Biomedical subjects

D Cella

Publications and source records attributed to D Cella.

At least 19 recordsLinked to original sources

PubMed2006

Equating EORTC QLQ-C30 and FACT-G scores and its use in oncological research.

OBJECTIVE: To investigate the equivalence of the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) and the Functional Assessment for Cancer Therapy-General (FACT-G) on the basis of corresponding subscales, and where appropriate to derive a scheme for converting QLQ-C30 scores into FACT-G scores and vice versa for use in oncological research. METHOD: A calibration sample of 737 cancer patients (mean age 51.4+/-7.6 (SD), 63% female, 25% with current chemotherapy) who filled in both quality of life (QOL) questionnaires was used. Both classical test theory and the Rasch measurement model were applied. RESULTS: Three of the four subscales common to both QOL instruments (physical, emotional, functional) proved suitable for equating (acceptable inter-correlations of corresponding subscales physical (r=0.77), emotional domain (r=0.60) role/functional (r=0.63) relative to their internal consistency, sufficient unidimensionality of pooled subscales, satisfactory fit to the Rasch model). Conversion tables for these subscales were generated. CONCLUSIONS: The conversion tables developed in this study (physical, emotional and functional/role domain) appear promising for the comparison between EORTC QLQ-C30 and FACT-G scores of patient samples.

Biomedical Research↗

PubMed2006

The relationship between patient knowledge of hemoglobin levels and health-related quality of life.

BACKGROUND: An anti-anemia drug may improve self-reported quality of life (QOL) partly because patients know their hemoglobin level is rising. In the absence of any published studies on this topic, the authors investigated the association between knowledge of hemoglobin levels and self-reported QOL. METHODS: The study analyzed health-related QOL (HRQOL) data from five randomized clinical trials of erythropoietic therapy in patients with cancer-related anemia. Patients were asked whether they knew their hemoglobin level and, if so, to report its value. Patients (n=1007) were grouped into three categories depending on the extent and accuracy of hemoglobin level knowledge. HRQOL scale scores were compared between categories. RESULTS: Only 23.2% of patients reported knowing their hemoglobin level at the end of the study; however, the value was accurate (within 1 g/dl) in 88.0% of these patients. On five of the 11 HRQOL scales studied, there was a significant association between knowledge of hemoglobin level and HRQOL score. However, the magnitude of the mean difference between those who knew vs. those who did not know their hemoglobin was generally below scale thresholds for minimally important differences. CONCLUSIONS: Patient knowledge of hemoglobin level has a modest association with some aspects of self-reported HRQOL. The magnitude of this association, where it exists, would be unlikely to explain large group differences in HRQOL reports over time, even for patients who know their hemoglobin level.

Aged↗

PubMed2005

Clinically meaningful changes in health-related quality of life in patients diagnosed with hepatobiliary carcinoma.

BACKGROUND: To test the reliability, sensitivity to change in biomarkers associated with disease progression and response to treatment, and clinical meaningfulness of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) in patients with hepatobiliary carcinoma. PATIENTS AND METHODS: One hundred and fifty-eight patients diagnosed with hepatobiliary carcinoma were prospectively studied. Health-related quality of life (HRQL) was assessed at baseline (prior to treatment), 3-month follow-up (n=55) and 6-month follow-up (n=27). RESULTS: The internal consistency of all the scales of the FACT-Hep were adequate at all time points (>0.75). The FACT-Hep was found to be sensitive to changes in clinical indicators (alkaline phosphate, alpha-fetoprotein, hemoglobin and survival) that reflect disease progression and response to treatment. Combined results from distribution-based and cross-sectional anchor-based analyses provide the following minimally important difference (MID) estimates: FACT-General (FACT-G) subscales=2-3; FACT-G=6-7; Hepatobiliary Cancer Subscale=5-6; FACT-Hep=8-9; Trial Outcome Index=7-8; and FACT-Hepatobiliary Symptom Index=2-3 points. CONCLUSIONS: The FACT-Hep is a reliable instrument that is responsive to clinical indicators of disease progression and response to treatment. The MID estimates can aid interpretation of HRQL data and facilitate sample size calculation in clinical trials.

