The Brief Perceived Cognitive Impairment Scale-Korean: A Validation Study.

BACKGROUND: Practical brief measures are needed for clinicians and researchers to identify and effectively manage cognitive impairment in cancer patients. OBJECTIVE: This study evaluated the reliability (ie, internal consistency reliability) and validity (ie, construct, convergent, concurrent, and known-group validity) of the Brief Perceived Cognitive Impairment Scale-Korean (BPCIS-K). METHODS: From a university hospital, 249 cancer patients participated. The BPCIS-K was constructed with 6 items evaluating key aspects of cognitive impairment in cancer patients. For internal consistency reliability, Cronbach's α and item-total correlations were evaluated. For construct validity, confirmatory factor analysis was performed. For convergent validity, Pearson correlations were tested with the Functional Assessment of Cancer Therapy-Cognitive Function. For concurrent validity, Pearson correlations were tested with the Functional Assessment of Chronic Illness Therapy-Fatigue. For known-group validity, t tests were performed. RESULTS: The BPCIS-K showed high internal consistency reliability (Cronbach's α = .92; item-total correlations ranged from 0.76 to 0.81). Factor analysis confirmed the scale is unidimensional. It is highly associated with another validated cognitive impairment measure (r = -0.91, P < .001) and moderately correlated with a fatigue measure (r = -0.52, P < .001). In known-group validity, female and patients undergoing treatment experienced more severe impairment than did male patients and patient awaiting treatment (P = .05, P = .08, respectively). CONCLUSION: The BPCIS-K is valid and reliable for assessing cancer patients' perceived cognitive impairment, particularly in concentration, memory, and executive functions. IMPLICATION FOR PRACTICE: This study introduces a practical brief measure to clinicians and researchers.

Chemotherapy-associated cognitive impairments in Korean cancer patients: Risk factors and functional outcome.

OBJECTIVE: To identify those experiencing significant self-reported cognitive decline over 2 time points during chemotherapy, examine the risk factors for cognitive decline, and examine differences between those with and without significant decline in functional limitations. METHODS: This secondary analysis used data from 163 cancer patients, collected from a Korean University hospital. Significant decline was determined by 15% or more reduction from baseline in the Functional Assessment of Cancer Therapy-Cognitive Function. Multivariate logistic regression was performed to estimate risk factors. Repeated-measures ANOVA and t tests tested differences in groups with and without cognitive decline in cognitive impairment and functional limitation. RESULTS: About 31% (n = 51) experienced significant cognitive decline. Groups with and without decline significantly differed in cognitive-impairment changes over time (F = 238.49, P < .001) and in functional limitations at follow-up (t test, P < .01). Those experiencing increased fatigue over time (odds = 0.94, P < .05) and those who underwent 2 or more cycles between time 1 and 2 (odds = 2.61; P < .05) had higher risk of significant decline over time during chemotherapy. CONCLUSION: Significant cognitive decline occurred during active chemotherapy; attention to cognitive impairment should be given in the early phase of chemotherapy.

Identifying the subtypes of cancer-related fatigue: results from the population-based PROFILES registry.

PURPOSE: Little research has been done to identify possible cancer-related fatigue (CRF) subtypes and to classify cancer survivors accordingly. We aimed to identify CRF subtypes in a large population-based sample of (long term) stage I-III colorectal cancer survivors. We also identified factors associated with the CRF subtypes. METHODS: Respondents completed the Multidimensional Fatigue Inventory and other validated questionnaires on anxiety and reduced positive affect (anhedonia), sleep quality, and lifestyle factors (body mass index and physical activity). Latent class analysis was used to derive the CRF subtypes. Factors associated with the derived CRF subtypes were determined with multinomial logistic regression. RESULTS: Three CRF classes were identified: class 1 (no fatigue and distress, n = 644, 56%), class 2 (low fatigue, moderate distress, n = 256, 22%), and class 3 (high fatigue, moderate distress, n = 256, 22%). Multinomial logistic regression results show that survivors in class 3 were more likely to be female, were treated with radiotherapy, have comorbid diabetes mellitus, and be overweight/obese than survivors in class 1 (reference). Survivors in classes 2 and 3 were also more likely to have comorbid heart condition, report poorer sleep quality, experience anhedonia, and report more anxiety symptoms when compared with survivors in class 1. CONCLUSIONS: Three distinct classes of CRF were identified which could be differentiated with sleep quality, anxiety, anhedonia, and lifestyle factors. IMPLICATIONS FOR CANCER SURVIVORS: The identification of CRF subtypes with distinct characteristics suggests that interventions should be targeted to the CRF subtype.

Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial.

INTRODUCTION: This multicenter phase 2 study assessed the combination of estramustine and weekly paclitaxel with metastatic castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: We enrolled 77 patients who had received no prior chemotherapy for CRPC between 1998 and 2000; a total of 74 subjects were eligible for the study. Each 8-week cycle included paclitaxel 90 mg/m2 provided intravenously weekly for 6 weeks, followed by 2 weeks off therapy and oral estramustine 280 mg twice daily for 3 days beginning 24 hours before the first dose of paclitaxel. The primary end point was rate of objective or prostate-specific antigen (PSA) response at 16 weeks. A 50% response rate was considered of further interest. RESULTS: Eligible patients received a median of 3 cycles (range, 1-10 cycles). The response rate among patients with measurable disease was 34% (95% confidence interval [CI], 19-52). The PSA response rate was 58% (95% CI, 47-70). Clinical benefit rate was 45% (95% CI, 33-57). The median progression-free survival was 5.9 months (95% CI, 4.4-6.7). The median overall survival was 17.6 months (95% CI, 14.6-20.8). The most common clinical grade 3/4 toxicities were fatigue (14%) and sensory neuropathy (7%). Grade 3/4 hematologic toxicities included lymphopenia (21%) and anemia (9%). There was one toxicity-related death. Quality-of-life scores improved by week 8, but the change was not statistically significant. CONCLUSION: The combination has activity defined by PSA declines in CRPC but did not meet the protocol-specified end point for efficacy as defined by objective response rate. Since this study was conducted, more effective, better-tolerated regimens have been developed.

Post-treatment problems of African American breast cancer survivors.

PURPOSE: African American breast cancer survivors (AABCS) have a lower survival rate across all disease stages (79 %) compared with White survivors (92 %) and often have more aggressive forms of breast cancer requiring multimodality treatment, so they could experience a larger burden of post-treatment quality of life (QOL) problems. This paper reports a comprehensive assessment of the number, severity, and domains of problems faced by AABCS within 5 years after treatment completion and identifies subgroups at risk for these problems. METHODS: A population-based random sample was obtained from the Pennsylvania Cancer Registry of African American females over 18 years of age who completed primary treatment for breast cancer in the past 5 years. A mailed survey was used to document survivorship problems. RESULTS: Two hundred ninety-seven AABCS completed the survey. The median number of survivor problems reported was 15. Exploratory factor analysis of the problem scale revealed four domains: emotional problems, physical problems, lack of resources, and sexuality problems. Across problem domains, younger age, more comorbid conditions, and greater medical mistrust were risk factors for more severe problems. CONCLUSIONS: The results demonstrated that AABCS experienced significant problem burden in the early years after diagnosis and treatment. In addition to emotional and physical problem domains that were documented in previous research, two problem domains unique to AABCS included lack of resources and sexuality concerns. At risk groups should be targeted for intervention. The study results reported in this manuscript will inform future research to address problems of AABCS as they make the transition from cancer patient to cancer survivor.

Validity and Reliability of the Taiwanese Version of the General Fatigue Scale in Cancer Patients.

