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David Cella

Publications and source records attributed to David Cella.

At least 109 records · Page 6Linked to original sources
PubMed2002

Fatigue in cancer patients compared with fatigue in the general United States population.

BACKGROUND: Although fatigue is a common symptom among cancer patients, it is also a common experience in the general, healthy population. Its universality has made it difficult to appreciate whether the fatigue experienced by patients with cancer is distinguishable from the fatigue experienced by the general population. Because the etiology of fatigue is multifactorial, it also has been difficult to appreciate fully the relative contribution of anemia to cancer-related fatigue. METHODS: To address this issue, responses to a brief, standardized set of 13 questions from the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System were compared across three groups: anemic cancer patients (n = 2369 patients), nonanemic cancer patients (n = 113 patients), and the general United States population (n = 1010 persons). RESULTS: Fatigue scores of the anemic cancer patients (at both baseline and upon completion of anemia therapy) were significantly worse compared with the scores of nonanemic cancer patients that, in turn, were worse compared with the scores of the general United States population (P < 0.001). Score distributions were quite distinct for these three groups. Within the group of anemic cancer patients, the degree of anemia (mild, moderate, or severe) also was predictive of the degree of fatigue (P < 0.001), although the distributions were not dramatically distinct. CONCLUSIONS: Although anemia is clearly a factor that contributes to the severity of disease-related fatigue among cancer patients, hemoglobin levels explain only part of the difference compared with fatigue among the general United States population. The distinct distributions of fatigue scores of anemic cancer patients compared with the general United States population and the substantial sample sizes of these two groups enabled a discriminant analysis approach that allowed the differentiation of anemic cancer patients from the general population with high sensitivity (0.92) and reasonable specificity (0.69). Thus, although fatigue is a symptom most anyone can relate to, the fatigue of cancer patients, particularly those who are anemic, is decidedly worse. Interventions targeting this common and life-disrupting symptom likely would be of considerable value to patients with cancer.

Anemia↗
PubMed2002

Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: the FACT Hepatobiliary Symptom Index.

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.

Adult↗
PubMed2002

Patient-related barriers to fatigue communication: initial validation of the fatigue management barriers questionnaire.

Fatigue is a highly prevalent and distressing symptom of cancer and its treatment. However, cancer patients often fail to communicate with their oncologists about fatigue. In this study, we attempted to identify the patient-related barriers to communication about fatigue, as cited by patients. Two hundred patients were sampled across the Community Cancer Care, Inc. (CCC) network of Indiana using the Cancer Behavior Inventory-Brief scale (CBI-B), the Zung Self-Rating Depression Scale (ZSDS), the Functional Assessment of Cancer Inventory-Fatigue scale (FACT-F), and the Fatigue Management Barriers Questionnaire (FMBQ), a questionnaire devised by experts in the field of cancer-related fatigue. There were no significant correlations between the instrument scores and demographic variables. Scores on the instruments did not differ significantly based on whether the patient was from a rural or urban site. One hundred thirty-two patients (66%) reported that they had never spoken to their doctor about fatigue. The most frequently reported reasons for this lack of patient communication about fatigue included the doctor's failure to offer interventions (47%), patients' lack of awareness of effective treatments for fatigue (43%), a desire on the patient's part to treat fatigue without medications (40%), and not wanting to complain to the doctor (28%). Patients reported that medical staff offered a mean of 11.63 recommendations for dealing with fatigue. The FMBQ was found to correlate significantly with self-efficacy (CBI-B, r = -0.20, P < 0.01) and correlate weakly with the number of recommendations made (r = -0.15, P < 0.05). The FMBQ was noted to have acceptable internal consistency (alpha = 0.88) and validity and may prove to be a useful instrument for understanding why patients do not communicate about fatigue. Multiple barriers contribute to why cancer patients do not comment about fatigue but may be overcome if physicians screen and assess for this symptom.

Aged↗
PubMed2002

Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales.

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.

Adult↗
PubMed2002

What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592.

