Sleep-Wake Disturbance: A Systematic Review of Evidence-Based Interventions for Management in Patients With Cancer

Downloaded on 11 25 2018. Single-user license only. Copyright 2018 by the Oncology Nursing Society. For permission to post online, reprint, adapt, or reuse, please email pubpermissions@ons.org Sleep-Wake Disturbance A systematic review of evidence-based interventions for management in patients with cancer Ellyn Matthews, PhD, RN, AOCNS®, CBSM, FAAN, Patricia Carter, PhD, RN, CNS, Margaretta Page, MS, RN, Grace Dean, PhD, RN, and Ann Berger, PhD, APRN, AOCNS®, FAAN ✔ BACKGROUND: New or worsening sleep-wake disturbance (SWD) can occur throughout the cancer trajectory. OBJECTIVES: The purpose of this article is to criti- cally review available empirical evidence supporting the efficacy of interventions for SWD, highlighting new evidence since the 2006 and 2009 Putting Evidence Into Practice (PEP) SWD publications. METHODS: A systematic review of studies pub- lished from 2009–2017 was conducted to identify effective interventions for cancer-related SWD. The PEP weight of evidence classification schema was used to categorize the strength of evidence. FINDINGS: Cognitive behavioral intervention/ approach is the only intervention that is recommended for practice. Mindfulness-based stress reduction and exercise interventions are likely to be effective but require more evidence. Pharmacologic interventions, relaxation, imagery, meditation, acupuncture, yoga, massage, and psychoeducation have insufficient evidence. KEYWORDS evidence-based interventions; sleep-wake disturbance; Putting Evidence Into Practice DIGITAL OBJECT IDENTIFIER 10.1188/18.CJON.37-52 CJON.ONS.ORG C have a significant impact on quality of life (QOL) but receive little attention and inadequate assessment by primary care or oncology providers (Mercadante et al., 2015; Siefert, Hong, Valcarce, & Berry, 2014). Individuals may develop SWD before, during, or after cancer treatment (Palesh et al., 2010; Savard, Ivers, Villa, Caplette-Gingras, & Morin, 2011). Sleep disorders are linked to increased risk for cardiovascular disease, diabetes, and obesity (Grandner, Jackson, Pak, & Gehrman, 2012; Hargens, Kaleth, Edwards, & Butner, 2013; St-Onge et al., 2016). The literature provides strong links between sleep disorders and poor work performance (Hui & Grandner, 2015) and lower QOL in healthy and ill individuals (Mercadante et al., 2015). People with cancer require assessment and management of SWD and sleep disorders to prevent poor health outcomes. This article builds on previously published Oncology Nursing Society (ONS) Putting Evidence Into Practice (PEP) SWD summaries (ONS PEP Project Teams, 2009; Page, Berger, & Johnson, 2006). The purpose is to critically appraise the strength and quality of evidence regarding the safety and efficacy of nonpharmacologic and pharmacologic interventions for SWD in adults with cancer. Recommendations represent the most current best evidence; however, clinical judgment is needed to determine appropriate individual interventions. CANCER-RELATED SLEEP DISTURBANCES, OR SLEEP-WAKE DISTURBANCE (SWD), Sleep-Wake Disturbance Overview and Definitions Although defining sleep is challenging, experts agree that sleep is an active, biobehavioral process and state of temporary perceptual disengagement from and unresponsiveness to the environment (Carskadon & Dement, 2011). The key functions of sleep are to conserve energy, maintain homeostasis, and restore physiologic processes that degrade during wakefulness (Vassalli & Dijk, 2009). These functions are critical to physical and mental health, particularly in adults with cancer. Sleep medicine is a specialty area focused on sleep disorders. Each diagnosis is identified by criteria in The International Classification of Sleep Disorders: Diagnostic and Coding Manual (ICSD-3) (3rd ed.) (American Academy of Sleep VOLUME 22, NUMBER 1 CLINICAL JOURNAL OF ONCOLOGY NURSING 37 SLEEP-WAKE DISTURBANCE Medicine [AASM], 2014) and the Diagnostic and Statistical Manual of Mental Disorders (5th ed.) (American Psychiatric Association, 2013). The most common category of sleep disorder in oncology and general populations is insomnia (Morin & Benca, 2012). In people with cancer, it is important to rule out other disorders, such as sleep-disordered breathing (e.g., obstructive sleep apnea) and sleep-related movement disorders (e.g., restless leg syndrome), before suggesting interventions for insomnia (Otte et al., 2015). This update provides resources for oncology nurses working with adults with SWD. The terms sleep disturbance and SWD are used by patients and clinicians prior to confirmation of a diagnosis (Berger, 2009). SWD is an actual or perceived change in sleep, with resulting daytime impairment (Berger et al., 2017). The clinical manifestation of SWD includes difficulty falling asleep, difficulty staying asleep, early morning awakenings, unrefreshing or nonrestorative sleep, or daytime sleepiness (Dickerson, Connors, Fayad, & Dean, 2014). PEP focuses on this initial level of SWD interventions found to be effective in adults during cancer treatment and survivorship. Prevalence of Sleep-Wake Disturbance The prevalence of SWD in cancer populations is difficult to estimate because sleep screening and assessment are not performed routinely in practice (Berger, 2009; Siefert et al., 2014). However, numerous studies suggest that SWD is significantly more prevalent (30%–80%) in people with all cancer types compared to the general population and occurs during all phases of the cancer trajectory (Palesh et al., 2010, 2013; Savard et al., 2011). Impact of Sleep-Wake Disturbance After a cancer diagnosis, SWD has been associated with poorer QOL (Fleming, Gillespie, & Espie, 2010) and symptom clusters, including cancer-related fatigue and altered mood (Ancoli-Israel et al., 2014; Berger, Visovsky, Hertzog, Holtz, & Loberiza, 2012; Liu et al., 2012). Chronic sleep loss is associated with pain (GalianoCastillo et al., 2017), poor adherence to treatments (Kidwell et al., 2014), and higher morbidity and mortality (Irwin, 2013). Cost–utility analysis (CUA) is the preferred way to assess intervention efficiency; it uses quality-adjusted life years (QALY) as the health-related outcome. Interventions are evaluated based on costs per extra QALY (e.g., increased lifespan, decreased morbidities) (Neumann, Sanders, Russell, Siegel, & Ganiats, 2016). Direct and indirect intervention costs need to be evaluated (Greenberg, Earle, Fang, Eldar-Lissai, & Neumann, 2010). Arving, Brandberg, Feldman, Johansson, and Glimelius (2014) performed CUA of individual psychosocial support for women with breast cancer by nurses or psychologists compared to usual care. The study yielded significant outcomes about the cost-effectiveness (lower healthcare costs and higher QALY) of psychosocial support. 