Julie L. Otte

Systematic review of health-related quality of life models

BackgroundA systematic literature review was conducted to (a) identify the most frequently used health-related quality of life (HRQOL) models and (b) critique those models.MethodsOnline search engines were queried using pre-determined inclusion and exclusion criteria. We reviewed titles, abstracts, and then full-text articles for their relevance to this review. Then the most commonly used models were identified, reviewed in tables, and critiqued using published criteria.ResultsOf 1,602 titles identified, 100 articles from 21 countries met the inclusion criteria. The most frequently used HRQOL models were: Wilson and Cleary (16%), Ferrans and colleagues (4%), or World Health Organization (WHO) (5%). Ferrans and colleagues’ model was a revision of Wilson and Cleary’s model and appeared to have the greatest potential to guide future HRQOL research and practice.ConclusionsRecommendations are for researchers to use one of the three common HRQOL models unless there are compelling and clearly delineated reasons for creating new models. Disease-specific models can be derived from one of the three commonly used HRQOL models. We recommend Ferrans and colleagues’ model because they added individual and environmental characteristics to the popular Wilson and Cleary model to better explain HRQOL. Using a common HRQOL model across studies will promote a coherent body of evidence that will more quickly advance the science in the area of HRQOL.

Prevalence, Severity, and Correlates of Sleep-Wake Disturbances in Long-Term Breast Cancer Survivors

CONTEXT Current evidence shows that sleep-wake disturbances are a persistent problem linked to poor quality of life in women surviving breast cancer. Information regarding correlates of sleep-wake disturbances in long-term survivors is sparse. OBJECTIVES The objective of this study was to refine knowledge regarding prevalence, severity, and correlates of sleep-wake disturbances in long-term breast cancer survivors (BCS) compared with age-matched women without breast cancer (WWC). METHODS The cross-sectional convenience sample included 246 BCS and 246 WWC who completed a quality-of-life study and were matched within +/-5 years of age. RESULTS BCS were a mean of 5.6 years beyond completion of cancer treatment (range = 5.6-10.0 years). Based on Pittsburgh Sleep Quality Index (PSQI) scores, BCS had significantly more prevalent sleep-wake disturbances (65%) compared with WWC (55%) (P < 0.05). BCS also had significantly higher PSQI global scores indicating poorer sleep quality compared with WWC (P < 0.05). Significant correlates of prevalence of poor sleep for BCS included hot flashes, poor physical functioning, depressive symptoms, and distress, and for WWC, these included hot flashes, poor physical functioning, and depressive symptoms. Significant correlates (P < 0.05) of severity of poor sleep for BCS included presence of noncancer comorbidities, hot flashes, depressive symptoms, and residual effects of cancer treatment. For WWC, these included hot flashes, poor physical functioning, depressive symptoms, and impact of a life event. CONCLUSION Knowledge of prevalence, severity, and correlates of sleep-wake disturbances provides useful information to health care providers during clinical evaluations for treatment of sleep-wake disturbances in BCS.

Health-related quality of life of African American breast cancer survivors compared with healthy African American women

Background: The diagnosis and treatment of breast cancer can result in an array of late cancer-specific side effects and changes in general well-being. Research has focused on white samples, limiting our understanding of the unique health-related quality of life outcomes of African American breast cancer survivors (BCSs). Even when African American BCSs have been targeted, research is limited by small samples and failure to include comparisons of peers without a history of breast cancer. Objective: The purpose of this study was to compare health-related quality of life of African American female BCSs with that of African American women with no history of breast cancer (control group). Methods: A total of 140 women (62 BCSs and 78 controls), 18 years or older and 2 to 10 years postdiagnosis, were recruited from a breast cancer clinic and cancer support groups. Participants provided informed consent and completed a 1-time survey based on the proximal-distal health-related quality of life model of Brenner et al (1995). Results: After adjusting for age, education, income, and body mass index, results show that African American BCSs experienced more fatigue (P = .001), worse hot flashes (P < .001), and worse sleep quality (P < .001) but more social support from their partner (P = .028) and more positive change (P = .001) compared with African American female controls. Conclusions: Our results suggest that African American female BCSs may experience unique health-related outcomes that transcend age, education, socioeconomic status, and body mass index. Implications for Practice: Findings suggest the importance of understanding the survivorship experience for particular racial and ethnic subgroups to proactively assess difficulties and plan interventions.

Feasibility study of acupuncture for reducing sleep disturbances and hot flashes in postmenopausal breast cancer survivors.