To assess the impact of disease and treatment on patients with advanced non-small cell lung cancer (NSCLC), we set out to determine a clinically meaningful change (CMC) on the Lung Cancer Subscale (LCS) and the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. We used data from Eastern Cooperative Oncology Group study 5592 (E5592), a randomized trial comparing three chemotherapeutic regimens in 599 advanced NSCLC patients. Patients completed the FACT-L at baseline (pretreatment), 6 weeks, 12 weeks, and 6 months. Comparing across baseline performance status (0 vs. 1), prior weight loss (<5% vs. > or = 5%), and primary disease symptoms (< or = 1 vs. >1), LCS and TOI score differences ranged from 2.4 to 3.6 and 6.5 to 9.2, respectively (all Ps <.001). Mean improvement in LCS score from baseline to 12 weeks was 2.4 points in patients who had responded to treatment versus 0.0 points in patients who had progressive disease. Twelve-week LCS change scores for patients progressing early were 3.1 points worse than those of patients progressing later (mean = -1.2 vs.1.9, respectively). Similarly, the average TOI change score from baseline to 12 weeks was -6.1 for patients who had progressive disease versus -0.8 points for patients who had responded to treatment. Twelve-week TOI change scores for patients progressing early (mean = -8.1) were 5.7 points worse than those of patients progressing later (mean = -8.1 vs. -2.4, respectively). Analyses assuming nonrandom missing data resulted in slightly larger differences. Clinically relevant change scores were estimated as two to three points for the LCS and five to seven points for the TOI, setting upper limits for minimal CMCs. These values were comparable to suggested distribution-based criteria of a minimally important difference. These results support use of a two to three point change in the LCS and five to six point change on the TOI of the FACT-L as a CMC, and offer practical direction for inclusion of important patient-based endpoints in lung cancer clinical trials.

Adult↗
PubMed2002

Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening.

INTRODUCTION: There has been increased recent attention to the clinical meaningfulness of group change scores on health-related quality of life (HRQL) questionnaires. It has been assumed that improvements and declines of comparable magnitude have the same meaning or value. METHOD: We assessed 308 cancer patients with the Functional Assessment of Cancer Therapy (FACT) and a Global Rating of Change. Patients were classified into five levels of change in HRQL and its dimensions based upon their responses to retrospective ratings of change after 2 months: sizably worse, minimally worse, no change, minimally better, and sizably better. Raw score and standardized score changes on the FACT-G subscales and total score were then compared across different categories of patient-rated change. RESULTS: The relationship between actual FACT change scores and retrospective ratings of change was modest but usually statistically significant (r: 0.07 to 0.35). Change scores associated with each retrospective rating category were evaluated to determine estimates of meaningful difference. Patients who reported global worsening of HRQL dimensions had considerably larger change scores than those reporting comparable global improvements. Although related to a ceiling effect, this remained true even after removing cases that began near the ceiling of the questionnaire. DISCUSSION: Relatively small gains in HRQL have significant value. Comparable declines may be less meaningful, perhaps due to patients' tendency to minimize personal negative evaluations about one's condition. This has important implications for the interpretation of the meaningfulness of change scores in HRQL questionnaires. Factors such as adaptation to disease, response shift, dispositional optimism and the need for signs of clinical improvement may be contributing to the results and should be investigated in future studies.

Adaptation, Psychological↗
PubMed2002

Atherosclerotic risk factor reduction in peripheral arterial diseasea: results of a national physician survey.

OBJECTIVE: Individuals with peripheral arterial disease (PAD) have a 3- to 6-fold increased risk of coronary heart disease and stroke compared to those without PAD. We documented physician-reported practice behavior, knowledge, and attitudes regarding atherosclerotic risk factor reduction in patients with PAD. DESIGN: National physician survey. PATIENTS/PARTICIPANTS: General internists (N = 406), family practitioners (N = 435), cardiologists (N = 473), and vascular surgeons (N = 264) randomly identified using the American Medical Association's physician database. MEASUREMENTS AND MAIN RESULTS: Physicians were randomized to 1 of 3 questionnaires describing a) a 55- to 65-year-old patient with PAD; b) a 55- to 65-year-old patient with coronary artery disease (CAD), or c) a 55- to 65-year-old patient without clinically evident atherosclerosis (no disease). A mailed questionnaire was used to compare physician behavior, knowledge, and attitude regarding risk factor reduction for each patient. Rates of prescribed antiplatelet therapy were significantly lower for the patient with PAD than for the patient with CAD. Average low-density lipoprotein levels at which physicians "almost always" initiated lipid-lowering drugs were 121.6 +/- 23.5 mg/dL, 136.3 +/- 28.9 mg/dL, and 149.7 +/- 24.4 mg/dL for the CAD, PAD, and no-disease patients, respectively (P <.001). Physicians stated that antiplatelet therapy (P <.001) and cholesterol-lowering therapy (P <.001) were extremely important significantly more often for the CAD than for the PAD patient. Perceived importance of risk factor interventions was highly correlated with practice behavior. Compared to other specialties, cardiologists had lowest thresholds, whereas vascular surgeons had the highest thresholds for initiating cholesterol-lowering interventions for the patient with PAD. Cardiologists were significantly more likely to report "almost always" prescribing antiplatelet therapy for the patient with PAD than were all other physicians. CONCLUSIONS: Deficiencies in physician knowledge and attitudes contribute to lower rates of atherosclerotic risk factor reduction for patients with PAD. Reversing these deficiencies may reduce the high rates of cardiovascular morbidity and mortality associated with PAD.