BACKGROUND: Fatigue has been described as the most frequent and distressing problem of cancer patients undergoing chemotherapy. OBJECTIVE: The aim of this study is to evaluate the validity and reliability of the Taiwanese version of the General Fatigue Scale (GFS-T) and to evaluate the severity of the fatigue among breast cancer patients in Taiwan. METHODS: A cross-sectional research design was used, recruiting breast cancer patients from 2 medical centers in Taiwan. Patients completed the scale exploring their GFS-T, the Brief Fatigue Inventory-Taiwan Form, and the Eastern Cooperative Oncology Group Performance Status. The data were collected between the day before the first chemotherapy (T1) and 1 week after the first chemotherapy (T2). RESULTS: A total of 171 patients participated in this study. Cronbach's α for the GFS-T at both time points both were .94. Factor analysis generated 1 factor that accounted for 73.7% of variance in participants' fatigue. The receiver operating characteristic curve analyses suggested that the GFS-T cut-point of 24 had an adequate combination of sensitivity and specificity to distinguish high and low performance status. The receiver operating characteristic curve is 0.67 (95% confidence interval, 0.59-0.75). CONCLUSIONS: The GFS-T is a reliable and valid instrument for assessing fatigue among cancer patients. Further research is needed to better understand predictors of cancer-related fatigue. IMPLICATIONS FOR PRACTICE: The GFS-T can provide clinical nurses with a useful measure to assess fatigue in cancer patients.

Subgroups of cancer patients with unique pain and fatigue experiences during chemotherapy.

CONTEXT: Some cancer patients experience pain and fatigue, whereas others experience only one of the two symptoms. Yet, it is not clear who experiences these unique patterns and why. OBJECTIVES: This study aimed to identify subgroups of cancer patients with unique pain and fatigue experiences in two different chemotherapy cycles to examine how selected factors influenced subgroup membership and identify how subgroups differed in concurrently measured functional limitation outcome. METHODS: The sample included 276 patients with diverse cancer types from four U.S. sites. To investigate subgroups, latent profile analyses were performed. Multinomial logistic regression and one-way analysis of variance-type analyses were conducted to examine the influencing variables of subgroup membership and to examine differences among subgroups in patient outcome. RESULTS: The high-pain/high-fatigue (HPHF) and low-pain/low-fatigue subgroups were found at both time points. The low-pain/high-fatigue subgroup was present only in the first chemotherapy cycle. Pain and fatigue levels significantly differentiated subgroups at each time point (all P<0.05). Across the two time points, experiencing higher depressed mood increased the risk to be in the HPHF subgroup (all P<0.01). The HPHF subgroup had the most serious limitations in activities (all P<0.01). CONCLUSION: This study confirmed the existence of a unique symptom experience of pain and fatigue. This pattern should be acknowledged for symptom assessment and management.

Comparison of groups with different patterns of symptom cluster intensity across the breast cancer treatment trajectory.

BACKGROUND: Comparing subgroups with different patterns of change in symptom intensity would assist in sorting out individuals at risk for more severe symptoms and worse functional outcomes. OBJECTIVES: The objectives of this study were to identify and compare subgroups of breast cancer patients with different patterns of change in a psychoneurological symptom cluster intensity across the treatment trajectory. METHODS: This secondary analysis used the data from 160 breast cancer patients undergoing chemotherapy or radiation treatment. Psychoneurological symptom cluster intensity was a composite score of 5 symptoms (depressed mood, cognitive disturbance, fatigue, insomnia, and pain) in a psychoneurological cluster at each of 3 time points (ie, at baseline and at 2 follow-ups after chemotherapy or radiation treatment). RESULTS: Five distinct subgroups representing different patterns of psychoneurological symptom cluster intensity during breast cancer treatment were identified: the gradually increasing pattern subgroup (group 1), the constantly low pattern subgroup (group 2), the start low with dramatic increase and decrease pattern subgroup (group 3), the constantly high pattern subgroup (group 4), and the start high with dramatic decrease and leveling pattern subgroup (group 5). Patients without previous cancer treatment experience, with higher level of education, treated with chemotherapy, and/or with more limitations at the baseline were more likely to follow the pattern group 4. Patients in group 4 had the most serious functional limitations measured at the second follow-up time point. CONCLUSION: The results suggest the need to evaluate interventions for specific subgroups and to examine the causal mechanisms underlying a psychoneurological symptom cluster. IMPLICATION: Clinicians should consider these diverse symptom experiences for assessment/management.

Recommendations for high-priority research on cancer-related fatigue in children and adults.