Adult↗

PubMed2005

Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches.

OBJECTIVE: To estimate minimally important differences (MIDs) on the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using anchor- and distribution-based methods. STUDY DESIGN AND SETTING: Preliminary MIDs were generated for FACT-C scores based on published results for two samples (n = 60 and n = 63) from the FACT-C validation study. Preliminary MIDs were confirmed using data from a Phase II randomized controlled clinical trial (n = 104) and a population-based observational study (n = 568). MIDs were estimated for the colorectal cancer subscale (CCS); the FACT-C Trial Outcome Index (TOI-C), which is the sum of the CCS, physical well-being, and functional well-being subscales; and the FACT-C total score. Both cross-sectional and longitudinal analyses were used. RESULTS: MIDs were stable across the different patient samples. The recommended MIDs ranged from 2 to 3 points for the CCS, 4 to 6 points for the TOI-C, and 5 to 8 points for the FACT-C total score. CONCLUSIONS: MIDs can enhance the interpretability of FACT-C scores, and they can be used to provide a basis for sample size estimation and to determine clinical benefit in combination with other measures of efficacy. General guidelines for estimating MIDs for other FACT instruments are suggested.

Adult↗

PubMed2004

Fatigue and cancer: causes, prevalence and treatment approaches.

Fatigue is the most prevalent cancer-related symptom and has a significant adverse impact on patients' functional ability and quality of life. Hypotheses regarding the aetiology of cancer-related fatigue are discussed, and clinical practice guidelines for the evaluation and management of oncology patients with fatigue are reviewed. Both nonpharmacologic and pharmacologic strategies for the management of fatigue are summarised.

Fatigue↗

PubMed2004

The functional assessment of cancer therapy-BRM (FACT-BRM): a new tool for the assessment of quality of life in patients treated with biologic response modifiers.

PURPOSE: This paper reports on the development and validation of two biologic response modifier (BRM) subscales for use with the Functional Assessment of Cancer Therapy-General (FACT-G) quality of life (QOL) questionnaire. METHODS: Using the FACT-G as a base, 17 additional questions related to symptoms common to interferon and retinoid therapy were developed. Data collected at baseline (n = 191) and week 2 (n = 168) in a randomized trial of interferon +/- 13-cis-retinoic acid in advanced renal cell carcinoma patients were used to validate this measure. RESULTS: Using a combined empirical and conceptual approach, the 17 questions were reduced to 13 questions consisting of two subscales: 'BRM-physical' (7 items; baseline coefficient alpha(alpha) = 0.70; week-2 alpha = 0.75) and 'BRM-mental' (6 items; baseline alpha = 0.79; week-2 alpha = 0.78). Internal consistency of the trial outcome index (TOI) combining physical well-being, functional well-being and the BRM subscales, was 0.91 for baseline assessments and 0.92 for week 2. Discriminant validity was demonstrated for the TOI by its ability to differentiate among prognostic risk groups, and for the total FACT-G, TOI and total FACT-BRM scores by their ability to distinguish between groups differing in performance, response and toxicity status. CONCLUSIONS: The 'BRM-physical' and 'BRM-mental' subscales can be combined with the FACT-G to form the 'FACT BRM' scale, useful for measuring QOL in cancer patients who are receiving treatment with biologic response modifiers.

Activities of Daily Living↗

PubMed2004

The longitudinal relationship of hemoglobin, fatigue and quality of life in anemic cancer patients: results from five randomized clinical trials.

