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BACKGROUND: Human Papillomavirus-associated oropharyngeal cancer (HPV-OPC) incidence is increasing among men in the United States. Poor dental health has previously been associated with risk of head and neck cancers, oral HPV infection, and persistence but it is not understood whether dental health is associated with outcomes. We sought to determine the association of dental health with progression free survival and overall mortality among men with an HPV-OPC. METHODS: A cross sectional study of men diagnosed with HPV-OPC between 2014-2020 at Moffitt Cancer Center in Tampa, FL was conducted. Dental records were abstracted for assessment of dental fitness prior to cancer treatment. Five dental factors including number of teeth lost, pocket depth, gingival score, loss of attachment, and bone loss were individually examined. Risk factor and outcome data were collected from a patient risk questionnaire and medical record. Using item response theory, an overall dental fitness score from five dental factors was developed in which missing data were multiply imputed. Cox proportional hazards model was used to assess whether dental factors were associated with progression-free survival or overall mortality. RESULTS: Among 206 HPV-OPC cases, median follow-up was 3.4 years (IQR: 2.4-4.4) during which 40 cases involved progression or mortality and 25 deaths occurred. Overall dentition was significantly associated with progression free survival (p = 0.04) and with overall survival (p = 0.03) though findings were not significant after adjustment for age at diagnosis, stage, and smoking history (p = 0.146 and p = 0.120, respectively). A pocket depth of 7 mm or more was associated with overall survival (HR: 5.21; 95% CI: 1.43-19.11) and this remained significant after adjustment for confounding (aHR: 4.14; 95% CI: 1.72-16.26). CONCLUSIONS: Among men diagnosed with an HPV-associated OPC in the US, worse dental health was associated with reduced progression free survival and overall survival, but not after adjustment for confounders. Further studies are needed to examine whether dental health is associated with other prognostic factors and subsequent treatment-related outcomes.
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Neoplasias de Cabeça e Pescoço , Neoplasias Orofaríngeas , Infecções por Papillomavirus , Masculino , Humanos , Estados Unidos , Estudos Transversais , Infecções por Papillomavirus/complicações , Papillomavirus HumanoRESUMO
PURPOSE: Mobile health technology and integration of patient-reported outcome measures into clinical interventions have the potential to transform patient care. Though patient-reported outcome measure management has been shown to improve outcomes in ambulatory care settings, few studies have examined remote patient-reported outcome measure assessment after major cancer surgery. MATERIALS AND METHODS: A multiphased feasibility and usability study was designed. A mobile app-based postoperative symptom intervention tool was developed and evaluated by a focus group of bladder cancer patients and caregivers. Patients were prospectively accrued prior to cystectomy and asked to complete the daily mobile postoperative symptom intervention tool and wear biometric monitoring devices for 30 days post discharge. Retention, postoperative symptom intervention tool completion, and usability were assessed. Exploratory analysis of daily symptoms and patient-generated health information correlated signals with postsurgical complications and hospital readmission. RESULTS: Fifteen patients with a median age of 72 years completed 78% of daily surveys over the 30-day recovery period. Average time to complete the postoperative symptom intervention tool was 152 seconds. All patients agreed that the daily survey was easy to use, and most reported it would be a better way to communicate with the care team about symptoms than calling the clinic. Frequency and severity of patient-reported symptoms appeared to cluster prior to or at the time of complication or unplanned health care encounters on visual-analogue mapping. CONCLUSIONS: Using smartphone and wearable technology to capture patient-reported symptoms and biometric data is feasible and rated as highly usable by bladder cancer patients after cystectomy. Symptom scores may signal developing complications and help clinicians identify postsurgical patients who may benefit from intervention.