Objectives: The present study was a feasibility study of a tailored acupuncture intervention in postmenopausal breast cancer survivors (BCSs) reporting sleep disturbances and hot flashes. Objectiveswere (1) to describe patterns of acupuncture point use; (2) evaluate outcome expectancy, credibility, and acceptability relative to the intervention; and (3) evaluate patterns of symptom change over time. Design: This was a single-group, nonrandomized, quasi-experimental 8-week study. Sample/Setting: Ten BCSs with both sleep disturbances and hot flashes were referred to any of 4 Midwestern community acupuncturists. Methods: Assessments were done at baseline (weeks 1, 2), during treatment (weeks 3, 4), and after treatment (weeks 5, 8). Acupuncture treatment was tailored to the individual by community acupuncturists and provided as 3 sessions within a 2-week period (weeks 3, 4). Patients wore a wrist actigraph during weeks 1, 2, 3, 4, 5, and 8 and a sternal skin conductance monitor for 24 consecutive hours during weeks 1, 2, 3, 4, 5, and 8. Subjective data were obtained by questionnaire at weeks 1, 2, 3, 4, 5, and 8. Findings: Women were a mean age of 53 years, with an average 6.75 years since diagnosis. A mean of 10 needles were used per session, with the most common points located in the lung or lung meridian. Breast cancer survivors had high expectancy that acupuncture would decrease their symptoms, believed it was a credible treatment, and felt it an acceptable form of treatment. Three significant patterns of symptom change were noted from baseline: an increase in the number of minutes it took to fall asleep after treatment (from week 5 to 8; P = .04), a decrease in the percentage of time awake after sleep onset from baseline to follow-up 2 (week 8; P = .05), and a decrease in the number of hot flashes from baseline to follow-up 1 (week 5; P = .02). Implications for Nursing: Findings may be used by clinical nurse specialists to consider recommending acupuncture to improve sleep and reduce hot flashes in BCSs. Conclusions: Acupuncture treatment seems to be a feasible treatment option for highly motivated BCSs with sleep disturbances and hot flashes but needs to be further evaluated in a larger, randomized, controlled clinical trial.

Patient‐Reported Outcomes and Early Discontinuation in Aromatase Inhibitor‐Treated Postmenopausal Women With Early Stage Breast Cancer

In the prospective Exemestane and Letrozole Pharmacogenetics trial of adjuvant aromatase inhibitor (AI) therapy for early-stage breast cancer, worsening of multiple treatment-related symptoms during AI therapy predicted AI early discontinuation. If these findings are confirmed in independent trials, early detection of changes in PRO measures could be used clinically to target interventions in patients at high risk for early discontinuation.

Systematic review of sleep disorders in cancer patients: can the prevalence of sleep disorders be ascertained?

Although sleep is vital to all human functioning and poor sleep is a known problem in cancer, it is unclear whether the overall prevalence of the various types of sleep disorders in cancer is known. The purpose of this systematic literature review was to evaluate if the prevalence of sleep disorders could be ascertained from the current body of literature regarding sleep in cancer. This was a critical and systematic review of peer‐reviewed, English‐language, original articles published from 1980 through 15 October 2013, identified using electronic search engines, a set of key words, and prespecified inclusion and exclusion criteria. Information from 254 full‐text, English‐language articles was abstracted onto a paper checklist by one reviewer, with a second reviewer randomly verifying 50% (k = 99%). All abstracted data were entered into an electronic database, verified for accuracy, and analyzed using descriptive statistics and frequencies in SPSS (v.20) (North Castle, NY). Studies of sleep and cancer focus on specific types of symptoms of poor sleep, and there are no published prevalence studies that focus on underlying sleep disorders. Challenging the current paradigm of the way sleep is studied in cancer could produce better clinical screening tools for use in oncology clinics leading to better triaging of patients with sleep complaints to sleep specialists, and overall improvement in sleep quality.

Comparison of Subjective and Objective Hot Flash Measures Over Time Among Breast Cancer Survivors Initiating Aromatase Inhibitor Therapy