Adult↗
PubMed2002

Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system.

We focus on quality of life (QOL) measurement as applied to chronic illness. There are 2 major types of health-related quality of life (HRQOL) instruments-generic health status and targeted. Generic instruments offer the opportunity to compare results across patient and population cohorts, and some can provide normative or benchmark data from which to interpret results. Targeted instruments ask questions that focus more on the specific condition or treatment under study and, as a result, tend to be more responsive to clinically important changes than generic instruments. Each type of instrument has a place in the assessment of HRQOL in chronic illness, and consideration of the relative advantages and disadvantages of the 2 options best drives choice of instrument. The Functional Assessment of Chronic Illness Therapy (FACIT) system of HRQOL measurement is a hybrid of the 2 approaches. The FACIT system combines a core general measure with supplemental measures targeted toward specific diseases, conditions, or treatments. Thus, it capitalizes on the strengths of each type of measure. Recently, FACIT questionnaires were administered to a representative sample of the general population with results used to derive FACIT norms. These normative data can be used for benchmarking and to better understand changes in HRQOL that are often seen in clinical trials. Future directions in HRQOL assessment include test equating, item banking, and computerized adaptive testing.

Adult↗
PubMed2002

Age, anemia, and fatigue.

Many conditions that would not be considered normal in a younger population are routinely accepted in older people as a part of so-called "normal" aging. Among these conditions are many chronic and debilitating conditions such as chronic pain, insomnia, weakness, fatigue, and anemia. This article reviews current evidence regarding the relationships among age, fatigue, weakness, anemia, and erythropoiesis. Anemia in the elderly is important because it can lead to weakness, fatigue, limitations in activity, and may increase cardiovascular risk. Recent studies of the effect of erythropoietin in an aging population support the hypothesis that anemia is associated with pathologic factors and not with normal aging. While older individuals admitted to hospitals are more likely to be anemic, these same individuals have a bone marrow mass and numbers of cultured progenitor cells that are similar to that of the younger population; therefore, the predicted response to erythropoietin, and thus the function of the bone marrow and cellular progenitors, is maintained. Thus, we can conclude that anemia is a correctable pathologic finding in elderly people. A number of studies have shown a strong relationship between fatigue and anemia, but few studies investigate to what degree age is a factor in weakness and fatigue. In a study of 375 anemic cancer patients with a median age of 61 years, age as a covariate in multiple linear regression analysis failed to reach significance for most measures of function and quality of life (QOL), including measures of energy, activities, mental health, general cancer-related QOL, and overall QOL. Additional analysis suggests that other factors, including cancer progression, hemoglobin change, and baseline hemoglobin levels, are much more important in determining change in functional and quality-of-life scores. In another set of 2,000 cancer patients and 1,000 controls, cancer patients experienced significantly more fatigue compared with controls. There was no correlation between cancer patient age and fatigue, while in controls the cohort aged 65 or more reported more fatigue than did younger subjects. Finally, measurement of QOL in the general population demonstrated, for both the Short-Form 36 and Functional Assessment of Cancer Therapy - Anemia questionnaires, that age alone is not significantly correlated with QOL. We suggest that chronic conditions such as fatigue and anemia are no more "normal" in an aging population than in a general population, and that all patients with chronic conditions be adequately treated and counseled for their condition.

Age Factors↗
PubMed2002

Advances in quality of life measurements in oncology patients.

