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Context: Comprehensive symptom assessment is crucial for symptom management. The Memorial Symptom Assessment Scale-Short Form (MSAS-SF) has been validated for symptom assessment in cancer patients, but there is no simplified Chinese version., Objectives: To present the validation procedures and results for the simplified Chinese version of the Memorial Symptom Assessment Scale-Short Form (MSAS-SF-SC) among cancer patients in mainland China., Methods: The MSAS-SF was translated and culturally adapted into simplified Chinese. About 359 cancer patients completed the MSAS-SF-SC, the Chinese Functional Assessment of Cancer Therapy-General, the Chinese Brief Fatigue Inventory, the Chinese Hospital Anxiety and Depression Scale, and the Chinese Medical Outcomes Study Social Support Survey. Reliability was assessed by internal consistency and test-retest coefficients. Convergent and divergent validity were analyzed by Pearson's correlation coefficients between MSAS-SF-SC subscales and the other instruments. Known-groups validity used Eastern Cooperative Oncology Group-Performance Status, hemoglobin level, and primary site., Results: The MSAS-SF-SC was reliable with Cronbach's alpha coefficients for subscales ranging from 0.782 to 0.874 and test-retest coefficients ranging from 0.819 to 0.872. MSAS-SF-SC subscales correlated with corresponding Chinese Functional Assessment of Cancer Therapy-General subscales (-0.557 to -0.680; P < 0.001), Chinese Brief Fatigue Inventory (0.620; P < 0.001), and Chinese Hospital Anxiety and Depression Scale (0.663; P < 0.001) indicating convergent validity. MSAS-SF-SC subscales showed low or no correlations with the Chinese Medical Outcomes Study Social Support Survey (-0.146 to -0.165; P < 0.01), indicating divergent validity. MSAS-SF-SC subscales showed appropriate differences by Eastern Cooperative Oncology Group-Performance Status, hemoglobin level, and primary site., Conclusion: The MSAS-SF-SC demonstrated good psychometric properties and is culturally adapted. The instrument could be a valuable tool for Chinese health care professionals and researchers., (Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Cancer is prevalent in the rapidly growing Chinese American community, yet little is known about the symptom experience to guide comprehensive treatment planning. This study evaluated symptom prevalence and patient subgroups with symptom distress in a large sample of Chinese American cancer patients., Methods: Patients were consecutively recruited from 4 oncology practices, and they completed a translated cancer symptom scale. Latent class cluster analysis was used to identify subgroups of patients with distinct symptom distress profiles., Results: There were 1436 patients screened; 94.4% were non-English-speaking, and 45.1% were undergoing cancer therapy. The cancers included breast (32.6%), lung (14.8%), head and neck (12.5%), and hematologic cancer (10.1%). Overall, 1289 patients (89.8%) had 1 or more symptoms, and 1129 (78.6%) had 2 or more. The most prevalent symptoms were a lack of energy (57.0%), dry mouth (55.6%), feeling sad (49.3%), worrying (47.5%), and difficulty sleeping (46.8%). Symptoms causing "quite a bit" or "very much" distress included difficulty sleeping (37.9%), a lack of appetite (37.2%), feeling nervous (35.8%), pain (35.2%), and worrying (34.0%). Four patient subgroups were identified according to the probability of reporting moderate to high symptom distress: very low physical and psychological symptom distress (49.5%), low physical symptom distress and moderate psychological symptom distress (25.2%), moderate physical and psychological symptom distress (17.4%), and high physical and psychological symptom distress (7.8%)., Conclusions: Symptom prevalence is high in community-dwelling Chinese American cancer patients, and nearly half experience severe distress (rated as "quite a bit" or "very much" distressing) from physical symptoms, psychological symptoms, or both. These data have important implications for the development of effective symptom control interventions., (© 2015 American Cancer Society.)

Context: Physicians overestimate survival in patients with advanced cancer. Patient-reported outcomes could provide another way to estimate survival. We previously reported four prognostic groups based on Karnofsky Performance Status, Functional Assessment of Cancer Therapy physical well-being subscale, and Memorial Symptom Assessment Scale-Short Form physical symptom distress subscale scores., Objectives: To determine the validity of these four prognostic groups., Methods: We performed prospective surveys. Data from a total of 880 Veterans Affairs Medical Center patients, 417 in the First Cohort and 463 in the Validation Cohort, were analyzed. Both inpatients and outpatients were prospectively recruited in Institutional Review Board-approved studies from August 1999 to September 2009. Survival was measured from the date of entry until death or December 1, 2009. Patients completed self-assessments with the Functional Assessment of Cancer Therapy and Memorial Symptom Assessment Scale-Short Form. Analysis of variance was used to test differences between groups in continuous variables; a generalized Wilcoxon test was used for differences between groups for survival., Results: The average age in the Validation Cohort was 66.5 years and 98% were men. The majority of patients had metastatic cancer (90%), with lung (28%) and prostate (26%) cancers being predominant. The median Karnofsky Performance Status was 70. Median survival was 33, 46.5, 124, and 209.5 days for the four prognostic groups (P < 0.0001, all pair-wise comparisons P < 0.02)., Conclusion: The four prognostic groups remained distinct in the prospective cohort. Small differences in patient-reported physical well-being can halve survival estimates. Patient-reported outcomes can correct for physician overestimate of prognosis. This study provides a way to use patient-reported outcomes for prognosis in patients with advanced cancer, with important implications for assessment., (Published by Elsevier Inc.)

