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Functional Assessment (functional + assessment)
Selected AbstractsFUNCTIONAL ASSESSMENT OF OLDER ADULTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE LIVING AT HOMEJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 8 2010FNP-C, Janquilyn D. Merida MS No abstract is available for this article. [source] EORTC QLQ-C30 and FACT-BMT for the measurement of quality of life in bone marrow transplant recipients: a comparisonEUROPEAN JOURNAL OF HAEMATOLOGY, Issue 2 2000Martin Kopp Abstract: The purpose of the study was to compare two differentquality-of-life self-rating instruments, namely the EORTC QLQ-C30, developed by the quality-of-life study group of the European Organisation for Research and Treatment of Cancer, and the FACT-BMT (version 3), the Functional Assessment of Cancer Therapy , Bone Marrow Transplantation scale, which is the FACT-G(eneral measure) in combination with a module developed specifically for evaluating quality of life of bone marrow transplant (BMT) patients. Fifty-six BMT recipients completed both the EORTC QLQ-C30 and the FACT-BMT (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis and multiple linear regression. Correlations between corresponding subscales of EORTC QLQ-C30 and the FACT-BMT ranged from r=0.30 for the emotional domain (poor agreement) to r=0.77 for global QOL (good agreement). This suggests that the instruments, despite considerable overlap, possibly focus on different aspects of QOL, in particular in addressing emotional and social issues of BMT patients. It appears that the FACT-BMT gives a more comprehensive overview regarding the multidimensional construct of quality of life. The EORTC QLQ-C30 gives more insight into the physical aspects of quality of life and helps to identify symptoms which effectively decrease quality of life from the patient's perspective. The QLQ-C30 might be improved by the incorporation of a BMT-specific module currently under development. We therefore conclude that neither of the two instruments can be replaced by the other in the assessment of QOL of BMT patients and that a direct comparison of results obtained with the two instruments is likely to be misleading. [source] Psychosocial effects in long-term head and neck cancer survivorsHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 4 2005Richard L. Holloway PhD Abstract Background. To identify and rate the importance of several psychosocial and physiologic influences on quality of life (QOL) among a cohort of 5-year head and neck cancer survivors, we conducted a cross-sectional study of a convenience sample that used both questionnaires and physiologic evaluations. Methods. QOL was assessed by the Functional Assessment of Cancer Therapy (FACT) and the FACT Head and Neck additional concerns (FACT-H&N) questionnaires. Psychosocial characteristics (or risk factors) potentially influencing QOL were measured by the Millon Behavioral Health Inventory (MBHI) and the Social Support Questionnaire (SSQSR). Physiologic risk factors were measured in examinations that included shoulder and neck range of motion, whole and stimulated saliva measurements, and oropharyngeal swallowing efficiency. We evaluated the association of selected QOL measures with three groups of potential risk factors: psychosocial factors, consisting of selected MBHI and SSQSR scales; physiologic factors, consisting of selected physical ability measures; and a combination of psychosocial/physiologic factors. Results. The entire study population of 105 subjects completed the FACT and FACT-H&N questionnaires; 86 of these completed the physiologic tests as well. Combined psychosocial/physiologic models best predicted all QOL measures considered. Psychosocial models alone, compared with physiologic models alone, better predicted FACT physical and social/family well-being measures. Physiologic models alone, compared with psychosocial models alone, better predicted FACT-H&N additional concerns measures. Premorbid pessimism (MBHI) was consistently the best predictor of QOL measures. Conclusions. Both psychosocial and physiologic factors influence QOL in patients with head and neck cancer, but many QOL measures are most strongly influenced by psychosocial considerations. Physicians and surgeons caring for long-term head and neck cancer survivors should be cognizant of the importance of psychosocial risk factors in the QOL of their patients. © 2005 Wiley Periodicals, Inc. Head Neck27: XXX,XXX, 2005 [source] Augmentation of atypical antipsychotics with valproic acid.HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 8 2009An open-label study for most difficult patients with schizophrenia Abstract Objective Most difficult inpatients with schizophrenia are in serious needs but obviously underrepresented in clinical trials. Methods Very challenging patients received open-label treatment with atypical antipsychotics concurrently augmented with valproic acid. The primary outcome was the newly developed Functional Assessment for Comprehensive Treatment of Schizophrenia (FACT-Sz). Patients improving more than 20 points were classified as responders. Results Mean age and illness duration of 28 participants (22male) were 42 y.o. and 20 years, respectively. They had spent a half of their life admitted after the onset. The average Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression-Severity (CGI-S) were very severe at 79 and 6.1, respectively, with the baseline Global Assessment of Functioning (GAF) of as low as 21. As a result of augmentation, there were nine responders, 12 partial responders, and seven non-responders including only two patients who got worse. The main antipsychotics were mostly either risperidone or olanzapine. Mean maximum oral dose and blood level of valproic acid were 1907,mg and 91.7,µg/ml, respectively. Overall significant improvements whilst to an inadequate degree were noted in clinical parameters. Valproate augmentation was generally well tolerated but serious adverse effects included thrombocytopenia, anaemia and sedation/falls. Conclusions While these preliminary results need to be tested against tenacious monotherapy or polypharmacy involving clozapine, augmenting atypical antipsychotics with valproic acid can be useful for very severe schizophrenia. Copyright © 2009 John Wiley & Sons, Ltd. [source] Outcomes and predicting response in anaemic chemotherapy patients treated with epoetin alfa.INTERNAL MEDICINE JOURNAL, Issue 10 20084-month, A multicentre, New Zealand, open-label study in Australia Abstract Background:, The aim of the study was to evaluate the effectiveness, safety, and clinical outcomes of erythropoietin therapy in the