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Importance: Test accuracy studies often use small datasets to simultaneously select an optimal cutoff score that maximizes test accuracy and generate accuracy estimates., Objective: To evaluate the degree to which using data-driven methods to simultaneously select an optimal Patient Health Questionnaire-9 (PHQ-9) cutoff score and estimate accuracy yields (1) optimal cutoff scores that differ from the population-level optimal cutoff score and (2) biased accuracy estimates., Design, Setting, and Participants: This study used cross-sectional data from an existing individual participant data meta-analysis (IPDMA) database on PHQ-9 screening accuracy to represent a hypothetical population. Studies in the IPDMA database compared participant PHQ-9 scores with a major depression classification. From the IPDMA population, 1000 studies of 100, 200, 500, and 1000 participants each were resampled., Main Outcomes and Measures: For the full IPDMA population and each simulated study, an optimal cutoff score was selected by maximizing the Youden index. Accuracy estimates for optimal cutoff scores in simulated studies were compared with accuracy in the full population., Results: The IPDMA database included 100 primary studies with 44 503 participants (4541 [10%] cases of major depression). The population-level optimal cutoff score was 8 or higher. Optimal cutoff scores in simulated studies ranged from 2 or higher to 21 or higher in samples of 100 participants and 5 or higher to 11 or higher in samples of 1000 participants. The percentage of simulated studies that identified the true optimal cutoff score of 8 or higher was 17% for samples of 100 participants and 33% for samples of 1000 participants. Compared with estimates for a cutoff score of 8 or higher in the population, sensitivity was overestimated by 6.4 (95% CI, 5.7-7.1) percentage points in samples of 100 participants, 4.9 (95% CI, 4.3-5.5) percentage points in samples of 200 participants, 2.2 (95% CI, 1.8-2.6) percentage points in samples of 500 participants, and 1.8 (95% CI, 1.5-2.1) percentage points in samples of 1000 participants. Specificity was within 1 percentage point across sample sizes., Conclusions and Relevance: This study of cross-sectional data found that optimal cutoff scores and accuracy estimates differed substantially from population values when data-driven methods were used to simultaneously identify an optimal cutoff score and estimate accuracy. Users of diagnostic accuracy evidence should evaluate studies of accuracy with caution and ensure that cutoff score recommendations are based on adequately powered research or well-conducted meta-analyses.

Background: While preventive swallowing exercises reduce the risk of radiation-associated dysphagia in patients with head and neck cancer, strategies are needed to improve patient adherence., Methods: Before radiation, all participants were taught preventive swallowing exercises and randomized to either an adherence intervention or enhanced usual care. During radiation, all participants met twice with a speech pathologist for swallowing assessment and reinforcement of exercises. Intervention participants met weekly with a counselor in-person or by phone. At 6-week post-radiation follow-up, all participants completed a follow-up assessment of self-reported adherence, which was then corroborated with medical record documentation., Results: Newly diagnosed pharyngeal and laryngeal cancer patients without distant metastases were randomized (n = 265; 135 to intervention, and 130 to usual care). Intervention participants were more likely to adhere to exercises during radiation compared to the control group (p < 0.0001)., Conclusion: The weekly in-person adherence intervention program significantly increased patient's adherence to preventive swallowing exercises during radiation., (© 2024 Wiley Periodicals LLC.)

Background: Small extracellular vesicle (sEV) analysis can potentially improve cancer detection and diagnostics. However, this potential has been constrained by insufficient sensitivity, dynamic range, and the need for complex labeling., Methods: In this study, we demonstrate the combination of PANORAMA and fluorescence imaging for single sEV analysis. The co-acquisition of PANORAMA and fluorescence images enables label-free visualization, enumeration, size determination, and enables detection of cargo microRNAs (miRs)., Results: An increased sEV count is observed in human plasma samples from patients with cancer, regardless of cancer type. The cargo miR-21 provides molecular specificity within the same sEV population at the single unit level, which pinpoints the sEVs subset of cancer origin. Using cancer cells-implanted animals, cancer-specific sEVs from 20 µl of plasma can be detected before tumors were palpable. The level plateaus between 5-15 absolute sEV count (ASC) per µl with tumors ≥8 mm 3 . In healthy human individuals (N = 106), the levels are on average 1.5 ASC/µl (+/- 0.95) without miR-21 expression. However, for stage I-III cancer patients (N = 205), nearly all (204 out of 205) have levels exceeding 3.5 ASC/µl with an average of 12.2 ASC/µl (±9.6), and a variable proportion of miR-21 labeling among different tumor types with 100% cancer specificity. Using a threshold of 3.5 ASC/µl to test a separate sample set in a blinded fashion yields accurate classification of healthy individuals from cancer patients., Conclusions: Our techniques and findings can impact the understanding of cancer biology and the development of new cancer detection and diagnostic technologies., (© 2024. The Author(s).)

