Longitudinal relationships between fatigue and depression in cancer patients with depression and/or pain.

OBJECTIVE: Fatigue is one of the most common and debilitating symptoms reported by cancer patients, yet relatively little is understood about its etiology. Recently, as researchers have begun to focus attention on cancer-related fatigue (CRF), depression has emerged as its strongest correlate. Few longitudinal studies, however, have examined directionality of the relationship between the two symptoms. Our aim was to evaluate the directionality of the association between depression and CRF. METHOD: The study used a single-group cohort design of longitudinal data (N = 329) from a randomized controlled trial of an intervention for pain and depression in a heterogeneous sample of cancer patients. Participants met criteria for clinically significant pain and/or depression. Our hypothesis that depression would predict change in fatigue over 3 months was tested using latent variable cross-lagged panel analysis. RESULTS: Depressive symptoms and fatigue were strongly correlated in the sample (baseline correlation of latent variables = 0.71). Although the model showed good fit to the data, χ(2) (66, N = 329) = 88.16, p = .04, SRMR = 0.030, RMSEA = 0.032, and CFI = 1.00, neither structural path linking depression and fatigue was significant, suggesting neither symptom preceded and predicted the other. CONCLUSIONS: Our findings did not support hypotheses regarding the directionality of the relationship between depressive symptoms and fatigue. The clinical implication is that depression-specific treatments may not be sufficient to treat CRF and that instead, interventions specifically targeting fatigue are needed.

Somatic symptoms in cancer patients trajectory over 12 months and impact on functional status and disability.

PURPOSE: Cross-sectional studies have established the prevalence and functional impairment of somatic symptoms in cancer patients. The purpose of this study was to determine the trajectory and adverse consequences of such symptoms over time. METHODS: Secondary analysis of longitudinal data from 405 cancer patients enrolled in a telecare management trial for pain and/or depression. Somatic symptom burden was measured with a 22-item scale at baseline, 1, 3, 6, and 12 months. Outcomes included the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, the Sheehan Disability Scale (SDS) score, and self-reported total disability days. Mixed methods repeated measures analyses were conducted to determine whether antecedent change in somatic symptom burden predicted functional status and disability. RESULTS: Symptoms were highly prevalent at baseline, with 15 of the 22 symptoms endorsed by more than half of the patients. A rather constant cross-sectional prevalence over 12 months at the group level belied a quite different trajectory at the patient level where the median persistence, resolution, and incidence rates for 14 of the most common symptoms were 39%, 37%, and 24%, respectively. A clinically significant (i.e., five points) reduction in somatic symptom burden predicted improvement in PCS, MCS, and SDS (all P < 0.001), as well as a lower likelihood of ≥14 disability days in the past 4 weeks (odds ratio, 0.84; 95% CI, 0.74 to 0.95). CONCLUSIONS: Somatic symptoms remain burdensome in cancer patients over 12 months and symptom improvement predicts significantly better functional status and less disability.

Longitudinal comparison of three depression measures in adult cancer patients.

CONTEXT: Although a number of depression measures have been used with cancer patients, longitudinal comparisons of several measures in the same patient population have been infrequently reported. OBJECTIVES: To compare the Hopkins Symptom Checklist 20-item depression scale, Short-Form 36 Mental Health Inventory five-item distress scale, and Patient Health Questionnaire nine-item depression scale in adults with cancer. METHODS: Of the 309 cancer patients enrolled in a telecare management trial for depression, 247 completed the three depression measures at both baseline and at three months and a retrospective assessment of global rating of change in depression at three months. Internal consistency and construct validity of each measure were evaluated. Responsiveness was compared by calculating standardized response means and receiver operating characteristic area under the curve, using global rating of change as the external comparator measure. Differences between intervention and control groups in depression change scores were compared by calculating standardized effect sizes (SESs). RESULTS: Internal reliability coefficients for the three measures were ≥0.77 at baseline and ≥0.84 at three months. Construct validity was supported with strong correlations of the depression measures among themselves, moderately strong correlations with other measures of mental health, and moderate correlations with vitality and disability. In terms of responsiveness, standardized response means for all measures significantly differentiated between three groups (improved, unchanged, and worse) as classified by patient-reported global rating of change in depression at three months. The three measures were able to detect a modest treatment effect in the intervention group compared with the control group (SES ranging from 0.21 to 0.43) in the full sample, whereas detecting a greater treatment effect in depressed participants with comorbid pain (SES ranging from 0.30 to 0.58). Finally, the three measures performed similarly in detecting patients with improvement. CONCLUSION: The Hopkins Symptom Checklist 20-item depression scale, Mental Health Inventory five-item distress scale, and Patient Health Questionnaire nine-item depression scale were established as reliable, valid, and responsive depression measures in adults with cancer. Given the current recommendations for measurement-based care, our study shows that clinicians treating depressed cancer patients have several measures from which to choose.