38 CLINICAL JOURNAL OF ONCOLOGY NURSING VOLUME 22, NUMBER 1 “The contributing factors and complex nature of sleep-wake disturbance make recommending one assessment tool or method difficult.” Screening and Assessment The contributing factors and complex nature of SWD make recommending one assessment tool or method for all situations difficult. Expert recommendations exist for the use of a brief, regular screening and focused assessment of SWD in cancer settings. The National Comprehensive Cancer Network ([NCCN], 2017), the ONS PEP team (Berger, Desaulniers, Matthews, Otte, & Page, 2014), and a Pan-Canadian expert panel (Howell et al., 2013) developed recommendations for screening, assessment, and interventions for SWD in adult cancer populations. The first step in these guidelines is screening by healthcare providers using standardized tools or a few brief questions at regular intervals or upon clinical status changes. The following are NCCN (2017) screening questions: ɐ Are you having problems falling asleep or staying asleep? ɐ Are you experiencing excessive sleepiness? ɐ Have you been told that you snore frequently or stop breathing during sleep? If the response to the screening questions is yes, the next step is a focused assessment of the nature of the sleep disturbance, contributing factors, and daytime consequences. Several instruments for common sleep disorders have acceptable validity and reliability in adult cancer populations. The 19-item Pittsburgh Sleep Quality Index (PSQI) (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989), the seven-item Insomnia Severity Index (ISI) (Bastien, Vallières, & Morin, 2001; Savard, Savard, Simard, & Ivers, 2005), and the PROMIS sleep disturbance and sleep-related impairment items (Buysse et al., 2010) are widely used measures in adult cancer populations. Quickly scored and easily interpreted obstructive sleep apnea (OSA) screening tools include STOP (snoring, tiredness, observed apnea, and blood pressure) and STOP-BANG (body mass index, age, neck circumference, and gender) (Chung et al., 2008; Nagappa et al., 2015). Excessive daytime sleepiness can CJON.ONS.ORG be screened quickly using the Epworth Sleepiness Scale (ESS) (Johns, 1991). Disruption of daily sleep-wake patterns may be identified using a sleep diary (Carney et al., 2012) or actigraphy (i.e., a small accelerometer device usually worn on the wrist that monitors sleep-wake cycles by recording activity) (Moore, Schmiege, & Matthews, 2015). Polysomnography, also called a sleep study, records sleep patterns, breathing, heart activity, and limb movement. It is used in research and by sleep specialists to diagnose sleep disorders (AASM, 2014). Cutoff scores for the PSQI, ISI, STOP-BANG, and ESS help guide decisions about appropriate sleep specialist referrals. For the PSQI, a total score of 5 or more indicates poor sleep quality (Buysse et al., 1989). ISI scores of 15–21 are indicative of moderate insomnia and 22–28 of severe insomnia (Bastien et al., 2001). A score of 5–8 on the STOP-BANG indicates a high risk of OSA (Chung et al., 2008), and ESS scores of 10 or more suggest excessive daytime sleepiness (Johns, 1991). Because SWDs occur throughout the cancer trajectory, regular, ongoing screening and assessment are vital to quality care (Siefert et al., 2014). Methods An extensive literature search was performed in PubMed and CINAHL®. This update includes published research studies retrieved from January 1, 2009, to January 31, 2017, in addition to 24 articles published prior to 2009 that were included in previous reviews. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram is shown in Figure 1. The full search strategy, including search terms, can be found on the PEP website at https://www.ons.org/content/sleep-wake-disturbances -search-strategy. Inclusion criteria were: (a) full research report, systematic review, guideline, or meta-analysis; (b) study must report results of measurement of sleep disturbance or sleep quality; (c) the study examines an intervention aimed at affecting the symptom of sleep disturbance or sleep quality; and (d) study sample must include patients with cancer. Inclusion criteria have evolved in response to the quality and amount of evidence. As of January 2016, additions include the following: (a) sample size of at least 40 with at least 20 per study group and (b) for complex interventions, the description must identify intervention components. Studies were excluded if they were descriptive-only; project, annual, or activity reports; theses; dissertations; conference proceedings; or newsletters. The current PEP update writing team included RNs, advanced practice nurses, and nurse scientists. The team prepared tables of evidence and identified study design flaws using a standardized worksheet based on a taxonomy system to evaluate the quality of evidence for practice (Hadorn, Baker, Hodges, & Hicks, 1996). After critical appraisal of the evidence, the team classified the interventions using study quality, design, effect size, safety, and agreement among studies. The team examined the collective strength of each intervention and recommended the level of evi- CJON.ONS.ORG FIGURE 1. PRISMA DIAGRAM OF SEARCH STRATEGY Initial articles included (n = 24) Total articles identified through database searching and monthly automatic alerts from January 1, 2009, to January 31, 2017 (n = 2,066) PubMed (n = 1,654) CINAHL® (n = 412) Studies selected after removal of duplicates and those that did not meet inclusion criteria (n = 147) Final studies included for full review after additional studies identified through other sources (N = 163) PRISMA—Preferred Reporting Items for Systematic Reviews and Meta-Analyses dence using the PEP decision rules and weight-of-evidence classification schema (Mitchell & Friese, 2009). Evidence Review The 2006 PEP recommendations for cancer-related SWD for practice, published in the Clinical Journal of Oncology Nursing, were based on 24 research studies published in 2005 or earlier (Page et al., 2006), with a brief update in 2009 (ONS PEP Project Teams, 2009). Many interventions for SWD have been published since 2006. Several interventions were examined in only one study, or the evidence was inconsistent. Many studies had small samples (less than 100) and design limitations. According to the PEP schema, these interventions remain as effectiveness not established. RECOMMENDED FOR PRACTICE: Cognitive behavioral intervention/approach (CBI/A) refers to interventions that reflect concepts from cognitive behavioral