treatment of anaemic cancer subjects receiving chemotherapy and to examine hypochromic red blood cell measurement as an indicator of functional iron sufficiency and as a predictor of responsiveness or non-responsiveness to erythropoietin therapy. Methods:, Patients who had a non-myeloid malignancy, had Hb , 11.0 g/dL, had a life expectancy of more than 6 months, were 18 years or older, were receiving chemotherapy and would continue to be treated for at least 2 months were given s.c. epoetin alfa three times a week. Results:, Haemoglobin levels increased significantly at all time periods compared with baseline and the number of transfusions received decreased significantly at all time periods compared with baseline. Quality of life as measured by Functional Assessment of Cancer Therapy-Anaemia showed significant increases at months 2 and 4 and there were significant improvements in the fatigue subscale at both time points (P < 0.05). Significant improvements at end-point were observed for the physical, emotional and functional well-being, and additional concern subscales (all P < 0.05). Haematocrit and reticulocytes increased significantly at end-point compared with at baseline (haematocrit 33.4 vs 28.3%, P < 0.001; reticulocytes 105.8 vs 78.6 × 109/dL, P = 0.005). The percentage of hypochromic red blood cells did not show predictive value for response to treatment status. Conclusion:, Epoetin alfa improved haemoglobin levels and quality of life in anaemic cancer patients receiving chemotherapy. [source] Outcome Predictors of Pneumonia in Elderly Patients: Importance of Functional AssessmentJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2004Olga H. Torres MD Objectives: To evaluate the outcome of elderly patients with community-acquired pneumonia (CAP) seen at an acute-care hospital, analyzing the importance of CAP severity, functional status, comorbidity, and frailty. Design: Prospective observational study. Setting: Emergency department and geriatric medical day hospital of a university teaching hospital. Participants: Ninety-nine patients aged 65 and older seen for CAP over a 6-month recruitment period. Measurements: Clinical data were used to calculate Pneumonia Severity Index (PSI), Barthel Index (BI), Charlson Comorbidity Index, and Hospital Admission Risk Profile (HARP). Patients were then assessed 15 days later to determine functional decline and 30 days and 18 months later for mortality and readmission. Multiple logistic regression was used to analyze outcomes. Results: Functional decline was observed in 23% of the 93 survivors. Within the 30-day period, case-fatality rate was 6% and readmission rate 11%; 18-month rates were 24% and 59%, respectively. Higher BI was a protective factor for 30-day and 18-month mortality (odds ratio (OR)=0.96, 95% confidence interval (CI)=0.94,0.98 and OR=0.97, 95% CI=0.95,0.99, respectively; P<.01), and PSI was the only predictor for functional decline (OR=1.03, 95% CI=1.01,1.05; P=.01). Indices did not predict readmission. Analyses were repeated for the 74 inpatients and indicated similar results except for 18-month mortality, which HARP predicted (OR=1.73; 95% CI=1.16,2.57; P<.01). Conclusion: Functional status was an independent predictor for short- and long-term mortality in hospitalized patients whereas CAP severity predicted functional decline. Severity indices for CAP should possibly thus be adjusted in the elderly population, taking functional status assessment into account. [source] Darbepoetin alfa 300 or 500 ,g once every 3 weeks with or without intravenous Iron in patients with chemotherapy-induced anemia,AMERICAN JOURNAL OF HEMATOLOGY, Issue 9 2010Michael Auerbach This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 ,g with or without intravenous (IV) iron in treating anemia in patients receiving multicycle chemotherapy. This Phase 2, double-blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 ,g (n = 62), darbepoetin alfa 300 ,g plus IV iron (n = 60), darbepoetin alfa 500 ,g (n = 60), or darbepoetin alfa 500 ,g plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels ,10 g dL,1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin (,11 g dL,1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT-F) score from baseline to end of study. Safety was evaluated by incidence of adverse events. No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed, therefore, results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups. Similar proportions of patients receiving darbepoetin alfa 300 or 500 ,g achieved target hemoglobin (75 and 78%, respectively); Kaplan,Meier median time to target hemoglobin was 10 and 8 weeks, respectively. More patients receiving IV iron (82%) than not receiving IV iron (72%) achieved hemoglobin target. Adverse events profiles were similar for darbepoetin alfa treatment groups. Transient anaphylactoid reactions were reported in two patients receiving IV iron. Darbepoetin alfa at 300 ,g Q3W and 500 ,g Q3W showed similar benefit, while added IV iron improved treatment response in these patients. Am. J. Hematol., 2010. © 2010 Wiley-Liss, Inc. [source] Quality of life and use of red cell transfusion in patients with myelodysplastic syndromes.AMERICAN JOURNAL OF HEMATOLOGY, Issue 10 2009A systematic review The main treatment for many patients with Myelodysplastic Syndromes (MDS) remains red cell transfusion to attenuate the symptoms of chronic anemia. Fatigue can reduce a patient's health related quality of life (HRQoL), but there is little understanding of the optimal use of transfusions to improve this. A systematic review was performed to identify and appraise publications reporting the use of HRQoL instruments in patients with MDS. A total of 17 separate studies were identified that used 14 HRQoL instruments, but only one MDS disease specific HRQoL instrument (QOL-E) was reported. Two well established HRQoL instruments were most often used in MDS research (variants of the Functional Assessment of Cancer Therapy (FACT) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30)). Several common problems were identified in the published literature including a lack of power calculations to detect clinically relevant changes, small sample sizes and significant attrition rates for completion of HRQoL assessments, all of which limit the strength of any conclusions. There is no consensus on the optimal transfusion regimen to improve HRQoL in transfusion-dependent MDS. Future research into HRQoL within MDS is a pressing requirement. Studies should focus on the domains that are of most clinical importance to the patient as well as traditional quantitative changes of hemoglobin concentration. Am. J. Hematol., 2009. © 2009 