Comparative responsiveness of pain measures in cancer patients.

UNLABELLED: Brief measures to assess and monitor pain in cancer patients are available, but few head-to-head psychometric comparisons of different measures have been reported. Baseline and 3-month data were analyzed from 274 patients enrolled in the Indiana Cancer Pain and Depression (INCPAD) trial. Participants completed the Brief Pain Inventory (BPI), the PEG (a 3-item abbreviated version of the BPI), the short form (SF)-36 pain scale, and a pain global rating of change measure. The global rating was used as the criterion for standardized response mean and receiver operating characteristic curve analyses. To assess responsiveness to the trial intervention, we evaluated standardized effect size statistics stratified by trial arm. All measures were responsive to global improvement, discriminated between participants with and without improvement, and detected a significant intervention treatment effect. Short and longer measures were similarly responsive. Also, composite measures that combined pain severity and interference into a single score (BPI total, PEG, SF-36 pain) performed comparably to separate measures of each domain (BPI severity and BPI interference). PERSPECTIVE: Pain measures as brief as 2 or 3 items that provide a single score are responsive in patients with cancer-related pain. Ultra-brief measures offer a valid and efficient means of assessing and monitoring pain for the clinical management as well as research of cancer-related pain.

Predictors of cancer-related pain improvement over time.

OBJECTIVE: To determine the predictors of pain improvement among patients being treated for cancer-related pain over 12 months. METHODS: A secondary analysis of the telephone care Indiana Cancer Pain and Depression trial was performed. Patients (n = 274) were interviewed at baseline and after 1, 3, 6, and 12 months. Pain improvement outcomes included both a continuous measure (Brief Pain Inventory score) and a categorical measure (pain improved versus pain not improved). Predictor variables included change in depression, age, sex, race, marital status, socioeconomic disadvantage, medical comorbidity, type of cancer, and phase of cancer. Multivariable repeated measures were conducted, adjusting for intervention group assignment, baseline pain severity, and time in months since baseline assessment. RESULTS: Factors significantly predicting both continuous and categorical pain improvement included participating in the intervention group (ß = -0.92, p < .001, odds ratio [OR] = 2.53, 95% confidence interval [CI] = 1.65-3.89), greater improvement in depression (ß = -0.31, p = .003, OR = 1.84, 95% CI = 1.35-2.51), higher socioeconomic status (Socioeconomic Disadvantage index; ß = 0.25, p = .034; OR = 0.73, 95% CI = 0.56-0.94), and fewer comorbid conditions (ß = 0.20, p = .002; OR = 0.84, 95% CI = 0.73-0.96). Patients with more severe pain at baseline or with recurrent or progressive cancer were less likely to experience continuous or categorical pain improvement, respectively. CONCLUSIONS: Effective management of depression and comorbid conditions along with improvement of social services could be critical components of a comprehensive pain management. Patients with more severe pain or with recurrent or progressive cancers may require closer monitoring and adequate treatment of pain. Trial Registration clinicaltrials.gov Identifier: NCT00313573.