Background: Cancer pain is usually managed by oncologists, occasionally with input from specialists in hospice and palliative medicine (PLM) or pain medicine (PMD). We evaluated the knowledge of cancer pain management in these three specialty groups., Methods: Eight vignettes depicting challenging scenarios of patients with poorly controlled pain were developed; each had five or six treatment choices. Respondents indicated choices likely to be safe and efficacious as "true" and choices likely to be unsafe or inefficacious as "false." Two questionnaires were created, each with four vignettes. Three anonymous mailings targeted geographically representative U.S. samples of 570 oncologists, 266 PMD specialists, and 280 PLM specialists, each randomly assigned one version of the questionnaire. Vignette scores were normalized to a 0-100 numeric rating scale (NRS); a score of 50 indicates that the number of correct choices equals the number of incorrect choices (consistent with guessing)., Results: Overall response rate was 49% (oncologists, 39%; PMD specialists, 48%; and PLM specialists, 70%). Average vignette score ranges were 53.2-66.5, 45.6-65.6, and 50.8-72.0 for oncologists, PMD specialists, and PLM specialists, respectively. Oncologists scored lower than PLM specialists on both questionnaires and lower than PMD specialists on one. On a 0-10 NRS, oncologists rated their ability to manage pain highly (median 7, with an interquartile range [IQR] of 5-8). Lower ratings were assigned to pain-related training in medical school (median 3, with an IQR of 2-5) and residency/fellowship (median 5, with an IQR of 4-7). Oncologists older than 46-47 years rated their training lower than younger oncologists., Conclusion: These data suggest that oncologists and other medical specialists who manage cancer pain have knowledge deficiencies in cancer pain management. These gaps help clarify the need for pain management education., (©AlphaMed Press.)

Purpose: To understand changes in pain severity over time and to explore the factors associated with pain changes in ambulatory patients with solid tumors., Patients and Methods: We enrolled 3,106 patients with invasive cancer of the breast, prostate, colon/rectum, or lung from multiple sites. At baseline and 4 to 5 weeks later, patients rated their pain level on a 0 to 10 numerical rating scale. A 2-point change in pain score was defined as a clinically significant change in pain. Multivariable logistic models were fitted to examine the effects of pain management and demographic and clinical factors on change in pain severity., Results: We analyzed 2,761 patients for changes in pain severity. At initial assessment, 53.0% had no pain, 23.5% had mild pain, 10.3% had moderate pain, and 13.2% had severe pain. Overall, one third of patients with initial pain had pain reduction within 1 month of follow-up, and one fifth had an increase, and the improvement and worsening of pain varied by baseline pain score. Of the patients without pain at initial assessment, 28.4% had pain (8.9% moderate to severe) at the follow-up assessment. Logistic regression analysis showed that inadequate pain management was significantly associated with pain deterioration, as were lower baseline pain level, younger age, and poor health status., Conclusion: One third of patients have pain improvement and one fifth experience pain deterioration within 1 month after initial assessment. Inadequate pain management, baseline pain severity, and certain patient demographic and disease characteristics are associated with pain deterioration.

Background: A set of common cancer-related and treatment-related symptoms has been proposed for quality of care assessment and clinical research. Using data from a large, multicenter, prospective study, the authors assessed the effects of disease site and stage on the percentages of patients rating these proposed symptoms as moderate to severe., Methods: The severity of 13 symptoms proposed to represent "core" oncology symptoms was rated by 3106 ambulatory patients with cancer of the breast, prostate, colon/rectum, or lung, regardless of disease stage or phase of care; 2801 patients (90%) repeated the assessment 4 to 5 weeks later., Results: At the time of the initial assessment, approximately 33% of the patients reported ≥ 3 symptoms in the moderate-to-severe range; 11 of the 13 symptoms were rated as moderate to severe by at least 10% of all patients and 6 were rated as moderate to severe by at least 20% of those receiving active treatment. Fatigue/tiredness was the most severe symptom, followed by disturbed sleep, pain, dry mouth, and numbness/tingling. More patients with lung cancer and patients receiving active treatment reported moderate to severe symptoms. Percentages of symptomatic patients increased by disease stage, less adequate response to therapy, and declining Eastern Cooperative Oncology Group performance status. The percentages of patients reporting moderate to severe symptoms were stable across both assessments., Conclusions: The results of the current study support a core set of moderate to severe symptoms that are common across outpatients with solid tumors, that can guide consideration of progression-free survival as a trial outcome, and that should be considered in clinical care and in assessments of quality of care and treatment benefit., (© 2013 American Cancer Society.)