Background: Breast cancer patients experienced heightened anxiety during the pandemic. Also, modifications to clinical trial activities allowing for virtual platforms, local assessments, and greater flexibility were introduced to facilitate participation. We sought to evaluate the association between pandemic-related anxiety and willingness to participate in trials and how pandemic-era modifications to trial activities affect the decision to participate., Methods: We conducted an online survey from August to September, 2021 of patients with breast cancer assessing pandemic-related anxiety; clinical trials knowledge and attitudes; willingness to participate during and before the pandemic; and how each modification affects the decision to participate. Fisher's exact tests evaluated differences in proportions and two-sample t-tests evaluated differences in means. The association of pandemic-related anxiety with a decline in willingness to participate during compared to prior to the pandemic was modeled using logistic regression., Results: Among 385 respondents who completed the survey, 81% reported moderate-severe pandemic-related anxiety. Mean willingness to participate in a trial was lower during the pandemic than prior [2.97 (SD 1.17) vs. 3.10 (SD 1.09), (p < 0.001)]. Severe anxiety was associated with higher odds of diminished willingness to participate during the pandemic compared to prior (OR 5.07). Each of the modifications, with the exception of opting out of research-only blood tests, were endorsed by >50% of respondents as strategies that would increase their likelihood of deciding to participate., Conclusions: While pandemic-related anxiety was associated with diminished willingness to participate in trials, the leading reasons for reluctance to consider trial participation were unrelated to the pandemic but included worries about not getting the best treatment, side effects, and delaying care. Patients view trial modifications favorably, supporting continuation of these modifications, as endorsed by the National Cancer Institute and others., (© 2024 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background: Frequent sensor-assisted monitoring of changes in swallowing function may help improve detection of radiation-associated dysphagia before it becomes permanent. While our group has prototyped an epidermal strain/surface electromyography sensor that can detect minute changes in swallowing muscle movement, it is unknown whether patients with head and neck cancer would be willing to wear such a device at home after radiation for several months., Objective: We iteratively assessed patients' design preferences and perceived barriers to long-term use of the prototype sensor., Methods: In study 1 (questionnaire only), survivors of pharyngeal cancer who were 3-5 years post treatment and part of a larger prospective study were asked their design preferences for a hypothetical throat sensor and rated their willingness to use the sensor at home during the first year after radiation. In studies 2 and 3 (iterative user testing), patients with and survivors of head and neck cancer attending visits at MD Anderson's Head and Neck Cancer Center were recruited for two rounds of on-throat testing with prototype sensors while completing a series of swallowing tasks. Afterward, participants were asked about their willingness to use the sensor during the first year post radiation. In study 2, patients also rated the sensor's ease of use and comfort, whereas in study 3, preferences were elicited regarding haptic feedback., Results: The majority of respondents in study 1 (116/138, 84%) were willing to wear the sensor 9 months after radiation, and participant willingness rates were similar in studies 2 (10/14, 71.4%) and 3 (12/14, 85.7%). The most prevalent reasons for participants' unwillingness to wear the sensor were 9 months being excessive, unwanted increase in responsibility, and feeling self-conscious. Across all three studies, the sensor's ability to detect developing dysphagia increased willingness the most compared to its appearance and ability to increase adherence to preventive speech pathology exercises. Direct haptic signaling was also rated highly, especially to indicate correct sensor placement and swallowing exercise performance., Conclusions: Patients and survivors were receptive to the idea of wearing a personalized risk sensor for an extended period during the first year after radiation, although this may have been limited to well-educated non-Hispanic participants. A significant minority of patients expressed concern with various aspects of the sensor's burden and its appearance., Trial Registration: ClinicalTrials.gov NCT03010150; https://clinicaltrials.gov/study/NCT03010150., (©Eileen H Shinn, Adam S Garden, Susan K Peterson, Dylan J Leupi, Minxing Chen, Rachel Blau, Laura Becerra, Tarek Rafeedi, Julian Ramirez, Daniel Rodriquez, Finley VanFossen, Sydney Zehner, Patrick P Mercier, Joseph Wang, Kate Hutcheson, Ehab Hanna, Darren J Lipomi. Originally published in JMIR Cancer (https://cancer.jmir.org), 28.02.2024.)

