Brett R. Kuhn

Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue

Background: To determine whether sleep quality and fatigue associated with breast cancer adjuvant chemotherapy treatments can be improved with behavioral therapy (BT) [Individualized Sleep Promotion Plan (ISPP©)] including modified stimulus control, modified sleep restriction, relaxation therapy, and sleep hygiene.

One-Year Outcomes of a Behavioral Therapy Intervention Trial on Sleep Quality and Cancer-Related Fatigue

PURPOSE To determine 1-year outcomes of a four-component behavioral therapy (BT) sleep intervention (Individualized Sleep Promotion Plan [ISPP]) versus a healthy eating control (HEC) on cancer-related fatigue in women receiving breast cancer adjuvant chemotherapy treatment (CTX). PATIENTS AND METHODS A total of 219 participants from 12 oncology clinics were randomly assigned in a clinical trial. Before CTX, research nurses coached intervention participants to develop a BT plan including stimulus control, modified sleep restriction, relaxation therapy, and sleep hygiene. BT plans were revised before each CTX and 30, 60, and 90 days after the last CTX and reinforced 7 to 9 days later. HEC participants received nutritional information and equal attention. Pittsburgh Sleep Quality Index (PSQI), Daily Diary, Wrist Actigraph, and Piper Fatigue Scale measures and Repeated Linear Mixed Model analysis following the Intent to Treat paradigm were used. RESULTS Sleep quality differed over 1 years time (F [4,162] = 7.7, P < .001; by group, F [1,173] = 4.8, P = .029; and over time by group, F [4,162] = 3.3, P = .013). Pairwise comparisons revealed significant differences between groups at 90 days (P = .002) but not at 1 year (P = .052). Seven days of diary and actigraphy data did not corroborate with monthly reflections (PSQI). The night awakenings (Actigraph) pattern was significantly different by group over time (P = .046), with no differences between groups at 90 days or at 1 year. Fatigue was lower at 1 year than before CTX; no group effects were found. CONCLUSION The BT group, on average, experienced significant improvement on global sleep quality compared with the HEC group, but not on objective sleep or fatigue outcomes.

The intervention selection bias: an underrecognized confound in intervention research.

Selection bias can be the most important threat to internal validity in intervention research, but is often insufficiently recognized and controlled. The bias is illustrated in research on parental interventions (punishment, homework assistance); medical interventions (hospitalization); and psychological interventions for suicide risk, sex offending, and juvenile delinquency. The intervention selection bias is most adequately controlled in randomized studies or strong quasi-experimental designs, although recent statistical innovations can enhance weaker designs. The most important points are to increase awareness of the intervention selection bias and to systematically evaluate plausible alternative explanations of data before making causal conclusions.

Feasibility of a Sleep Intervention During Adjuvant Breast Cancer Chemotherapy

PURPOSE/OBJECTIVES To evaluate the feasibility of an intervention designed to promote sleep and modify fatigue during four cycles of adjuvant breast cancer chemotherapy. DESIGN Prospective, repeated measures, quasi-experimental feasibility study. SETTING Midwestern urban oncology clinics. SAMPLE 25 women between the ages of 40-65 (mean = 54.3) with stage I-II breast cancer receiving doxorubicin-based chemotherapy. METHODS Each woman developed, reinforced, and revised an individualized sleep promotion plan (ISPP) with four components: sleep hygiene, relaxation therapy, stimulus control, and sleep restriction techniques. A daily diary, the Pittsburgh Sleep Quality Index, a wrist actigraph, and the Piper Fatigue Scale were used to collect data two days before and seven days after each treatment. MAIN RESEARCH VARIABLES Adherence, sleep and wake outcomes, and fatigue. FINDINGS Adherence rates with the components of the ISPP varied during treatments one through four: sleep hygiene (68%-78%), relaxation therapy (57%-67%), stimulus control (46%-67%), and sleep restriction (76%-80%). Mean sleep and wake outcomes at baseline, peak, and rebound times were that (a) sleep latency remained brief (less than 30 minutes per night), (b) time awake after sleep onset exceeded the desired less than 30 minutes per night, (c) sleep efficiency scores remained stable at 85%-90%, (d) total rest time remained stable at 8-10 hours per night, (e) subjective ratings of feelings on arising were stable, and (f) nighttime awakenings were 8-10 per night. Fatigue outcomes were that fatigue was stable two days after each treatment and mean daily fatigue intensity was lower at treatment three than at treatment one but rebounded at treatment four. CONCLUSIONS The intervention was feasible, adherence rates improved over time, and most sleep and wake patterns were consistent with normal values. Revisions will focus on decreasing nighttime awakenings. IMPLICATIONS FOR NURSING Adopting behaviors to promote sleep may assist in maintaining sleep and managing fatigue during chemotherapy.

Adherence, Sleep, and Fatigue Outcomes After Adjuvant Breast Cancer Chemotherapy: Results of a Feasibility Intervention Study