Introduction: Risk factors for employment difficulties after cancer diagnosis are incompletely understood, and interventions to improve post-cancer employment remain few. New targets for intervention are needed., Methods: We assessed a cohort of 530 nonmetastatic cancer patients (aged ≤ 65 years, >6 months from diagnosis, off chemo- or radiotherapy) from the observational multi-site Symptom Outcomes and Practice Patterns study. Participants reported employment change, current employment, and symptoms. Groups were based on employment at survey (working full- or part-time versus not working) and whether there had been a change due to illness (yes versus no). The predictive power of symptom interference with work was evaluated for employment group (working stably versus no longer working). Race/ethnicity, gender, cancer type, therapy, and time since diagnosis were also assessed. Association between employment group and specific symptoms was examined., Results: The cohort was largely non-Hispanic white (76 %), female (85 %), and diagnosed with breast cancer (75 %); 24 % reported a change in employment. On multivariable analysis, participants with at least moderate symptom interference were more likely to report no longer working than their less effected counterparts (odds ratio (OR) = 8.0, 95 % CI, 4.2-15.4), as were minority participants compared with their non-Hispanic white counterparts (OR = 3.2, 95 % CI, 1.8-5.6). Results from the multiple regression model indicated the combination of fatigue (OR = 2.3, 95 % CI, 1.1-4.7), distress (OR = 3.9, 95 % CI, 1.7-9.0), and dry mouth (OR = 2.6, 95 % CI, 1.1-6.2) together with race/ethnicity and time since diagnosis adequately accounted for employment group., Conclusions: Our findings support the hypothesis that residual symptom burden is related to post-cancer employment: Residual symptoms may be targets for intervention to improve work outcomes among cancer survivors., Implications for Cancer Survivors: This analysis examines whether increased symptom burden is associated with a change to not working following a cancer diagnosis. We also examined individual symptoms to assess which symptoms were most strongly associated with not working after a cancer diagnosis. Our hope is that we will be able to use this information to both screen survivors post-active treatment as well as target high-risk symptoms for further and more aggressive intervention, in an attempt to improve post-cancer work outcomes.

Background: Little is known about cancer pain in Chinese Americans. The objective of this study was to describe the epidemiology of pain in this population. This information is needed to identify and address unmet clinical needs for culturally relevant interventions targeting pain and its consequences., Methods: A consecutive sample of underserved ethnic Chinese patients in a large community-based oncology practice was screened for persistent or frequent pain. Those patients with pain completed translated instruments assessing demographics, linguistic acculturation, disease-related characteristics, and pain-related characteristics., Results: Of 312 patients screened, 178 (57.1%) reported frequent or persistent pain, 175 were eligible, and 170 participated. Most participants (85.9%) were born in China and 84.7% overall spoke Cantonese only. The most common cancers were gastrointestinal (28.2%), lung (21.8%), breast (20.6%), head and neck (12.9%), and genitourinary (4.7%); 43.5% had metastatic disease. The mean worst pain severity on a 0-10 numeric scale was 4.7 (standard deviation, 2.4), with 28.2% of patients rating their worst pain at ≥7 of 10. Although 37.6% used opioids and 47.1% used nonopioids, 45.8% reported "little" or "no" pain relief from medications. Complementary or alternative medicine therapies for cancer pain were used by 35.8%. In multiple regression analyses, worst pain was positively associated with acculturation to the English language and opioid therapy, and pain-related distress was positively associated with opioid therapy., Conclusion: Pain is prevalent among community-dwelling, ethnic Chinese American cancer patients. Additional studies are needed to confirm these results and investigate the finding that higher linguistic acculturation is associated with reports of more intense pain.

There are very few symptom assessment instruments in Chinese. We present the validity and reliability of the Memorial Symptom Assessment Scale Short Form (MSAS-SF) and the Condensed Form MSAS (CMSAS) in Chinese cancer patients. The Chinese version of the 32-item MSAS-SF, a self-report measure for assessing symptom distress and frequency in cancer patients, was administered to 256 Chinese patients with colorectal cancer at a clinical oncology outpatient unit. Highly prevalent symptoms included worrying (59%), dry mouth (54%), lack of energy (54%), feeling sad (48%), feeling irritable (48%), and pain (41%). Both the MSAS-SF and CMSAS demonstrated good validity and reliability. For the MSAS-SF subscales, Cronbach alphas ranged from 0.84 to 0.91, and for CMSAS subscales, from 0.79 to 0.87. Moderate-to-high correlations of MSAS-SF and CMSAS subscales with appropriate European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 subscales (0.42-0.71, Ps<0.001) indicated acceptable convergent validity. Low correlations with the Rosenberg Self-Esteem and Optimism Scale (0.22, P<0.001) indicated divergent validity. MSAS subscales varied as expected with other Chinese scales--the Chinese Health Questionnaire (CHQ) and the Life Orientation Scale. Construct validity of both MSAS versions was demonstrated by effective differentiation between clinically distinct patient groups (Karnofsky scores <80% vs. > or =80% [P<0.001]; no active treatment vs. active treatment [P<0.002-0.034]; CHQ-12 scores < or =4 vs. CHQ-12 scores >4 [P<0.001]). The Number of Symptoms subscale correlated appropriately with the EORTC QLQ-C30 function (-0.46 to -0.60, P<0.001) and symptom scales (0.31-0.64, P<0.001). The average time to complete the MSAS-SF was six minutes. The Chinese versions of the MSAS-SF and CMSAS are valid and practical measures. Further validation is needed for Chinese patients with other cancer types and with other symptom instruments.

Cancer pain often presents in a body region. This review summarizes articles from 1999-2004 relevant to cancer pain syndromes in the head and neck, chest, back, abdomen, pelvis, and limbs. Although the evidence is limited, progress is being made in further development of the evidence base to support and guide current practice.

Cancer pain assessment and management are integral to palliative medicine. This paper reviews recent publications in the period 1999-2004 in the broad categories of epidemiology, pain assessment, nonpharmacologic approaches to cancer pain (radiation therapy, anesthetic blocks, palliative surgery and chemotherapy, complementary and alternative medicine), and in nociceptive pain, neuropathic pain, visceral pain, and bone pain.