Wiley-Liss, Inc. [source] Antecedents of domain-specific quality of life after colorectal cancerPSYCHO-ONCOLOGY, Issue 2 2009Suzanne K. Steginga Abstract Objective: The present study prospectively assessed the influence of medical, socio-demographic, psychological, and lifestyle variables on physical, social/family, emotional, functional well-being and colorectal cancer-specific concerns in a population-based sample of colorectal cancer survivors. Methods: Participants (n=1822) were assessed at 6 and 24 months post-diagnosis. Predictor variables assessed at 6 months included socio-demographic and medical variables, symptoms/side-effects, body mass index, physical activity, optimism, social support, and cancer threat appraisal. Quality of life (QOL) was assessed at 6 and 24 months post-diagnosis using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C). Results: For each QOL subscale and for the overall FACT-C scale, 6 month scores were the strongest predictor of QOL scores at 24 months post-diagnosis (e.g. ,=0.447, p < 0.001 for overall QOL). Socio-demographic, medical, and psychosocial variables, but not lifestyle variables, differentially predicted domain specific QOL. Only cancer threat appraisal was associated with all five QOL domains. Conclusion: Cancer threat appraisal presents as a potentially modifiable variable for interventions seeking to improve QOL. Symptom management and lifestyle strategies to ameliorate the effects of co-morbidities, disease stage and troublesome symptoms such as faecal incontinence on QOL should also be included. Copyright © 2008 John Wiley & Sons, Ltd. [source] Longitudinal course of depression, fatigue, and quality of life in patients with high risk melanoma receiving adjuvant interferonPSYCHO-ONCOLOGY, Issue 8 2004Peter C. Trask Purpose: Treatment of malignant melanoma with interferon- , has been associated with a variety of side effects ranging from fatigue to depression, and a concomitant impact on quality of life (QOL), in a variety of case reports and cross-sectional clinical trials. Few, if any, studies have been conducted with the express purpose of assessing the longitudinal course of depression, fatigue, and QOL before and during interferon therapy. Description of study: The current study reports on 16 patients who were assessed at 6 points in time: baseline, post high dose, and 1, 2, 3, and 6 months post high dose treatment with interferon- , with the Brief Symptom Inventory, Beck Depression Inventory, Revised Piper Fatigue Scale, and Functional Assessment of Cancer Therapy-Biological Response Modifiers. Results: Results revealed consistent changes from baseline through 6 month assessment. Specifically, increased somatic complaints, depression, and fatigue were observed on the BSI, BDI, and RPFS, respectively. Additional reductions in QOL on the FACT-BRM were also identified. Clinical implications: The findings suggest that IFN has a significant effect on QOL, but that it may be the somatic symptoms of fatigue that contribute to changes on measures of mood. Limiting the amount of fatigue and depression would appear to be significant if individuals are to successfully complete IFN therapy. Copyright © 2003 John Wiley & Sons, Ltd. [source] Quality of life in patients diagnosed with primary hepatocellular carcinoma: Hepatic arterial infusion of Cisplatin versus 90-Yttrium microspheres (Therasphere®)PSYCHO-ONCOLOGY, Issue 2 2004Jennifer Steel Background. The aims of the study were to test the difference in health-related quality (HRQL) of life and survival in patients diagnosed with primary hepatocellular carcionma (HCC) and treated with either hepatic arterial infusion (HAI) of Cisplatin or 90-Yttrium microspheres (Therasphere®). Method. The design of the study was a non-randomized parallel cohort study. Twenty-eight patients participated in the present study. HRQL was assessed by administration of the Functional Assessment of Cancer Therapy-Hepatobiliary. Survival was measured using Kaplan Meier methods. Results. The results of present study suggest treatment with Therasphere® had an advantage in regard to HRQL and survival when compared to Cisplatin. At 3-month follow-up, patients who were treated with Therasphere® had a higher level of functional well-being as well as overall quality of life when compared to patients treated with Cisplatin. At 6-month follow-up patients (treated with Therasphere®) continued to have better functional well-being when compared to patients being treated with HAI of Cisplatin. At 6-month follow-up, survival was found to be similar for patients treated with Therasphere® when compared to patients being treated with Cisplatin. Conclusions. Preliminary data suggest that treatment with Therasphere® has a modest advantage in regard to HRQL when compared patients treated with HAI of Cisplatin. Future research with Therasphere®, that includes a larger sample size and longer follow-up, is necessary to make definitive conclusions regarding the efficacy and effect on HRQL. Copyright © 2003 John Wiley & Sons, Ltd. [source] Health-Related Quality-of-Life Study in Patients With Carcinoma of the Thyroid After Thyroxine Withdrawal for Whole Body ScanningTHE LARYNGOSCOPE, Issue 11 2006Sin-Ming Chow FRCR Abstract Objectives/Hypothesis: The authors studied the change of health-related quality of life (HR-QOL) in patients with differentiated thyroid carcinoma (DTC) with thyroxine (T4) withdrawal in preparation for whole body radioactive iodine scanning. Study Design: Seventy-eight patients with DTC and history of radioactive iodine (RAI) ablation were prospectively recruited. They completed the Functional Assessment of Cancer Treatment-General (FACT-G) questionnaire on weeks 0, 2, and 4 after T4 withdrawal with corresponding checking of serum thyroid-stimulating hormone (TSH). Results: Overall, 74.5% (58 of 78) of patients completed all FACT-G. Comparing FACT-G scores at weeks 0 and 4, "physical" (P < .001), "social" (P = .04), and "emotional" (P = .047) aspects were lowered as well as "total" HR-QOL (P = .001). However, the "functional" domain of HR-QOL was not affected (P = .14). Comparing FACT-G scores at week 0 and 2, we found that "physical" (P = .049) and "total" (P = .05) HR-QOL were affected early (in the first 2 weeks) in T4 withdrawal. Comparison of week 2 and 4 showed that in the later half of the withdrawal period, "physical" (P = .001), "emotional" (P = .02), and "total" FACT-G scores (P = .002) were affected. Mean TSH level (in mIU/L) increased gradually: 2.8 (week 0), 42.8 (week 2), 97 (week 3), and 153 (week 4). The percentage of patients attaining TSH level of >30 mIU/L were 55% (week 2), 96.2% (week 3), and 100% (week 4). Conclusions: HR-QOL declines with time of T4 withdrawal. The impact is more severe in the later period of T4 withdrawal. In 3 weeks, 96.2% of our patients attained TSH level of 30 mIU/L. To minimize the impact on HR-QOL, duration of T4 withdrawal can be decreased to 3 weeks. [source] Preoperative Functional Assessment of Auditory Cortex in Adult Cochlear Implant Users,,THE LARYNGOSCOPE, Issue 1 2001Peter S. Roland MD Abstract Objectives To e-plore functional neuroanatomical responses to auditory stimulation before and after implantation. Study Design A prospective study of three cochlear implant candidates (pure-tone averages of 90 dB HL or greater bilaterally and hearing in noise test [HINT] performances of <40%) in which regional cerebral blood flow (rCBF) was assessed using single photon emission computed tomography (SPECT). Methods Candidates watched a 15-minute videotaped story under four conditions: audio presented monaurally in the right and left ears (aided), audio presented binaurally (aided), and visual-only presentation of the story. Five minutes into each story, 20 to 25 mCi of technetium 99m (99mTc) hexamethyl-propyleneamine-oxime (HMPAO) (Ceratec; Nycomed Amersham, Princeton, NJ, U.S.A.) was injected over a 30-second period to ensure that subjects were unaware of tracer administration. Subjects were scanned for 20 minutes using a PRISM 3000 gamma camera (Picker International, Cleveland, OH, U.S.A.). Data were normalized and co-registered, and subtraction images were compiled. Subtraction images contrasted activation patterns generated under the visual-only control condition to the auditory activation states acquired monaurally and binaurally. Results Right and left ear monaural stimulation in normal hearing subjects resulted in significant bilateral activation of Brodmann areas 41, 42, 21, 22, and 38. Although substantial intersubject response variability was noted, subjects generally failed to bilaterally activate these areas under monaural hearing aid presentations; however, bilateral activation of areas 41 and 22 was noted under binaural presentations. Conclusions Despite relatively similar hearing losses in each ear, significant differences in preoperative auditory corte- activation were observed between ears. These data suggest that functional brain imaging provides a useful tool for e-ploring the responsiveness of the auditory corte- in cochlear implant candidates. [source] Rituximab for rheumatoid arthritis refractory to anti,tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeksARTHRITIS & RHEUMATISM, Issue 9 2006Stanley B. Cohen Objective To determine the efficacy and safety of treatment with rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to anti,tumor necrosis factor (anti-TNF) therapies and to explore the pharmacokinetics and pharmacodynamics of rituximab in this population. Methods We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the Randomized Evaluation of Long-Term Efficacy of Rituximab in RA (REFLEX) Trial, a 2-year, multicenter, randomized, double-blind, placebo-controlled, phase III study of rituximab therapy. Patients with active RA and an inadequate response to 1 or more anti-TNF agents were randomized to receive intravenous rituximab (1 course, consisting of 2 infusions of 1,000 mg each) or placebo, both with background MTX. The primary efficacy end point was a response on the American College of Rheumatology 20% improvement criteria (ACR20) at 24 weeks. Secondary end points were responses on the ACR50 and ACR70 improvement criteria, the Disease Activity Score in 28 joints, and the European League against Rheumatism (EULAR) response criteria at 24 weeks. Additional end points included scores on the Functional Assessment of Chronic Illness Therapy,Fatigue (FACIT-F), Health Assessment Questionnaire (HAQ) Disability Index (DI), and Short Form 36 (SF-36) instruments, as well as Genant-modified Sharp radiographic scores at 24 weeks. Results Patients assigned to placebo (n = 209) and rituximab (n = 311) had active, longstanding RA. At week 24, significantly more (P < 0.0001) rituximab-treated patients than placebo-treated patients demonstrated ACR20 (51% versus 18%), ACR50 (27% versus 5%), and ACR70 (12% versus 1%) responses and moderate-to-good EULAR responses (65% versus 22%). All ACR response parameters were significantly improved in rituximab-treated patients, who also had clinically meaningful improvements in fatigue, disability, and health-related quality of life (demonstrated by FACIT-F, HAQ DI, and SF-36 scores, respectively) and showed a trend toward less progression in radiographic end points. Rituximab depleted peripheral CD20+ B cells, but the mean immunoglobulin levels (IgG, IgM, and IgA) remained within normal ranges. Most adverse events occurred with the first rituximab infusion and were of mild-to-moderate severity. The rate of serious infections was 5.2 per 100 patient-years in the rituximab group and 3.7 per 100 patient-years in the placebo group. Conclusion At 24 weeks, a single course of rituximab with concomitant MTX therapy provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more anti-TNF therapies. [source] What determines the health-related quality of life among regional and rural breast cancer survivors?AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 6 2009Tracey DiSipio Abstract Objective: To assess the health-related quality of life (HRQoL) of regional and rural breast cancer survivors at 12 months post-diagnosis and to identify correlates of HRQoL. Methods: In 2006/07, 323 (202 regional and 121 rural) Queensland women diagnosed with unilateral breast cancer participated in a population-based, cross-sectional study. HRQoL was measured using the Functional Assessment of Cancer Therapy, Breast plus arm morbidity (FACT-B+4) self-administered questionnaire. Results: In age-adjusted analyses, mean HRQoL scores of regional breast cancer survivors were comparable to their rural counterparts 12 months post-diagnosis (122.9, 95% CI: 119.8, 126.0 vs. 123.7, 95% CI: 119.7, 127.8; p>0.05). Irrespective of residence, younger (<50 years) women reported lower HRQoL than older (50+ years) women (113.5, 95% CI: 109.3, 117.8 vs. 128.2, 95%CI: 125.1, 131.2; p<0.05). Those women who received chemotherapy, reported two complications post-surgery, had poorer upper-body function than most, reported more stress, reduced coping, who were socially isolated, had no confidante for social-emotional support, had unmet health care needs, and low health self-efficacy reported lower HRQoL scores. Conclusions and Implications: The results underscore the importance of supporting and promoting regional and rural breast cancer programs that are designed to