Cancer-related pain and disability: a longitudinal study.

CONTEXT: Although the cross-sectional association between cancer-related pain and disability is well established, their longitudinal relationship has been less studied. OBJECTIVES: Data from the Indiana Cancer Pain and Depression (INCPAD) trial were analyzed to determine whether baseline cancer-related pain and changes in pain over time predict disability over 12 months. METHODS: A total of 274 cancer survivors with cancer-related pain were accrued in the INCPAD trial. Data were collected at baseline, one, three, six, and 12 months by interviewers blinded to treatment arm. Disability outcomes included a continuous measure (Sheehan Disability Scale [SDS] score) and a categorical measure (≥14 days in the past four weeks with a ≥50% reduction in usual activities). Predictor variables, operationalized by the Brief Pain Inventory, included baseline pain severity and changes in pain severity scores between each time point. Multivariable analyses were conducted adjusting for treatment group, baseline disability, and selected covariates including depression. RESULTS: Baseline pain severity did not predict disability outcomes at 12 months. However, improvement in pain severity predicted less disability over 12 months both in terms of SDS scores (b=-0.17, t=-5.33, P<0.001) and ≥14 disability days in the past month (odds ratio=0.85; 95% confidence interval, 0.79-0.93; P<0.001). CONCLUSION: Disability over 12 months in patients with cancer-related pain is predicted by changes in pain severity over time. Results suggest that effective pain management may reduce subsequent disability among cancer survivors.

Comparison of SF-36 vitality scale and Fatigue Symptom Inventory in assessing cancer-related fatigue.

PURPOSE: Cancer-related fatigue (CRF) is an important symptom in clinical practice and research. The best way to measure it, however, remains unsettled. The SF-36 vitality scale, a general measure of energy/fatigue, is a frequently cited measure. With only four items, however, its ability to adequately represent multiple CRF facets has been questioned. The 13-item Fatigue Symptom Inventory (FSI) was developed to assess multidimensional aspects of CRF. Our objectives were to assess the convergent validity and to compare the sensitivity to change of the two scales. METHODS: We administered both scales at 1 month (n = 68) and 6 months (n = 96) to a subset of heterogeneous patients receiving treatment in 16 cancer centers who were enrolled in a clinical trial of pain and depression. Distributions of standardized response means (SRMs) were compared to assess sensitivity to change. Results of both scales were compared to scores on a single fatigue item from the Patient Health Questionnaire (PHQ). RESULTS: Mean scores for both the FSI and the vitality scale demonstrated clinically significant fatigue in the sample. The vitality scale was strongly correlated with all three FSI scales (r = -0.68 to -0.77). The vitality and FSI scales also correlated strongly with the PHQ fatigue item. Moreover, distributions of SRMs for both scales were approximately normal. CONCLUSIONS: Both the FSI and the vitality scale are supported as valid measures of CRF. Both demonstrated sensitivity to change across a range of effect sizes. The vitality scale may be an excellent choice when brevity is paramount; the FSI may be more appropriate when tapping specific dimensions is warranted.

Telecare management of pain and depression in patients with cancer: patient satisfaction and predictors of use.

Pain and depression are 2 of the most common and disabling cancer-related symptoms. In the Indiana Cancer Pain and Depression trial, 202 cancer patients with pain and/or depression were randomized to the intervention group and received centralized telecare management augmented by automated symptom monitoring (ASM). Over the 12-month trial, the average patient completed 2 ASM reports and 1 nurse call per month. Satisfaction with both ASM and care management was high regardless of patient characteristics or cancer type. Adherence was also generally good, although several predictors of fewer ASM reports and nurse calls were identified. Only a minority of ASM reports triggered a nurse call, suggesting the efficiency of coupling clinician-delivered telecare management with automated monitoring.

Somatic symptoms in patients with cancer experiencing pain or depression: prevalence, disability, and health care use.