Accurate assessment of the quality of life (QOL) of patients can provide important clinical information to physicians, especially in the area of oncology. Changes in QOL are important indicators of the impact of a new cytotoxic therapy, can affect a patient's willingness to continue treatment, and may aid in defining response in the absence of quantifiable endpoints such as tumor regression. Because QOL is becoming an increasingly important aspect in the management of patients with malignant disease, it is vital that the instruments used to measure QOL are reliable and accurate. Assessment of QOL involves a multidimensional approach that includes physical, functional, social, and emotional well-being, and the most comprehensive instruments measure at least three of these domains. Instruments to measure QOL can be generic (eg, the Nottingham Health Profile), targeted toward specific illnesses (eg, Functional Assessment of Cancer Therapy - Lung), or be a combination of generic and targeted. Two of the most widely used examples of the combination, or hybrid, instruments are the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Items and the Functional Assessment of Chronic Illness Therapy. A consequence of the increasing international collaboration in clinical trials has been the growing necessity for instruments that are valid across languages and cultures. To assure the continuing reliability and validity of QOL instruments in this regard, item response theory can be applied. Techniques such as item response theory may be used in the future to construct QOL item banks containing large sets of validated questions that represent various levels of QOL domains. As QOL becomes increasingly important in understanding and approaching the overall management of cancer patients, the tools available to clinicians and researchers to assess QOL will continue to evolve. While the instruments currently available provide reliable and valid measurement, further improvements in precision and application are anticipated.

Cross-Cultural Comparison↗
PubMed2002

Methods and progress in assessing the quality of life effects of supportive care with erythropoietin therapy.

Anemia is a common disorder in patients with cancer and can be caused by the disease itself or by cancer-related therapy. The cardinal symptom of anemia, fatigue, is the most commonly reported symptom in patients with cancer and has profound effects on patient well-being and quality of life. Until recently, blood transfusions were the mainstay of management of cancer-related anemia, despite attendant risks of transfusion-related reactions and transmission of infection. Recombinant human erythropoietin (epoetin-alpha), an effective alternative to blood transfusion, has been shown to improve hematologic parameters, including hemoglobin levels, Hematocrit, and transfusion requirements. Clinical trials have also suggested that this intervention has a positive impact on the quality of life of patients with cancer. The literature published between November 2000 and October 2001 continues to support a positive effect of epoetin-alpha therapy on the quality of life of patients with cancer and includes investigations of dosing schedules more convenient for patients and trials of longer-acting versions of epoetin-alpha, such as the novel erythropoiesis-stimulating protein. Future studies that incorporate measures of patient-reported outcomes and rigorous methodologic designs are needed to strengthen and elucidate this association between these pharmacologic therapies for cancer-related anemia and quality of life.

Anemia↗
PubMed2002

Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp).

A significant relation between religion and better health has been demonstrated in a variety of healthy and patient populations. In the past several years, there has been a focus on the role of spirituality, as distinctfrom religion, in health promotion and coping with illness. Despite the growing interest, there remains a dearth of well-validated, psychometrically sound instruments to measure aspects of spirituality. In this article we report on the development and testing of a measure of spiritual well-being, the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), within two samples of cancer patients. The instrument comprises two subscales--one measuring a sense of meaning and peace and the other assessing the role offaith in illness. A total score for spiritual well-being is also produced. Study 1 demonstrates good internal consistency reliability and a significant relation with quality of life in a large, multiethnic sample. Study 2 examines convergent validity with 5 other measures of religion and spirituality in a sample of individuals with mixed early stage and metastatic cancer diagnoses. Results of the two studies demonstrate that the FACIT-Sp is a psychometrically sound measure of spiritual well-being for people with cancer and other chronic illnesses.

Adolescent↗
PubMed2002

Real-time clinical application of quality-of-life assessment in advanced lung cancer.

In the management of advanced non-small-cell lung cancer (NSCLC), quality of life (QOL) is a very important consideration when determining therapy. However, clinicians and patients generally make their treatment decisions based upon informal appraisal of QOL rather than formal assessment. Previously, we showed that Functional Assessment of Cancer Therapy-Lung (FACT-L) data were highly prognostic of survival in advanced NSCLC, suggesting the potential value of FACT-L scores for treatment decision making. A key barrier is the impracticality and burden of real-time administration and scoring of paper forms in the clinic. Handheld and touch screen computer administration and scoring can address that barrier. This pilot study assessed the feasibility of using computer technology to aid in the collection and interpretation of QOL and selected clinical data in real time, reducing human effort. The technology was found to be acceptable to patients and staff and feasible within the clinical setting. Integrating formal QOL assessment into treatment decision making in a clinical oncology setting requires further evaluation.

