Symptom trajectories during chemotherapy in outpatients with lung cancer colorectal cancer, or lymphoma.

Purpose Pain, depression, distress, fatigue, and sleep disturbance are common symptoms in oncology patients, but little data are available that examine the trajectories of these symptoms during chemotherapy (CTX). The purposes of this study were to examine the trajectories of these symptoms during the first six cycles of CTX and to determine whether individual characteristics predicted the trajectories of these symptoms. Methods Oncology outpatients (n = 118) with newly diagnosed lung cancer, colorectal cancer, or lymphoma rated symptoms using an electronic patient care monitor system. Pain, fatigue, and sleep disturbance were rated on 0–10 numeric rating scales; depression and distress were evaluated using scales converted to normalized T scores. Latent growth curve analyses (LGCA) examined for intra- and inter-individual differences in the trajectories of these five symptoms during the six cycles of CTX. Results Symptoms were present at the initiation of CTX (p < 0.0001) for all symptoms (p < 0.05). Distress (p = 0.03) and pain (p = 0.02) intensity decreased significantly over the six cycles of CTX. Advanced disease and a higher number of comorbidities predicted higher fatigue at baseline (p = 0.02 and 0.01 respectively). A diagnosis of lung cancer predicted an increasing intensity of fatigue during CTX (p = 0.04). Concurrent radiation therapy predicted more intense pain over time (p = 0.03). Conclusions While symptom trajectories were highly variable in patients undergoing initial CTX, the majority of the symptom intensity scores decreased over time. However, patients with lung cancer, those with a higher number of comorbidities, and those with advanced disease experienced more intense fatigue and sleep disturbance over time

SAS macros for testing statistical mediation in data with binary mediators or outcomes.

Background: Statistical mediation is an important tool in behavioral health sciences, but it has been confined primarily to continuous variables. As prevention studies become increasingly common, more often the mediator or outcome is binary. Recent work by D. P. MacKinnon and J. H. Dwyer (1993) has explicated the steps necessary to estimate models for mediation when the mediator or the outcome is binary. Objective: To report the release of a set of SAS macros used to implement the statistical analyses required to analyze data with binary and continuous-level data. Approach: A brief introduction to the methodology of mediation analysis in the presence of a binary outcome, mediator, or both is provided. The macros are tested on a sample of 84 participants who were experiencing pain. It is hypothesized that the relationship between pain and fatigue is mediated by sleep disturbance. Results: The relationship between pain and fatigue was mediated by the presence of sleep disturbances, and the amount of mediation was 23.34%. Discussion: The SAS macros are available for download without charge from the second author's Web site. Instructions are provided in an included technical manual

Social cognitive factors associated with mother-adolescent communication about sex.

To better understand why some mothers talk to their children about sex and others do not, we examined the role of two social cognitive variables- self-efficacy and outcome expectancies- in explaining sex-based communication. The present study was part of a larger study to test the efficacy of two HIV prevention programs for mothers and their adolescents. Mothers and their adolescents were recruited from a large community organization that serves youth who live in disadvantaged circumstances. The sample for the present study included 486 mothers who averaged 38.4 years of age (SD = 6.73). The majority were African American (97.7%), not married (66.7%), and had a high school degree (89.5%). Their adolescents ranged in age from 11 through 14 years of age and most were male (61.3%). The results of the analysis revealed that mothers who expressed higher levels of self-efficacy and more favorable outcomes associated with talking to their children about sex were more likely to do so. In a regression analysis, we learned that the mother’s degree of efficacy beliefs, along with her expected outcomes associated with talking about sex, the importance of religious beliefs to her, and the age and sex of her adolescents were important factors associated with talking with them about sex

Patient-centered communication during oncology follow-up visits for breast cancer survivors: content and temporal structure