Objective: Neuroendocrine cervical carcinoma (NECC) is rare. Educational resources are limited for NECC patients, leading many to seek information online through patient-led social networks. We sought to characterize the relationships between anxiety and depression levels and social media use among NECC patients., Methods: Seven surveys assessing social media use, anxiety, and depression were distributed to living NECC patients enrolled in our NECC registry. The primary outcomes were associations between Social Network Time Use Scale (SONTUS) global score and Generalized Anxiety Disorder (GAD-7) and Center for Epidemiologic Studies Depression Scale (CESD) total scores., Results: Eighty-eight patients enrolled; 81 who completed at least 1 survey were included. Ninety-seven percent (70/72) of patients completing SONTUS were low-to-average social media users. Seventy-four percent (53/72) of patients visited a patient-led NECC support-group page on Facebook within the past 4 weeks, and of those, 79% (42/53) reported receiving useful information. Among the patients who did not visit the page, 47% (9/19) reported that the page elicited anxiety and/or sadness. The mean GAD-7 and CES-D scores for the entire cohort were 7.3 and 18.1, respectively. The Spearman correlations between social media use and these scores were significant (GAD-7: 0.23 [p = 0.05]; CESD: 0.25 [p = 0.04]). The estimated odds ratios for moderate/severe anxiety and depression as a function of SONTUS global score were 1.26 (95% CI 1.03-1.55; p = 0.03) and 1.23 (95% CI 1.01-1.49; p = 0.04), respectively., Conclusions: NECC patients demonstrated low-to-average social media use and relatively high anxiety and depression. Increased social media use was associated with elevated anxiety and depression., Competing Interests: Declaration of Competing Interest Michael Frumovitz – Consulting/speaking Stryker; Consulting Astellas; Research funding AkesoBio. Eileen Shinn – Education track leader ASCO, Co-Leader TBCRC Patient Reported Outcomes, Reviewer DOD 2023. All other authors have no conflict of interest to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Early patient discontinuation from adjuvant endocrine treatment (ET) is multifactorial and complex: Patients must adapt to various challenges and make the best decisions they can within changing contexts over time. Predictive models are needed that can account for the changing influence of multiple factors over time as well as decisional uncertainty due to incomplete data. AtlasTi8 analyses of longitudinal interview data from 82 estrogen receptor-positive (ER+) breast cancer patients generated a model conceptualizing patient-, patient-provider relationship, and treatment-related influences on early discontinuation. Prospective self-report data from validated psychometric measures were discretized and constrained into a decisional logic network to refine and validate the conceptual model. Minimal intervention set (MIS) optimization identified parsimonious intervention strategies that reversed discontinuation paths back to adherence. Logic network simulation produced 96 candidate decisional models which accounted for 75% of the coordinated changes in the 16 network nodes over time. Collectively the models supported 15 persistent end-states, all discontinued. The 15 end-states were characterized by median levels of general anxiety and low levels of perceived recurrence risk, quality of life (QoL) and ET side effects. MIS optimization identified 3 effective interventions: reducing general anxiety, reinforcing pill-taking routines, and increasing trust in healthcare providers. Increasing health literacy also improved adherence for patients without a college degree. Given complex regulatory networks' intractability to end-state identification, the predictive models performed reasonably well in identifying specific discontinuation profiles and potentially effective interventions., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Shinn, Busch, Jasemi, Lyman, Toole, Richman, Symmans, Chavez-MacGregor, Peterson and Broderick.)

Objectives. Remote monitoring (RM) of health-related outcomes may optimize cancer care and prevention outside of clinic settings. CYCORE is a software-based system for collection and analyses of sensor and mobile data. We evaluated CYCORE's feasibility in studies assessing: (1) physical functioning in colorectal cancer (CRC) patients; (2) swallowing exercise adherence in head and neck cancer (HNC) patients during radiation therapy; and (3) tobacco use in cancer survivors post-tobacco treatment (TTP). Methods. Participants completed RM: for CRC, blood pressure, activity, GPS; for HNC, video of swallowing exercises; for TTP, expired carbon monoxide. Patient-reported outcomes were assessed daily. Results. For CRC, HNC and TTP, respectively, 50, 37, and 50 participants achieved 96%, 84%, 96% completion rates. Also, 91-100% rated ease and self-efficacy as highly favorable, 72-100% gave equivalent ratings for overall satisfaction, 72-93% had low/no data privacy concerns. Conclusion. RM was highly feasible and acceptable for patients across diverse use cases., (©2021 AMIA - All rights reserved.)

Background: An expanding body of research documents the benefits of physical activity for cancer survivors' physical functioning and quality of life, but few successful models provide community-based physical activity programs to cancer survivors. This report presents an evaluation of Active Living After Cancer, an evidence-based physical activity program for breast cancer survivors, adapted for community delivery to minority and medically underserved survivors., Methods: Survivors were recruited from health care and community settings. The program consisted of 12 weekly group sessions providing training in cognitive and behavioral skills for behavior change, brief physical activity, and cancer survivorship-related content. At the baseline and follow-up, participants completed assessments of their physical activity, quality of life, and physical functioning (6-minute walk and 30-second sit-to-stand test). At follow-up, they also completed questionnaires to measure program content mastery and satisfaction., Results: The outcome analysis included 127 participants. Physical activity and quality of life (mental and physical) improved from the baseline to follow-up (all P < .01). Physical functioning improved, with increases in sit-to-stand repetitions (mean, 12.5 at the baseline vs 14.9 at the follow-up; P < .01) and 6-minute walk distances (mean, 428 m at the baseline vs 470 m at the follow-up; P < .01)., Conclusions: The results highlight the effectiveness of an evidence-based program adapted for community-based delivery to minority and medically underserved breast cancer survivors. The program could be delivered to improve outcomes in diverse survivor populations., Lay Summary: Physical activity in breast cancer survivors is related to better quality of life and longer cancer-free survival. However, there are few community-based programs to help breast cancer survivors to become more physically active. The Active Living After Cancer program was adapted from an evidence-based program and delivered in community-based settings to minority and medically underserved breast cancer survivors. It consisted of 12 weekly group sessions in which participants learned skills to increase their physical activity. The program participants increased their physical activity and improved their mental and physical well-being and physical functioning., (© 2021 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)