BACKGROUND: The adverse impact of a high somatic symptom burden is well established for primary care and other noncancer populations with chronic medical disorders. METHODS: This study examines the impact of somatic symptom burden on disability and health care use in patients with cancer experiencing pain, depression, or both. We performed secondary analyses of baseline data from 405 patients with cancer enrolled in a telecare management trial for pain or depression. Somatic symptom burden was measured using a 22-item scale. Multivariable models were conducted to determine the association of somatic symptom burden with the Sheehan Disability Scale (SDS) score, the number of self-reported disability days in the past 3 months, and health care use. Models were adjusted for sociodemographic characteristics, medical comorbidity, and depression and pain severity. RESULTS: Somatic symptoms were highly prevalent, with 15 of the 22 symptoms reported by more than 50% of patients. The somatic symptom burden was similar across different types and phases of cancer. The mean SDS score (scored 0-10 [not at all disabled to unable to carry out any activities]) was 5.4, and the mean number of self-reported disability days in the past 4 weeks was 16.9. In multivariable models, somatic symptom burden was associated with SDS score (P < .001) and the likelihood of at least 14 disability days in the past 4 weeks (odds ratio, 1.51; 95% confidence interval, 1.19-1.92) but not with increased health care use. CONCLUSIONS: The somatic symptom burden is high in patients with cancer who experience pain or depression. Given the strong association with disability and the high prevalence of many types of symptoms, recognizing and managing somatic symptoms may be important in improving quality of life and functional status regardless of type or phase of cancer. Trial Registration clinicaltrials.gov Identifier: NCT00313573.

Effect of telecare management on pain and depression in patients with cancer: a randomized trial.

CONTEXT: Pain and depression are 2 of the most prevalent and treatable cancer-related symptoms, yet they frequently go unrecognized, undertreated, or both. OBJECTIVE: To determine whether centralized telephone-based care management coupled with automated symptom monitoring can improve depression and pain in patients with cancer. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial conducted in 16 community-based urban and rural oncology practices involved in the Indiana Cancer Pain and Depression (INCPAD) trial. Recruitment occurred from March 2006 through August 2008 and follow-up concluded in August 2009. The participating patients had depression (Patient Health Questionnaire-9 score > or = 10), cancer-related pain (Brief Pain Inventory [BPI] worst pain score > or = 6), or both. INTERVENTION: The 202 patients randomly assigned to receive the intervention and 203 to receive usual care were stratified by symptom type. Patients in the intervention group received centralized telecare management by a nurse-physician specialist team coupled with automated home-based symptom monitoring by interactive voice recording or Internet. MAIN OUTCOME MEASURES: Blinded assessment at baseline and at months 1, 3, 6, and 12 for depression (20-item Hopkins Symptom Checklist [HSCL-20]) and pain (BPI) severity. RESULTS: Of the 405 participants enrolled in the study, 131 had depression only, 96 had pain only, and 178 had both depression and pain. Of the 274 patients with pain, 137 patients in the intervention group had greater improvements in BPI pain severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical pain responder (> or = 30% decrease in BPI) than the 137 patients in the usual-care group (P < .001 for both). Similarly, of the 309 patients with depression, the 154 patients in the intervention group had greater improvements in HSCL-20 depression severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical depression responder (> or = 50% decrease in HSCL) than the 155 patients in the usual care group (P < .001 for both). The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% confidence interval [CI], 0.33-1.02) and 0.39 (95% CI, 0.01-0.77) for pain, and 0.42 (95% CI, 0.16-0.69) and 0.41 (95% CI, 0.08-0.72) for depression. CONCLUSION: Centralized telecare management coupled with automated symptom monitoring resulted in improved pain and depression outcomes in cancer patients receiving care in geographically dispersed urban and rural oncology practices. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00313573.

The association of depression and pain with health-related quality of life, disability, and health care use in cancer patients.