therapy. CBI/A helps individuals to identify helpful and maladaptive thoughts, feelings, and behaviors; establish goals; and develop skills to solve problems and implement beneficial coping behaviors (ONS, 2017). CBI/A for SWD has been confirmed as effective in the management of SWD in adults with cancer (see Table 1). Common evidence-based components of CBI/A are sleep restriction, stimulus control, sleep hygiene education, and cognitive therapy with or without relaxation (Morin & Benca, 2012). Mounting evidence from systematic reviews and meta-analyses indicates that CBI/A demonstrates VOLUME 22, NUMBER 1 CLINICAL JOURNAL OF ONCOLOGY NURSING 39 SLEEP-WAKE DISTURBANCE TABLE 1. RECOMMENDED FOR PRACTICE: COGNITIVE BEHAVIORAL INTERVENTION/APPROACH STUDY INTERVENTIONS DESIGN AND SAMPLE SIGNIFICANT FINDINGS STUDY LIMITATIONS Allison et al., 2004 NuCare coping strategy training; participant-selected modality (group, individual, or self-study) Prospective, nonrandomized; 59 patients with head and neck cancer Improvement was reported in sleep disturbance. Limited analysis; no control group; small sample size Arving et al., 2007 Individual psychosocial support sessions; frequency based on patient need; randomly assigned to nurse or psychologist provider versus standard care RCT; 179 patients with breast cancer Significant difference in insomnia with intervention compared to controls No attention control; dosage of intervention varied Barsevick et al., 2010 Energy and sleep enhancement intervention compared to attention control Multisite RCT; 276 patients with mixed cancers No significant effect on sleep, fatigue, or functional status Variation in populations and severity of symptoms Berger et al., 2002 Multicomponent CBT individual planning Prospective pilot; 25 patients with early-stage breast cancer Sleep efficiency and total rest were stable. WASO and night awakenings exceeded desired levels. Pilot study; not designed to test intervention Berger et al., 2003 Multicomponent CBT individual planning Prospective repeated measures; 21 patients with breast cancer High adherence to the study components Feasibility pilot study; not designed to test intervention Berger et al., 2009 Individualized sleep promotion plan compared to a healthy eating control RCT; 219 patients with breast cancer Not significant, but trend toward improved sleep quality in intervention group; fatigue improved significantly over time in both groups. Baseline values did not indicate poor sleep quality. Carpenter et al., 2007 CBT approach delivered by DVD Pre-/postintervention (nonrandom); 40 patients with breast cancer or individuals at high risk for breast cancer No change or effect on sleep No control or blinding; fewer than 50 participants; no information on frequency of use Casault et al., 2015 CBT delivered via self-help written materials, quizzes, and telephone consultation compared to an untreated control group RCT; 35 patients with mixed cancers Significant effects over time by study group on Insomnia Sleep Index scores in favor of the CBT intervention at 6 weeks No attention control Cohen & Fried, 2007 CBT group intervention versus relaxation or guided imagery versus control RCT; 170 patients with breast cancer Reduction in mean sleep difficulties in both intervention groups, but was significant only in the relaxation/guided imagery group No attention control Dalton et al., 2004 Standard CBT, profiled CBT (patients are matched to specific CBT modules), or usual care RCT; 131 patients with chronic cancer pain Immediate pre-/postintervention sleep improvement in the profiled CBT group 79% dropout rate; no attention control Davidson et al., 2001 Multimodal group; CBT group Quasi-experimental design; 12 patients with mixed cancers Sleep improved from baseline to 8 weeks after intervention Fewer than 20 participants; relatively healthy group; no control; self-report measures only Significant pre-/postintervention changes in some sleep measures; compared to control, the intervention group rated overall sleep as improved. Selective sample; clinical nurse specialist in psychology and mental health trained in delivering the intervention CBT was associated with reduction in WASO per night and improvement in sleep efficiency. No attention controls Epstein & Dirksen, 2007 Multicomponent CBT RCT; 72 patients with breast cancer Espie et al., 2008 CBT group sessions RCT; 150 patients with mixed cancers Continued on the next page 40 CLINICAL JOURNAL OF ONCOLOGY NURSING VOLUME 22, NUMBER 1 CJON.ONS.ORG TABLE 1. (CONTINUED) RECOMMENDED FOR PRACTICE: COGNITIVE BEHAVIORAL INTERVENTION/APPROACH STUDY INTERVENTIONS DESIGN AND SAMPLE SIGNIFICANT FINDINGS STUDY LIMITATIONS Fiorentino et al., 2010 Individual CBT RCT (crossover design); 14 breast cancer survivors Significant difference in sleep quality change scores between treatment and delayed control groups Fewer than 20 participants Fleming et al., 2014 CBT group sessions Multisite RCT; 113 patients with mixed cancers 52% reduction in insomnia in the CBT group versus 17.5% in the control group No attention control Garland, Carlson, et al., 2014 CBT versus MBSR group sessions Randomized noninferiority; 111 patients with mixed cancers CBT improved sleep quality; both groups experienced improved total sleep time and reduced WASO. No control group Garland, Johnson, et al., 2014 CBT Systematic review; 12 studies 4 of 4 uncontrolled trials reported a positive effect of CBT on sleep. 5 of 8 RCTs reported a positive effect; 3 had no effect. No quality evaluation of studies reported Garland et al., 2015 CBT for insomnia versus MBSR RCT; secondary analysis; 72 patients with mixed cancers No significant differences between groups in the percentage of patients with clinically important insomnia severity postprogram or at follow-up Fewer than 75 participants; relevant primary study information not reported Heckler et al., 2016 CBT with and without armodafinil or placebo RCT; 88 patients at multiple sites in the United States and Canada CBT for insomnia improved fatigue. No improvement was seen in the other three arms. Fewer than 100 participants Hunter et al., 2009 CBT group sessions Pre-/postintervention pilot; 17 women with breast cancer Sleep improved from baseline to postintervention. Fewer than 20 participants; lack of controls RCTs for CBT for insomnia Meta-analysis; 8 RCTs, 752 patients Overall, statistically significant improvements in insomnia severity following CBT for insomnia compared to control from pre- to postintervention Diverse modes of delivery; homogeneous sample Timing, dosage, and frequency of interventions varied; limited information on study methods and samples Johnson et al., 2016 Kwekkeboom et al., 2010 Mind–body