Purpose/Objectives: To understand the content and temporal structure of survivor-provider communication during breast cancer survivor follow-up visits. Design: Descriptive correlational. Setting: Private outpatient oncology practice. Sample: 55 breast cancer survivors; 6 oncology providers. Methods: A secondary analysis of audio recordings of survivor follow-up visits. Main Research Variables: Survivors: demographics, uncertainty, mood, length of survival, years receiving care from providers, survivor expectations. Providers: demographics, medical uncertainty, specialty (physician, nurse practitioner, or physician assistant). Outcomes: time spent in patient-centered communication, perception of patient-centeredness. Findings: Most visit time (55%) was spent waiting. Of the remaining 45%, silence represented the most time spent with providers, followed by symptom conversations. More specific survivor discussion plans predicted more time spent discussing symptoms and in reassurance interactions. More specificity of visit purpose predicted survivor perceptions of less patient-centeredness; however, more time in contextual conversations predicted a greater perception of patient-centeredness. Provider factors were not associated with time spent in patient-centered communication or survivor perceptions of patient-centeredness. All dimensions of patient-centered communication occurred during each visit section (before, during, and after the physical examination). Conclusions: Discussing symptoms and concerns with providers offers reassurance about cancer recurrence. When visit expectations are very high, achieving a survivor perception of patient-centered communication may be difficult. However, time spent understanding a survivor within the context of her life can enhance survivor perceptions of patient-centeredness. Implications for Nursing: Providers must be sensitive to concerns that are presented throughout a visit. When visit time is short, a second appointment may be necessary to address survivor concerns

Determinants of functional performance in long-term survivors of allogeneic hematopoietic stem cell transplantation with chronic graft-versus-host disease (cGVHD)

This study examined factors accounting for functional performance limitations in 100 long-term survivors of allogeneic hematopoietic stem cell transplantation with chronic graft-versus-host disease (cGVHD). Functional performance, measured by the SF-36 physical component summary score, was substantially lower (mean = 36.8 ± 10.7) than the US population norm of 50 (P<0.001). The most severe decrements were in physical function (mean = 38.8 ± 10.9) and physical role function (mean = 37.88 ± 11.88); 68% of respondents exceeded the five-point threshold of minimum clinically important difference below the norm on these subscales. Controlling for age and gender, six variables explained 56% of the variance in functional performance: time since cGVHD diagnosis, cGVHD severity, intensity of immunosuppression, comorbidity, functional capacity (distance walked in 2 min, grip strength, and range of motion), and cGVHD symptom bother (F=11.26; P<0.001).Significant independent predictors of impaired performance were intensive systemic immunosuppression, reduced capacity for ambulation, and greater cGVHD symptom bother (P<0.05). Symptom bother had a direct effect on functional performance, as well as an indirect effect partially mediated by functional capacity (Sobel test, P = 0.004). Results suggest two possible mechanisms underlying impaired functional performance in survivors with cGVHD and underscore the importance of testing interventions to enhance functional capacity and reduce symptom bother. Bone Marrow Transplantation (2010) 45, 762–769; doi:10.1038/bmt.2009.238; published online 28 September 200

Fox_Path: A microcomputer program for the computation of effects in path analytic models.

Path analysis was first proposed by Wright (1934) as a means for analyzing the path coefficients within noncausal models. More recent texts concerned with regression models (Cohen & Cohen, 1983; Pedhazur, 1982) have devoted considerable space to the statistical methods used for the calculation of path coefficients within the path analytic framework. These regression methods provide the researcher with direct paths between variables, but in the absence of extended analysis, fail to provide information regarding the indirect paths, the unanalyzed effects, or the spurious effects among variables. Fox (1980; cited by Pedhazur, 1982) provided the means for computing indirect, spurious, and unanalyzed effects using a series of matrix manipulations. Pedhazur (1982) recommended the method for complex models; however, Fox (1980) presented the methods in APL (a programming language that is rarely implemented) and offered to send the FORTRAN listing to interested readers. Thus, this valuable method seems to be largely unavailable to those who need to calculate the more subtle effects for complex path analytic models

Fatigue, Sleep-wake Disturbances, and Quality of Life in Adolescents Receiving Chemotherapy