BACKGROUND: Anemia is common in cancer and has been associated with fatigue and reduced health-related quality of life (HRQOL). We report the association between hemoglobin and fatigue and the impact of reducing fatigue on several domains of HRQOL. PATIENTS AND METHODS: These analyses were based on five randomized trials. Patients completed the Functional Assessment of Cancer Therapy (FACT) Anemia scales and numeric rating scales of Energy, Activity and Overall Health at baseline and after the 12-week treatment period. t-tests and linear regression models were used to evaluate associations. Analyses were stratified into three groups: solid tumor chemotherapy patients, lymphoproliferative malignancy chemotherapy patients and non-chemotherapy patients. RESULTS: Adjusted mean differences (95% CI) in FACT Fatigue change scores between hemoglobin responders (> or =2 g/dl increase) and non-responders were 3.0 (1.2, 4.7), 2.8 (0.6, 5.0) and 5.8 (2.2, 9.5) among the solid tumor, lymphoproliferative malignancy and non-chemotherapy groups, respectively. Significantly greater improvements (P <0.01) were observed in the FACT well-being scales for patients with meaningful improvement in fatigue (FACT Fatigue change score > or =3 points). After controlling for other factors, patients whose fatigue improved reported substantially greater improvements in energy, ability to perform usual activities and overall health (P <0.0001). CONCLUSIONS: Across five trials of cancer patients on and off chemotherapy, hemoglobin response was associated with meaningful improvements in fatigue, which, in turn, was associated with improved physical, functional, emotional and overall well-being.

Adolescent↗

PubMed2004

Assessing mortality risk in very low birthweight infants: a comparison of CRIB, CRIB-II, and SNAPPE-II.

BACKGROUND: Illness severity scores are increasingly used for risk adjustment in clinical research and quality assessment. Recently, a simplified version of the score for neonatal acute physiology (SNAPPE-II) and a revised clinical risk index for babies (CRIB-II) score have been published. AIM: To compare the discriminatory ability and goodness of fit of CRIB, CRIB-II, and SNAPPE-II in a cohort of neonates < 1500 g birth weight (VLBWI). METHODS: Data from 720 VLBWI, admitted to 12 neonatal units in Lombardy (Northern Italy) participating in a regional network, were analysed. The discriminatory ability of the scores was assessed measuring the area under the receiver operating characteristic curve (AUC). Outcome measure was in-hospital death. RESULTS: CRIB and CRIB-II showed greater discrimination than SNAPPE-II (AUC 0.90 and 0.91 v 0.84, p < 0.0004), partly because of the poor quality of some of the data required for the SNAPPE-II calculation-for example, urine output-but also because of the relative weight given to some items. In addition to each score, several variables significantly influenced survival in logistic regression models. Antenatal steroid prophylaxis, singleton birth, absence of congenital anomalies, and gestational age were independent predictors of survival for all scores, in addition to caesarean section and not being small for gestation (for SNAPPE-II) and a five minute Apgar score of > or = 7 (for SNAPPE-II and CRIB). CONCLUSIONS: CRIB and CRIB-II had greater discriminatory ability than SNAPPE-II. Risk adjustment using all scores is imperfect, and other perinatal factors significantly influence VLBWI survival. CRIB-II seems to be less confounded by these factors.

Epidemiologic Methods↗

PubMed2003

Quality of life and understanding of disease status among cancer patients of different ethnic origin.

Patients managed in European or North American cancer centres have a variety of ethnic backgrounds and primary languages. To gain insight into the impact of ethnic origin, we have investigated understanding of disease status and quality of life (QoL) for 202 patients. Patients completed questionnaires in their first language (52 English, 50 Chinese, 50 Italian, 50 Spanish or Portuguese), including the Functional Assessment of Cancer Therapy - General (FACT-G) QoL instrument, questions about disease status, expectations of cure and the language and/or type of interpretation used at initial consultation. Physicians also evaluated their status of disease and expectation of cure, and performance status was estimated by a trained health professional. The initial consultation was usually provided in English (except for 32% of Chinese-speaking patients); interpretation was provided by a family member for 34% of patients with limited English proficiency (LEP) and by a bilingual member of staff for 21%. Patients underestimated their extent of disease and overestimated their probability of cure (P=0.001 and <0.0001, respectively). Estimates of probability of cure by the English speakers were closer to those of their physicians than the other groups (P=0.02). English-speaking patients reported better and Italian-speaking patients poorer overall QoL (P<0.001 for Italian vs other groups). Performance status was correlated with QoL and most closely related with the extent of disease. Understanding of cultural differences is important for optimal management of patients with cancer.

Activities of Daily Living↗

PubMed2003

Quality of life in patients receiving treatment for gynecologic malignancies: special considerations for patient care.