CONTEXT: Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20%-30% of oncology patients. OBJECTIVE: To determine the associations of pain and depression with health-related quality of life (HRQL), disability, and health care use in cancer patients. METHODS: The Indiana Cancer Pain and Depression study is a randomized clinical trial comparing telecare management vs. usual care for patients with cancer-related pain and/or clinically significant depression. In this article, baseline data on patients enrolled from 16 urban or rural community-based oncology practices are analyzed to test the associations of pain and depression with HRQL, disability, and health care use. RESULTS: Of the 405 participants, 32% had depression only, 24% pain only, and 44% both depression and pain. The average Hopkins Symptom Checklist 20-item depression score in the 309 depressed participants was 1.64 (on 0-4 scale), and the average Brief Pain Inventory (BPI) severity score in the 274 participants with pain was 5.2 (on 0-10 scale), representing at least moderate levels of symptom severity. Symptom-specific disability was high, with participants reporting an average of 16.8 of the past 28 days (i.e., 60% of their days in the past four weeks) in which they were either confined to bed (5.6 days) or had to reduce their usual activities by 50% (11.2 days) because of pain or depression. Moreover, 176 (43%) participants reported being unable to work because of health-related reasons. Depression and pain had both individual and additive adverse associations with quality of life. Most patients were currently not receiving care from a mental health or pain specialist. CONCLUSION: Depression and pain are prevalent and disabling across a wide range of types and phases of cancer, commonly co-occur, and have additive adverse effects. Enhanced detection and management of this disabling symptom dyad is warranted.

The association of depression and anxiety with health-related quality of life in cancer patients with depression and/or pain.

OBJECTIVES: Depression is known to be a major problem in cancer patients, and evidence is emerging about the importance of anxiety. Because the disorders are highly comorbid, we examined the relationship of anxiety and depression with health-related quality of life (HRQL) in cancer patients. METHODS: Sample included 405 adult oncology patients participating in a randomized controlled trial of telecare management for pain and depression. This secondary cross-sectional analysis of baseline data examined independent and additive effects of anxiety and depression on HRQL, disability, and somatic symptom severity. RESULTS: In 397 patients who screened positive for either pain or depression or both, 135 had comorbid anxiety and depression, 174 had depression but not anxiety, and 88 had neither. Differences existed across all nonphysical HRQL domains and were more pronounced incrementally across the three groups in the expected direction. In GLM modeling, anxiety and depression were each associated with all the domains when modeled separately (p<0.0001). When modeled together, anxiety and depression had independent and additive effects on the mental health domains of HRQL and on somatic symptom burden. In other domains (vitality, perceived disability, overall quality of life, and general health perceptions), only depression had an effect. CONCLUSION: Anxiety and depression have strong and independent associations with mental health domains and somatic symptom burden in cancer patients. However, depression has a more pervasive association with multiple other domains of HRQL. Paying attention to both anxiety and depression may be particularly important when addressing mental health needs and somatic symptom distress.

The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients.

BACKGROUND: Depression is the most common mental disorder, and suicide is its most serious consequence. The primary objective of this study was to evaluate preliminary evidence for the P4 screener as a brief measure to assess potential suicide risk. METHOD: The P4 screener was prospectively evaluated in 2 randomized effectiveness trials of primary care (January 2005-June 2008; N = 250) and oncology patients (March 2006-August 2009; N = 309). Potential suicide ideation was assessed at 5 time points in both trials: baseline and 1, 3, 6, and 12 months. The P4 screener asks about the "4 P's": past suicide attempts, suicide plan, probability of completing suicide, and preventive factors. Patients were classified as minimal, lower, and higher risk based upon responses to these 4 items. RESULTS: A suicide assessment was triggered 1 or more times by 17.6% (44 of 250) of Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) participants and 16.5% (51 of 309) of Indiana Cancer Pain and Depression (INCPAD) participants at some point in the trial. Of the patients who triggered a suicide assessment, the majority (29 of 44 in SCAMP and 27 of 51 in INCPAD) were classified as minimal risk by the algorithm. Only 1 (0.4%) of the SCAMP participants and 5 (1.6%) of the INCPAD participants were classified as higher risk. Among the latter, the most common factors preventing patients from attempting suicide were the "4 F's": faith, family, future hope, and fear of failing in their attempt. CONCLUSIONS: Preliminary findings suggest that the P4 screener may be useful in assessing potential suicide risk in the clinical care of depressed patients as well as in clinical research. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00118430 (SCAMP) and NCT00313573 (INCPAD).