improve physical functioning, reduce stress and provide psychosocial support following diagnosis. Further, the information can be used by general practitioners and other allied health professionals for identifying women at risk of poorer HRQoL. [source] Bortezomib is associated with better health-related quality of life than high-dose dexamethasone in patients with relapsed multiple myeloma: results from the APEX studyBRITISH JOURNAL OF HAEMATOLOGY, Issue 4 2008Stephanie J. Lee Summary Health-related quality of life (HRQL) was prospectively measured during the phase III APEX trial of bortezomib versus dexamethasone in relapsed multiple myeloma patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire , Core (QLQ-C30) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group,Neurotoxicity (NTX) side-effects questionnaires were administered at baseline and every 6 weeks up to 42 weeks. Patients receiving bortezomib (1·3 mg/m2, days 1, 4, 8 and 11 for eight 3-week cycles, then days 1, 8, 15 and 22 for three 5-week cycles; n = 296) demonstrated significantly better mean Global Health Status over the study versus patients receiving dexamethasone (40 mg/d, days 1,4, 9,12, and 17,20 for four 5-week cycles, then days 1,4 only for five 4-week cycles; n = 302), plus significantly better physical health, role, cognitive, and emotional functioning scores, lower dyspnoea and sleep symptom scores, and better NTX questionnaire score, using multiple imputation to account for missing data. Results were similar using available-data analyses. Sensitivity analyses suggested that improved HRQL with bortezomib is at least partially explained by improved survival. These results show that bortezomib was associated with significantly better multidimensional HRQL compared with dexamethasone, consistent with the better clinical outcomes seen with bortezomib. [source] Health-related quality of life assessment after breast reconstruction,BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 6 2009S. Potter Background: Health-related quality of life (HRQL) is an important outcome following breast reconstruction. This study evaluated current methods of HRQL assessment in patients undergoing latissimus dorsi breast reconstruction, hypothesizing that early surgical morbidity would be reflected by poorer HRQL scores. Methods: Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and breast module (QLQ-BR23), the Functional Assessment of Cancer Therapy (FACT) general measure, and breast module and arm subscale (FACT-B + 4), and the Body Image Scale and Hospital Anxiety and Depression Scale (HADS) 3 months after surgery. They also reported additional HRQL problems not included in the questionnaires. HRQL scores were compared between patients with and without early surgical morbidity. Results: Sixty women completed the questionnaires, of whom 25 (42 per cent) experienced complications. All EORTC and FACT subscale and HADS scores were similar in patients with or without morbidity. Women with complications were twice as likely to report feeling less feminine and dissatisfied with the appearance of their scar than those without problems. Thirty-two women (53 per cent) complained of problems not covered by the questionnaires, most commonly donor-site morbidity. Conclusion: Existing HRQL instruments are not sufficiently sensitive to detect clinically relevant problems following breast reconstruction. Copyright © 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancerCANCER, Issue 3 2010Maxine de la Cruz MD Abstract BACKGROUND: A significant response to placebo in randomized controlled trials of treatments for cancer-related fatigue (CRF) had been reported. A retrospective study was conducted to determine the frequency and predictors of response to placebo effect and nocebo effects in patients with CRF treated in those trials. METHODS: The records of 105 patients who received placebo in 2 previous randomized clinical trials conducted by this group were reviewed. The proportion of patients who demonstrated clinical response to fatigue, defined as an increase in Functional Assessment of Chronic Illness Therapy-Fatigue score of ,7 from baseline to Day 8, and the proportion of patients with a nocebo effect, defined as those reporting >2 side effects, were determined. Baseline patient characteristics and symptoms recorded using the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. RESULTS: Fifty-nine (56%) patients had a placebo response. Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate) were significantly associated with placebo response. Commonly reported side effects were insomnia (79%), anorexia (53%), nausea (38%), and restlessness (34%). Multivariate analysis indicated that worse baseline (ESAS) sleep, appetite, and nausea were associated with increased reporting of the corresponding side effects. CONCLUSIONS: Greater than half of advanced cancer patients enrolled in CRF trials had a placebo response. Worse baseline physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in the design of future CRF trials. Cancer 2010. © 2009 American Cancer Society. [source] Vinorelbine, doxorubicin, and prednisone in androgen-independent prostate cancerCANCER, Issue 5 2006Lester S. Borden Jr. MD Abstract BACKGROUND. Ultimately, patients with metastatic prostate cancer progress on androgen ablation therapy. The investigation of new chemotherapeutic regimens for the treatment of androgen-independent prostate cancer (AIPC) is essential. The authors conducted a Phase II trial with vinorelbine, doxorubicin, and daily prednisone (NAP) to investigate the antitumor activity and palliative response of this regimen in patients with AIPC. METHODS. Forty-six patients entered this Phase II combination chemotherapy trial. Patients were treated with both vinorelbine and doxorubicin at doses of 20 mg/m2 on Days 1, 8, and 15 every 28 days and prednisone 5 mg twice daily. Endpoints included prostate-specific antigen (PSA) response and palliation, as measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) instrument, the Brief Pain Inventory Scale, and a narcotic analgesic log. RESULTS. The median follow-up for all 46 patients was 13.4 months. Fifty-two percent of patients had impaired performance status at baseline. One responding patient remained on NAP and was progression-free at 11.5 months. Thirty-nine patients progressed, 3 patients died prior to response assessment, and 3 patients refused therapy. The median overall survival was 57 weeks (95% confidence interval [95% CI], 36,76 weeks), and the median time to disease progression was 17 weeks (range, 11,24 weeks). The PSA response among the 36 patients who completed 3 cycles of NAP was 42% (95% CI, 