Over the past decades, some scientific progress has been made in understanding and treating cancer-related fatigue (CRF). However, three major problems have limited further progress: lack of agreement about measurement, inadequate understanding of the underlying biology, and problems in the conduct of clinical trials for CRF. This commentary reports the recommendations of a National Cancer Institute Clinical Trials Planning Meeting and an ongoing National Cancer Institute working group to address these problems so that high-priority research and clinical trials can be conducted to advance the science of CRF and its treatment. Recommendations to address measurement issues included revising the current case definition to reflect more rigorous criteria, adopting the Patient Reported Outcomes Measurement Information System fatigue scales as standard measures of CRF, and linking legacy measures to the scales. With regard to the biology of CRF, the group identified the need for longitudinal research to examine biobehavioral mechanisms underlying CRF and testing mechanistic hypotheses within the context of intervention research. To address clinical trial issues, recommendations included using only placebo-controlled trial designs. setting eligibility to minimize sample heterogeneity or enable subgroup analysis, establishing a CRF severity threshold for participation in clinical trials, conducting dissemination trials of efficacious interventions (such as exercise), and combining nonpharmacologic and pharmacologic interventions to exploit the potential synergy between these approaches. Accomplishing these goals has the potential to advance the science of CRF and improve the clinical management of this troubling symptom.

Predictors of depression in breast cancer patients treated with radiation: role of prior chemotherapy and nuclear factor kappa B.

BACKGROUND: Depression is common during and after breast cancer treatment. However, the role of specific therapeutic modalities and related biologic mechanisms remains unclear. Radiation is an essential component of breast-conserving therapy and may contribute to depression in patients with breast cancer through the activation of inflammatory pathways. METHODS: Depressive symptoms and inflammatory mediators, including nuclear factor kappa B (NF-κB), were assessed at baseline (before radiation), during radiation, and 6 weeks after radiation in 64 women who had stage 0 through IIIA breast cancer. RESULTS: No significant increases in depressive symptoms occurred during or after radiation, although a number of patients exhibited moderate-to-severe depression throughout the study. Multivariate analyses of baseline factors predictive of depression revealed that educational status, perceived stress, prior chemotherapy, and peripheral blood NF-κB DNA binding all were independent predictors of persistent depressive symptoms after radiation (all P < .05). Of these factors, only prior chemotherapy was associated with inflammatory mediators, including NF-κB DNA binding, soluble tumor necrosis factor-alpha receptor 2, and interleukin-6, which, in univariate analyses predicted depressive symptoms after radiation (all P < .05). Chemotherapy-treated patients also exhibited an over-representation of gene transcripts regulated by NF-κB. CONCLUSIONS: Radiation was not associated with increased depressive symptoms in the current study, but of disease and treatment-related factors, prior chemotherapy predicted significant depression after radiation. Longitudinal studies are warranted to investigate the relationship among prior chemotherapy, inflammation, and persistent depression after breast cancer treatment.

Preparing individuals to communicate genetic test results to their relatives: report of a randomized control trial.

This study reports a randomized clinical trial evaluating the efficacy of an intervention to prepare individuals to communicate BRCA1/BRCA2 results to family members. Women aged 18 years and older, who had genetic testing, and who had adult first-degree relatives, were randomly assigned to a communication skills-building intervention or a wellness control session. Primary outcomes were the percentage of probands sharing test results, and the level of distress associated with sharing. The ability of the theory of planned behavior variables to predict the outcomes was explored. Four hundred twenty-two women were enrolled in the study, 219 (intervention) and 203 (control). Data from 137 in the intervention group and 112 in the control group were analyzed. Two hundred forty-nine probands shared test results with 838 relatives (80.1 %). There were no significant differences between study groups in the primary outcomes. Combining data from both arms revealed that perceived control and specific social influence were associated with sharing. Probands were more likely to share genetic test results with their children, female relatives and relatives who they perceived had a favorable opinion about learning the results. The communication skills intervention did not impact sharing of test results. The proband's perception of her relative's opinion of genetic testing and her sense of control in relaying this information influenced sharing. Communication of test results is selective, with male relatives and parents less likely to be informed. Prevalent psychosocial factors play a role in the communication of genetic test results within families.

Common biological pathways underlying the psychoneurological symptom cluster in cancer patients.

