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D Osoba

Publications and source records attributed to D Osoba.

At least 19 recordsLinked to original sources
PubMed1996

The development and psychometric validation of a brain cancer quality-of-life questionnaire for use in combination with general cancer-specific questionnaires.

A self-report questionnaire module consisting of 24 items, comprising 5 scales and 7 single items, has been developed for measuring health-related quality of life in patients with brain cancer. Module development proceeded through several stages, including a listing of patient, family and health care professional concerns, the writing of items, field testing in 105 patients with brain cancer and subsequent item reduction and scale construction after multitrait scaling analysis and assessment of internal consistency (Cronbach's coefficient alpha). The final version of the module exhibits reasonable test-retest stability over a period of one week. Differences in the responses between patients with recently-diagnosed and recurrent cancer and between patients with a Karnofsky Performance Score (KPS) of 50-70 and 80-100 were in the expected direction, indicating that the module of questions is responsive to differing conditions. Patients with either mental confusion, motor deficit or dysphasia indicated problems in several domains and single items as compared to patients without these neurological deficits. Thus, differences in the responses to the items in the brain cancer module appear to reflect differences in neurological status. In addition, deteriorating neurological status was accompanied by a marked increase in emotional distress, future uncertainty and motor dysfunction. A comparison of the responses in the module with the KPS and with a modified Barthel Activities of Daily Living Index (BADLI) shows moderate correlations, primarily with scales and items that pertain to motor dysfunction, while other scales (such as emotional distress, visual disorder and communication deficit) and most single items are not associated with the KPS or BADLI. Since the emotional distress scale of the module was found to be highly correlated with the emotional function scale of the EORTC QLQ-C30, it could be omitted when the module is used in combination with the QLQ-C30. This would reduce the module to a total of 20 items with four scales and seven single items. The intention is to combine this module of questions with other core or general quality-of-life questionnaires when studying patients with brain cancer in clinical trials.

Adult↗
PubMed1996

Guidelines for reporting results of quality of life assessments in clinical trials.

Clinical trials involving quality of life measurement published in the literature suffer from important weaknesses due to the lack of information on numerous topics. The psychometric properties of the instruments are often lacking as well as data on the number of patients treated and analyzed. The handling of missing data is rarely documented. In order to facilitate the reporting of trials and the evaluation of published results, this article proposes a set of general guidelines for the reporting of clinical trials which include a quality of life assessment. A checklist designed to assist authors is appended.

Clinical Trials as Topic↗
PubMed1996

Quality of life studies in chemotherapy-induced emesis.

Health-related quality of life (HQL) was assessed before and after either moderately or highly emetogenic chemotherapy. When the pretreatment HQL in patients who did not vomit after chemotherapy (n = 203) was compared to those who vomited (n = 230), it was found that patients who did not vomit had better physical, role, and social function scores as well as a better global quality of life score than did patients who had one or more episodes of vomiting. Furthermore, in patients who did not vomit, the pretreatment fatigue and anorexia scores were better than in patients who did vomit. Thus, pretreatment HQL scores appear to have value in predicting which patients will experience chemotherapy-induced emesis. In the week following chemotherapy, HQL change scores from prechemotherapy values for cognitive function, global quality of life, fatigue, anorexia, insomnia and dyspnea were significantly worse in the group experiencing emesis than in the group who remained completely free of emesis. There were no differences in physical, role, emotional and social function attributable to chemotherapy-induced vomiting.

Antiemetics↗
PubMed1996

Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points.

PURPOSE: To investigate the benefit of chemotherapy in patients with symptomatic hormone-resistant prostate cancer using relevant end points of palliation in a randomized controlled trial. PATIENTS AND METHODS: We randomized 161 hormone-refractory patients with pain to receive mitoxantrone plus prednisone or prednisone alone (10 mg daily). Nonresponding patients on prednisone could receive mitoxantrone subsequently. The primary end point was a palliative response defined as a 2-point decrease in pain as assessed by a 6-point pain scale completed by patients (or complete loss of pain if initially 1 +) without an increase in analgesic medication and maintained for two consecutive evaluations at least 3 weeks apart. Secondary end points were a decrease of > or = 50% in use of analgesic medication without an increase in pain, duration of response, and survival. Health-related quality of life was evaluated with a series of linear analog self-assessment scales (LASA and the Prostate Cancer-Specific Quality-of-Life Instrument [PROSQOLI]), the core questionnaire of the European Organization for Research and Treatment of Cancer (EORTC), and a disease-specific module. RESULTS: Palliative response was observed in 23 of 80 patients (29%; 95% confidence interval, 19% to 40%) who received mitoxantrone plus prednisone, and in 10 of 81 patients (12%; 95% confidence interval, 6% to 22%) who received prednisone alone (P = .01). An additional seven patients in each group reduced analgesic medication > or = 50% without an increase in pain. The duration of palliation was longer in patients who received chemotherapy (median, 43 and 18 weeks; P < .0001, log-rank). Eleven of 50 patients randomized to prednisone treatment responded after addition of mitoxantrone. There was no difference in overall survival. Treatment was well tolerated, except for five episodes of possible cardiac toxicity in 130 patients who received mitoxantrone. Most responding patients had an improvement in quality-of-life scales and a decrease in serum prostate-specific antigen (PSA) level. CONCLUSION: Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer.