PURPOSE/OBJECTIVES To evaluate outcomes of an intervention designed to promote sleep and modify fatigue after adjuvant breast cancer chemotherapy. DESIGN Prospective, repeated measures, quasi-experimental, feasibility study. SETTING Midwestern urban oncology clinics. SAMPLE 21 female participants, ages 43-66 years (meanX = 55.3) with stage I or II breast cancer status post four cycles of doxorubicin chemotherapy. Eight had four additional cycles of paclitaxel, 10 also had radiation, and 18 took tamoxifen. METHODS each woman continued to revise her Individualized Sleep Promotion Plan (ISPP), developed during her first cycle of chemotherapy, that included sleep hygiene, relaxation therapy, stimulus control, and sleep restriction components. The daily diary, Pittsburgh Sleep Quality Index, wrist actigraph, and Piper Fatigue Scale were used for seven days 30, 60, and 90 days after the last chemotherapy treatment and one year after the first chemotherapy treatment. MAIN RESEARCH VARIABLES Adherence and sleep and wake, fatigue, and ISPP components. FINDINGS Adherence to the ISPP components remained high at all times (77%-88%) except for stimulus control (36%-56%). Sleep outcome means and the actigraph revealed that (a) sleep latency remained less than 30 minutes per night, (b) the time awake after sleep onset exceeded the desired less than 30 minutes per night, (c) sleep efficiency scores ranged from 82%-92%, (d) total rest time ranged from seven to eight hours per night, (e) feelings on arising ranged from 3.7-3.8 (on a 0-5 scale), (f) nighttime awakenings ranged from 10-11 per night, and (g) daytime naps ranged from 10-15 minutes in length. Fatigue remained low, from 2.9-3.5 on a 0-10 scale. CONCLUSIONS Adherence rates remained high for most components. Sleep and wake patterns were within normal limits except for the number and duration of night awakenings. Fatigue remained low. IMPLICATIONS FOR NURSING Future testing using an experimental design will focus on increasing ISPP adherence and decreasing nighttime awakenings. Adopting behavioral techniques to promote sleep may result in improved sleep and lower fatigue after chemotherapy.

Pediatric Prescribing Practices for Clonidine and Other Pharmacologic Agents for Children With Sleep Disturbance

The prescription rates of clonidine have risen dramatically and the extent to which these increases can be attributed to treatment of sleep disturbance is unknown. Surveys were mailed to 800 pediatricians across four geographically diverse states to assess prescribing practices specific to sleep disturbance. Ninety-six percent of the respondents treated sleep disturbance. More than one third of the sample reported using clonidine specifically for sleep disturbance including sleep onset, sleep schedule, nighttime awakening, and early morning awakening problems and parasomnias. Clonidine ranked second only to antihistamines as the most commonly used medication for treating sleep disturbance.

Clinical Perspectives in Primary Nocturnal Enuresis

Primary nocturnal enuresis (PNE) is prevalent among the pediatric population, but not all professionals are aware of the current research regarding the etiology and treatment of this disorder. This paper presents a broad overview of PNE, including etiology and evaluation, with a specific emphasis on treatment issues. The most current treatments (imipramine, desmopressin acetate arginine vasopressin, enuresis alarms) are discussed, including recent research on their effectiveness. In considering the recent data on long-term efficacy, overall cost, and safety, the treatment of choice appears to be the enuresis alarm for those families who are capable of following protocols. Desmopressin acetate arginine vasopressin is a safe alternative that has the advantage of quick response and ease of administration.

Differences in causal estimates from longitudinal analyses of residualized versus simple gain scores: Contrasting controls for selection and regression artifacts

This study estimates the causal effects of six corrective actions for childrens problem behaviors, comparing four types of longitudinal analyses that correct for pre-existing differences in a cohort of 1,464 4- and 5-year-olds from Canadian National Longitudinal Survey of Children and Youth (NLSCY) data. Analyses of residualized gain scores found apparently detrimental effects of all corrective actions by parents and professionals on subsequent antisocial behavior and hyperactivity. In contrast, analyses of simple gain scores found only apparently beneficial effects. Temporally reversed analyses yielded the same pattern of results, consistent with selection biases and regression artifacts, not with unidirectional causal effects. The findings were similar for corrective actions by professionals (e.g., Ritalin, psychotherapy) and by parents (physical and nonphysical punishment, scolding/yelling, “hostile-ineffective” parenting). Longitudinal analyses should check for similar artifacts by implementing temporally-reversed analyses and by determining whether causally relevant coefficients would replicate without artifacts biased in their favor.

“Don’t Kick Me Out!”: Day Treatment for Two Preschool Children With Severe Behavior Problems:

Parents of young children with severe emotional and behavior problems have few services from which to choose if their child is expelled from preschool for aggressive and disruptive behavior. Two case studies provide an overview of a multicomponent, intensive, day-treatment program for children with moderate to severe behavior disorders. Proximal and distal program goals are to eliminate presenting problem behaviors and increase social competencies and to reintegrate children back to their school, preschool, or daycare, respectively. The cases presented in this study provide preliminary evidence that day treatment can be a viable option for young children with disruptive behavior disorders.

Behavioral Management of Children's Seizure Activity Intervention Guidelines for Primary-Care Providers

The objective of this study was to describe the proportion of children with a behavior problem and examine which independent variables are associated with the presence of a behavior problem in a group of 392 inner-city children with asthma. Data on child asthma symptoms, medication use, health-care utilization, and school absences were obtained from the parent during a structured telephone interview. Included in the interview was a measure of behavior problems and social support questions. Children classified with a high level of asthma symptoms were more than twice as likely to experience a behavior problem than children classified with a low level of asthma symptoms (P = 0.002). Use of theophylline medication was not correlated with behavior problems (P = 0.45). Significant variables were low level of social support and high or moderate level of asthma symptoms. We have identified a group of children at risk for behavior problems, specifically in families that lack adequate social and financial resources.We present behavioral treatment guidelines, based on empirically established behavioral interventions, for pediatric paroxysmal disorders. The guidelines include affirming the disability and normalizing the role of the environment; teaching the child anticonvulsant coping behaviors; giving caregivers guidelines to encourage independent functioning; and involving teachers and other supervising adults in treatment. The guidelines were developed for economic feasibility, time efficiency, and easy execution in any primary-care clinic. A patient report demonstrates significant reduction in drug-refractory seizures in an 11-year-old girl by implementing the guidelines. Discussion is provided on effective implementation of the behavioral guidelines in the primary-care clinic.