BACKGROUND: A symptom cluster is a group of symptoms that occur together and are interrelated. The clinical implication of symptom cluster research is to use the clustering patterns of symptoms to understand the mechanisms for these symptoms and develop management strategies targeted at multiple symptoms. OBJECTIVE: The purposes of this review were to summarize the evidence for a psychoneurological symptom cluster in cancer patients, to provide information regarding the underlying biological mechanisms for each of the psychoneurological symptoms within the cluster, and to propose possible common biological pathways that may underlie this cluster. METHODS: A systematic review of the literature was conducted. RESULTS: Empirical evidence exists to support a cluster of psychoneurological symptoms (ie, depressive symptoms, cognitive disturbance, fatigue, sleep disturbance, pain). At a molecular level, common biological pathways (ie, proinflammatory cytokines, hypothalamic-pituitary-adrenal axis, and monoamine neurotransmission system) may underlie the development of symptoms within this cluster. Activation of proinflammatory cytokines is proposed as a first stage of mechanistic pathway. However, other biological factors, such as lowered estrogen or hemoglobin levels, may influence psychoneurological cluster. CONCLUSION: Additional studies are needed to confirm the roles of cytokines as well as other biological factors in the development of the psychoneurological cluster and to determine the biomarkers to identify the subgroups of cancer patients who are at greatest risk for this cluster. IMPLICATIONS FOR PRACTICE: This information can be used by researchers and clinicians to guide the selection of symptom management strategies that are ideally targeted to the biological mechanisms that underlie this symptom cluster.

Clinical subgroups of a psychoneurologic symptom cluster in women receiving treatment for breast cancer: a secondary analysis.

PURPOSE/OBJECTIVES: To investigate clinical subgroups using an empirically identified psychoneurologic symptom cluster (depressed mood, cognitive disturbance, fatigue, insomnia, and pain) and to examine the differences among subgroups in the selected demographic and clinical variables, as well as in patient outcome (i.e., functional performance). DESIGN: Secondary analysis. SETTING: A university health science center in Salt Lake City, UT, and a National Cancer Institute-designated comprehensive cancer center in Philadelphia, PA. SAMPLE: 282 patients with breast cancer undergoing chemotherapy or radiotherapy. METHODS: Cluster analyses were conducted to identify subgroups. Multinomial logistic regression and one-way analyses of variance were used to examine the differences among subgroups. MAIN RESEARCH VARIABLES: Depressed mood, cognitive disturbance, fatigue, insomnia, pain, and functional performance. FINDINGS: Patients were classified into four distinct subgroups based on their symptom cluster experience: all low symptom, high fatigue and low pain, high pain, and all high symptom. Such patient classification patterns were consistent across the treatment trajectory, although group memberships were inconsistent. After initiating treatment, two additional subgroups emerged: high depressed mood and cognitive disturbance, and high fatigue and insomnia. Subgroups differed in physical performance status at baseline, symptom burden, and treatment modality in a relatively consistent pattern across time points. Patients in the all-high-symptom subgroup experienced the most serious limitations in activities across all time points. CONCLUSIONS: Patient subgroups exist that share the unique experience of psychoneurologic symptoms. IMPLICATIONS FOR NURSING: Findings are useful to determine who needs more intensive symptom management during cancer treatment. Future studies should examine whether specific symptom management strategies are more efficient for certain subgroups.

Patients' experiences with cancer-related fatigue: a review and synthesis of qualitative research.

PURPOSE/OBJECTIVES: To systematically review published qualitative reports of descriptions of fatigue by patients with cancer and how cancer-related fatigue (CF) affects their lives. DATA SOURCES: MEDLINE®, CANCERLIT®, Cochrane Database of Systematic Reviews, and the Cumulative Index to Nursing and Allied Health Literature. DATA SYNTHESIS: Two researchers conducted independent reviews of 667 patient quotes found in 154 articles published from 1996-2009 to identify concepts and language used to describe CF. CONCLUSIONS: CF is more intense than the tiredness patients recalled from before diagnosis or treatment. Published patient quotes fail to adjudicate whether CF should be approached as a single symptom or a more complex symptom cluster. IMPLICATIONS FOR NURSING: Systematic study of patients with different cancer types and stages is needed to identify effective, valid, and reliable self-reported assessments of CF for clinical practice and trials.