Advances in the treatment of gynecologic cancer have extended the duration of survival of many patients. However, these patients frequently experience a variety of treatment- and disease-related side effects that diminish their quality of life (QOL) during and after treatment; among these are pain, nausea and vomiting, anemia, fatigue, peripheral neuropathy, emotional distress, and sexual dysfunction. Given the gains in survival time, patient care is being expanded to include enhancement or preservation of QOL in addition to early diagnosis and disease treatment, thus treating the whole person. In parallel with this evolution in cancer care, supportive measures are being increasingly recognized as crucial to effective patient management. This paper reviews some of the potential causes of diminished QOL in gynecologic cancer patients and basic treatment strategies for their control, with a focus on short-term QOL issues. It is important that clinicians monitor QOL during the course of the disease and its treatment, utilize procedures and therapeutic agents that take patient preferences and QOL into account, and proactively prevent and treat relevant symptoms.

Antineoplastic Agents↗

PubMed2003

Control of cancer-related anemia with erythropoietic agents: a review of evidence for improved quality of life and clinical outcomes.

BACKGROUND: Anemia occurs frequently in patients with cancer and is associated with impaired health-related quality of life (HRQOL). Treatment of anemia results in significant improvements in energy, activity and overall HRQOL, particularly among patients with mild-to-moderate anemia. Importantly, studies have indicated that anemia may have a negative impact on the success of radiotherapy, reducing survival and locoregional control. Recent preclinical and preliminary clinical data have also suggested that anemia may be associated with poorer outcomes following chemotherapy or surgery. MATERIALS AND METHODS: Data for review were identified and selected from searches of the literature published from January 1990 through to October 2002 using Medline, and searches of proceedings from key international oncology and hematology meetings. RESULTS: A wealth of data indicate that treatment of anemia improves HRQOL in patients with cancer. Prospective studies exploring survival and/or treatment outcomes in anemic cancer patients are currently in their early stages, preventing any firm conclusions from being drawn, although they do indicate a benefit in treating anemia. CONCLUSIONS: Recent studies support the use of erythropoietic agents in anemic cancer patients as a means of raising their hemoglobin levels and consequently improving their HRQOL. Randomized, controlled trials are needed to determine whether treating anemia with erythropoietic agents will improve other outcomes following therapy.

Anemia↗

PubMed2003

Psychometric evaluation of the Chicago Multiscale Depression Inventory in multiple sclerosis patients.

OBJECTIVE: The Chicago Multiscale Depression Inventory (CMDI), a comprehensive self-report measure of depression, has proven useful in the assessment of patients with chronic medical conditions. The objective of this study was to determine the validity of the CMDI in multiple sclerosis (MS) patients and explore the nature of depressive symptoms reported by people with MS. METHOD: Using a combined classical and modern psychometric approach, the factor structure of responses in MS patients was compared with that of a normative sample to confirm meaningful subtypes of depression in MS (mood, depressive cognition, and vegetative symptoms). Patient groups also were compared by disease severity to evaluate differences in depression associated with differences in disease severity. RESULTS: The results supported the factor structures of the measure, which was internally consistent, reliable, and factorially valid. Some items function differently in MS patients when compared with depressed patients and normals, offering a further opportunity to understand the unique clinical aspects of depression in people with MS compared with those without a concurrent physical illness. CONCLUSIONS: Use of the CMDI to assess separate dimensions of depression may help to clarify the complex interrelationships among aspects of depression and health-related behavior.

Adult↗

PubMed2002

Multivariate regression analyses of data from a randomised, double-blind, placebo-controlled study confirm quality of life benefit of epoetin alfa in patients receiving non-platinum chemotherapy.