Anorexia and appetite assessment is an important priority in supportive oncology. A series of 156 veterans participating in a hematology oncology service completed the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), the Functional Assessment of Cancer Therapy-General scale, the Memorial Symptom Assessment Scale Short Form (MSAS-SF), and the Zung Self-Rating Depression Scale and were followed for survival. The FAACT score correlated well with Karnofsky performance status, quality of life, and symptom distress subscales. A single appetite distress item from the MSAS-SF correlated well with these measures. Both appetite measures correlated with the presence of other symptoms and with concurrently measured hemoglobin, serum sodium, albumin, and cholesterol levels. These self-reported appetite measures were univariate predictors of survival and contributed additional prognostic information to data related to weight-loss distress. In a smaller study, the FAACT score correlated with a visual analogue measure of appetite and with the North Center Cancer Treatment Group appetite instrument. These data support use of these tools for the evaluation of appetite concerns among patients with advanced cancer.

Veteran patients possess distinctive characteristics such as a higher mortality rate, lower socioeconomic status and poorer health status. We report the prevalence and predictors of unmet needs and examine the association between unmet needs and quality of life (QOL). Two hundred ninety-six male cancer patients who presented with distressing symptom(s) completed the following instruments: a 14-item multidimensional unmet needs questionnaire, Functional Assessment of Cancer Therapy (FACT-G), Memorial Symptom Assessment Scale-Short Form (MSAS-SF) and other validated measurements of function, depression, health and social support. Multiple linear regression models were used to identify independent predictors of each unmet needs domain and of total unmet needs. The relationships between total unmet needs, QOL and multidimensional variables were also explored. The median number of total unmet needs was three, and the most frequently reported unmet needs areas were physical (80.0%), activities of daily living (53.3%), nutrition (46.1%) and emotional (32.5%). Different predictors of each unmet needs domain were identified. Younger age was associated with a higher risk of unmet needs in physical, economic and medical domains. Higher psychological symptom distress was associated with more unmet needs in the emotional/social, economic and medical domains. Physical symptom distress, extent of disease and health measure were only significant in the physical unmet needs domain. The depression, psychological and physical symptom distress scores, confident and affective social support scores, total unmet needs and age independently predicted FACT-G total QOL score (R(2)=63%, P < 0.00001). Patients with higher psychological, physical symptom distress and depression scores, younger age, lower functional status and metastatic disease were more likely to report more unmet needs. The total number of unmet needs was predictive of QOL. The unmet needs and QOL outcomes model was developed but needs further validation.

Background: Rapid and efficient symptom assessment is an important aspect of palliative care. The objective was to determine whether a smaller number of symptoms from the 32-item Memorial Symptom Assessment Scale Short-Form (MSAS-SF) could convey equivalent quality of life (QOL) information., Methods: Responses from 479 medical oncology patients who completed the MSAS-SF and the Functional Assessment Cancer Therapy (FACT-G) were analyzed. Canonical correlations were performed to assess the relationships of 32 MSAS-SF symptoms to quality of life (FACT-G domains) and clinical variables [age, Karnofsky performance status (KPS), stage of disease, and inpatient status]. The relation of the subscales of the Condensed MSAS (CMSAS) and FACT-G to survival was assessed in a multivariate model., Results: The median age was 67 years (range, 20-89) and median KPS was 80% (range, 20-100). Primary sites were prostate in 141 (29%) patients, lung in 121 (26%) patients, colorectal in 53 (11%) patients, hematologic in 50 (10%) patients, head and neck in 30 (6%) patients and other in 84 (18%) patients. Median survival was 245 days (range, 1-2,215 days). Canonical correlation analyses identified a five-dimensional QOL factor structure. Symptoms important for QOL also correlated significantly with survival and provided the basis for the CMSAS with 14 symptoms and 3 subscales (CMSAS SUM, CMSAS PHYS, and CMSAS PSYCH). In multivariate analyses, the CMSAS PSYCH predicted survival independently of stage, performance status, and QOL. The CMSAS takes 2-4 minutes to complete., Conclusion: The CMSAS contains both QOL and survival information approximately equivalent to the original 32 items.

We performed an exploratory recursive partitioning analysis (RPA) in 429 metastatic cancer patients who had completed a Functional Assessment of Cancer Therapy-General (FACT-G) and a Memorial Symptom Assessment Scale-Short Form (MSAS-SF) to define survival prognostic groups. The Cox model analysis also was performed. Both RPA and Cox models included Karnofsky performance status (KPS), age, FACT-G subscales, and MSAS-SF subscales as survival predictors. Of 429 patients, 348 patients (81.1%) had expired at time of analysis. The median age was 67 years (27-89), with median length of survival of 147 days. The RPA identified four distinct survival groups (p < .0001) with three variables: KPS, physical well-being, and physical symptom distress. The most significant split was KPS of 50%, followed by physical well-being score of 25 and physical symptom distress score of 0.6. The median survival time was 29 days for patients with KPS < 50%; 146 days for patients with KPS > or = 50% and physical well-being < 25; 292 days for patients with KPS > 50%, physical well-being > or = 25, and physical symptom distress score > 0.6; and 610 days for patients with KPS > or = 50%, physical well-being > or = 25, and physical symptom distress score < or = 0.6. The Cox model found, in addition to KPS (p < .0001) and physical well-being (p = .08), different predictors: psychological symptom distress (p = .0007), global distress index (p = .02), and age (p < .0001). We concluded that the KPS, quality of life, and symptom distress scores can be combined to define prognostic groups. Such models may be helpful for clinical decision making.