Adenocarcinoma↗
PubMed1996

Health-related quality-of-life studies of the National Cancer Institute of Canada Clinical Trials Group.

Since 1989, the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) has been successful in implementing and completing health-related quality-of-life (HQL) assessments as part of phase III clinical trials. Compliance rates for completing HQL instruments remain high, with a minimal amount of missing data. It is believed that this success is attributable not only to the high degree of commitment to measuring HQL by clinical trials investigators, nurses, data managers, and central office administrative staff, but also to the educational process that was instituted after the development of a CTG policy for measuring HQL. From inception to May 1995, a total of 27 clinical trials with HQL assessment have been initiated or completed. In the majority of trials, the core HQL instrument is the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). In addition to answering specific questions about HQL in these clinical trials, the trials provide the opportunity to do research into the measurement of HQL. Thus, current clinical trials include research questions about the appropriate timing of assessments, the reliability and validity of the QLQ-C30 and other instruments, the role of HQL data in assessing toxicity, and the significance of the results of HQL assessments. It is anticipated that this activity not only will be a rich source of information about the effects of cancer and its treatment on HQL but also will lead to improvements in measuring HQL in oncology.

Canada↗
PubMed1995

Health-related quality of life: measurement and clinical application. A workshop report.

The process of measuring health-related quality of life (HQL) in oncology is reviewed and the role of these results in clinical practice and clinical trials is discussed. It is determined that comparisons of HQL measurement instruments are needed to clarify which questionnaires are preferable in particular populations or situations. "Calibration" data are also needed, to help explain the meaning of HQL scores and to link them to external reality. In phase III clinical trials, HQL assessment is most important in trials involving disease sites and stages with a poor prognosis and when comparing treatments not expected to affect survival.

Bias↗
PubMed1995

Guidelines for the optimal management of chemotherapy-induced nausea and vomiting: a consensus.

Nausea and vomiting are the most frequently reported adverse effects of cancer chemotherapy and have a significant impact on patients' daily functioning, quality of life and compliance with chemotherapy. Summarized in this article are the recommendations for the optimal management of nausea and vomiting developed by a multidisciplinary group of health care professionals. Issues relating to chemotherapy-induced nausea and vomiting are discussed; general principles of treatment are reviewed; treatment algorithms based on emetogenicity and types of chemotherapy are presented; and the importance of issues including non-pharmacological approaches, patient education and pharmacoeconomic perspectives are considered. The goal of antiemetic therapy should be no episodes of vomiting or retching and minimal or no nausea. Data from clinical trials support the clear superiority of 5-HT3 receptor antagonists in a variety of clinical situations. Their cost must be considered not only as an isolated item from the institutional perspective, but also from the perspective of the impact of successful therapy on the patient.

Algorithms↗
PubMed1995

Health-related quality of life as a treatment endpoint in metastatic breast cancer.

In incurable breast cancer all therapy is palliative, i.e. intended primarily to relieve symptoms, preserve health-related quality of life (HQL) and, if possible, prolong life without undue toxicity and loss of HQL. In this situation the measure of success if the extent to which palliative therapy achieves these goals. Unless the effects of therapy on symptoms and HQL are measured, it will never be certain whether the goals of palliation are being achieved. Recent studies in metastatic breast cancer have begun to focus on these goals, and the results are encouraging. It is becoming clear that HQL is improved by using appropriately aggressive chemotherapy, with the benefits outweighing the deleterious effects of treatment toxicity. In addition, there are some unexpected results indicating that pre-treatment HQL may be a better predictor of response, on-treatment HQL and length of survival than other known prognostic variables. These advances in our understanding of HQL in metastatic breast cancer will aid in the development of rational treatment policies for the management of this disease.

Antineoplastic Agents↗
PubMed1994

Inconsistency of prognostic factors for post-chemotherapy nausea and vomiting.