Background: Only 8-23% of advanced epithelial ovarian cancer patients survive for 10 years or longer. Given the need for targeted interventions to improve survival, we interviewed this relatively rare survivor population to gain personalized insights into the reasons for their survival. The aim of this study was to characterize subjective attributions of survival and specific coping mechanisms long-term survivors of ovarian cancer., Methods: Twenty-two semi-structured, qualitative interviews assessing survival attributions and coping strategies were conducted from April to November 2014. Data were analyzed in a multistep process using ATLAS.ti.8: codes were identified during review of the transcripts and refined with literature review; the frequency of codes and code co-occurrence was calculated, and codes were grouped into themes. Resulting themes were checked by a national leader of an ovarian cancer advocacy organization and compared against available literature., Results: Thematic analysis found that participants credited their long-term survival to a variety of factors including medical, social, religious/spiritual, and lifestyle/personal characteristics. Some participants rejected these same attributions, concluding that the reason for survival was due to luck or unknowable. Several of Carver et al.'s theoretical dimensions of coping were evident in our sample: planning, positive reinterpretation, social support, religion and acceptance whereas three relatively new strategies were uncovered: conserving emotional energy, value-based activity coping, and self-care., Conclusions: Long-term survivors' perspectives were largely consistent with those of newly diagnosed ovarian cancer patients and ovarian cancer survivors of shorter duration. However, the long-term survivors were also willing to reject conventional attributions for survival and recognized the importance of disciplined self-preservational coping strategies., (© 2021. The Author(s).)

Objectives: Depression symptom questionnaires are not for diagnostic classification. Patient Health Questionnaire-9 (PHQ-9) scores ≥10 are nonetheless often used to estimate depression prevalence. We compared PHQ-9 ≥10 prevalence to Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) major depression prevalence and assessed whether an alternative PHQ-9 cutoff could more accurately estimate prevalence., Study Design and Setting: Individual participant data meta-analysis of datasets comparing PHQ-9 scores to SCID major depression status., Results: A total of 9,242 participants (1,389 SCID major depression cases) from 44 primary studies were included. Pooled PHQ-9 ≥10 prevalence was 24.6% (95% confidence interval [CI]: 20.8%, 28.9%); pooled SCID major depression prevalence was 12.1% (95% CI: 9.6%, 15.2%); and pooled difference was 11.9% (95% CI: 9.3%, 14.6%). The mean study-level PHQ-9 ≥10 to SCID-based prevalence ratio was 2.5 times. PHQ-9 ≥14 and the PHQ-9 diagnostic algorithm provided prevalence closest to SCID major depression prevalence, but study-level prevalence differed from SCID-based prevalence by an average absolute difference of 4.8% for PHQ-9 ≥14 (95% prediction interval: -13.6%, 14.5%) and 5.6% for the PHQ-9 diagnostic algorithm (95% prediction interval: -16.4%, 15.0%)., Conclusion: PHQ-9 ≥10 substantially overestimates depression prevalence. There is too much heterogeneity to correct statistically in individual studies., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Members of the Translational Breast Cancer Research Consortium conducted an expert-driven literature review to identify a list of domains and to evaluate potential measures of these domains for inclusion in a list of preferred measures. Measures were included if they were easily available, free of charge, and had acceptable psychometrics based on published peer-reviewed analyses. A total of 22 domains and 52 measures were identified during the selection process. Taken together, these measures form a reliable and validated list of measurement tools that are easily available and used in multiple cancer trials to assess patient-reported outcomes in relevant patients., (© 2019 American Cancer Society.)

Introduction: Pharyngeal and laryngeal cancers are highly curable; however survivors are at high risk for long-term dysphagia after radiation. To address lack of access to preventive care in community settings, we developed a responsive web-based application to help patients adhere to preventive swallowing exercises and cope with radiation side effects. We conducted an interim study analysis to determine website usage characteristics and to examine the effect size for future trials., Methods: Pharyngeal and laryngeal cancer patients were recruited for enrollment by speech language pathologists before primary radiation and introduced to the interactive website. The program (English and Spanish) features tracking logs for preventive exercises, instructional videos, patient stories and search features. Patients' self-reported swallowing function was assessed with the MD Anderson Dysphagia Inventory (MDADI) at baseline and at 6 months. Adherence to preventive exercises was assessed during the 10 week intervention. Number of unique website visits, total duration of website exposure, and rankings of the most popular webpages were calculated. Preliminary regression models were run using adherence and MDADI as outcomes., Results: Of the 160 enrolled, 96 had 10-week adherence data and 61 had 6-month MDADI data. The average age was 63 (SD = 12.26), 49.4% were from rural counties, 44% had a high school education or lower, and 42% reported annual income of $30,000 or less. The average number of visits was 5.49 (SD = 9.96) and the average total time spent with the website was 41.09 min (SD =88.48). Preliminary analyses indicated that number of unique visits to the website was independently associated with increased adherence to preventive exercises (p = .001-.008)., Conclusion: Our website showed significant effects in promoting adherence to swallowing exercises. However, our return visit rate showed that the platform needs improvement in navigability and usability for this older population undergoing challenging treatment in community settings with low resources., Competing Interests: All authors have participated in (a) conception and design, or analysis and interpretation of the data; (b) drafting the article or revising it critically for important intellectual content; and (c) approval of the final version., (© 2019 The Authors.)