Objectives: Caregiver outcomes among those caring for symptomatic advanced cancer patients at VA Medical Centers have not been well reported. The purposes of this study were (1) to identify the caregiver characteristics and their unmet needs; (2) to examine the association between caregiver unmet needs, caregiver burden, and caregiver satisfaction; and (3) to identify the independent predictors of different caregiver outcomes., Methods: One hundred caregivers completed three caregiver outcomes instruments: Family Inventory of Needs (FIN), Care Strain Index (CSI), and Family Satisfaction with Advanced Cancer Care (FAMCARE). The caregivers' demographics and their function, depression, health status, and social support status as well as the caregivers' perception of the patients' unmet needs (PPUN) were obtained. Principal component analysis was performed to examine the underlying dimensions of caregiver outcome measures. Pearson correlation and stepwise multivariate regression analyses were performed., Results: The median number of unmet needs was 2 and the median CSI score was 4. Most of unmet needs were related to information needs (needing more information related to home care, finding help with the problems at home, and disease prognosis) and symptom management. The majority of caregivers were satisfied or very satisfied by the care patients received. Spouse caregivers (N = 60, 60%) were significantly older (p = 0.006) with higher unemployment rates (p = 0.001), higher depression scores (p = 0.04), and lower social support scores (p < 0.0001) than nonspouse caregivers (N = 40, 40%). The PPUN predicted caregiver burden and the presence of caregiver unmet needs independently. The presence of caregiver unmet needs was the only independent predictor of caregiver satisfaction. Caregivers with a high PPUN and higher depression score experienced a higher burden., Significance of the Research: The caregiver outcome model is proposed and needs to be further validated in a new cohort of caregivers.

Objective: To identify prospectively functional impairments and rehabilitation needs in an acute care medical oncology unit., Design: Prospective cohort study., Setting: Inpatient medical oncology unit at a Veterans Affairs hospital., Participants: Fifty-five patients admitted over a 6-month period., Interventions: Not applicable., Main Outcome Measures: FIM instrument, functionally based physical examination, Rehabilitation Needs Assessment, and Recreational Needs Assessment., Results: On admission, the mean FIM total score was 105 out of 126, the FIM motor score was 72 out of 91, and the FIM cognitive score was 34 out of 35. The functionally based physical examination did not generally correlate with scores obtained on the FIM. Forty-eight (87%) patients had rehabilitation needs on admission. Forty-six (84%) patients had rehabilitation needs on discharge. Rehabilitation Needs Assessment on admission showed deconditioning in 42 (76%) patients; mobility impairment in 32 (58%) patients; a significant decrease in range of motion in 23 (42%) patients; deficits in activities of daily living in 12 (22%) patients; a need for recreational therapy in 7 (13%) patients; potential for benefit from patient education in 30 (55%) patients; and a need for modalities, edema control, or wound care in fever than 5% of patients. The most commonly requested recreational activity was reading., Conclusions: Patients admitted to inpatient medical oncology units have many unmet, remediable rehabilitation needs that may not be recognized by nonrehabilitation physicians and other clinical staff. These findings suggest that assessment of medical oncology patients may be enhanced by consultation with rehabilitation medicine specialists.

Objectives: The purposes of this study were to study symptomatic metastatic cancer patients' knowledge and attitudes toward end-of-life (EOL) care and to examine how patient-perceived health status affects attitudes toward EOL care and survival., Methods: From 1999 to 2002, 254 symptomatic metastatic cancer patients at the VA New Jersey Health Care System completed the Vermont Voices on Care of the Dying Questionnaire. Survival status and location of death were obtained. Descriptive statistics and the chi square method were used to assess the differences between African Americans (N=109) and Caucasians (N=135), and between different patient-perceived health status groups. A log-rank test was performed to assess for differences in median survival length between different patient-perceived health-status groups., Results: Veterans' responses to the Vermont questionnaire showed knowledge deficits regarding EOL care. There was wide variation in self-rankings of health status: 45.6% of patients rated their illness as serious and life threatening, 18.9% considered their health problem significant but not life threatening, 2.8% thought they were in good health, and one-third of patients were unsure about their health status. Most patients (86.2%) preferred physician frankness when communicating bad news and 61.8% preferred family involvement in EOL discussions. African American patients were less likely to have completed advance directives (p < 0.0001), to have knowledge about hospice programs (p < 0.00001), and to feel capable of assessing their health situation (p = 0.04). Patient-rated health status affected completion rates of advance directives and survival., Significance of the Research: These findings demonstrate knowledge deficits and racial differences in attitudes and values toward EOL care in veterans with cancer. The Vermont questionnaire enables patients to state their EOL preferences but may not be detailed enough for clinical applications. Patient-rated health status may be an important explanatory variable for EOL preferences and length of survival.

The purpose of this study was to identify independent predictors of clinically significant fatigue based upon a multidimensional model. A total of 180 cancer patients completed the Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Memorial Symptom Assessment Scale Short Form (MSAS-SF), and the Zung Self-Rating Depression Scale (SDS). Additional data included Karnofsky Performance Status (KPS) score, laboratory tests, and demographic information. The BFI usual fatigue severity > or =3/10 was defined as clinically significant fatigue. Possible independent variables were identified from a biopsychosocial model of fatigue. Fisher's exact test was used to univariately assess the association of each variable with clinically significant fatigue. Multiple logistic regression analyses were used to identify independent predictors of fatigue within each dimension, and then across dimensions. Fatigue was present in 113 (62%) patients, and 80 (44.4%) patients had usual fatigue > or =3/10. The unidimensional independent predictors were use of analgesics (situation dimension); hemoglobin and serum sodium (biomedical dimension); feeling drowsy, dyspnea, pain and lack of appetite (physical symptom dimension); and feeling sad and feeling irritable (psychological symptom dimension). In a multidimensional model, dyspnea, pain, lack of appetite, feeling drowsy, feeling sad, and feeling irritable predicted fatigue independently with good calibration (Hosmer Lemeshow Chi Square=5.73, P=0.68) and discrimination (area under the receiver operating characteristic curve=0.88). Physical and psychological symptoms predict fatigue independently in the multidimensional model, and superseded laboratory data. These findings support a symptom-oriented approach to assessment of cancer-related fatigue.