26,59%). There was a statistically significant improvement in quality of life measured both by the FACT-General instrument (P = .03) and the FACT-P instrument (P = .0006) over the 3 months compared with baseline measurements. Pain medicine use also improved: The median morphine equivalents among patients who were taking pain medications at the time of study enrollment showed a substantial decline after 1 cycle of treatment that was maintained. Pain (as assessed by the Brief Pain Inventory) improved compared with baseline pain at the 2nd-month assessment (worst pain, P = .08; least pain, P = .02; and average pain, P = .003). Overall, the regimen was tolerated well. The most common side effects were mild fatigue and gastrointestinal complaints (all of which were Grade 1 or 2 [according to Version 2.0 of the Expanded Common Toxicity Criteria]). Seventeen patients (37%) experienced Grade 3 or 4 neutropenia. Five patients (11%) developed a cardiac ejection fraction of <50% during treatment and had doxorubicin discontinued. No patients developed clinical congestive heart failure. CONCLUSIONS. The NAP combination produced substantive palliation and a moderate response rate in men with AIPC. Cancer 2006. © American Cancer Society. [source] Determinants of quality of life in patients with cancerCANCER, Issue 5 2005A South American study Abstract BACKGROUND Because health-related quality of life (QOL) is an important outcome in cancer management, the authors sought to better understand its determinants. To address this subject, they analyzed QOL, as measured with the Functional Assessment of Cancer Therapy-General questionnaire (FACT-G), Spanish Version 4, and depicted the complex relations among physical, psychological, social, and cultural factors, including spirituality. METHODS A cross-sectional study design was used with a sample of 309 patients with cancer. The influence of several possible determinants was first studied by univariate regression analysis. Variables showing an association were included in a forward stepwise multivariate regression model. RESULTS Five regression models were studied, for the FACT-G total score and its four subscales. Five variables explained 32.1% of the variance of the FACT-G total score: tumor stage, spiritual well-being, income, mood disorders, and mode of questionnaire administration. The type and relevance of the explanatory variables differed among the various dimensions of QOL. CONCLUSIONS The authors underlined the entwining of biologic, psychosocial, and spiritual factors as determinants of the QOL of patients with cancer, thus supporting the multidimensional definition and modeling of the construct. Cancer 2005. © 2005 American Cancer Society. [source] Phase III trial of methotrexate, vinblastine, doxorubicin, and cisplatin versus carboplatin and paclitaxel in patients with advanced carcinoma of the urothelium,CANCER, Issue 8 2004A trial of the Eastern Cooperative Oncology Group Abstract BACKGROUND The regimens of carboplatin plus paclitaxel (CP) and methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) were compared in patients with advanced urothelial carcinoma. METHODS Patients with metastatic urothelial carcinoma were randomized to receive either CP (paclitaxel at a dose of 225 mg/m2 and carboplatin [targeted area under the concentration-time curve (AUC) of 6] given every 21 days) or the standard M-VAC dosage. RESULTS Eighty-five patients were randomized to the respective treatment regimens (41 to CP and 44 to M-VAC). Response rates and overall survival were similar for both treatment arms. Patients treated with CP had an overall response rate of 28.2% (95% binomial confidence interval, 15.0,44.9%) compared with an overall response rate of 35.9% for the M-VAC arm (95% binomial confidence interval, 21.2,52.8%) (P = 0.63, Fisher exact test). The median progression-free survival among patients who were treated with M-VAC was 8.7 months and was 5.2 months for patients receiving CP (P = 0.24, log-rank test). At a median follow-up of 32.5 months, the median survival for patients treated with M-VAC was 15.4 months versus 13.8 months for patients treated with CP (P = 0.65, log-rank test). Patients treated with M-VAC were found to have more severe worst-degree toxicities compared with patients treated with CP (P = 0.0001). There were no significant differences with regard to quality of life as assessed by the Functional Assessment of Cancer Therapy,Bladder (FACT-BL) instrument (P = 0.33). CONCLUSIONS Interpretation of the results of this study must be made with caution because the study failed to reach its accrual goal. Patients treated with CP had a median survival of 13.8 months compared with 15.4 months for patients treated with M-VAC. Patients treated with CP appeared in general to better tolerate their treatment; however, there were no significant differences noted with regard to measured quality of life parameters. Cancer 2004. © 2004 American Cancer Society. [source] Symptomatic hypogonadism in male survivors of cancer with chronic exposure to opioidsCANCER, Issue 4 2004Arun Rajagopal M.D. Abstract BACKGROUND Profound hypogonadism has been noted in patients receiving intrathecal opioids. The purpose of the current study was to determine whether chronic consumption of oral opioids by male survivors of cancer also would lead to central hypogonadism and whether this hypogonadism was associated with symptoms of sexual dysfunction, fatigue, anxiety, and depression. METHODS A case,control study was conducted at The University of Texas M. D. Anderson Cancer Center (Houston, TX), in which 20 patients who were chronically consuming opioids were compared with 20 matched controls. Patients completed the Sexual Desire Inventory (SDI), the Hospital Anxiety and Depression Scale (HADS), the Functional Assessment of Chronic Illness Therapy with general and fatigue subscales (FACT-G/FACIT-F), and the Edmonton Symptom Assessment System (ESAS) questionnaires. Serum samples were collected for testosterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH). RESULTS Comparing the opioid group with the control group, 18 of the 20 patients (90%; 95% confidence interval [CI], 65,98%) exhibited hypogonadism, compared with 8 of the 20 control patients (40%; 95% CI, 19,64%). The median testosterone level was 145 ng/dL versus 399.5 ng/dL (5.0 nmol/L vs. 13.9 nmol/L; P < 0.0001), the median FSH level was 2.85 milli,International Units (mIU)/mL versus 5.3 mIU/mL (P = 0.08), the median LH level was 1.8 mIU/mL versus 4.2 mIU/mL (P = 0.0014), the median SDI-dyadic score was 18.5 versus 40 (P = 0.01), the median SDI-solitary score was 0 versus 5 (P = 0.007), the HADS (anxiety) score was 8.5 versus 