interventions Systematic review; 21 studies Equivocal results across studies; imagery/hypnosis and CBT interventions produced improvement in single symptoms of sleep, pain, and fatigue. Langford et al., 2012 Nonpharmacologic intervention studies Meta-analysis and systematic review; 47 studies, 1,202 patients Moderate effects of CBT on sleep disturbance across studies Data presented only graphically; no confidence interval data given Mann et al., 2012 CBT group sessions compared to usual care Triple-blind RCT; 88 patients with breast cancer Intervention group reported fewer sleep problems at 9 weeks; maintained at 26 weeks Sleep measure was single item from the General Health Survey Short Form 36 Matthews et al., 2014 CBT for insomnia versus placebo Placebo-controlled RCT; 56 patients with breast cancer Compared to the control, sleep efficiency and sleep latency improved more in the CBT for insomnia group; the difference was maintained at 6 months. Fewer than 60 participants Quesnel et al., 2003 CBT Pre-/postintervention study; 10 women with breast cancer Most women had significant improvement in sleep efficiency; improvement continued at 6 months. Fewer than 20 participants; sleep diaries incomplete Continued on the next page CJON.ONS.ORG VOLUME 22, NUMBER 1 CLINICAL JOURNAL OF ONCOLOGY NURSING 41 SLEEP-WAKE DISTURBANCE TABLE 1. (CONTINUED) RECOMMENDED FOR PRACTICE: COGNITIVE BEHAVIORAL INTERVENTION/APPROACH STUDY INTERVENTIONS DESIGN AND SAMPLE SIGNIFICANT FINDINGS STUDY LIMITATIONS Ritterband et al., 2012 Internet-based CBT for insomnia compared to a waitlist control RCT; 28 survivors of mixed cancers Internet CBT for insomnia improved severity with a reduction in percentage of patients with insomnia pre- to postintervention. Fewer than 30 participants; homogeneous sample Savard, Simard, et al., 2005 CBT group sessions RCT; 57 patients with breast cancer Self-reported improvement postintervention and as many as 12 months later; results equivocal on polysomnographic indices Fewer than 60 participants; no appropriate control; no blinding Savard et al., 2006 CBT group sessions compared to a waitlist control Multisite RCT; 45 patients with breast cancer Pooled data showed decreased anxiety, fatigue, and insomnia symptoms. Fewer than 60 participants; no attention control; no blinding Savard et al., 2011 Self-administered CBT Pre-/postintervention study; 11 patients with breast cancer Large effect size change pre- to postintervention in insomnia severity, sleep efficiency, WASO, and dysfunctional attitudes about sleep; maintained at 3 months Small sample; 27% dropout before 3-month follow-up Savard et al., 2014 Video-delivered CBT versus provider-delivered CBT versus control 3-arm RCT; 242 patients with breast cancer No difference between video and professional CBT for onset, sleep latency, WASO, total wake time, and sleep efficiency; both video and professional showed greater improvement than controls. Participant withdrawals greater than 10% Savard et al.,2016 Video-based CBT versus in-person CBT for insomnia versus control 3-arm RCT; 242 patients with breast cancer post–radiation therapy Video-based and regular CBT showed improvement immediately and at 3 and 6 months in some sleep measures; best results with video-based CBT No attention control; no blinding; loss of participants to follow-up Tang et al., 2015 Nonpharmacologic interventions Meta-analysis; 11 studies, 1,066 patients All interventions had a CBT component and showed effects for sleep, pain, and fatigue. High heterogeneity Vargas et al., 2014 CBSM RCT; 240 patients with early-stage breast cancer No difference in PSQI scores between groups; CBSM group reported improvements in sleep quality and reductions in fatiguerelated daytime interference. No attention control; high attrition; no blinding Vilela et al., 2006 NuCare program Pre-/postintervention study; 101 patients with head and neck cancer Improved sleep disturbance, depressive symptoms, and functioning No specific sleep measure; no control; no randomization Wanchai et al., 2011 Nonpharmacologic interventions Systematic review; 28 studies, 3 of which examined sleep Improvement in sleep was seen in 3 studies of CBT. Included studies had small samples. CBSM—cognitive-based stress management; CBT—cognitive behavioral therapy; MBSR—mindfulness-based stress reduction; PSQI—Pittsburgh Sleep Quality Index; RCT—randomized, controlled trial; WASO—wake after sleep onset (total minutes awake) positive effects on acute and chronic sleep outcomes (Johnson et al., 2016; Langford, Lee, & Miaskowski, 2012; Tang et al., 2015). Added evidence is provided by seven large (N greater than 100) randomized, controlled trials (RCTs) that showed improvement in a variety of sleep outcomes (Arving et al., 2007; Berger et al., 2009; Espie et al., 2008, 2014; Garland, Carlson, et al., 2014; Savard, Ivers, Savard, & Morin, 2014, 2016). 42 CLINICAL JOURNAL OF ONCOLOGY NURSING VOLUME 22, NUMBER 1 A series of smaller (N less than 100), well-designed RCT, quasiexperimental, and pilot studies provided additional support for CBI/A as recommended for practice (Allison et al., 2004; Berger et al., 2002, 2003; Casault, Savard, Ivers, & Savard, 2015; Dalton, Keefe, Carlson, & Youngblood, 2004; Davidson, Waisberg, Brundage, & MacLean, 2001; Epstein & Dirksen, 2007; Fiorentino et al., 2010; Garland, Rouleau, Campbell, Samuels, & Carlson, 2015; Heckler et CJON.ONS.ORG TABLE 2. LIKELY TO BE EFFECTIVE: MINDFULNESS-BASED STRESS REDUCTION (MBSR) STUDY INTERVENTIONS DESIGN AND SAMPLE SIGNIFICANT FINDINGS STUDY LIMITATIONS Andersen et al., 2013 8-week MBSR program with athome practice Randomized, controlled trial; 264 patients with breast cancer Sleep quality improved postintervention. No differences at 6 and 12 months; greater change in sleep quality over time in the intervention group Sleep measure is not validated in patients with breast cancer. Carlson & Garland, 2005 MBSR program Single-group pilot; 63 patients with mixed cancers Self-reported sleep disturbance reduced and sleep quality improved from pre- to postintervention. Fewer than 75 participants; no control; no information on adherence Carlson et al., 2003 8-week MBSR sessions, booklet and weekly instruction, audio recording for meditation Pre-/postintervention; 59 patients with breast or prostate cancer Improvement reported in sleep quality from pre- to postintervention. Fewer than 60 participants; no control; limited time frame; no information on program adherence for attendance or home practice Analysis and design nonspecific Chiu et al., 2015 Various mind–body interventions Meta-analysis; 15 studies Meta-analysis indicated that mind–body interventions had a medium effect size on the