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This review compares the key features and psychometric properties of three site-specific quality of life measures that are currently being used in clinical trials for new therapeutic agents for lung cancer. These measures include the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and its lung cancer module (EORTC-QLQ-LC13), the Functional Assessment of Cancer Therapy--Lung Cancer Quality of Life Instrument (FACT-L), and the Lung Cancer Symptom Scale (LCSS). Differences are found among the three instruments. However, these differences allow choice of detail concerning specific aspects of quality of life, depending on the purpose of the assessment. All three instruments have acceptable feasibility. The FACT-L and LCSS are also reliable measures for lung cancer patients, but the EORTC lung cancer module needs refinement of its pain subscale and further testing of reliability. Additionally, all three instruments have support for validity, with the LCSS and EORTC lung cancer modules having had more extensive testing, and having been tested with larger samples than the FACT-L. The EORTC and FACT are still under development; thus, each will need further testing. The LCSS has fewer questionable psychometric properties than the other two measures, and the development of items is complete. For repeated measures with patients with the progressive disease of lung cancer, the LCSS provides less patient and staff burden with its nine-item patient and six-item observer scales. Both the EORTC lung cancer module and FACT-L are measures that expect the core measure to be administered, requiring 40+ items each. Alternatively, the EORTC and the FACT, including their site-specific modules, provide a more comprehensive assessment than the LCSS, if that is the intent of the quality of life assessment.
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PMID:Comparison of instruments for measuring quality of life in patients with lung cancer. 861 Feb 35

This paper reports the development and validation of a questionnaire assessing fatigue and anemia-related concerns in people with cancer. Using the 28-item Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire as a base, 20 additional questions related to the symptoms and concerns of patients with anemia were developed. Thirteen of these 20 questions dealt with fatigue, while the remaining 7 covered other concerns related to anemia. Using semi-structured interviews with 14 anemic oncology patients and 5 oncology experts, two instruments were produced: The FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items, and the FACT-Anemia (FACT-An), consisting of the FACT-F plus 7 nonfatigue items. These measures were, in turn, tested on a second sample of 50 cancer patients with hemoglobin levels ranging from 7 to 15.9 g/dL. The 41-item FACT-F and the 48 item FACT-An scores were found to be stable (test-retest r = 0.87 for both) and internally consistent (coefficient alpha range = 0.95-0.96). The symptom-specific subscales also showed good stability (test-retest r range = 0.84-0.90), and the Fatigue subscale showed strong internal consistency (coefficient alpha range = 0.93-0.95). Internal consistency of the miscellaneous nonfatigue items was lower but acceptable (alpha range = 0.59-0.70), particularly in light of their strong relationship to patient-rated performance status and hemoglobin level. Convergent and discriminant validity testing revealed a significant positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and a predicted lack of relationship with social desirability. The total scores of both scales differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < 0.0001). The 13-item Fatigue subscale of the FACT-F and the 7 nonfatigue items of the FACT-An also differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < or = 0.001). The FACT-F and FACT-An are useful measures of quality of life in cancer treatment, adding more focus to the problems of fatigue and anemia. The Fatigue Subscale may also stand alone as a very brief, but reliable and valid measure of fatigue.
J Pain Symptom Manage 1997 Feb
PMID:Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. 909 63

This study evaluated post-treatment performance and quality of life (QOL) outcome in head and neck cancer (HNC) patients treated with organ preservation, intensive chemoradiotherapy (FHX). Participants were 47 Stage II-IV HNC patients with no evidence of disease at least one year post-completion of organ preservation, concomitant FHX treatment. Patients were assessed via a semi-structured in-person interview, standardized measures of QOL (FACT-H&N, CES-D), performance (PSS-HN) and patients' perception of residual side effects. Disease, treatment and toxicity data were retrieved from medical charts and protocol records. The most salient performance impairment was inability to eat a normal solid food diet, with 50% of patients able to eat soft foods or take liquids only. This specific functional deficit was not related to global QOL, nor to specific quality of life dimensions. Dry mouth, the most frequent and severe residual effect, was not associated with outcome diet, depression or QOL. Residual pain, seen in only 15% of patients, appeared to influence both functional and QOL parameters as well as being a marker for other troublesome symptoms. Twenty-three per cent of patients were depressed; depression was associated with past problems related to alcohol abuse. Decreased QOL and increased depressive symptomatology were related to total number and severity of residual effects. The data highlight the importance of systematic study of QOL dimensions and caution against making assumptions about patients' experience of particular disease and treatment sequelae.
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PMID:Performance and quality of life outcome in patients completing concomitant chemoradiotherapy protocols for head and neck cancer. 922 85

Quality of life (QoL) was investigated in 56 BMT recipients. The objective was to compare QoL in terms of physical, emotional, and social functioning between patients within the first year after BMT (n = 15) and patients who were alive more than 1 year after BMT (n=41). The Functional Assessment of Cancer Therapy Scale (FACT-BMT) and the EORTC-Quality of Life Questionnaire (EORTC-QLQ C30) were used to evaluate QoL as perceived by the patients. Results show a significantly reduced general QoL in patients within the first year after BMT. Specific differences were identified on the dimensions of physical and emotional well-being and the symptom scales of appetite loss, fatigue, pain, dyspnea, and nausea and vomiting. QoL improves significantly with time after BMT. We suggest that there should be more integration of QoL expectancy into the pre-BMT information process. Patients should be informed about potential deficits in physical and emotional well-being within the first year after BMT. This could enhance insight and compliance in the critical period early after BMT.
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PMID:Time after bone marrow transplantation as an important variable for quality of life: results of a cross-sectional investigation using two different instruments for quality-of-life assessment. 976 Jan 49