Purpose: Nearly 40% of patients with breast cancer discontinue their adjuvant oral endocrine treatment (ET). We measured discontinuation rates of ET at a comprehensive cancer center. We then used an iterative approach to model patterns of determinants associated with discontinuation of ET., Methods: Patients with nonmetastatic breast cancer receiving active adjuvant ET were approached by nurse practitioners to complete an anonymous survey at one time point. We simulated a prospective model by iteratively regressing adverse effects onto adherence status across windowed time periods of 2 to 3 consecutive years, bootstrapping the smaller group of nonadherent patients and subsampling the larger adherent group., Results: From February to April 2013, 216 participants were enrolled in the study. Forty patients (18.5%) reported that they had discontinued ET during the first 5 years of ET, and an additional four patients (1.9%) missed > 20% of their doses. Using two-sided significance tests, simulations showed that all 13 ET adverse effects and reasons for discontinuation were significantly related to discontinuation at some time point during ET. Worry about ET cost (odds ratio [OR], 1.79), emotional distress (OR, 1.72), and bone and joint pain (OR, 1.69) were the three most impactful reasons for discontinuation, with varying patterns of influence over time., Conclusion: These analyses provide preliminary evidence that there are varying patterns of discontinuation of ET. Although some reasons for discontinuation exerted a steady influence over the 6-year ET trajectory (ie, bone and joint pain), other reasons, such as cost, cognitive complaints, and general dislike of pills, became more important in the later years of ET.

There is a need to monitor patients with cancer of the head and neck postradiation therapy, as diminished swallowing activity can result in disuse atrophy and fibrosis of the swallowing muscles. This paper describes a flexible strain sensor comprising palladium nanoislands on single-layer graphene. These piezoresistive sensors were tested on 14 disease-free head and neck cancer patients with various levels of swallowing function: from nondysphagic to severely dysphagic. The patch-like devices detected differences in (1) the consistencies of food boluses when swallowed and (2) dysphagic and nondysphagic swallows. When surface electromyography (sEMG) is obtained simultaneously with strain data, it is also possible to differentiate swallowing vs nonswallowing events. The plots of resistance vs time are correlated to specific events recorded by video X-ray fluoroscopy. Finally, we developed a machine-learning algorithm to automate the identification of bolus type being swallowed by a healthy subject (86.4%. accuracy). The algorithm was also able to discriminate between swallows of the same bolus from either the healthy subject or a dysphagic patient (94.7% accuracy). Taken together, these results may lead to noninvasive and home-based systems for monitoring of swallowing function and improved quality of life.

Objectives: We compared the diagnostic accuracy of 4 depression screening scales, using traditional and alternative scoring methods, to the gold standard Structured Clinical Interview-DSM IV major depressive episode (MDE) in ovarian cancer patients on active treatment., Methods: At the beginning of a new chemotherapy regimen, ovarian cancer patients completed the following surveys on the same day: the Center for Epidemiological Studies Depression Scale (CES-D), the Beck Depression Inventory Fast-Screen for Primary Care (BDI-FastScreen), the Patient Health Questionnaire-9 (PHQ-9), and a 1-item screener ("Are you depressed?"). Each instrument's sensitivity, specificity, positive predictive value (PPV) and negative predictive value were calculated with respect to major depression. To control for antidepressant use, the analyses were re-run for a subsample of patients who were not on antidepressants., Results: One hundred fifty-three ovarian cancer patients were enrolled into the study. Only fourteen participants met SCID criteria for current MDE (9%). When evaluating all patients regardless of whether they were already being treated with antidepressants, the two-phase scoring approach with an alternate cutpoint of 6 on the PHQ-9 had the best positive predictive value (PPV=32%). Using a traditional cutpoint of 16 on the CES-D resulted in the lowest PPV (5%); using a more stringent cutpoint of 22 resulted in a slightly improved but still poor PPV, 7%., Conclusions: Screening with a two-phase PHQ-9 proved best overall, and its accuracy was improved when used with patients who were not already being treated with antidepressants., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Studies have shown a modest relationship between depression and mortality in patients with cancer. Our study addressed methodological weaknesses in the literature by restricting the sample to patients with one cancer type, adjusting for factors known to affect outcome, and following up patients for a sufficient period., Methods: We prospectively followed patients newly diagnosed with squamous cell oropharyngeal cancer from the start of radiation therapy until death or until date of last clinical visit. All patients were optimally treated with radiation and sometimes chemotherapy. After adjusting for tumor stage, treatment, comorbidities, smoking, excessive alcohol use, and demographic factors, we assessed the effects of baseline self-reported depression on overall survival and recurrence., Results: One hundred thirty participants were followed for a median of 5 years. The average age was 56 years, and 83% were male. Eighteen participants died during the study and 15 experienced disease recurrence. Self-reported depression was associated with decreased overall survival duration (hazard ratio = 3.6, 95% confidence interval = 1.2-10.8) and disease recurrence (hazard ratio = 3.8, 95% confidence interval = 1.2-12.2) in multivariate analysis. In addition, smoking was associated with disease recurrence., Conclusions: Patients with oropharyngeal cancer may benefit from depression screening and evidence-based treatments, if appropriate. Future studies are needed to determine whether depression is an independent prognostic factor of outcome and to elucidate biobehavioral mechanisms involved in patients with oropharyngeal cancer.