Background: Adolescents with cancer experience distressing physical and psychosocial symptoms, especially during treatment. Fatigue and sleep disturbances commonly affect adolescents' quality of life, but little is known about how adolescents experience these symptoms during an early month of chemotherapy. This study measured fatigue, sleep disturbances, and quality of life in 20 adolescents over 1 month while they were receiving chemotherapy. Methods: Multidimensional fatigue and quality of life were measured weekly with modules from the PedsQL Measurement Model, and sleep disturbances were measured with the General Sleep Disturbance Scale. Results: Adolescents experienced increased severity of fatigue and sleep disturbances during the week after treatment. Common sleep-wake problems included daytime sleepiness, decreased alertness, and poor sleep quality. Fatigue and sleep-wake disturbances were related symptoms, and both symptoms were associated with various domains of quality of life. Conclusions: Fatigue and sleep-wake disturbances are significant problems for adolescents receiving chemotherapy and negatively affect the quality of life. Clinicians should routinely screen adolescent patients for fatigue and sleep disturbances and intervene to minimize their impact using pharmacologic and nonpharmacologic strategies

Patient-reported outcomes of pain and physical functioning in neurofibromatosis clinical trials

Objective: Tumors and other disease complications of neurofibromatosis (NF) can cause pain and negatively affect physical functioning. To document the clinical benefit of treatment in NF trials targeting these manifestations, patient-reported outcomes (PROs) assessing pain and physical functioning should be included as study endpoints. Currently, there is no consensus on the selection and use of such measures in the NF population. This article presents the recommendations of the PRO group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration for assessing the domains of pain and physical functioning for NF clinical trials.Methods: The REiNS PRO group reviewed and rated existing PRO measures assessing pain intensity, pain interference, and physical functioning using their systematic method. Final recommendations are based primarily on 4 main criteria: patient characteristics, item content, psychometric properties, and feasibility for clinical trials.Results: The REiNS PRO group chose the Numeric Rating Scale–11 (=8 years) to assess pain intensity, the Pain Interference Index (6–24 years) and the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale (=18 years) to evaluate pain interference, and the PROMIS Physical Functioning Scale to measure upper extremity function and mobility (=5 years) for NF clinical trials.Conclusions: The REiNS Collaboration currently recommends these PRO measures to assess the domains of pain and physical functioning for NF clinical trials; however, further research is needed to evaluate their use in individuals with NF. A final consensus recommendation for the pain interference measure will be disseminated in a future publication based on findings from additional published research

Association of mood disturbance and arrhythmia events in patients after cardioverter defibrillator implantation

Background: Life stresses and negative emotions, such as anxiety and depression, are associated with adverse cardiac events, including arrhythmia. Patients undergoing implantation of an automatic internal cardioverter defibrillator provide a unique opportunity to characterize these relationships since all tachyarrhythmia episodes are recorded by the device. Objectives: The purpose of this study was to examine the association of emotional status after internal cardioverter defibrillator (ICD) implantation and subsequent arrhythmia events. Methods: An analysis of data obtained in a prospective longitudinal study of responses to the ICD measured mood disturbance (Profile of Mood States; POMS) before implant and at 1, 3, 6, and 9 months postoperatively. Subjects included 144 men and 32 women with a mean age of 60 ± 13 years and a mean left ventricular ejection fraction (LVEF) of 33± 12%. Arrhythmia events were measured by self-report of shocks and by ICD device interrogation to obtain the number and type (defibrillation, cardioversion, and antitachycardia pacing) of therapies delivered by the ICD. For each time point, POMS scores of subjects who had arrhythmia events were compared with those who did not. For subjects who had ICD shocks, pre-event and post-event POMS scores were also compared. Multiple logistic regression was used at each time point to determine if clinical, demographic and psychological data could predict arrhythmia events. Results: Patients with arrhythmia events had higher POMS scores throughout the 9 months of follow-up. Higher level of mood disturbance (specifically anxiety, fatigue, and confusion) at 1 and 3 months were independent predictors of subsequent arrhythmia events at 3 and 6 months after controlling for LVEF, the presence of coronary artery disease, pre-implant arrhythmia history, and the use of amiodarone and beta-blocking agents. There were no differences in POMS scores before and after ICD shocks, reinforcing the notion that negative emotions were a cause, rather than a consequence, of arrhythmia events

The effects of arousal and attention on central, autonomic and behavioral processes

The present investigation was conducted primarily to clarify further the dissociative and associative effects of arousal and attention on the evoked cortical potential (ECP), contingent negative variation (CNV), heart rate (HR), and reaction time (RT). A secondary consideration was the evaluation of criticisms directed by Naatanen (1967) to selective attention research