improvement of sleep quality, which persisted as many as 3 months after treatment. Garland, Carlson, et al., 2014 Group cognitive behavioral therapy sessions versus group MBSR group sessions Randomized noninferiority; 111 patients with mixed cancers MBSR was inferior to cognitive behavioral therapy immediately after the program but was noninferior at follow-up. No control; MBSR had more time in sessions. Johns et al., 2016 MBSR versus psychoeducation/ support group Randomized, controlled trial; 69 patients with breast or colorectal cancer Both groups reported moderate to large effects and significant improvements in sleep disturbance from baseline to postintervention and 6 months later. Fewer than 75 participants; no control group Lengacher et al., 2012 6-week MBSR versus usual care Randomized, controlled trial; 84 patients with breast cancer Sleep disturbance declined in both groups from baseline to the end of the study, with no differences between groups. Fewer than 75 participants; no attentional control; low symptom scores at baseline Lengacher et al., 2015 6 MBSR 2-hour weekly sessions versus usual care with follow-up at week 12 Multisite randomized, controlled trial; 77 patients with breast cancer No difference between groups at 6 weeks; during weeks 6–12, the MBSR group improved in sleep efficiency and number of awakenings (actigraphy). Fewer than 100 participants; baseline sleep efficiency 80%; only 4% increase in efficiency Nakamura et al., 2013 MBSR versus awareness training versus sleep hygiene education Randomized, controlled trial; 57 survivors of mixed cancers All 3 groups showed improvement in sleep quality postintervention time; no difference between groups Significant baseline sleep score differences across groups Shapiro et al., 2003 6 MBSR weekly sessions with didactic material (meditationfocused) versus control Prospective nonrandomized trial; 63 patients with breast cancer MBSR improved sleep efficiency and quality. Lack of compliance to technique practice; self-report diary measures only; no attentional control Winbush et al., 2007 MBSR for sleep disturbance Systematic review; 7 studies, 423 patients Mixed results across studies for impact on sleep quality Small number of studies; variation in MBSR practice application; limited cancer information; variability in sleep measures used CJON.ONS.ORG VOLUME 22, NUMBER 1 CLINICAL JOURNAL OF ONCOLOGY NURSING 43 SLEEP-WAKE DISTURBANCE al., 2016; Mann et al., 2012; Matthews et al., 2014; Quesnel, Savard, Simard, Ivers, & Morin, 2003; Ritterband et al., 2012; Savard et al., 2006, 2011; Savard, Simard, Ivers, & Morin, 2005). Evidence suggests that CBI/A can be delivered individually (Arving et al., 2007), in groups (Espie et al., 2008; Fleming, Randell, Harvey, & Espie, 2014; Hunter, Coventry, Hamed, Fentiman, & Grunfeld, 2009), and via video (Savard et al., 2014, 2016). Despite this body of evidence, some studies showed inconsistent results. In a systematic review, Garland, Johnson, et al. (2014) analyzed 12 studies, of which 9 showed positive effects of CBI/A on sleep and 3 others reported none. Several individual studies reported inconsistent effects (Barsevick et al., 2010; Carpenter, Neal, Payne, Kimmick, & Storniolo, 2007; Cohen & Fried, 2007; Kwekkeboom, Abbott-Anderson, & Wanta, 2010); however, the interventions did not focus solely on SWD. Although overall efficacious, how the components and delivery affected the sleep outcomes is unclear. The delivery method, dose, or timing of CBI/A may improve sleep in some but not all cancer populations. For example, CBI/A may have a greater effect in those with worse baseline SWD compared to mild SWD. The CBI/A studies under review primarily were conducted in the United States and Canada, designed as single- and multiinstitutional studies, and most involved women with breast cancer. Efforts need to be directed toward evaluation of CBI/A in diverse cancer populations across the disease trajectory. LIKELY TO BE EFFECTIVE: Mindfulness-based stress reduction (MBSR) is a consciousness discipline that is grounded in Eastern philosophy and traditions, such as yoga and Buddhism, and focuses on awareness of the present moment. MBSR aims to teach people to cope more effectively through awareness of feelings, thoughts, and bodily sensations (ONS, 2017). MBSR may improve sleep by decreasing psychophysiologic arousal. Large and small studies across cancer populations and disease stage have tested interventions using MBSR principles, suggesting that MBSR is likely to be effective (see Table 2). No cancerspecific reviews focused on MBSR; however, a meta-analysis of 15 pooled RCTs of mind–body interventions including MBSR, meditation, yoga, and Qigong reported that combined mind–body intervention studies had a medium effect size on sleep outcomes (Chiu, Huang, Chen, Hou, & Tsai, 2015). A review of MBSR studies (one cancer study of seven) reported mixed results on sleep (Winbush, Gross, & Kreitzer, 2007). Two large RCTs (N greater than 100) examined the effect of MBSR on sleep outcomes. One reported short-term improvements in subjective sleep problems in women with breast cancer (Andersen et al., 2013). Another found that group-based MBSR reduced time to fall asleep (sleep latency) and wake after sleep onset (minutes awake during the sleep period) in mixed cancers (Garland, Carlson, et al., 2014). In smaller studies, MBSR demonstrated improvement in subjective insomnia severity (Johns et al., 2016), sleep efficiency (Lengacher et al., 2015; Shapiro, 44 CLINICAL JOURNAL OF ONCOLOGY NURSING VOLUME 22, NUMBER 1 Bootzin, Figueredo, Lopez, & Schwartz, 2003), sleep quality (Carlson & Garland, 2005; Carlson, Speca, Patel, & Goodey, 2003, 2004; Nakamura, Lipschitz, Kuhn, Kinney, & Donaldson, 2013; Shapiro et al., 2003), sleep latency, and number of awakenings (Lengacher et al., 2015). Limitations of MBSR studies included small samples, lack of attention control groups, unknown adherence to MBSR practice, and a wide range of interventions across studies. Exercise refers to physical activity that involves repetitive bodily movement performed to improve or maintain one or more components of physical fitness—cardiorespiratory endurance (aerobic fitness), muscular strength, muscular endurance, flexibility, or body composition (ONS, 2017). Studies suggest that exercise is likely to be effective for SWD (see Table 3). A meta-analysis of nine RCTs in people with cancer concluded that moderate-intensity walking has a modest effect on sleep improvement (Chiu et al., 2015). In a review of 56 RCTs and controlled trials, Mishra et al. (2012) concluded that exercise interventions improved sleep for as long as 12 weeks, with greater reduction in adults with