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Cistectomia , Neoplasias da Bexiga Urinária , Humanos , Idoso , Cistectomia/efeitos adversos , Projetos Piloto , Estudos de Viabilidade , Assistência ao Convalescente , Alta do Paciente , Neoplasias da Bexiga Urinária/cirurgia , BiometriaRESUMO
BACKGROUND: Obesity is a persistent public health concern and a risk factor for many chronic diseases including at least 13 different cancers. Adult Black females have the highest prevalence of obesity (57%) compared to other racial/gender groups in the U.S. Although behavioral weight loss (BWL) interventions have demonstrated effectiveness, Black females tend to lose less weight than White counterparts. The higher prevalence of chronic psychological stress reported by Black females may contribute to their disproportionate prevalence of obesity and observed suboptimal weight loss. This study will examine the effectiveness of a 12-month culturally-targeted, stress management-enhanced BWL intervention on weight loss and stress reduction among Black females in a fully-powered randomized, controlled trial. METHODS: Adult Black females with obesity (n = 340) will be randomized to either a culturally targeted stress management-enhanced BWL intervention (BWL-Stress) or the same BWL intervention alone (BWL-alone). The primary outcome is weight change at month 6. Secondary outcomes will include changes in stress measures (e.g., perceived stress, cortisol), energy intake, and physical activity at month 6. We will also assess process measures (e.g., treatment adherence, treatment burden). Each outcome will also be evaluated at month 12 to assess longer-term effects of the intervention. DISCUSSION: This novel approach for enhancing an evidence-based BWL program with culturally-targeted stress management strategies for Black females addresses an understudied barrier to effective weight management among a population at high risk for obesity and obesity-related chronic diseases. This study will potentially elucidate psychological or behavioral mechanisms linking our novel intervention to study outcomes. If the intervention is proven to be effective, this study will have significant clinical and public health implications for weight management among Black females. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov , identifier NCT04335799t , on April 6, 2020.
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Redução de Peso , Programas de Redução de Peso , Adulto , Terapia Comportamental/métodos , Feminino , Humanos , Obesidade/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Programas de Redução de Peso/métodosRESUMO
BACKGROUND: This protocol paper describes the overall design for HPV MISTICS, a multilevel intervention to increase human papillomavirus (HPV) vaccination initiation and completion rates among adolescents aged 11-17. METHODS: We will conduct a hybrid type 1 implementation-effectiveness trial using a stepped-wedge cluster randomized trial in eight federally qualified health centers (FQHCs) in Florida. Intervention components target three levels: system, providers, and parents. Outcomes will be assessed using quantitative (e.g., vaccination data, survey data) and qualitative methods (e.g., staff and parent interviews). We expect to quantify changes in HPV vaccine series initiation and completion rates for adolescents ages 11-17 in the eight FQHCs. We have hypothesized a 20-percentage point increase in HPV vaccine series initiation and a 10-percentage point increase in series completion. We also anticipate being able to explore factors at the system, provider, and patient levels as potential covariates. Implementation outcomes, barriers, and facilitators identified in the study will help characterize the implementation process and inform potential future intervention scale-up. RESULTS: The project is ongoing; effectiveness and implementation outcomes will be determined following project completion. CONCLUSIONS: Findings will provide evidence of an equity-informed research design and implementation procedures that could help improve HPV vaccination rates in similar health systems. CLINICAL TRIALS IDENTIFIER: NCT05677360 (date registered: 2022-12-22); https://clinicaltrials.gov/study/NCT05677360?lead=Moffitt%20Cancer%20Center%20&aggFilters=status:rec&page=2&rank=17.