Background: To reduce the risk of long-term swallowing complications after radiation, swallowing exercises may be helpful. Both the rate of adherence to swallowing exercises and its impact on future swallowing function are unknown., Methods: In all, 109 patients with oropharyngeal cancer beginning radiation were tracked for 2 years to determine adherence to swallowing exercises. Participants completed the MD Anderson Dysphagia Inventory (MDADI) 1-2 years after treatment, to assess self-reported swallowing function. Adherence, demographics, tumor, and treatment variables were multivariably regressed onto the MDADI physical subscale score., Results: In accord with speech pathologist documentation, 13% of the participants were fully adherent and 32% were partially adherent. Adherence was associated with the Physical MDADI Subscale score in the multivariate model (p = .01)., Conclusions: The majority of patients with head and neck cancer are nonadherent to swallowing exercise regimens and may benefit from supportive care strategies to optimize their adherence., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: Systems that enable remote monitoring of patients' symptoms and other health-related outcomes may optimize cancer care outside of the clinic setting. CYCORE (CYberinfrastructure for COmparative effectiveness REsearch) is a software-based prototype for a user-friendly cyberinfrastructure supporting the comprehensive collection and analyses of data from multiple domains using a suite of home-based and mobile sensors. This study evaluated the feasibility of using CYCORE to address early at-home identification of dehydration risk in head and neck cancer patients undergoing radiation therapy., Methods: Head and neck cancer patients used home-based sensors to capture weight, blood pressure, pulse, and patient-reported outcomes for two 5-day periods during radiation therapy. Data were sent to the radiation oncologist of each head and neck cancer patient, who viewed them online via a Web-based interface. Feasibility outcomes included study completion rate, acceptability and perceived usefulness of the intervention, and adherence to the monitoring protocol. We also evaluated whether sensor data could identify dehydration-related events., Results: Fifty patients consented to participate, and 48 (96%) completed the study. More than 90% of patients rated their ease, self-efficacy, and satisfaction regarding use of the sensor suite as extremely favorable, with minimal concerns expressed regarding data privacy issues. Patients highly valued the ability to have immediate access to objective, self-monitoring data related to personal risk for dehydration. Clinician assessments indicated a high degree of satisfaction with the ease of using the CYCORE system and the resulting ability to monitor their patients remotely., Conclusion: Implementing CYCORE in a clinical oncology care setting is feasible and highly acceptable to both patients and providers.

Background: A retrospective cohort study utilizing prospectively collected data was conducted from August 2003 until March 2008 at M.D. Anderson Cancer Center. It is unknown whether cardiovascular comorbidity and chronic stress impact ovarian cancer outcome, which remains poor despite advances in therapy. The purpose of this study was to determine whether cardiovascular disease and markers that may be associated with stress are also associated with survival in patients with ovarian cancer., Methods: Participants with newly diagnosed epithelial ovarian cancer were followed until time of death or truncation of study period (median follow-up = 4.2 years; n = 271). Tumor characteristics (stage, tumor grade, histology, debulking status), demographic variables, and cardiovascular comorbidity were documented and compared to overall survival., Results: Of the nine cardiovascular events tracked during follow-up, venous thromboembolism [VTE; HR, 3.2; 95% confidence interval (CI), 1.8-5.5] and pulmonary hypertension (HR, 8.5; 95% CI, 3.9-18.7) were associated with shorter survival in multivariate analysis. In addition, high tumor grade, suboptimal cytoreduction, and baseline heart rate (HR, 1.02; 95% CI, 1.01-1.04) were related to decreased survival., Conclusion: Careful management of certain cardiovascular comorbidities may extend survival in patients with ovarian cancer. Our findings suggest that increased baseline heart rate and the development of VTE and pulmonary hypertension after cancer diagnosis may be significant predictors of survival in women with ovarian cancer., Impact: Our study emphasizes the importance of identifying and optimally treating tachycardia, VTE, and pulmonary hypertension in conjunction with cancer therapy., (©2013 AACR.)

Importance: Data support proactive swallowing therapy during radiotherapy (RT) or chemoradiotherapy (CRT) for pharyngeal cancers. The benefits of adherence to a regimen of swallowing exercises and maintaining oral intake throughout treatment are reported, but independent effects are unclear., Objective: To evaluate the independent effects of maintaining oral intake throughout radiotherapy and adherence to preventive swallowing exercise., Design: Retrospective observational study., Setting: The University of Texas MD Anderson Cancer Center, Houston., Patients: The study included 497 patients treated with definitive RT or CRT for pharyngeal cancer (458 oropharynx, 39 hypopharynx) between 2002 and 2008., Main Outcomes and Measures: Swallowing-related end points were final diet after RT or CRT and duration of gastrostomy dependence. Primary independent variables included oral intake status at the end of RT or CRT (no oral intake, partial oral intake, or full oral intake) and adherence to a swallowing exercise regimen. Multiple linear regression and ordered logistic regression models were analyzed., Results: At the conclusion of RT or CRT, 131 patients (26%) had no oral intake and 74% maintained oral intake (167 partial [34%], 199 full [40%]). Fifty-eight percent (286 of 497) reported adherence to swallowing exercises. Maintenance of oral intake during RT or CRT and swallowing exercise adherence were independently associated with better long-term diet after RT or CRT (P = .045 and P < .001, respectively) and shorter duration of gastrostomy dependence (P < .001 and P = .007, respectively) in models adjusted for tumor and treatment burden., Conclusions and Relevance: The data indicate independent, positive associations of maintenance of oral intake throughout RT or CRT and swallowing exercise adherence with long-term swallowing outcomes. Patients who either eat or exercise fare better than those who do neither. Patients who both eat and exercise have the highest rate of return to a regular diet and shortest duration of gastrostomy dependence.