cancers other than breast, and greater improvements from moderate to vigorous exercise. In contrast, a meta-analysis of 10 RCTs showed no effect of exercise on subjective or objective SWD compared to control groups (Mercier, Savard, & Bernard, 2016). A review of interventions for SWD reported no substantial effects of exercise on sleep outcomes (Langford et al., 2012). Larger RCTs and quasi-experimental studies (N greater than 100) supported positive trends. One community-based exercise study (Rajotte et al., 2012) showed improved insomnia ratings, and another RCT (Courneya et al., 2012) demonstrated improvement in participants with poor baseline sleep patterns. One home-based walking study (Wenzel et al., 2013) showed improved sleep quality, and another (Courneya et al., 2014) reported improved sleep quality and latency in women with breast cancer. However, in an RCT of 187 adults with multiple myeloma, no difference was seen in a home-based exercise versus control (Coleman et al., 2012). Additional studies show positive effects of exercise but are limited by small samples (N less than 100), quasi-experimental design, and breast cancer oversampling (Cheville et al., 2013; Mishra et al., 2012; Mock et al., 1997; Payne, Held, Thorpe, & Shaw, 2008; Rabin, Pinto, Dunsiger, Nash, & Trask, 2009; Rogers et al., 2014; Sprod et al., 2010; Swenson et al., 2014; Tang, Liou, & Lin, 2010; Wang, Boehmke, Wu, Dickerson, & Fisher, 2011). Other small studies reported conflicting results, with no effect of exercise on SWD (Kwiatkowski et al., 2013; Naraphong, Lane, Schafer, Whitmer, & Wilson, 2014; Young-McCaughan et al., 2003). The general benefits of exercise to improve sleep are supported by various studies but had mixed results in several sleep parameters and cancer populations. This lack of consistency is likely because of the variety of exercise interventions, delivery modalities, doses, and timing, sleep measures, and lack of adherence data. For exercise to be recommended for practice, additional well-designed CJON.ONS.ORG TABLE 3. LIKELY TO BE EFFECTIVE: EXERCISE STUDY INTERVENTIONS DESIGN AND SAMPLE SIGNIFICANT FINDINGS STUDY LIMITATIONS Chen et al., 2016 12-week walking program RCT; 111 patients with lung cancer Participants completed 58.2% of planned sessions. No significant differences were reported over time between groups. Participant withdrawal was greater than 10%. Cheville et al., 2013 1.5-hour strength training and walking plus resistance versus usual care Single-blind RCT; 56 patients with advanced lung or colorectal cancer Sleep rating improved in the intervention group and remained about the same in controls (p < 0.05). More than 20% lost to follow-up; no attention control Chiu et al., 2015 Walking exercise Meta-analysis; 9 studies Overall effect size for walking on sleep disturbance was –0.52 (95% confidence interval [–0.79, –0.25]). Excluded studies were those that showed lack of effect; high heterogeneity Coleman et al., 2003 Home-based aerobic and resistance training versus usual care RCT; 24 patients receiving stem cell transplantation Feasibility study only; results not summarized Fewer than 30 participants; 42% attrition rate Coleman et al., 2012 12-week home-based individualized exercise program; resistance bands and walking versus exercise recommendations RCT; 187 patients with multiple myeloma No difference between groups for sleep, fatigue, or performance Risk of sampling bias Courneya et al., 2012 12-week supervised aerobic sessions (3 days per week) RCT; 117 patients with nonHodgkin lymphoma Exercise results in small (d = 0.19) not significant improvement in sleep quality; improved significantly in those who had poor sleep at baseline More poor sleepers in intervention group at baseline; unclear how many in intervention participated Courneya et al., 2014 Standard-dose aerobic exercise versus higher-dose exercise versus combined aerobic and resistance Single-blind RCT; 296 patients with breast cancer during chemotherapy Some mixed results; findings in high-dose group better than those for standard exercise in global sleep (d = 0.22, p= 0.039), sleep quality (d = 0.26, p = 0.028), and sleep latency (d = 0.18, p = 0.049) No baseline group characteristics analyzed or reported; used only some Pittsburgh Sleep Quality Index measures, not entire tool Kwiatkowski et al., 2013 2-week stay at a spa with daily physical training 2-group prospective, randomized trial; 222 patients with breast cancer States effect on depression but not sleep or anxiety Sample characteristics not reported; design unclear; not all data reported; questionable feasibility Langford et al., 2012 Nonpharmacologic interventions for sleep disturbance Systematic review; 47 studies Moderate effects of CBT and exercise for improvement in sleep disturbance Only 2 studies included sleep outcomes. Mishra et al., 2012 Exercise interventions Systematic review and metaanalysis; 40 studies Exercise interventions showed beneficial effects on sleep disturbances and other health-related quality of life domains. Various types and duration of exercise; high risk of bias in trials; high heterogeneity Mock et al., 1997 Home-based walking versus usual care Pre-/postintervention study; 46 patients with breast cancer Women who exercised regularly reported less difficulty sleeping. Assignment not random; small sample; actual adherence unknown Naraphong et al., 2014 Self-directed exercise and walking with weekly telephone follow-up versus control RCT; 23 patients with breast cancer No group by time effects for sleep Fewer than 30 participants RCT; 18 patients with breast cancer on hormonal therapy Actigraphy showed shorter wake after sleep onset (p = 0.02), shorter sleep time (p = 0.05), and less movement during sleep (p = 0.002) in the exercise group; no difference in other results Fewer than 20 participants; adherence to exercise not known; activity level of controls not known; 10% dropouts Payne et al., 2008 14-week prescribed home-based walking program Continued on the next page CJON.ONS.ORG VOLUME 22, NUMBER 1 CLINICAL JOURNAL OF ONCOLOGY NURSING 45 SLEEP-WAKE DISTURBANCE TABLE 3. (CONTINUED) LIKELY TO BE EFFECTIVE: EXERCISE STUDY INTERVENTIONS DESIGN AND SAMPLE SIGNIFICANT FINDINGS STUDY LIMITATIONS Rabin et al., 2009 12-week progressive walking and progressive muscle relaxation with weekly telephone counseling, review, and reinforcement Multisite prospective trial; 23 patients with breast cancer At 12 and 24 weeks, walking improved sleep quality and mood, and reduced fatigue. Fewer than 30 participants; no control or comparison; socioeconomic homogeneity in sample Rajotte et al., 2012 12-week supervised exercise sessions at YMCAs Quasi-experimental; 187 