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Infecções por Papillomavirus , Vacinas contra Papillomavirus , Pais , Humanos , Vacinas contra Papillomavirus/administração & dosagem , Adolescente , Infecções por Papillomavirus/prevenção & controle , Criança , Feminino , Pais/psicologia , Florida , Masculino , Projetos de PesquisaRESUMO
OBJECTIVES: To better understand palliative care knowledge and beliefs of patients with stage II or greater bladder cancer and their caregivers. SUBJECTS AND METHODS: Participants were primarily patients diagnosed with muscle-invasive or locally advanced bladder cancer. All were encouraged to enroll with a caregiver (defined as the individual who most closely assists with a patient's care). Participants completed a survey and semistructured interview. Applied thematic analysis techniques were used to analyze the interview data. In total, we recruited 16 dyads, 11 patients who participated alone, and 1 caregiver who participated alone. RESULTS: Patients and caregivers had high levels of palliative care knowledge and there was no difference in baseline knowledge. Palliative care receptivity was also high, with most participants stating that they would be "very likely" to consider palliative care for themselves or a loved one. However, based on the analysis of multiple-choice palliative care questions and interview transcripts, many participants lacked a nuanced understanding of palliative care and harbored many common misconceptions of the basic tenants. Five main themes emerged related to palliative care: (1) Participants have a general lack of awareness of it, (2) Participants associate it with hospice and death, (3) Participants view it as primarily emotional or psychological support, (4) Participants believe it is for patients without a strong support system, and (5) Participants believe it is for people who have "given up." CONCLUSIONS: High educational attainment and baseline palliative care knowledge did not preclude the most common misperceptions related to palliative care. These study results indicate that patients need clearer counseling regarding the definition, goals, benefits, and availability of palliative care.
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Cuidados Paliativos na Terminalidade da Vida , Neoplasias da Bexiga Urinária , Humanos , Cuidados Paliativos/métodos , Cuidados Paliativos na Terminalidade da Vida/psicologia , Cuidadores/psicologia , Inquéritos e Questionários , Neoplasias da Bexiga Urinária/terapiaRESUMO
AIMS: To identify subpopulations of dual users of combustible and electronic cigarettes using current smoking and vaping behaviors. DESIGN: Secondary analysis of baseline data from a randomized controlled trial testing a smoking cessation intervention for dual users. Finite mixture modeling of frequency, quantity, and dependence on combustible and electronic cigarettes was used to identify classes. Demographics and additional smoking and vaping variables were used to further characterize the classes. SETTING: United States. PARTICIPANTS: A total of 2896 adults who smoked weekly for the past year and vaped weekly for the past month. MEASUREMENTS: Self-report baseline measures assessed demographics and smoking and vaping behaviors and characteristics including days of use per week, frequency of use within a day, time to first use after waking, urges to smoke, smoking cessation motivation, self-efficacy to abstain from smoking, months since vaping initiation, reasons for initiating and maintaining vaping, and future plans to stop vaping. FINDINGS: Eight probabilistic classes were identified and well-defined (relative entropy = 0.95, Lo-Mendell-Rubin adjusted likelihood ratio test P < 0.0001; class probabilities 0.89-0.97). In general, classes crossed two levels of smoking with four levels of vaping. The largest class (31%) had relatively high levels of smoking (72% daily, 56% 11+ cigarettes per day [CPD], 96% within 30 minutes of waking) and vaping (74% daily, 100% 20+ electronic-CPD, 74% <30 minutes). The next largest class (27%) had relatively high levels of vaping (93% daily, 100% 20+ electronic-CPD, 82% <30 minutes) and very low levels of smoking (28% daily, 12% 11+ CPD, 0% <30 minutes). The six smaller classes (3%-13%) also had distinct smoking and vaping behaviors. All eight classes exhibited distinguishing characteristics beyond current smoking and vaping behaviors. CONCLUSIONS: Dual users of combustible and electronic cigarettes are not a homogeneous population, having eight well-defined prospective subpopulations.
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Sistemas Eletrônicos de Liberação de Nicotina , Produtos do Tabaco , Vaping , Adulto , Humanos , Estudos Prospectivos , Fumantes , Estados Unidos/epidemiologia , Vaping/epidemiologiaRESUMO
[This corrects the article DOI: 10.1371/journal.pone.0266316.].