Purpose: To determine the prevalence rate of health behaviors in testis cancer survivors and to determine whether the rate of health behaviors in survivors was significantly different than those of their age-matched relative controls and a population-based control group matched for age, sex, education, and income., Patients and Methods: The health behaviors of 162 testis cancer survivors were compared with their age-matched relative controls (n = 74) and an age-, sex-, education-, and income-matched population-based control group (n ranged from 1,123 to 9,775). Health behaviors were assessed with the telephone-administered Behavioral Risk Factor and Surveillance Survey., Results: Nearly one in five testis cancer survivors reported current smoking and one third reported problem drinking. Only 11% reported having at least five servings of fruits and vegetables per day. Compared with their relative controls, the survivors were more likely to engage in regular exercise. For those participants who drank, survivors were twice as likely to engage in problem drinking and averaged a higher number of drinks compared to their Centers for Disease Control (CDC) controls. Survivors were also half as likely to have at least five servings of fruits and vegetables per day compared with the CDC controls., Conclusion: The overall picture regarding testis cancer survivors' health behaviors was mixed compared with the relative and CDC control groups. Our results suggest that reduced alcohol use and increased fruit and vegetable consumption may be important targets for future disease prevention in testis cancer survivors.

Objective: Women with ovarian cancer face a poor prognosis, with prolonged periods of treatment but relatively high levels of physical functioning. Their thoughts and feelings regarding the prospect of dying are complex and have not been adequately studied. Various demographic, medical and psychosocial factors were examined to determine their independent associations with fear of dying and hopelessness in a cross-sectional design., Method: Two hundred fifty-four ovarian cancer patients were assessed at the beginning of a new chemotherapy regimen. Separate logistic regressions were performed for worry about dying and loss of hope. For each analysis, psychosocial variables were entered after the demographic and medical variables to determine whether the psychosocial variables had an independent association with the respective outcome., Results: Fifty-five percent of the sample acknowledged fear of dying, and 31.6% acknowledged loss of hope in the fight against their illness. Being younger (p = .001), being of non-Hispanic White ethnicity (p = .026), and having poorer physical well-being (p = .000) were significantly associated with worry about dying after controlling for all other variables in the model. Regarding loss of hope, depressive symptoms (p = .002), lack of social support/well-being (p = .001), and number of treatments (p = .04) were significant., Significance of Results: This is one of the largest studies to examine end-of-life concerns in a sample of advanced cancer patients. Our results underscore the importance of demographic and psychosocial variables in the examination of ovarian cancer patients' end-of-life concerns. Their fears and concerns should be openly acknowledged, even when the clinical focus is still on curative treatment.

Background: Research suggests that glucose levels in cancer patients may be an important prognostic indicator. In ovarian tumors, increased expression of glucose transporter 1 (GLUT1), a transmembrane protein responsible for glucose uptake, is related to shorter survival time in ovarian cancer patients. This study tested the hypothesis that higher presurgical glucose levels predict shorter disease-specific survival time and time to recurrence in ovarian cancer patients., Methods: Nonfasting plasma glucose levels were determined for 74 patients with ovarian cancer at the time of their presurgical consultation and for 125 ovarian cancer patients in an independent validation set. Survival time and time to recurrence (disease-free interval [DFI]) were ascertained from medical records. Cox proportional hazards regression models were used to estimate the hazard ratio (HR) for survival time and DFI in relation to glucose level, adjusting for body mass index (BMI), stage, grade, and cytoreduction as appropriate., Results: Higher glucose levels were associated with shorter survival times in univariate analyses (HR, 1.88; P = .05). Multivariate analysis adjusting for stage showed that higher glucose levels were associated with shorter survival times (HR, 2.01; P = .04) and DFI (HR, 2.32; P = .05). In the validation set, higher glucose levels were associated with shorter survival times (HR, 2.01; P = .02) and DFI (HR, 2.48; P = .001) in univariate analysis, although glucose was not independent of the effect of cytoreduction when predicting survival time in this latter set., Conclusions: These findings contribute to mounting evidence that glucose levels have prognostic value in ovarian carcinoma., ((c) 2009 American Cancer Society.)

Objectives: Testicular cancer has one of the highest 5-year survival rates of all cancer sites. The survival period is marked by an increased risk of secondary cancer and cardiovascular events owing to treatment-related toxicities. The purposes of this cross-sectional study were to determine the prevalence of health behaviors and depressive symptoms and to assess the relationship between depression and health behaviors in survivors of testicular cancer., Methods: A total of 162 survivors of testicular cancer 2 to 10 years after their diagnosis completed a one-time telephone interview. The interview included a battery of questions from the Behavioral Risk Factor Surveillance System assessing health behaviors (smoking, physical activity, cholesterol screening, colorectal cancer screening, alcohol consumption, and fruit and vegetable intake) and the Centers for Epidemiological Studies-Depression (CES-D) questionnaire assessing depressive symptoms., Results: The interviews revealed a low prevalence of positive health behaviors among survivors of testicular cancer. The percentage (17.5%) of survivors of testicular cancer who scored above the cutoff on the CES-D was greater than that (11%) of large-scale population-based estimates in men aged 19 to 44 years. Smoking was significantly related to depression. Depressive symptoms (CES-D score) differed significantly depending on smoking status (current smokers, mean = 15.2; former smokers, mean = 6.2, P <0.001; and never smokers, mean = 8.7, P <0.001)., Conclusions: Given the increased risk of cancer and treatment-related morbidities of these survivors, the findings of this study suggest that healthcare professionals should encourage survivors of testicular cancer to engage in positive health behaviors and check for depressive symptoms.