Fatigue is a highly prevalent and distressing symptom in cancer patients. The purpose of this study was to assess the validity of three fatigue measures [the Brief Fatigue Inventory (BFI), the Functional Assessment of Cancer Therapy Fatigue Subscale (FACT-F), and the lack of energy item from the Memorial Symptom Assessment Scale Short Form (MSAS-SF)] and compare these measures in relation to broader quality-of-life (QOL) constructs and clinical factors in veteran cancer patients. One-hundred-eighty cancer patients completed the BFI, FACT-F, FACT-G, MSAS-SF, and the Zung depression scale with concurrent Karnofsky performance status (KPS), laboratory tests, and demographic data. The Cronbach alpha coefficient was from 0.93 to 0.94 for BFI fatigue scales and 0.94 for FACT-F. There were significant correlations between BFI subscales, FACT-F, and lack of energy from MSAS-SF (p < 0.0001). All three fatigue measures showed significant correlation with MSAS-SF symptom subscales (p < 0.0001), FACT-G subscales (p < 0.0001), depression (p < 0.0001), KPS (p < 0.0001), inpatient status (P < 0.0001), insomnia (p < 0.05), hemoglobin (p < 0.05), and albumin levels (p < 0.01). Distress from lack of energy discriminated among levels from the BFI, FACT-F, and FACT-G subscales and MSAS-SF subsclea by one-way of variance analysis. Patient responses to BFI, FACT-F, and the lack of energy item yielded similar information about broader QOL constructs and clinical factors. Single questions about lack of energy, or fatigue severity, may provide a simple and acceptable way to assess fatigue.

To document quality-of-life (QOL), symptom distress and Karnofsky Performance Status (KPS) over time, 67 advanced cancer patients completed the Functional Assessment of Cancer Therapy (FACT-G) and Memorial Symptom Assessment Scale - Short Form (MSAS-SF) from the time of determination of no active anti-cancer treatment to death at 3-6 week intervals. The KPS was determined at each time point. Statistical analyses with mixed effects models were performed to examine the association between changes in QOL, symptom distress and KPS at selected time points in the advanced cancer trajectory. Median survival for the population was 115 days, and a median of 5 interviews was completed per patient. Slow steady changes in KPS, MSAS-SF and FACT-G QOL parameters started 6 months prior to death, with accelerated decline in the last 2 to 3 months and dramatic increase in psychological symptoms during the last month. Different domains changed at different rates at different selected time points. The correlation between changes in KPS, FACT-G parameters and MSAS-SF subscales at enrollment and near death suggests that when patients were stable, changes in KPS correlated significantly with changes in sum FACT-G QOL and physical well being, and with changes in the MSAS-SF subscales. However, when patients were near death, changes in KPS did not correlate with any other changes, and only emotional well being reflected changes in physical and psychological symptom distress. The sequence of changes, and how determinants of symptom distress and QOL change over time, may help clinicians assess the prognosis of terminally ill patients and plan appropriate interventions.

Symptom control has become increasingly recognized as an important goal in patient care. In this article, advances in symptom assessment, and various definitions of symptom improvement are reviewed. Theoretical concepts underlying symptom control and clinically significant change are presented, as well as the role of symptom control as an endpoint in clinical trials. Symptom control is then surveyed in two broad categories for selected symptoms. The first area is therapy related symptoms, secondary to chemotherapy, radiation, hormonal therapy, and surgery. Symptoms reviewed include chemotherapy related mucositis, emesis, fatigue; hot flashes; and radiation related dermatitis, xerostomia, and mucositis. The second area is palliative oncologic approaches to disease-related symptoms. Results in palliative chemotherapy, palliative radiation therapy, cancer pain, and lack of appetite are summarized. Areas requiring further research are noted. Findings are presented in both a clinical and research context to help guide the reader with interpreting symptom control studies.

The purpose of this study is to analyze cancer breakthrough pain (BP) characteristics and how BP responds to conventional cancer pain management. Seventy-four cancer pain patients with worst pain severity >or=4 out of 10 completed the Brief Pain Inventory (BPI), Memorial Symptom Assessment Scale-Short Form, Functional Assessment Cancer Therapy and Breakthrough Pain Questionnaires (BPQ) at an initial interview. Agency for Health Care Policy and Research (AHCPR) cancer pain management guidelines were followed. Pain syndromes and morphine equivalent daily dose (MEDD) orally were determined. One-week follow-up assessments were obtained in 66 patients with BPI and BPQ. The BP characteristics were similar at both time points. On day 1, 52 patients (70%) had BP, and the BP was unpredictable in 30 patients (58%). The median time to worst BP severity was 3 min. Patients with BP had significantly higher worst pain (P<0.001). At week 1, the median MEDD doubled from 60 to 120 mg orally, and the number of patients who received adjuvant analgesics doubled from 31.1% (23 patients) on day 1 to 62.2% (41 patients). At week 1, 21 patients (32%) remained without BP, 21 patients (32%) were classified as BP responders and 24 patients (36%) were BP non-responders. The mean pain relief was similar for all three subgroups, i.e. around 80%. Compared to BP responders, BP non-responders had significantly higher worst pain (P<0.0001), average pain (P<0.004), and higher BPI interference parameters and shorter time to worst pain severity. The study confirmed the applicability of the BPQ to an US veteran population, and that pain management following the AHCPR guidelines is effective for a group of patients with cancer related BP. Underlying pain syndromes and the BP location may influence the response of BP to treatment. Patients with bone pain located in the spine, back, and pelvis may be at risk for resistant BP.