Journal Article↗
PubMed2002

The validity and clinical utility of symptom monitoring in advanced lung cancer: a literature review.

Symptom monitoring and quality-of-life (QOL) evaluation in lung cancer patients might improve care. Brief, valid, and responsive tools are available to measure symptoms and their effect on QOL. Instruments available for use in lung cancer patients can be classified into 3 categories: generic, cancer-specific, and lung cancer symptom-specific. These instruments might assist clinicians in assessing and interpreting treatment outcomes from the patient perspective. They also can assist in treatment decision making, symptom palliation, and they might even be prognostic of survival. Over the past 20 years, these brief evaluations have been used in clinical trials to evaluate patient-reported outcomes. Now, with the advent of less toxic, targeted molecular therapies such as gefitinib (Iressa) in non-small-cell lung cancer, these instruments' value in showing symptomatic improvement from tumor control or regression might be further enhanced. To date, however, such assessments are not widely implemented in routine clinical practice. To better understand benefits of such assessments, we review existing evidence surrounding the instruments' use, evaluate their success, and highlight recent developments. We hope to encourage clinicians to incorporate these evaluations in clinical practice.

Journal Article↗
PubMed2002

Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms.

The Clinical Significance Consensus Meeting Group of the Symposium on the Clinical Significance of Quality-of-Life Measures in Cancer Patients produced 6 articles regarding the clinical significance of quality of life (QOL) assessments in oncology. The 6 articles deal with the methods used to date: group-vs-individual clinical significance; single items vs summated scores; patient, clinician, and population perspectives; assessment of changes over time; and communication of results. The articles were produced by a team of 30 QOL research experts assembled in a consensus writing meeting held at the Mayo Clinic, Rochester, Minn, October 6 and 7, 2000. This introduction describes the need for the articles, definitions of key terms, and plans for the future. It is hoped that this series of articles will serve as a resource for individuals conducting cancer QOL research and for clinicians considering incorporation of QOL assessment in the treatment of patients with neoplastic diseases. A secondary goal is to stimulate further discussion and research in the interpretation of QOL assessments.

Clinical Trials as Topic↗
PubMed2002

Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life.

This article focuses on the traversing of group and individual levels of quality-of-life data. A deductive approach is used to address the extent to which group data can be used to estimate clinical significance at the individual level. An inductive approach is used to evaluate the extent to which individual change data can be brought to the group level to define clinical significance. Both approaches have benefits and drawbacks. This article addresses how clinical significance can be defined for an individual when the threshold for meaningfulness is drawn from group data. It also addresses the condition under which one can use the same threshold difference for group vs individual differences or changes. A sample inductive approach explores the means to identify a clinically significant result or change, with use of insights from cognitive psychology. In most deductive approaches, the identification of a clinically significant difference or change requires identification of a criterion (or at least an interpretable anchor) against which the significance of a change in respondent score is compared.

Confidence Intervals↗
PubMed2002

The effects of anemia and anemia treatment on the quality of life of people with cancer.

Anemia, common in people with cancer, can be due to the disease itself or to the associated therapy. Fatigue, the most prevalent of all symptoms experienced by cancer patients, is the primary symptom of anemia. Caused by many factors,fatigue, regardless of etiology, has an adverse impact on health-related quality of life. Anemia is among the more treatable of those causes. Prior to the development of recombinant human erythropoietin, red blood cell transfusion was the standard treatment for cancer-related anemia. Erythropoietic agents are an effective alternative to blood transfusion: they improve hematocrit, reduce transfusion dependency, and eliminate transfusion-related risks. Although studies are mixed, most clinical trials have also suggested that erythropoietic agents have a positive impact upon cancer patients' quality of life. However, the cost of drug supply is quite high in the oncology setting, where much higher doses are required relative to the nephrology setting. Thus, although few challenge the treatment's effectiveness, cost-effectiveness remains an open question. The data collected over the years to address these questions have helped define and clarify the relationship between anemia and health-related quality of life in people with cancer. That relationship is summarized in this article.

Anemia↗