Objective: This paper will report the results of a pilot test of a 6-month, 21-session intervention to increase breast cancer survivors' physical activity by teaching them to incorporate short periods of moderate activity into their daily routines (lifestyle intervention). The effect of the intervention on physical performance, quality of life, and physical activity are reported., Methods: Sixty breast cancer survivors were randomized to either a lifestyle intervention or a standard care control group. Physical performance, quality of life (Medical outcomes study short form-36 [SF-36]), and physical activity (7-day recall and motivation readiness), were assessed at baseline and 6 months., Results: The lifestyle group had significantly better performance in the 6-min walk task than the controls (p=0.005) at 6 months. The intervention had positive effects on the bodily pain (p=0.020) and general health (p=0.006) subscales from the SF-36. The lifestyle group had a greater motivational readiness for physical activity at 6-month than standard care, but no significant differences were seen between the two in terms of number of minutes of moderate or more intense physical activity or number of days on which they did > or =30 min of moderate or more intense activity., Conclusions: Despite the small sample size, the lifestyle intervention showed promise for improving physical functioning and quality of life and increasing physical activity, and should be tested in a larger randomized trial., Practice Implications: If the lifestyle approach is shown to be effective in a larger trial, it represents a highly feasible intervention that it can be delivered to cancer survivors by health care institutions or community organizations without dedicated exercise facilities and equipment.

Purpose: To characterize sexual functioning of ovarian cancer patients and identify factors predicting sexual activity, functioning or satisfaction, discomfort, and habit or frequency., Patients and Methods: Data were collected on 232 women with epithelial ovarian cancer, 47% of whom were receiving treatment., Results: Fifty percent of the patients had engaged in sexual activity in the past month. Of those who were sexually active, 47% reported no or little desire, 80% reported problems with vaginal dryness, and 62% reported pain or discomfort during penetration. Of those who were sexually inactive, reasons included no partner (44.1%), lack of interest (38.7%), physical problems making sex difficult (23.4%), and fatigue (10.8%). Partner factors also were identified, including physical problems (16.2%), lack of interest (15.3%), and fatigue (5.4%). A multivariate model was used to predict sexual activity and included demographic, medical, and psychosocial factors as predictors. Women who were married (P <.001), were younger than 56 years (P <.001), were not receiving active treatment (P <.01), had a longer time since original diagnosis (P =.104), and liked the appearance of their bodies (P =.004) were more likely to be sexually active. Univariate analyses indicated that demographic, medical, and psychosocial factors are significantly associated with sexual functioning or satisfaction, sexual discomfort, and sexual frequency or habit., Conclusion: Sexual rehabilitation for ovarian cancer patients should address management of physical and psychologic symptoms and include the patient's partner when appropriate.

Objective: The aim of this investigation was to evaluate the impact of optical spectroscopy, a new approach for the detection of cervical dysplasia, on patient well-being and satisfaction., Study Design: Patient distress and satisfaction with optical spectroscopy compared with the Papanicolaou test and colposcopically directed biopsy were measured in a volunteer sample of 314 women with no history of abnormal Papanicolaou test findings., Results: Participants reported significantly less pain and anxiety (P<.001) during optical spectroscopy than during the Papanicolaou test or colposcopically directed biopsy. Generally, participants found spectroscopy equal to the Papanicolaou test and to biopsy on a variety of questions that measured satisfaction. There were statistically significant differences between spectroscopy and the Papanicolaou test or biopsy on issues such as the discomfort and fear caused by the test, the amount of time taken, the room lighting, and perceptions of accuracy., Conclusion: That patients reported less distress during spectroscopy than during a Papanicolaou test, colposcopy, or biopsy suggests the possibility of improved adherence to cervical cancer screening and follow-up in settings in which it is used.

This study investigated whether symptoms of depression and anxiety were related to the development of elevated blood pressure in initially normotensive adults. The study's hypothesis was addressed with an existing set of prospective data gathered from an age-, sex-, and weight-stratified sample of 508 adults. Four years of follow-up data were analyzed both with logistic analysis, which used hypertension (blood pressure > or =140 mm Hg systolic or 90 mm Hg diastolic) as the dependent variable, and with multiple regression analysis, which used change in blood pressure as the dependent variable. Five physical risk factors for hypertension (age, sex, baseline body mass index, family history of hypertension, and baseline blood pressure levels) were controlled for in the regression analyses. Use of antidepressant/antianxiety and antihypertensive medications were controlled for in the study. Of the 433 normotensive participants who were eligible for our study, 15% had missing data in the logistic regression analysis focusing on depression (n = 371); similarly, 15% of the eligible sample had missing data in the logistic regression using anxiety as the psychological variable of interest (n = 370). Both logistic regression analyses showed no significant relationship for either depression or anxiety in the development of hypertension. The multiple regression analyses (n = 369 for the depression analysis; n = 361 for the anxiety analysis) similarly showed no relationship between either depression or anxiety in changes in blood pressure during the 4-year follow-up. Thus, our results do not support the role of depressive or anxiety symptoms in the development of hypertension in our sample of initially normotensive adults.