5.5 (P = 0.053), the HADS (depression) score was 7.5 versus 1.5 (P = 0.0002), the FACT-G score was 64 versus 96.3 (P = 0.0001), and the FACIT-F score was 24 versus 46 (P = 0.0003). CONCLUSIONS Survivors of cancer who chronically consumed opioids experienced symptomatic hypogonadism with significantly higher levels of depression, fatigue, and sexual dysfunction. With the increasing use of opioids among patients with cancer, further research in improving quality-of-life outcomes is warranted. Cancer 2004;100:851,8. © 2004 American Cancer Society. [source] Can older cancer patients tolerate chemotherapy?CANCER, Issue 4 2003A prospective pilot study Abstract BACKGROUND To the authors' knowledge, few data currently are available regarding the tolerance to chemotherapy in older cancer patients. This prospective pilot study evaluated the changes in functional, mental, nutritional, and comorbid status, as well as the quality of life (QOL), in geriatric oncology patients receiving chemotherapy. METHODS Sixty patients age , 70 years who were undergoing cancer chemotherapy were recruited in a university-based comprehensive cancer center. Changes in physical function were measured by the Eastern Cooperative Oncology Group performance status (ECOG PS) and Instrumental Activities of Daily Living (IADLs), mental health changes were measured by the Mini-Mental State Examination and the Geriatric Depression Scale (GDS), comorbidity was measured by Charlson's index and the Cumulative Illness Rating Scale-Geriatric, nutrition was measured by the Mini-Nutritional Assessment, and QOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Changes were assessed at baseline and at the end of treatment (EOT). Grade 4 hematologic and Grade 3,4 nonhematologic toxicities were recorded. RESULTS Thirty-seven patients (63%) completed both assessments. Older cancer patients demonstrated a significant decline in measurements of physical function after receiving chemotherapy, as indicated by changes in scores on the IADL (P = 0.04) and on the physical (P = 0.01) and functional (P = 0.03) subscales of the FACT-G. They also displayed worse scores on the GDS administered postchemotherapy (P < 0.01). Patients who experienced severe chemotoxicity had more significant declines in ECOG PS (P = 0.03), IADL (P = 0.03), and GDS (P = 0.04), and more gain in the social well-being subscale (P = 0.02) of the FACT-G, than those who did not experience severe chemotoxicity. However, changes in most scores were small in magnitude clinically. No significant change was found between baseline and EOT in nutrition, comorbidity, and other aspects of the FACT-G. CONCLUSIONS Older cancer patients undergoing chemotherapy may experience toxicity but generally can tolerate it with limited impact on independence, comorbidity, and QOL levels. It is important to recognize and monitor these changes during geriatric oncology treatment. Cancer 2003;97:1107,14. © 2003 American Cancer Society. DOI 10.1002/cncr.11110 [source] Patient personality predicts postoperative stay after colorectal cancer resectionCOLORECTAL DISEASE, Issue 2 2008A. Sharma Abstract Objective, Postoperative length of stay (LOS) is an important outcome after colorectal cancer surgery. The aim of this study was to evaluate the putative effects of personality, mood, coping and quality of life on LOS. Method, A consecutive series of 110 eligible patients undergoing elective resection for colorectal cancer were invited to participate in the study. A battery of psychometric questionnaires including the Hospital Anxiety and Depression Scale, the Functional Assessment of Cancer Therapy (colorectal), the Courtauld Emotional Control Scale, the Positive and Negative Affectivity Scale and the Eysenck Personality Questionnaire (EPQ) were administered 5,12 days before surgery. Nonparametric correlations were computed for psychometric scores, demographic variables and the LOS. Factors found to be significantly correlated on this analysis were entered into a multiple regression model to determine the independent predictors of LOS. Results, One hundred and four patients with colorectal cancer participated. Seventy were male (67%) and the mean age was 68 years (range 39,86). The median LOS was 10 days (range 4,108). LOS was negatively correlated with pre- and postoperative albumin levels, PANAS +ve affect, Functional Assessment of Cancer Therapy questionnaire with the colorectal module functional well-being score and EPQ extroversion score. LOS was strongly positively correlated with postoperative morbidity. LOS was positively correlated with CECS anger score, age and being male. Postoperative morbidity (, = 0.379, P = 0.007) and extroversion (, = ,0.318, P = 0.05) were independent predictors of LOS. Conclusion, Personality as measured by EPQ predicts postoperative LOS in patients with colorectal cancer. Extroverts have a higher pain threshold and this may be part of the explanation. [source] Functional assessment of centrosomes of spermatozoa and spermatids microinjected into rabbit oocytes,MOLECULAR REPRODUCTION & DEVELOPMENT, Issue 3 2009Masahito Tachibana Abstract Although intracytoplasmic sperm injection (ICSI) is a widely used assisted reproductive technique, the fertilization rates and pregnancy rates of immature spermatids especially in round spermatid injection (ROSI) remain very low. During mammalian fertilization, the sperm typically introduces its own centrosome which then acts as a microtubule organizing center (MTOC) and is essential for the male and female genome union. In order to evaluate the function of immature germ cell centrosomes, we used the rabbit gamete model because rabbit fertilization follows paternal pattern of centrosome inheritance. First, rabbit spermatids and spermatozoa were injected into oocytes using a piezo-micromanipulator. Next, the centrosomal function to form a sperm aster was determined. Furthermore, two functional centrosome proteins (,-tubulin and centrin) of the rabbit spermatogenic cells were examined. Our results show that the oocyte activation rates by spermatozoa, elongated spermatids, and round spermatids were 86% (30/35), 30% (11/36), and 5% (1/22), respectively. Sperm aster formation rates after spermatozoa, elongated spermatids, and round spermatids injections were 47% (14/30), 27% (3/11), and 0% (0/1), respectively. The aster formation rate of the injected elongating/elongated spermatids was significantly lower than that of the mature spermatozoa (P,=,0.0242). Moreover, sperm asters were not observed in round spermatid injection even after artificial activation. These data suggest that poor centrosomal function, as measured by diminished aster formation rates, is