We measured pain outcomes in a cohort of patients with cancer pain in a general hematology/oncology setting at a Veterans Administration Medical center (VA). The outcomes included pain relief, pain severity, changes in pain severity, interference scores, symptom distress, quality of life (QOL), and satisfaction. Seventy-four (74) consecutive patients with worst cancer-related pain equal to or greater than 4/10 were recruited. Cancer pain diagnoses were made and the cancer pain management guidelines of the United States Agency for Health Care Policy and Research were followed. Patients were followed weekly using the Brief Pain Inventory (BPI), medication diary, satisfaction questionnaire, visual analogue quality of life scale (VASQOL) and record of side effects for 3 weeks. The Functional Assessment of Cancer Therapy (FACT-G) and Memorial Symptom Assessment Scale Short Form (MSAS-SF) were used at initial and final interviews. The mean initial worst pain severity was 8.3 (range 4-10) and mean pain relief was 40% (range 0-100). By week 1, the majority of patients achieved pain relief of >/=80%, with a corresponding decrease in worst pain severity and pain interference scores. Pain continued to decrease over three weeks. At week 3, there was a significant improvement in the MSAS-SF psychological symptom distress subscale (P = 0.02). The average number of opioid-related side effects was 5 and remained steady over time. Most patients felt "quite a bit" or "very much" satisfied at all weeks. There was a significant improvement in VASQOL (P < 0.005) and in FACTG SUMQOL scores (P = 0.007). This experience demonstrates that cancer pain management can result in measurable and significant changes in pain relief, pain severity, pain interference scores, psychological symptom distress, and QOL scores.

The purpose of this study was to develop a Cancer Pain Prognostic Scale (CPPS) which could predict the likelihood of pain relief within 2 weeks for cancer patients with moderate to severe pain. Seventy-four (74) consecutive patients who presented with cancer-related pain were managed in accordance with the guidelines for pain management developed by the United States Agency for Health Care Policy and Research (AHCPR). Patients were followed weekly using the Brief Pain Inventory (BPI), and medications were recorded weekly for 3 weeks. Baseline scores from the Functional Assessment of Cancer Therapy (FACT-G), Mental Health Inventory (MHI), Karnofsky Performance Status (KPS), and Memorial Symptom Assessment Scale Short Form (MSAS-SF) at initial interview served as explanatory variables in a logistic regression model. Pain relief > or = 80% at the end of weeks 1 and 2 were used as outcomes in this model. From this analysis, we developed a predictive formula, the CPPS, which includes the worst pain severity, FACT-G emotional well being, daily opioid dose, and pain characteristics. The rule yields a numerical score that ranges from 0-17. Higher scores correspond to a higher probability of good pain relief. The CPPS has the potential to rapidly identify patients with poor pain prognosis. It can be used as a research tool to characterize pain in cancer patients.

Background: The correlation of fatigue levels with functional interference, symptom distress, and quality of life may help determine clinically significant fatigue levels., Methods: One hundred eighty consecutive patients with cancer completed the Functional Assessment of Cancer Therapy (FACT) General and Fatigue subscales (FACT-G and FACT-F, respectively), the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), the Depression Scale (Zung), and the Brief Fatigue Inventory (BFI). The Karnofsky performance status (KPS) was determined for each patient. Multivariate analyses of variance were performed to compare fatigue models with different cut-off points to categorize fatigue levels. Cox proportional hazards analysis was performed to assess the association between fatigue severity and survival., Results: Increased fatigue levels were associated with greater symptom distress and decreased quality of life. A model with usual fatigue cut-off points of 0 (no fatigue), 1-2 (mild fatigue), 3-6 (moderate fatigue), and 7-10 (severe fatigue) was optimal in relation to functional interference items (Wilks lambda, 0.36; F = 11.61; P < 0.0001), symptom distress scores (Wilks lambda, 0.52; F = 10.41; P < 0.0001), and quality-of-life scores (Wilks lambda, 0.50; F = 0.50; P < 0.0001). Fatigue severity predicted survival in univariate analysis (chi-square test, 25.42; P < 0.0001). The KPS, stage of disease, and number of symptoms independently predicted survival in patients with fatigue., Conclusions: Clinically relevant fatigue levels are correlated with symptom and quality-of-life measurements. Patients with a usual fatigue severity > 3 or a worst fatigue severity > 4 on a 1-10 scale may require further assessment., (Copyright 2002 American Cancer Society.DOI 10.1002/cncr.10507)

To examine the relationship between different cancer pain management outcomes over time, 74 patients with the worst cancer related pain rated as four or greater on an 11-point numeric scale were followed weekly with the Brief Pain Inventory (BPI), and the satisfaction questionnaire and global visual analogue scale quality of life (VASQOL) for 3 weeks. Univariate and multivariate regression analyses were performed at weekly time points. The analyses indicated that pain outcomes can be categorized into separate QOL and satisfaction paths linked by the worst pain severity. In the QOL path, the worst pain severity predicted a pain interference score, which consistently predicted VASQOL. For the satisfaction path, independent predictors were pain relief at Week 1, and worst pain severity and changes in worst pain severity at Week 2. No variables predicted satisfaction at Week 3. The data suggest that satisfaction and quality of life may be independent outcomes of pain management. The timing of assessment may itself be important.