The Indiana Cancer Pain and Depression (INCPAD) trial Design of a telecare management intervention for cancer-related symptoms and baseline characteristics of study participants.

OBJECTIVE: Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20-30% of oncology patients. Both symptoms are frequently either unrecognized or undertreated, however. This article describes a telecare management intervention delivered by a nurse-psychiatrist team that is designed to improve recognition and treatment of pain and depression. The enrolled sample is also described. METHODS: The Indiana Cancer Pain and Depression study is a National Cancer Institute-sponsored randomized clinical trial. Four hundred five patients with cancer-related pain and/or clinically significant depression from 16 urban or rural oncology practices throughout Indiana have been enrolled and randomized to either the intervention group or to a usual-care control group. Intervention patients receive centralized telecare management coupled with automated home-based symptom monitoring. Outcomes will be assessed at 1, 3, 6 and 12 months by research assistants blinded to treatment arms. RESULTS: Of 4465 patients screened, 2185 (49%) endorsed symptoms of pain or depression. Of screen-positive patients, about one-third were ineligible (most commonly due to pain or depression not meeting severity thresholds or to pain that is not related to cancer). Of the 405 patients enrolled, 32% have depression only, 24% have pain only and 44% have both depression and pain. At baseline, participants reported an average of 16.8 days out of the past 4 weeks during which they were confined to bed or had to reduce their usual activities by > or =50% due to pain or depression. Also, 176 (44%) reported being unable to work due to health reasons. CONCLUSIONS: When completed, the Indiana Cancer Pain and Depression trial will test whether centralized telecare management coupled with automated home-based symptom monitoring improves outcomes in cancer patients with depression and/or pain. Findings will be important for both oncologists and mental health clinicians confronted with oncology patients' depression or pain.

Access to communication technologies in a sample of cancer patients: an urban and rural survey.

BACKGROUND: There is a growing awareness among providers of the symptom burden experienced by cancer patients. Systematic symptom screening is difficult. Our plan was to evaluate a technology-based symptom screening process using touch-tone telephone and Internet in our rural outreach cancer program in Indiana. Would rural patients have adequate access to technologies for home-based symptom reporting? OBJECTIVES: 1) To determine access to touch-tone telephone service and Internet for patients in urban and rural clinics; 2) to determine barriers to access; 3) to determine willingness to use technology for home-based symptom reporting. METHODS: Patients from representative clinics (seven rural and three urban) in our network were surveyed. Inclusion criteria were age greater than 18, able to read, and diagnosis of malignancy. RESULTS: The response rate was 97%. Of 416 patients completing the survey (230 rural, 186 urban), 95% had access to touch-tone telephone service, while 46% had Internet access (56% of urban patients, 38% of rural patients). Higher rates of Internet access were related to younger patient age, current employment, and higher education and income. The primary barrier to Internet access was lack of interest. Use of the Internet for health related activities was less than 50%. The preferred means of symptom reporting in patients with internet access were the touch-tone telephone (70%), compared to reporting by the Internet (28%). CONCLUSION: Access to communication technologies appears adequate for home-based symptom reporting. The use of touch-tone telephone and Internet reporting, based upon patient preference, has the potential of enhancing symptom detection among cancer patients that is not dependent solely upon clinic visits and clinician inquiry.

Cancer pain, fatigue, distress, and insomnia in cancer patients.