related to the poor fertilization rates when immature spermatogenic cells are injected. Mol. Reprod. Dev. 76: 270,277, 2009. © 2008 Wiley-Liss, Inc. [source] Functional assessment and treatment of pica: a single-case experimentBEHAVIORAL INTERVENTIONS, Issue 2 2001John T. Rapp The pica of a 6-year-old girl diagnosed with autism was initially shown to persist in the absence of socially mediated consequences. In an attempt to provide a competing source of oral stimulation, we used a stimulus preference assessment to identify food items that were subsequently presented noncontingently. However, the noncontingent schedule could not be thinned to a practical variation while still maintaining reductions in pica. A subsequent multielement evaluation of response blocking and verbal reprimands demonstrated that neither intervention both produced and maintained low levels of pica. Verbal reprimands were then used in conjunction with noncontingent food presentation, but this intervention did not produce significant reductions in pica. Suppression of pica was ultimately obtained in both a clinic setting and in the child's natural environment using contingent, varied auditory stimulation. The results are discussed in the context of the ,least restrictive alternative' model of treatment selection. Copyright © 2001 John Wiley & Sons, Ltd. [source] Long-Term Evaluation of Myoblast Seeded Patches Implanted on Infarcted Rat HeartsARTIFICIAL ORGANS, Issue 6 2010Marie-Noėlle Giraud Abstract Cell transplantation presents great potential for treatment of patients with severe heart failure. However, its clinical application was revealed to be more challenging than initially expected in experimental studies. Further investigations need to be undertaken to define the optimal treatment conditions. We previously reported on the epicardial implantation of a bio-engineered construct of skeletal myoblast-seeded polyurethane and its preventive effect on progression toward heart failure. In the present study, we present a long-term evaluation of this functional outcome. Left anterior descending coronary ligation was performed in female Lewis rats. Two weeks later, animals were treated with either epicardial implantation of biograft, acellular scaffold, sham operation, or direct intramyocardial skeletal myoblast injection. Functional assessments were performed with serial echocardiographies every 3 months and end point left ventricle pressure was assessed. Hearts were then harvested for histological examinations. Myocardial infarction induced a slow and progressive reduction in fractional shortening after 3 months. Progression toward heart failure was significantly prevented for up to 6 months after injection of myoblasts and for up to 9 months following biograft implantation. Nevertheless, this effect vanished after 12 months, with immunohistological examinations revealing an absence of the transplanted myoblasts within the scaffold. We demonstrated that tissue therapy is superior to cell therapy for stabilization of heart function. However, beneficial effects are transient. [source] Imaging of the lymphatic system: new horizons,CONTRAST MEDIA & MOLECULAR IMAGING, Issue 6 2006Tristan Barrett Abstract The lymphatic system is a complex network of lymph vessels, lymphatic organs and lymph nodes. Traditionally, imaging of the lymphatic system has been based on conventional imaging methods like computed tomography (CT) and magnetic resonance imaging (MRI), whereby enlargement of lymph nodes is considered the primary diagnostic criterion for disease. This is particularly true in oncology, where nodal enlargement can be indicative of nodal metastases or lymphoma. CT and MRI on their own are, however, anatomical imaging methods. Newer imaging methods such as positron emission tomography (PET), dynamic contrast-enhanced MRI (DCE-MRI) and color Doppler ultrasound (CDUS) provide a functional assessment of node status. None of these techniques is capable of detecting flow within the lymphatics and, thus, several intra-lymphatic imaging methods have been developed. Direct lymphangiography is an all-but-extinct method of visualizing the lymphatic drainage from an extremity using oil-based iodine contrast agents. More recently, interstitially injected intra-lymphatic imaging, such as lymphoscintigraphy, has been used for lymphedema assessment and sentinel node detection. Nevertheless, radionuclide-based imaging has the disadvantage of poor resolution. This has lead to the development of novel systemic and interstitial imaging techniques which are minimally invasive and have the potential to provide both structural and functional information; this is a particular advantage for cancer imaging, where anatomical depiction alone often provides insufficient information. At present the respective role each modality plays remains to be determined. Indeed, multi-modal imaging may be more appropriate for certain lymphatic disorders. The field of lymphatic imaging is ever evolving, and technological advances, combined with the development of new contrast agents, continue to improve diagnostic accuracy. Published in 2006 by John Wiley & Sons, Ltd. [source] Quantitation of Ventricular Size and Function:ECHOCARDIOGRAPHY, Issue 8 2000Accuracy of Transthoracic Rotational Scanning, Principles Two-dimensional echocardiography is a readily applicable method for the quantification of ventricular volumes. However, it is limited by assumptions regarding ventricular shape. Three-dimensional echocardiography has emerged as a more accurate and reproducible approach to ventricular volume and functional assessment compared with two-dimensional echocardiography. We review the principles of transthoracic rotational scanning and its clinical application for quantitative assessment of ventricular volume and function. [source] Steroid-responsive functional B12 deficiency in association with transcobalamin II polymorphism 776C,GEUROPEAN JOURNAL OF HAEMATOLOGY, Issue 1 2006Daniel P. Gale Abstract:, We present a case of intracellular vitamin B12 deficiency presenting with confusion, subacute combined degeneration of the cord, megaloblastic anaemia and intrinsic factor antibodies in the serum. Diagnosis was delayed by a normal serum B12 level and was confirmed by a grossly elevated serum homocysteine. There was a dramatic response to steroids. The patient was heterozygous for the transcobalamin (TC) II polymorphism 776C,G. This case demonstrates the importance of functional assessment of intracellular B12 activity (e.g. serum homocysteine) in excluding B12 deficiency, the role of steroids in pernicious anaemia and a possible clinical correlation of a TCII polymorphism. [source] |