Cancer-related anaemia is associated with a wide spectrum of symptoms that can negatively affect quality of life. Because epoetin alfa has demonstrated efficacy in correcting cancer-related anaemia, the impact of this treatment on quality of life was evaluated in a multinational, randomised, double-blind, placebo-controlled trial in 375 anaemic cancer patients receiving non-platinum-based chemotherapy. The cancer-specific measures of quality of life included the general scale (FACT-G Total) and fatigue subscale (FACT-An Fatigue subscale) of the Functional Assessment of Cancer Therapy-Anaemia and the Cancer Linear Analogue Scales measuring energy, ability to do daily activities, and overall quality of life. These measures were also used to examine the relationship between haemoglobin levels and quality of life. Both univariate and multiple linear regression analyses of quality of life data were performed. Results of the univariate analysis have been reported previously. The a priori-planned multiple linear regression analysis, which accounted for the effects of disease progression and several other possibly confounding variables on quality of life, showed a significant advantage for epoetin alfa over placebo for the five scales (all, P<0.05), and confirmed the results of the univariate analysis. For cancer-specific measures, significant correlations were demonstrated between baseline haemoglobin and quality of life (r, range: 0.14-0.26, all P<0.05) and between change in haemoglobin and change in quality of life (r, range: 0.26-0.34, all P<0.01). These findings provide evidence that increasing haemoglobin levels by epoetin alfa administration can significantly improve cancer patients' quality of life.

Activities of Daily Living↗

PubMed2002

Mother-to-child transmission of TT virus: sequence analysis of non-coding region of TT virus in infected mother-infant pairs.

To investigate vertical transmission of TT virus, TTV-DNA was looked for in serum samples taken from 22 mothers and their 22 infants at birth and during nine months of follow-up. Sixteen mothers at delivery and six infants within nine months of age had TTV-DNA detected by the amplification of the non coding (NC) region. Two of these newborns had positive viremia at birth. Sequence analysis of the NC region of five mother-infant pairs revealed that the TTV strains detected at three and six months of age in two of the infants were closely related to that of their mothers, whereas two that became TTV-DNA positive at three moths had a different nucleotide sequence from that of their mothers. One of the two infants with detectable viremia at birth also had a different nucleotide sequence from her mother. These findings suggest that both in utero and perinatal transmission of TT virus may occur, and that the strain detected in the infants was not invariably dominant in the mothers at delivery.

Adult↗

PubMed2002

Quality of life in multiple sclerosis patients in Spain.

OBJECTIVE: The cross-sectional study evaluated the psychometric properties of the Functional Assessment of Multiple Sclerosis (FAMS) Spanish version and its use in measuring quality of life (QOL) of multiple sclerosis (MS) patients in Spain. METHODS: The FAMS is a factorially derived self-report scale designed to assess six primary aspects of QOL of patients with MS: Mobility, Symptoms, Emotional Well-Being, General Contentment, Thinking and Fatigue, and Family/Social Well-Being. Its Spanish translated version was used to assess QOL of 625 MS patients recruited in an outpatient clinic setting from 58 hospitals in Spain. Internal consistency of the Spanish FAMS was evaluated Multiple regression analyses were performed to identify significant predictors from demographic, clinical and treatment characteristics, and Kurtzke Expanded Disability Status Scale (EDSS) scores in predicting FAMS scale scores. RESULTS: Most of the patients are females (66%), and 74% were of the relapsing-remitting (RR) clinical subtype. Cronbach's alpha coefficients were high (range=0.78-0.96), indicating subscale homogeneity comparable to that of the original English version. Linear multivariate regression analyses revealed that the EDSS is a dominant variable in predicting all the FAMS subscales, especially mobility (R2=0.51) and the total scores. CONCLUSIONS: The Spanish FAMS is a psychometrically valid instrument that allows clinicians and clinical researchers the ability to measure the QOL concerns of MS patients in Spain.

Adult↗

PubMed2001

Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors.

PURPOSE: To evaluate the proposed cancer-related fatigue (CRF) diagnostic criteria in a sample of cancer survivors. More accurate prevalence estimates of CRF may result in improved diagnosis and management of one of the most common symptoms associated with cancer and its treatment. METHODS: Three hundred seventy-nine individuals who had been treated with chemotherapy, either alone or in combination with radiation therapy, were surveyed. Patients were asked background questions about their current condition, their medical history, and the frequency of fatigue during their chemotherapy. Additionally, patients who reported experiencing fatigue at least a few days each month during treatment were asked a series of questions about the impact of fatigue on their daily functioning. RESULTS: One hundred forty-one (37%) individuals reported at least 2 weeks of fatigue in the previous month. Of the respondents who had received their last treatment more than 5 years ago, 33% still reported at least a 2-week period of fatigue in the month before the interview. Evaluation of the proposed criteria revealed that 17% of respondents met at least two criteria for CRF. CONCLUSION: The prevalence of diagnosable CRF in the individuals in this sample, most of whom had completed treatment more than 1 year ago, was 17%-lower than expected based on previous reports that have used less-strict criteria. In a sizable number of people, CRF persists well beyond active treatment and should be a focus of intervention. Although they will require replication in other samples and clinical validation, these formal diagnostic criteria can be a step toward common language and a better understanding of the severity range and persistence of CRF.