Objective:Hot flashes are valuable indicators of physiological condition and drug effect; however, subjective and objective measures do not always agree. No study has examined both subjective and objective hot flashes in women prescribed aromatase inhibitors. The study (1) compared subjective and objective hot flash measures, (2) examined changes in subjective and objective hot flashes over time, and (3) evaluated predictors of change in hot flashes in aromatase inhibitor-treated women. Methods:Participants (n = 135) were enrolled in a randomized clinical trial comparing exemestane and letrozole for the treatment of breast cancer. Hot flashes were assessed before the start of the drug therapy and 1, 3, and 6 months later. Participants wore a sternal skin conductance monitor for 24 hours or longer at each time point. With each perceived hot flash, women pressed an event button and rated intensity and bother in a paper diary. Results:Participants had a mean age of 60 years and were mainly white (92%). Across time points, monitor hot flashes were (1) significantly more frequent than diary and/or event button flashes (P < 0.05) and (2) moderately correlated with subjective measures (0.35 < r < 0.56). Monitor hot flashes did not significantly change over time with aromatase inhibitor therapy, whereas both diary and event button frequencies significantly varied but in dissimilar patterns (51% nonlinear). No consistent predictors of hot flashes across measures or time points were identified. Conclusions:Findings indicated dissimilarities between subjective and objective measures of hot flashes. Despite statistical significance, there was little clinically meaningful change in hot flashes after initiating aromatase inhibitor therapy.

Risk factors, pathophysiology, and treatment of hot flashes in cancer.

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Prevalence and Morbidity Associated with Muscle Cramps in Patients with Cirrhosis

PURPOSE Patients with cirrhosis often experience muscle cramps with varying severity. We investigated the factors associated with the prevalence and morbidity associated with muscle cramps. METHODS A total of 150 adult patients with cirrhosis were enrolled consecutively. Cramp questionnaire with visual analogue scale for pain, Chronic Liver Disease Questionnaire (CLDQ), and blood for measurement of 25-(OH) vitamin D levels were obtained after informed consent. RESULTS A total of 101 patients (67%) reported muscle cramps in the preceding 3 months. Patients with cramps had significantly lower serum albumin (3.1±0.6 g/dL vs 3.3±0.7 g/dL, P=.04) and CLDQ scores (107±37 vs 137±34, P<.0001) compared with those without cramps. The median composite symptom score, defined as product of frequency and severity of cramps, in the study cohort was 12 with a range of 0.3 to 200. There were no clinical or biochemical predictors for occurrence of any cramps or severe cramps (composite symptom score>12). Muscle cramps (P<.001) and hepatic encephalopathy (P=.009) were associated independently with decreased CLDQ scores. Vitamin D deficiency was seen in 66% of the study cohort, but the serum 25-(OH) vitamin D levels were not significantly different between patients with and without cramps (18.0±8.9 ng/mL vs 19.6±9.5 ng/mL, P=.49). CONCLUSIONS Muscle cramps are associated with significantly diminished quality of life in patients with cirrhosis. More research is needed to better understand their mechanism to develop effective treatment.

Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes.

STUDY OBJECTIVES Determine effects of low-dose estradiol and low-dose venlafaxine on self-reported sleep measures in menopausal women with hot flashes. DESIGN 3-arm double-blind randomized trial. Participants assigned in a 2:2:3 ratio to 17β estradiol 0.5 mg/day (n = 97), venlafaxine XR 75 mg/day (n = 96), or placebo (n = 146) for 8 weeks. SETTING Academic research centers. PARTICIPANTS 339 community-dwelling perimenopausal and postmenopausal women with ≥2 bothersome hot flashes per day. MEASUREMENTS AND RESULTS Insomnia symptoms (Insomnia Severity Index [ISI]) and sleep quality (Pittsburgh Sleep Quality Index [PSQI]) at baseline, week 4 and 8; 325 women (96%) provided ISI data and 312 women (92%) provided PSQI data at baseline and follow-up. At baseline, mean (SD) hot flash frequency was 8.1/day (5.3), mean ISI was 11.1 (6.0), and mean PSQI was 7.5 (3.4). Mean (95% CI) change from baseline in ISI at week 8 was -4.1 points (-5.3 to -3.0) with estradiol, -5.0 points (-6.1 to -3.9) with venlafaxine, and -3.0 points (-3.8 to -2.3) with placebo (P overall treatment effect vs. placebo 0.09 for estradiol and 0.007 for venlafaxine). Mean (95% CI) change from baseline in PSQI at week 8 was -2.2 points (-2.8 to -1.6) with estradiol, -2.3 points (-2.9 to -1.6) with venlafaxine, and -1.2 points (-1.7 to -0.8) with placebo (P overall treatment effect vs. placebo 0.04 for estradiol and 0.06 for venlafaxine). CONCLUSIONS Among perimenopausal and postmenopausal women with hot flashes, both low dose oral estradiol and low-dose venlafaxine compared with placebo modestly reduced insomnia symptoms and improved subjective sleep quality. CLINICAL TRIAL REGISTRATION NCT01418209 at www.clinicaltrials.gov.