patients with mixed cancers Self-rated insomnia declined from pre- to postintervention. Insomnia measurement not validated; 15% dropout rate; analysis may overestimate effect. Rogers et al., 2014 9-week resistance and walking exercise with group sessions every 2 weeks versus usual care RCT; 42 patients with breast cancer post–initial treatment Sleep-wake dysfunction declined more in the intervention group from pre- to postintervention. Baseline sleep dysfunction lower in the intervention group; fewer than 50 participants; no blinding; no attention control Sprod et al., 2010 Home-based exercise compared to control group RCT; secondary analysis; 38 patients with breast or prostate cancer Overall sleep quality improved in both groups, and no difference was seen between groups. No analysis of sleep medications used, although mentioned Swenson et al., 2014 8-week supervised outpatient aerobic exercise and strength training with 6-month maintenance Quasi-experimental; 75 patients with mixed cancers After 6 months, sleep disturbance improved from baseline. No specific sleep measure; more than 30% withdrawals Tang et al., 2010 8-week home-based walking (30 minutes 3 times per week) compared to usual care Multisite RCT; 71 patients with mixed cancers Exercise group had significant improvement in sleep quality at 1 and 2 months. Fewer than 75 participants; only subjective sleep and activity data; additional activity in either group not known; relatively short duration follow-up Wang et al., 2011 6-week walking program versus control RCT; 62 patients newly diagnosed with breast cancer Compared to control, sleep improved more in the walking group over time. Fewer than 75 participants; 30% contamination rate across groups; no attentional control; short duration No blinding; dropouts more than 10% Substantial missing actigraphy data Wenzel et al., 2013 Home-based walking program versus usual care RCT; 126 patients with mixed cancers during active treatment No difference between groups in sleep quality at the end of the study; patients with prostate cancer who exercised more reported better sleep quality and less fatigue. YoungMcCaughan et al., 2003 12-week group exercise (2 times per week) Pre-/postintervention; 62 patients with mixed cancers No improvement in sleep as measured by actigraphy RCT—randomized, controlled trial studies are needed to identify the type and intensity of exercise that is effective for diverse cancer populations at different phases of treatment. EFFECTIVENESS NOT ESTABLISHED: This category includes interventions that have yet to be shown in the published literature to be effective in adults with cancer. Pharmacologic interventions have not been studied with sufficient rigor to draw conclusions regarding efficacy in people with cancer. The AASM (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017) published a clinical practice guideline for pharmacologic treatment of chronic insomnia in adults without specific information regarding patients with 46 CLINICAL JOURNAL OF ONCOLOGY NURSING VOLUME 22, NUMBER 1 cancer. The National Cancer Institute (2016) and NCCN (2017) have synthesized information regarding U.S. Food and Drug Administration–approved sedative and hypnotic medications to guide clinicians who treat SWD. Sedative and hypnotic medications are accepted as beneficial for short-term use to treat SWD and often are prescribed along with nonpharmacologic strategies that take longer to show benefits (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017). Selection of a sedative or hypnotic agent needs to be based on the type of sleep problem; see the AASM guideline for examples (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017). Short-acting agents CJON.ONS.ORG IMPLICATIONS FOR PRACTICE ɔ are preferred for sleep initiation, with long-acting agents used for sleep maintenance. Comorbid conditions; symptoms such as anxiety, depression, and pain; and other medications need to be considered. The decision to prescribe a sleep medication needs to be made carefully with awareness of potential adverse effects, drug–drug interactions, and safety issues (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017). The preferred classes of prescription drugs for short-term use (less than seven days) by patients with SWD is benzodiazepines and non-benzodiazepine, benzodiazepine-receptor agonists (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017). Zolpidem has shown benefits in patients with cancer (Joffe et al., 2010) and is included on the AASM, NCCN, and NCI lists (NCCN, 2017; NCI, 2016; Sateia, Buysse, Krystal, Neubauer, & Heald, 2017). Hypnotics and sedatives are not suggested because they create a hangover effect on waking and may result in reduced memory and performance, leading to impaired daytime functioning (Sateia, Buysse, Krystal, & Neubauer, 2017). Over-the-counter sleep aids that contain antihistamines, such as diphenhydramine, also have this effect (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017). Sleep experts recommend initiating medications at a low dose, monitoring for side effects, and tapering slowly to prevent withdrawal symptoms and rebound insomnia (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017). Nutritional and herbal supplements fall in the effectiveness not established category because of the limited quality and quantity of existing evidence. Herbal sleep aids, such as tryptophan and valerian, are strongly discouraged because of lack of information about outcomes (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017) and interactions with cancer pharmaceuticals. In a limited number of studies in patients with cancer, melatonin has shown positive benefits (Chen et al., 2014; Hansen et al., 2014; Kurdi & Muthukalai, 2016; Lund Rasmussen et al., 2015; Madsen et al., 2016); however, the AASM guidelines do not recommend that clinicians use melatonin as a treatment for sleep onset or sleep maintenance insomnia (Sateia, Buysse, Krystal, Neubauer, & Heald, 2017). Because the published literature has not shown melatonin to be effective in adults with cancer, the PEP SWD team has categorized it as effectiveness not established. Similarly, complementary and alternative therapies and relaxation therapies remain in the effectiveness not established category based on the limited current evidence. Descriptions of these interventions and additional information are provided on the PEP SWD website (ONS, 2017). Most of the studies have small samples, nonrandom designs, and insufficient evidence to change PEP recommendations. ɔ ɔ Incorporate practice guidelines for sleep-wake disturbance (SWD) screening, focused assessments, education about SWD, and referrals to sleep