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OBJECTIVES: Caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients experience high caregiver burden and carry a significant amount of responsibility. Mindfulness has the potential to lessen caregiver burden by aiding in stress management. To date, no studies have examined the efficacy of mindfulness in reducing caregiver burden in this population. Based on our pilot study demonstrating initial feasibility and acceptability of FOCUS (Focusing On mindfulness for Caregivers Under Stress), this 3-arm randomized controlled trial aims to examine the efficacy of a 6-week mindfulness-based stress management program for allogeneic HCT caregivers. Hypotheses include that the FOCUS condition will have lower post-treatment caregiver burden and that patients of these caregivers will have better patient health outcomes compared to other treatment conditions. METHOD: Eligible caregivers will be randomly assigned to one of three treatment conditions: FOCUS, Healthy Living (HL; active control), and Enhanced Care (EC; usual care). Caregivers in FOCUS and HL will participate in 6-week weekly individual treatment sessions and will be sent brief daily momentary interventions/messages. Caregivers in all conditions will complete daily diaries over the course of treatment. Patients of enrolled caregivers will be enrolled for assessments only. Participants will complete assessments at baseline, end of treatment, 2- and 6-months post-treatment. Biomarker data will be collected via hair cortisol concentrations from caregivers at baseline and 6 months post-treatment. RESULTS: Recruitment is ongoing. CONCLUSIONS: The data collected from this study will provide evidence on the efficacy of mindfulness in alleviating HCT caregiver stress and impacting patient health outcomes. TRIAL REGISTRATION: The current study is registered in clinicaltrials.gov (NCT05078229); see https://clinicaltrials.gov/ct2/show/NCT05078229?term=christine+vinci&draw=2&rank=1.
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Transplante de Células-Tronco Hematopoéticas , Atenção Plena , Cuidadores , Humanos , Hidrocortisona , Atenção Plena/métodos , Projetos Piloto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Importance: Level I evidence has failed to demonstrate an overall survival (OS) advantage for cytoreductive nephrectomy in patients with metastatic clear cell renal cell carcinoma (ccRCC) in the modern era, which is at odds with observational studies reporting a marked OS benefit associated with these operations. These observational studies were not designed to adjust for unmeasured confounding. Objective: To assess whether cytoreductive nephrectomy is associated with improved OS in patients with metastatic ccRCC. Design, Setting, and Participants: This cohort study identified patients with metastatic ccRCC in the National Cancer Database from January 1, 2006, to December 31, 2016, who received systemic targeted therapy. The analysis was finalized on July 23, 2021. Exposures: Receipt of cytoreductive nephrectomy. Main Outcomes and Measures: The primary outcome was OS from the date of diagnosis to death or censoring at last follow-up. Distance from the patients' zip code of residence to the treating facility was identified as a valid instrument and was used in a 2-stage residual inclusion instrumental variable analysis. Conventional adjustments for selection bias, multivariable Cox proportional hazards regression, and propensity score matching were performed for comparison. Measured covariates adjusted for in all analyses included age, sex, race, Charlson-Deyo score, facility type, year of diagnosis, clinical T stage, and clinical N stage. Results: The final study population included 12â¯766 patients (median age, 63 years; IQR, 56-70 years; 8744 [68%] male; 11â¯206 [88%] White). Cytoreductive nephrectomy was performed in 5005 patients (39%). Conventional adjustments for selection bias demonstrated a significant OS benefit associated with cytoreductive nephrectomy (multivariable Cox proportional hazards regression: hazard ratio [HR], 0.49; 95% CI, 0.47-0.51; propensity score matching: HR, 0.48; 95% CI, 0.46-0.50). Instrumental variable estimates did not demonstrate an association between cytoreductive nephrectomy and OS (HR, 0.92; 95% CI, 0.78-1.09). Conclusions and Relevance: Instrumental variable analysis did not demonstrate a survival advantage associated with cytoreductive nephrectomy for patients with metastatic ccRCC. This discrepancy likely reflects the fact that surgical indication for cytoreductive nephrectomy is primarily driven by factors that are not commonly measured or available in observational data sets.