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.

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.

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.

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.

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.

An open label pilot study of citalopram for depression and boredom in ambulatory cancer patients.

OBJECTIVE: Significant levels of depressive symptoms are an impediment to adjustment and affect greater than one-third of people with cancer. The clinical diagnosis of major depression is estimated to occur in 25%. Depression is dramatically underrecognized by oncologists and oncology nurses, and as a result, often undertreated. Clinical experience suggests that antidepressants of virtually all types are well tolerated and potentially efficacious. There is, however, a lack of an evidence base for the use of antidepressants in cancer patients. METHODS: We undertook an open-label pilot study using citalopram in 30 cancer patients who reported a high level of depressive symptoms on the Zung Self-Rating Depression Scale (ZSDS). In addition to the ZSDS, eligible patients completed a series of visual analog scales for pain, depression, and sleep disturbance; the Functional Assessment of Cancer Therapy-General Module; and the Purposelessness, Understimulation, and Boredom Scale developed by the research team. Patients began a 2-month course of therapy with citalopram 20 mg, increasing to 40 mg at the end of the fourth week if the patient was in the same range of depressive symptoms as measured by the ZSDS. RESULTS: Twenty-one of 30 patients completed the protocol. The average age of the sample was 57.32 years (SD = 12.6) and was comprised of 11 women (52.4%) and 10 men (47.6%). Depressive symptoms decreased and quality of life improved during the 8-week treatment period. Of special interest was the rate of improvement in boredom, and using the total boredom score of the PUB, significant improvement compared to baseline was seen in weeks 6 (F = 5.266, p < .05) and 8 (F = 9.248, p < .01). SIGNIFICANCE OF RESULTS: Overall, the positive findings suggest the need for a randomized, double-blind, placebo-controlled trial of citalopram in cancer patients. Regarding the interplay of boredom and depression, the relationship between improvements in depressive symptoms and boredom is complex. This is illustrated by the way in which the different elements respond to antidepressant treatment. Depression began to improve almost immediately upon initiation of treatment whereas improvement in boredom does not become evident until week 6.

An open-label, crossover trial of mirtazapine (15 and 30 mg) in cancer patients with pain and other distressing symptoms.

We performed a pilot open-label, crossover trial of mirtazapine (15 and 30 mg at night) in advanced cancer patients with pain and other distressing symptoms. Twenty patients completed the trial and sixteen dropped out. Following a baseline assessment, patients completed a one-week observation period and were then randomized to a starting dose of either 15 mg or 30 mg of mirtazapine given at bedtime. After three weeks, subjects were switched to the alternate dose and followed by an additional three-week period, completing the treatment. The average age of the completers was 60.2 years and consisted of 7 women and 13 men. The majority were Caucasian (n = 18, 90%) and married (n = 18, 90%). The drop-out group did not significantly differ from the completers based on age, gender, race, marital status, or tumor type. We examined the impact of mirtazapine therapy on patients' levels of depression, pain intensity, appetite, insomnia, weight, and overall quality of life. A series of repeated measures ANOVAs were conducted to compare the completers' status at Weeks 1, 4, and 7 compared to baseline and to examine the interaction with starting dose and baseline observations. Scores on the Zung self-rating Depression Scale (F = 8.20, P < 0.05) and the Functional Assessment of Cancer Therapy - General Measure (F = 5.73, P < 0.05) were significantly improved at study end (Week 7) and were not dependent on mirtazapine dosage. Patients' weights were significantly higher at both Week 4 and Week 7, independent of dosage. Trend level differences were found on Memorial Pain Assessment Card items for pain, pain relief, and mood and on numeric rating scales measuring nausea, anxiety, insomnia, and appetite. This open-label pilot study suggests that mirtazapine may be effective for improving multiple symptoms, depression and quality of life in patients with advanced cancer. A controlled trial of this drug would be valuable.

Pain clinicians' rankings of aberrant drug-taking behaviors.

A pilot study was conducted to examine experienced pain physicians' perceptions of aberrant drug taking behaviors. One hundred pain physicians attending a meeting on pain management were asked to rank order (from most aberrant = 1 to least aberrant = 13) a list of aberrant drug-taking behaviors. The sample was comprised mainly of anesthesiologists (50%) and half of the group had 10 or more years of pain management experience. The group prescribed an average of 19-96 opioid medications per week. Practice variables were not related to the rank ordering of the behaviors. All of the various behaviors appeared in all 13 of the rank ordering slots, suggesting a great deal of individual difference in the perception of these behaviors. By examining the average ranking of the behaviors, we noted that physicians' focus on illegal behaviors as the most aberrant followed by the alteration of route of delivery and self-escalation of dose. This survey suggests that an experienced group of pain clinicians does not view aberrant drug related behaviors uniformly. Average rankings suggest clinicians seem to view illegal behavior as the most worrisome. These results must be interpreted with caution due to the small convenience sample, the lack of data on the level of addiction medicine training of the respondents and the lack of data on those physicians who chose not to respond. Further inquiry could be used to guide clinicians' responses to aberrant behaviors when encountered in patients on controlled substances for pain.