescent vaccines. This protocol describes a multilevel intervention to improve HPV vaccination rates. METHODS: Using a cluster randomized trial, we will evaluate the independent and combined impact of two evidence-based implementation strategies with innovative enhancements on HPV vaccination rates for female and male patients. The clusters are six primary care sites providing care to pediatric populations. We will use a stepped-wedge cluster randomized design, including process evaluation, to test the hypothesis that compared with the current course of care and a practice-level intervention using reminder-recall interventions coupled with provider-level audit and feedback with education increases HPV vaccination rates in exposed clusters. The factorial design allows us to use a single trial to test these two interventions and to assess each individually and in combination. Our design has four 12-month steps. The first step will be a baseline period; data collected during it will provide a within-practice control group for each cluster. Second, two clusters will be randomly assigned to receive intervention 1 (reminder and recall), and two clusters will be randomly selected to receive intervention 2 (audit and feedback with education). Third, the other two clusters will be randomly allocated to intervention 1 or 2. Clusters initially with intervention 1 will be randomly allocated to 1 + 2 or 1; clusters initially with intervention 2 will be randomly allocated to 1 + 2 or 2. Fourth, all clusters will receive both interventions. To ensure balance of patient numbers across interventions, we will use block randomization at the first step, with the six clusters grouped into three pairs according to volume. Our primary outcome will be vaccination rates. DISCUSSION: Results of our clinical trial and process evaluation will provide evidence showing whether practice- and provider-level interventions improve HPV vaccination rates and will offer insight into contextual factors associated with direction and magnitude of trial outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03501992 , registered April 18, 2018.

Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: A randomized controlled trial.

BACKGROUND: Tobacco use is prevalent among persons with alcohol abuse and dependence. Varenicline has been shown to be the most effective pharmacotherapy for smoking cessation and may decrease alcohol consumption. The purpose of this study was to evaluate the efficacy of 12 weeks of varenicline for increasing smoking abstinence rates in smokers with alcohol abuse or dependence. METHODS: Participants were eligible for enrollment if they were 18 years or older, smoked 10 or more cigarettes per day for at least 6 months, had current alcohol abuse or dependence, and were interested in quitting smoking. Participants were randomly assigned to receive 12 weeks of varenicline 1 mg twice daily or matching placebo. The primary end point was 7-day point prevalence smoking abstinence at week 12. RESULTS: The 7-day point prevalence smoking abstinence rate at 12 weeks was significantly higher with varenicline (n = 16) than placebo (n = 17) (43.8% vs 5.9%; P = .01). At 24 weeks, the 7-day point prevalence smoking abstinence rate was still significantly higher with varenicline than placebo (31.3% vs 0%; P = .02). At 12 weeks, mean (SD) drinks per drinking day was significantly lower with varenicline than placebo (5.7 [3.9] vs 9.0 [5.3] drinks; treatment effect estimate, -2.8 [90% CI, -6.6 to -1.0]). Adverse events were minor and comparable to varenicline clinical trials. CONCLUSIONS: Varenicline is safe and efficacious for increasing smoking abstinence rates in smokers with alcohol abuse or dependence. Varenicline may decrease alcohol consumption in this population of smokers.