A number of prognostic factors have been reported to influence the probability of developing nausea and vomiting after cytotoxic chemotherapy. This study used data collected in four randomized anti-emetic trials conducted by the Clinical Trials Group of the National Cancer Institute of Canada (NCIC-CTG) to assess the consistency of the effects of these prognostic factors. A total of 582 patients, all of whom had received moderately emetogenic chemotherapy for the first time, but who were assigned to different anti-emetics, were included in the analysis. The major findings was that the probability of post-chemotherapy nausea and vomiting was much more strongly influenced by the type of chemotherapy given and the type of anti-emetic used than by patient (e.g., age, gender) or environmental (e.g., treatment location, time of administration) characteristics. Further, patient-related factors had different, and sometimes opposite, effects in different anti-emetic and chemotherapy subgroups. Finally, the relative potency of anti-emetics appeared to vary with chemotherapy regimens. Implications of these findings for future studies are discussed.

Antiemetics↗
PubMed1994

Research on health-related quality of life: dissemination into practical applications.

Strategies and processes for the effective dissemination and diffusion of research findings on health-related quality of life (HQL) into practical applications were explored at a workshop held in Montreal in April, 1994. A conceptual model for dissemination and diffusion of evidence about HQL was used to identify five different target groups: HQL assessors, policy makers, planners of clinical trials, developers of clinical practice guidelines, and those at the level of patient-practitioner clinical decision making. A framework designed to facilitate the translation of fundamental research knowledge into effective action was then used as a starting point for discussions about priorities for research on HQL. The most important problem identified at the workshop was how best to strike an appropriate balance between priorities deemed to be important to those directly involved in HQL research, and priorities deemed to be important to potential users of the results of HQL research?

Algorithms↗
PubMed1994

The Karnofsky Performance Status Scale re-examined: a cross-validation with the EORTC-C30.

A cross-validation of the Karnofsky Performance Status (KPS) and quality of life (QOL) as measured by item 30 of the quality of life questionnaire developed by the European Organization for Research and Treatment of Cancer Study Group (EORTC QLQ-C30) was conducted using ordered logit analysis and prospective data from a continuous sample of 139 lung cancer patients. The QOL is found to be a much broader concept than the KPS, since it likely captures not only physical functioning but also functioning in the non-physical dimensions of social, emotional, and possibly cognitive well-being as well as the level of distress in the physical dimensions of pain, breathing and fatigue. These results suggest that the palliative treatment of advanced cancer and the terminally ill should be guided by a broad concept of well-being that goes beyond one based only on physical functioning.

Humans↗
PubMed1994

Psychometric properties and responsiveness of the EORTC quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer.

The QLQ-C30, a health-related quality of life questionnaire developed for use in patients with cancer, has been previously validated in patients with lung cancer and head and neck cancer. In this study, further validation was carried out for 535 patients, including patients with breast cancer (n = 143) and ovarian cancer (n = 111) for whom there is no previously published validation, as well as patients with lung cancer (n = 160) and a heterogeneous group of other cancers (n = 121). All patients were entered in one of two trials of anti-emetics to prevent chemotherapy-induced emesis. The QLQ-C30 was completed before chemotherapy and on day 8 after chemotherapy. The factor structure in patients with breast and ovarian cancer was similar to that previously described. Interdomain correlations, in the entire group, were strongest for the physical and role function domains and the fatigue, pain and global quality of life domains before and after chemotherapy. In addition, after chemotherapy, social function was also strongly correlated with fatigue and global quality of life. These correlations were not always of equal strength in the breast, ovarian and lung groups, suggesting that there may be differences between these groups. The responsiveness of the QLQ-C30 in the presence of widely metastatic, as compared with locoregional, disease showed changes in the expected directions (i.e., diminished function in physical and social role functions and in global quality of life, with greater fatigue and pain in patients with metastatic disease). Eight days after chemotherapy, decreases were seen in physical, role and social functioning and in global quality of life, and there was greater fatigue, nausea and vomiting compared with before chemotherapy. Patients with breast cancer had better physical, role and social functioning and less fatigue and pain than patients with ovarian cancer. This result is expected, since many of the patients with breast cancer had early stage disease, whereas those with ovarian cancer had advanced stage disease. Mean scores for patients with lung cancer were between the other two groups, in keeping with the mixture of early and advanced stage disease in these patients. There was a strong correlation between ECOG performance status scores and several domains of the QLQ-C30; these were all in the expected directions. The results of this study confirm those in earlier studies on patients with lung cancer, and provide new information on patients with breast and ovarian cancer. In addition, the QLQ-C30 is responsive to the effects of chemotherapy and of metastatic disease.