Studying cancer-related fatigue: report of the NCCN scientific research committee.

NCCN convened a committee of experts to make recommendations for future studies of cancer-related fatigue (CRF). The committee reviewed the current data on the incidence, clinical measurement, and treatment of CRF. The assessment of fatigue is largely derived from self-report questionnaires that address the symptom of fatigue, and do not correlate the presence of fatigue with change in physical activity. The committee developed a self-report questionnaire, NCCN Fatigue and Contributing Factors Inventory, which incorporates assessments of fatigue, pain, difficulty sleeping, distress, physical activity, and concurrent medications. A clinical research study using this measure in conjunction with the NCCN Breast Cancer Outcomes Database Project is planned. The committee noted a strong interaction among fatigue, pain, difficulty sleeping, and distress and recommended that future clinical research address these interactions.

ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials.

CONTEXT: Development of pharmacological and behavioral interventions for cancer-related fatigue (CRF) requires adequate measures of this symptom. A guidance document from the Food and Drug Administration offers criteria for the formulation and evaluation of patient-reported outcome measures used in clinical trials to support drug or device labeling claims. METHODS: An independent working group, ASCPRO (Assessing Symptoms of Cancer Using Patient-Reported Outcomes), has begun developing recommendations for the measurement of symptoms in oncology clinical trials. The recommendations of the Fatigue Task Force for measurement of CRF are presented here. RESULTS: There was consensus that CRF could be measured effectively in clinical trials as the sensation of fatigue or tiredness, impact of fatigue/tiredness on usual functioning, or as both sensation and impact. The ASCPRO Fatigue Task Force constructed a definition and conceptual model to guide the measurement of CRF. ASCPRO recommendations do not endorse a specific fatigue measure but clarify how to evaluate and implement fatigue assessments in clinical studies. The selection of a CRF measure should be tailored to the goals of the research. Measurement issues related to various research environments were also discussed. CONCLUSIONS: There exist in the literature good measures of CRF for clinical trials, with strong evidence of clarity and comprehensibility to patients, content and construct validity, reliability, and sensitivity to change in conditions in which one would expect them to change (assay sensitivity), and sufficient evidence to establish guides for interpreting changes in scores. Direction for future research is discussed.

Sleep quality after initial chemotherapy for breast cancer.

GOALS OF WORK: The goal of this study is to characterize sleep quality and quantity prior to and in the first three nights after initial chemotherapy for breast cancer. MATERIALS AND METHODS: This study makes use of secondary analysis of data from two separate randomized clinical trials (RCT) of behavioral interventions to improve fatigue and sleep. Patients came from two comprehensive cancer centers, three clinical cancer centers, and 10 community clinics in five states. Participants were women with stage I-IIIA breast cancer treated with anthracycline and/or cyclophosphamide-based regimens. MAIN RESULTS: Baseline data from each RCT were used in the analysis. Sixty-five percent of women self-reported poor sleep in the month preceding chemotherapy using the Pittsburgh Sleep Quality Index (PSQI) score >5. Three nights of actigraphy data indicated a wide range of sleep experience with an average of 10 awakenings and time (minutes) awake after sleep onset (WASO-M) averaging 61 min per night. The first night's sleep was the worst. There was no statistically significant relationship between self-reported poor sleep and sleep measures obtained by actigraphy. Women with poor sleep at baseline (global PSQI >5) had significantly lower (p < 0.001) physical (PCS) and mental (MCS) health status. However, neither the PCS nor MCS was associated with any of the average actigraphy sleep parameters or night 1 parameters in the aggregated sample. Increasing age was also associated with poorer sleep. CONCLUSIONS: A high percent of women with breast cancer begin chemotherapy with disturbed sleep and the initial nights after chemotherapy are characterized by sleep fragmentation that disrupts sleep maintenance. Interventions should focus on strategies to decrease the number and duration of night awakenings. Further research is needed to identify predictors of poor sleep during this time.