Insomnia is common among cancer patients, occurring in approximately 30% to 50% of the cancer population. The interactions between cancer pain, insomnia, fatigue, and depression/anxiety are complex, warranting treatment plans that focus not only on the relief of specific symptoms to improve quality of life but also on the impact of treatment on other related symptoms. Pain is one of the most common symptoms experienced by cancer patients and is one of the primary factors that precipitate insomnia in this population. Fatigue is also commonly reported by cancer patients, with a prevalence of nearly 80% in some tumor types. Cancer-related fatigue occurs most often after surgery, chemotherapy, radiotherapy, or immunotherapy and has been reported by cancer patients to be the major obstacle to normal functioning and a good quality of life. Insomnia in cancer patients often occurs in association with psychological disorders such as depression or anxiety. Sleep disturbances are associated with aberrant patterns of cortisol secretion, such as those found in insomnia, which are known to significantly depress the immune system, particularly the cells of the immune system responsible for mounting a defense against tumors. Evidence suggests that management of insomnia through a combination of pharmacologic and nonpharmacologic means can have a positive impact not only on insomnia but also on related symptoms and, consequently, on overall health and quality of life. Although the treatment of insomnia in cancer patients can improve cancer-related fatigue, immune functioning, and overall quality of life, insomnia in the context of cancer is still undertreated. Physicians should use hypnotic agents appropriately and be aware of the reduced potential for producing tolerance and dependence with the nonbenzodiazepine hypnotic agents. The management of insomnia in cancer patients should include a global treatment plan designed to address not only the underlying sleep disturbance but also the related symptoms that may contribute to insomnia or occur as a result of it.

A retrospective chart review of the use of olanzapine for the prevention of delayed emesis in cancer patients.

Chemotherapy-induced delayed emesis (DE) affects approximately 50-70% of patients receiving moderately and highly emetogenic chemotherapy. DE most commonly occurs within the first 24-48 hours of chemotherapy administration and can persist for 2-5 days. Olanzapine, which has been used anecdotally for chronic nausea in advanced cancer patients, might be a useful treatment for the prevention of delayed emesis in chemotherapy patients. We conducted a chart review to explore this hypothesis and to plan potential studies. Using pharmacy records or an electronic medical record, we identified all patients who had received olanzapine in the oncology clinic (n = 98). We reviewed these records and selected all patients (n = 28) who had received olanzapine for the prevention of delayed emesis for structured review. There were 17 women (60.7%) and 11 men (39.3%). Eleven patients (39.3%) had at least one instance of nausea recorded while undergoing olanzapine treatment and seven (25%) had an episode of vomiting recorded. During 95 total cycles of chemotherapy with olanzapine (mean = 3.4 cycles per patient), there were 21 incidents of nausea (22.1%) and 10 instances of vomiting (10.5%). Side effects were rarely noted. These data suggest that olanzapine was well tolerated and may reduce the incidence of delayed emesis in patients receiving moderate to highly emetogenic chemotherapy. A series of prospective trials are underway.

An unsuccessful attempt to develop a single-item screen for insomnia in cancer patients.

The focus of this pilot study was to examine issues of criterion validity and detection of insomnia utilizing a single item from the Zung Self-Rating Depression Scale (ZSDS) as a means to rapidly screen cancer patients in ambulatory oncology clinics. In our previous work, we have demonstrated the usefulness of other single items for screening purposes, such as for fatigue. The sleep item reads "I have trouble sleeping through the night" and is rated on a 4-point Likert scale ranging from "none or little of the time" to "most or all of the time." Fifty-two oncology patients were administered the ZSDS and further evaluated with the Pittsburgh Sleep Quality Index (PSQI). The sensitivity and specificity of various cutoffs on the ZSDS sleep item were investigated as predictors of the PSQI. Results revealed that the ZSDS single-item screen has poor sensitivity and specificity for detecting insomnia in cancer patients, and that the relationship between insomnia and depression is more complicated than anticipated. The use of this single item, or perhaps any single item, as a means of screening for sleep disturbances in cancer patients may be problematic. A better understanding of insomnia and its measurement are worthwhile areas of study.

A chart review, pilot study of two single-item screens to detect cancer patients at risk for cachexia.