specialists. Recommend the use of cognitive behavioral intervention/approach to improve SWD and discuss mindfulness-based stress reduction and exercise as interventions likely to be effective in improving cancer-related SWD. Remain up to date on the latest SWD research and practice recommendations, and develop or update workplace policies to include interventions categorized as recommended for practice or likely to be effective. informed nurses can help people with cancer in a variety of settings to recognize unhelpful thoughts, beliefs, and behaviors that lead to SWD. As a component of patient teaching, oncology nurses can provide information about sleep hygiene, sleep promotion, and trustworthy local and online resources, and arrange for sleep specialist referrals as needed. MBSR is likely to be effective. Nurses can provide evidencebased information and resources about MBSR for sleep improvement. Preliminary evidence suggests exercise is likely to be effective, but additional evidence is needed to determine the type and intensity of the exercise that is most beneficial to manage SWD. Nurses can partner with patients with cancer and survivors to design an appropriate physical activity program. Many interventions tested in few studies, with small samples and nonrandom designs, were rated effectiveness not established. Continued testing of promising interventions requires rigorous study designs that are adequately powered. To expand generalizability of results, SWD research with heterogeneous cancer populations with various age groups, ethnicities, cancer types, and treatments is warranted. Numerous interventions are behavioral and integrate tailoring; therefore, design considerations include dose intensity, timing, essential components, treatment fidelity measures, patient preferences, and adequate statistical power. Additional research in CBI/A is needed to determine the components, doses, and timing that are most effective in diverse cancer populations at different phases of cancer treatment and survivorship. Economic evaluation is essential to inform health policy and program development. This includes direct and indirect costs of the delivery of different modalities. Intervention studies that include critical health outcomes associated with SWD, such as weight gain, depression, other symptoms, and functioning, can increase the impact of sleep research. Scientific knowledge about effective SWD interventions in cancer populations is growing rapidly. To realize the return on investment for such knowledge and to improve public health, translational research in oncology practice is urgently needed. Implications for Practice and Research Sufficient evidence exists for CBI/A to be recommended for practice for SWD; however, access to CBI/A is hampered by the scarcity of trained providers and limited insurance coverage. However, CJON.ONS.ORG Conclusion As interventions for cancer-related SWD evolve, clinicians are challenged to evaluate the evidence and integrate the most effective VOLUME 22, NUMBER 1 CLINICAL JOURNAL OF ONCOLOGY NURSING 47 SLEEP-WAKE DISTURBANCE interventions in their practice. As an update to a comprehensive review of cancer-related SWD studies, this PEP review includes the latest scientific and clinical information that clinicians, policymakers, and administrators can use to achieve optimal management of this common and distressing problem. This review also highlights the gaps in knowledge and identifies areas for future research to test and refine interventions that reduce SWD in patients with cancer and promote health. Efficacy of an intervention for fatigue and sleep disturbance during cancer chemotherapy. Journal of Pain and Symptom Management, 40, 200–216. https://doi.org/10.1016/j .jpainsymman.2009.12.020 Bastien, C.H., Vallières, A., & Morin, C.M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297–307. https://doi.org/10 .1016/S1389-9457(00)00065-4 Berger, A.M. (2009). Update on the state of the science: Sleep-wake disturbances in adult patients with cancer [Online exclusive]. Oncology Nursing Forum, 36, E165–E177. https:// doi.org/10.1188/09.ONF.E165-E177 Ellyn Matthews, PhD, RN, AOCNS®, CBSM, FAAN, is an associate professor in the College of Nursing at the University of Arkansas for Medical Sciences in Little Rock and the Elizabeth Stanley Cooper Endowed Chair in Oncology Nursing; Patricia Carter, PhD, RN, CNS, is an associate professor in the School of Nursing at the University of Texas in Austin; Margaretta Page, MS, RN, is a nurse coordinator in the University of California, San Francisco, Medical Center in San Francisco; Grace Dean, PhD, RN, is an associate professor in the School of Nursing at the University of Buffalo in New York; and Ann Berger, PhD, APRN, AOCNS®, FAAN, is a professor and the Dorothy Hodges Olson Endowed Chair in Nursing, and associate dean for research at the University of Nebraska Medical Center in Omaha. Matthews can be reached at eematthews@uams.edu, with copy to CJONEditor@ons.org. (Submitted February 2017. 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Comparison of psychosocial outcomes in head and neck cancer patients receiving a coping strategies intervention and control subjects receiving no intervention. Journal of Otolaryngology, 35, 88–96. https://doi.org/10.2310/7070.2005.5002 ONS members can earn free CNE for reading this article and completing an evaluation online. To do so, visit cjon.ons.org/cne to link to this article and then access its evaluation link after logging in. Wanchai, A., Armer, J.M., & Stewart, B.R. (2011). Nonpharmacologic supportive strategies to ing program on Taiwanese women newly diagnosed with early-stage breast cancer. Cancer Certified nurses can earn 0.4 ILNA points for one of the following based on reading the article and completing an evaluation online: ɔ 0.4 ILNA Symptom Management OR Psychosocial Dimensions of Care OR Survivorship OR Professional Performance points toward OCN® Nursing, 34(2), E1–E13. https://doi.org/10.1097/NCC.0b013e3181e4588d ɔ 0.4 ILNA Side Effect and Symptom Management OR Survivorship OR Psychosocial Issues OR Professional Issues OR Roles of the APN points toward AOCNP® or AOCNS® ɔ 0.4 ILNA Symptom Management OR Psychosocial and Spiritual OR Survivorship OR Professional Practice points toward CBCN® ɔ 0.4 ILNA Post-Transplant Issues OR Survivorship Issues OR Professional Practice points toward BMTCN® promote quality of life in patients experiencing cancer-related fatigue: A systematic review. Clinical Journal of Oncology Nursing, 15, 203–214. https://doi.org/10.1188/11.CJON.203-214 Wang, Y.J., Boehmke, M., Wu, Y.W., Dickerson, S.S., & Fisher, N. (2011). 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