Data Collection↗

PubMed2001

Topotecan versus observation after cisplatin plus etoposide in extensive-stage small-cell lung cancer: E7593--a phase III trial of the Eastern Cooperative Oncology Group.

PURPOSE: To determine the efficacy of topotecan in combination with standard chemotherapy in previously untreated patients with extensive-stage small-cell lung cancer (SCLC), the Eastern Cooperative Oncology Group (ECOG) conducted a phase III trial. PATIENTS AND METHODS: Eligible patients had measurable or assessable disease and an ECOG performance status of 0 to 2; stable brain metastases were allowed. All patients received four cycles of cisplatin and etoposide every 3 weeks (step 1; PE). Patients with stable or responding disease were then randomized to observation or four cycles of topotecan (1.5 mg/m(2)/d for 5 days, every 3 weeks; step 2). A total of 402 eligible patients were registered to step 1, and 223 eligible patients were registered to step 2 (observation, n = 111; topotecan, n = 112). RESULTS: Complete and partial response rates to induction PE were 3% and 32%, respectively. A 7% response rate was observed with topotecan (complete response, 2%; partial response, 5%). The median survival time for all 402 eligible patients was 9.6 months. Progression-free survival (PFS) from date of randomization on step 2 was significantly better with topotecan compared with observation (3.6 months v 2.3 months; P <.001). However, overall survival from date of randomization on step 2 was not significantly different between the observation and topotecan arms (8.9 months v 9.3 months; P =.43). Grade 4 neutropenia and thrombocytopenia occurred in 50% and 3%, respectively, of PE patients in step 1 and 60% and 13% of topotecan patients in step 2. Grade 4/5 infection was observed in 4.6% of PE patients and 1.8% of topotecan patients. Grade 3/4 anemia developed in 22% of patients who received topotecan. No difference in quality of life between topotecan and observation was observed at any assessment time or for any of the subscale scores. CONCLUSION: Four cycles of PE induction therapy followed by four cycles of topotecan improved PFS but failed to improve overall survival or quality of life in extensive-stage SCLC. Four cycles of standard PE remains an appropriate first-line treatment for extensive-stage SCLC patients with good performance status.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2001

Reliability and validity of the functional assessment of cancer therapy-ovarian.

PURPOSE: To report the reliability and validity of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) in a consecutive series of outpatients with epithelial ovarian cancer. PATIENTS AND METHODS: Two hundred thirty-two ovarian cancer patients attending an outpatient gynecologic oncology clinic completed questionnaires at baseline. The patients' FACT-O scores were compared with their performance status, disease stage, treatment status, and other factors hypothesized to be related to quality of life. Patients received a second questionnaire either one week after baseline to assess the instrument's test-retest reliability and/or two months after baseline to evaluate its sensitivity to change in performance status. RESULTS: Internal consistency and test-retest reliability of the FACT-O were adequate. Overall, the scales correlated with other measures as expected; all correlations were in the hypothesized direction. Patients with advanced disease, poor performance status, and who were receiving active treatment had lower scores on physical, functional, and ovarian cancer-specific scales. The total FACT-O and emotional well-being scores were lower for patients with poor performance status and patients in active treatment. The FACT-O total and all subscale scores except emotional well-being were sensitive to decreases in performance status. CONCLUSION: Overall, the FACT-O provides a reliable and valid assessment of the quality of life of women with ovarian cancer, and is appropriate as a brief quality of life assessment in clinical trials and descriptive studies.

Activities of Daily Living↗