OBJECTIVE: Cachexia is a problematic wasting syndrome experienced by some cancer patients that can lead to early death in these patients. The purpose of the present study was to examine the criterion validity and sensitivity and specificity of two single items from a depression scale to rapidly screen patients in ambulatory oncology clinics for cancer-related nutritional risk and cachexia. METHODS: A chart review was conducted of 50 randomly selected patient profiles. Patients' responses to item 5 ("I eat as much as I used to") and item 7 ("I notice I am losing weight") of the Zung Self Rating Depression Scale (ZSDS) were compared against the Scored Patient-Generated Subjective Global Assessment (PG-SGA) as well as to Body Mass Index (BMI) scores and weight at two time periods. RESULTS: Item 5 of the ZSDS was significantly related to initial weight (F3,45 = 6.06, p < 0.001), weight at 6-month follow-up (F3,27 = 4.16, p < 0.05), BMI score (F3,46 = 2.89, p < 0.05), and nutritional risk on the PG-SGA (F3,45 = 5.80, p < 0.01). Item 7 of the ZSDS was only a significant predictor of nutritional risk as measured by the PG-SGA (F3,46 = 6.01, p < 0.01). When the two items were combined to form a two-item scale, it maintained the individual items' significant relationship to the PG-SGA (F1,48 = 13.99, p < 0.001). Using this as the criterion for identifying nutritionally at-risk patients, the two-item screen yields a sensitivity of 50% and specificity of 88%. SIGNIFICANCE OF THE RESEARCH: It is concluded that a single item or a combination of two items can yield a reliable initial screen for identifying patients who might be at nutritional risk for the development of cachexia. Further study is needed in prospective trials to further explore the utility of these items.

Initial validation of a scale to measure purposelessness, understimulation, and boredom in cancer patients: toward a redefinition of depression in advanced disease.

OBJECTIVE: The problem of boredom in people with cancer has received little research attention, and yet clinical experience suggests that it has the potential to profoundly affect quality of life in those patients. We were interested in developing a Purposelessness, Understimulation, and Boredom (PUB) Scale to identify this problem and to begin to differentiate it from depression. METHODS: Cancer patients and professionals were interviewed using a semi-structured format to elicit their perceptions of the incidence, causes, scope, and consequences of boredom. From their responses, 45 questions were developed, edited for clarity, and piloted. A total of 100 cancer patients were recruited to participate in the study. Preliminary validation of the PUB using a cross-sectional survey of the measure was conducted. Other instruments used for purposes of convergent and divergent validity included the Functional Assessment of Cancer Therapy Scale-Anemia, Zung Self-Rating Depression Scale, Boredom Proneness Scale, Leisure Boredom Scale, Cancer Behavior Inventory, Systems of Belief Inventory, and the Eastern Cooperative Oncology Group Performance Status Scale. RESULTS: The average age of the sample was 62.37 years (SD = 13.43) and was comprised of 60 women (60.00%) and 40 men (40.00%). The results of a factor analysis on the 45 initial items (selected on the basis of professional and patient interviews) created a two-factor scale. The eight items from the strongest factor (items 1, 2, 3, 4, 5, 6, 9, 10) seemed to best tap the construct that could be deemed as overt boredom whereas the six items of the second factor (items 36, 38, 39, 42, 44, 45) seemed to tap the construct of boredom related to meaning and spirituality. Total scale internal consistency, when all 14 items were included in the analysis, yielded a coefficient alpha of 0.84 and good test-retest reliability at 2 weeks (r = .80, p < .001). The novel 14-item PUB Scale was significantly correlated to other measures of boredom; the Boredom Proneness Scale (r = -.588, p < .001) and the Leisure Boredom Scale (r = .576, p < .001). SIGNIFICANCE OF RESULTS: The PUB Scale was found to be a statistically viable tool with the ability to detect boredom and differentiate it from depression. In many respects this work is in concert with much of the current research and clinical effort going on in psycho-oncology that defines components of distress that in sum, redefines depression in advanced cancer.