This study examined the criterion validity and sensitivity and specificity of a single item to rapidly screen patients in ambulatory oncology clinics for cancer-related fatigue. In an effort to expand the utility of the Zung Self-Rating Depression Scale (ZSDS) as a screen for other symptoms, the utility of the single fatigue item was examined. The fatigue item reads "I get tired for no reason" and is rated on a four-point scale ranging from "none or a little of the time" to "most or all of the time." Fifty-two subjects were administered the Zung, the Functional Assessment of Cancer Therapy-Anemia (FACT-An) scale, and the Fatigue Symptom Inventory (FSI). The Zung item was highly correlated with the ZSDS (r= 0.63, p < 0.0001) and the FACT-An (r = -0.70, p < 0.0001), as well as to the individual items of the FSI, ranging from 0.41 (p < 0.003) to 0.71 (p < 0.0001). All 10 subjects considered to be depressed based on the ZSDS were also considered to fatigued on the FACT-An. Setting the ZSDS item cutoff point at level 3--"A good part of the time"--yielded a sensitivity of 78.95% and a specificity of 87.88%. It is concluded that a single item can be a fast and accurate way of screening cancer patients for fatigue to trigger additional follow-up, thus expanding the utility of a depression screening tool for problems other than the purely psychiatric.
J Pain Symptom Manage 2001 Nov
PMID:I get tired for no reason: a single item screening for cancer-related fatigue. 1172 96

Anemia is a common cause of cancer-related fatigue. A systematic review of the literature was performed to establish guidelines on the use of epoetin alfa for the treatment of anemia. The evidence in support of these guidelines was selected, reviewed, and summarized by the members of the Canadian Cancer and Anemia Guidelines Development Group. The effects of epoetin alfa on quality of life (QOL) in patients with cancer were examined in 5 randomized, placebo-controlled trials and 2 large, open-label, nonrandomized, community-based studies. The effects of epoetin alfa on red blood cell transfusion requirements were examined in 19 randomized controlled trials (RCTs) with 21 comparisons. All trials compared epoetin alfa to a suitable control group, examined specified outcome measures that could be analyzed, and studied patients with cancer who were receiving chemotherapy. Trials involving patients with hematologic malignancies originating in the bone marrow were excluded. Outcome measures included 1) quality of life (QOL) (as measured by scales including the Linear Analogue Self-Assessment [LASA] and the Functional Assessment of Cancer Therapy [FACT] subscales), and 2) transfusion requirements (as measured by the proportion of patients requiring transfusion and amount of transfusion). The analysis confirmed that epoetin alfa produced statistically significant and clinically relevant improvements in QOL in patients with cancer. The overall relative risk ratio for transfusion among patients receiving epoetin alfa was calculated to be 0.60 (95% Cl, 0.53-0.69; P < 0.00001), representing a 40% reduction in the proportion of patients requiring transfusion. These results support recommendations for the use of epoetin alfa in patients with cancer-related anemia.
J Pain Symptom Manage 2001 Nov
PMID:Epoetin alfa in cancer patients: evidence-based guidelines. 1172 99

This study's aim was to develop and validate a symptom index derived from the Functional Assessment of Cancer Therapy-Hepatobiliary, a questionnaire measuring general and hepatobiliary disease specific aspects of quality of life. The item pool was narrowed to 26 questions that assess symptoms and function. Each of 95 hepatobiliary cancer experts narrowed the list to 5 of the most important to attend to when treating advanced hepatobiliary disease. Eight symptoms were endorsed by more than 20% of the experts (3 pain, 2 fatigue, nausea, weight loss, jaundice) and were named the FACT-Hepatobiliary Symptom Index-8 (FHSI-8). Among 51 hepatobiliary cancer patients, the FHSI-8 showed good internal consistency (0.79), test-retest reliability (r = 0.86), strong association with mood (r = -0.56), and patient differentiation by ECOG Performance Status Rating ( P < 0.0001) and treatment status ( P = 0.057). Symptom scaling in diseases such as hepatobiliary cancer is feasible and may provide an efficient, clinically-relevant endpoint for following groups over time.
J Pain Symptom Manage 2002 Jul
PMID:Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: the FACT Hepatobiliary Symptom Index. 1218 93

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.
J Pain Symptom Manage 2002 Oct
PMID:Development of a cancer pain prognostic scale. 1250 5

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.
J Pain Symptom Manage 2002 Nov
PMID:Longitudinal documentation of cancer pain management outcomes: a pilot study at a VA medical center. 1254 49

Magnitude differences in scores on a measure of quality of life that correspond to differences in function or clinical course are called clinically important differences (CIDs). Anchor-based and distribution-based methods were used to provide ranges of CIDs for five targeted scale scores of the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. Three samples of cancer patients were used: Sample 1 included 50 patients participating in a validation study of the FACT-An; Sample 2 included 131 patients participating in a longitudinal study of chemotherapy-induced fatigue; sample 3 included 2,402 patients enrolled in a community-based clinical trial evaluating the effectiveness and safety of a treatment for anemia. Three clinical indicators (hemoglobin level; performance status; response to treatment) were used to determine anchor-based differences. One-half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Analyses supported the following whole number estimates of a minimal CID for these five targeted scores: Fatigue Scale = 3.0; FACT-G total score = 4.0; FACT-An total score = 7.0; Trial Outcome Index-Fatigue = 5.0; and Trial Outcome Index-Anemia = 6.0. These estimates provide a basis for sample size estimation when planning for a clinical trial or other longitudinal study, when the purpose is to ensure detection of meaningful change over time. They can also be used in conjunction with more traditional clinical markers to assist investigators in determining treatment efficacy.
J Pain Symptom Manage 2002 Dec
PMID:Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. 1255 4


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