Background: The Memorial Symptom Assessment Scale Short Form (MSAS-SF), an abbreviated version of the Memorial Symptom Assessment Scale, measures each of 32 symptoms with respect to distress or frequency alone. A physical symptom subscale (PHYS), psychologic symptom subscale (PSYCH), and global distress index (GDI) can be derived from the Short Form. We validated the MSAS-SF in a population of cancer patients., Methods: Two hundred ninety-nine cancer patients examined at the Section of Hematology/Oncology completed the MSAS-SF and the Functional Assessment Cancer Therapy (FACT-G). The Karnofsky performance status (KPS), extent of disease (EOD), and demographic data were assessed. The Cronbach alpha coefficient was used to assess internal reliability. MSAS-SF subscales were assessed against subscales of the FACT-G, the KPS, and EOD to determine criterion validity. Test-retest analysis was performed at 1 day and at 1 week., Results: The Cronbach alpha coefficients for the MSAS-SF subscales ranged from 0.76 to 0.87. The MSAS-SF subscales showed convergent validity with FACT subscales. Correlation coefficients were -0.74 (P < 0.001) for the PHYS and FACT-G physical well-being subscales, -0.68 (P < 0.001) for the PSYCH and FACT emotional well-being subscales, and -0.70 (P < 0.001) for GDI and FACT summary of quality-of-life subscales. The MSAS-SF subscales demonstrated convergent validity with performance status, inpatient status, and extent of disease. The test-retest correlation coefficients for the MSAS-SF subscales ranged from 0.86 to 0.94 at 1 day and from 0.40 to 0.84 for the 1 week group., Conclusions: The MSAS-SF is a valid and easy to use instrument for symptom assessment.

Background: The current study was conducted to assess symptom prevalence and symptom intensity and their relation to quality of life in medical oncology patients at a Veterans Affairs medical center., Methods: Consecutive inpatients and outpatients were asked to complete the Functional Assessment Cancer Therapy (FACT-G), Memorial Symptom Assessment Scale (MSAS), and the Brief Pain Inventory. Symptoms then were analyzed by their relation to Karnofsky performance status (KPS) and quality of life., Results: Two hundred forty patients participated. The median number of symptoms was 8 per patient (range, 0-30 symptoms). The 5 most prevalent symptoms were lack of energy (62%), pain (59%), dry mouth (54%), shortness of breath (50%), and difficulty sleeping (45%). Patients with moderate intensity pain had a median number of 11 symptoms and patients with moderate intensity lack of energy had a median number of 13 symptoms. The number of intense symptoms increased as the KPS decreased (P < 0.001). Patients with moderately intense pain or fatigue also were more likely to experience nausea, dyspnea, and lack of appetite. The number of symptoms rated as present on the MSAS was found to correlate significantly with the FACT-G Sum Quality of Life score., Conclusions: Intense symptoms were highly prevalent in this population. The presence of pain, lack of energy, or poor performance status should lead to comprehensive symptom assessment. Patients free of disease nevertheless still may experience intense symptoms. The number of symptoms present may be a helpful guide to quality of life. Routine comprehensive symptom assessment may identify a significant fraction of patients who urgently require intensive symptom palliation., (Copyright 2000 American Cancer Society.)

Background: Recent data from clinical trials suggest that quality-of-life (QOL) measurements may independently predict survival. The relation between survival and QOL measurements was tested among 122 inpatients and 96 outpatients with malignancies at one of four sites (colon, breast, ovary, or prostate) who participated in a cross-sectional validation study of the Memorial Symptom Assessment Scale (MSAS), a measure of the frequency of, severity of, and distress caused by physical symptoms., Methods: The relation between MSAS summary scores and survival was evaluated in a multivariate analysis that adjusted concurrently for other important covariates, such as age, site and extent of disease, inpatient status, Karnofsky performance status (KPS), and other QOL measurements., Results: In the multivariate analysis, extent of disease (P < 0.0001), inpatient status (P=0.014), higher MSAS physical symptom subscale score (P=0.004), and lower KPS score (P=0.009) independently predicted decreased survival. Other QOL measurements did not contribute significantly to the model., Conclusions: The MSAS physical symptom subscale score significantly predicts survival and adds to the prognostic information provided by KPS and extent of disease. Patients may be under-assessed regarding both the number and the severity of symptoms. Measurements of physical symptoms and related distress offer additional prognostic information concerning the survival of patients with cancer and may account for the predictive value of QOL scores.

Group sequential testing procedures have seen wide use in Phase II clinical trials. The sample proportion p of responders is the commonly used estimator for the binomial response probability p. It can be shown that p is the maximum likelihood estimator (MLE) of p. It is well known that MLE can be in general (Whitehead) and p in particular (Dupont) biased estimators, if ther computation follows a group sequential procedure. In this paper we numerically investigate the bias of p. We find that the magnitude of the bias of p is less than 0.025 in all cases we investigated. We apply the idea in Whitehead to propose a bias-adjusted estimator that reduces the bias substantially and reduces the mean square error as well in a certain range of p. We also evaluate the uniformly minimum variance unbiased (UMVU) estimator. If one does not mind a bias of 0.025, one may find the sample proportion a suitable estimator for p because of its simplicity and easy explanation. If one is concerned with bias, the bias-adjusted estimator may be a good choice.