Breast Neoplasms↗
PubMed1994

Lessons learned from measuring health-related quality of life in oncology.

PURPOSE: Measurement of health-related quality of life (HQL) is becoming more common in oncology, particularly in clinical trials. The purpose of this report is to review our progress and assess whether we are learning anything new from these studies. DESIGN: The subject was reviewed by a literature search and selection of available literature in the English language. The results emerged from this review. RESULTS: Six lessons that emerged from measurement of HQL in oncology were chosen for emphasis. These are (1) HQL is a multidimensional construct and should be measured with multidimensional instruments, (2) observers are poor judges of how patients feel about their HQL, (3) it is possible to achieve high rates of compliance in the collection of self-report HQL data, (4) aggressive therapy may result in improved HQL, (5) symptoms are associated with quantifiable disruptions in HQL, and (6) pretreatment HQL may be predictive of on-treatment HQL and of survival. CONCLUSION: None of the six points chosen for emphasis was known with certainty as little as 10 years ago. Although other points for emphasis may be chosen, those emphasized in this review could have a major impact on how we judge success in future clinical trials.

Humans↗
PubMed1994

Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer.

PURPOSE: This phase II study was designed to assess the effects of mitoxantrone with prednisone in patients with metastatic prostate cancer who had progressed on hormonal therapy. The methods of assessment included quality-of-life analyses, pain indices, analgesic scores, and the National Prostatic Cancer Project (NPCP) criteria. PATIENTS AND METHODS: Patients received mitoxantrone 12 mg/m2 intravenously every 3 weeks plus prednisone 10 mg orally daily. All had a castrate serum testosterone and Eastern Cooperation Oncology Group (ECOG) performance status < or = 3, and had not received prior chemotherapy. Every 3 weeks, analgesic intake was scored, and a present pain intensity (PPI) record and visual analog scale (VAS) describing pain were collected. Every 6 weeks, the European Organization for Research and Treatment of Cancer (EORTC) core quality-of-life questionnaire plus a prostate-specific module were completed. A palliative response was defined as a decrease in analgesic score by > or = 50% or a decrease in PPI by > or = two integers without any increase in the other. RESULTS: Twenty-seven patients were entered onto the study. Nine of 25 (36%) assessable patients achieved a palliative response maintained for > or = two cycles (range, two to eight or more). Improvements in mean PPI and VAS pain scores after each cycle of therapy (P < .05) were seen. Quality-of-life analysis showed improvements in social and emotional functioning, and in pain and anorexia. Using NPCP criteria, one patient achieved a partial response (PR) and 12 had stable disease; one of seven patients with measurable disease had a PR. No serious nonhematologic toxicity was experienced, and there were no episodes of febrile neutropenia. CONCLUSION: Mitoxantrone with low-dose prednisone is a well-tolerated treatment regimen that has some beneficial effects on disease-related symptoms and quality of life for patients with advanced prostate cancer.

Aged↗
PubMed1994

Phase II trial of megestrol in the supportive care of patients receiving dose-intensive chemotherapy.

Megestrol acetate was given daily to lung cancer patients undergoing therapy with CODE and to recurrent head and neck cancer patients receiving DEB/M in an attempt to prevent weight loss. The outcomes in this study were compared with the same outcomes in similar groups of patients treated with the same chemotherapy regimens, but in which prednisone was used as the main supportive drug along with co-trimoxazole, ketoconazole, and either cimetidine or sucralfate. Weight loss was less pronounced in the current patients than in the previous ones. Nevertheless, there were several factors that led us to conclude that megestrol is not an adequate substitute for prednisone in patients receiving this kind of chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1994

Quality of life, appetite, and weight change in patients receiving dose-intensive chemotherapy.

Quality of life was assessed by self-report questionnaires in 30 patients receiving dose-intensive chemotherapy for either non-small-cell lung cancer (20 patients) or recurrent head and neck cancer (10 patients). Megestrol acetate was given daily to try to improve appetite and prevent the weight loss usually associated with this chemotherapy. Appetite did not change significantly overall during the first 4 weeks of chemotherapy, but it did improve in those patients still receiving chemotherapy at 8 weeks. Changes in global quality of life were significantly correlated with changes in appetite, fatigue, energy level, and physical function. Thus, these parameters may have more relevance to patients' perceptions of quality of life than does weight change, and should be used more frequently as endpoints in studies of supportive care and palliative treatment of patients with cancer.

Antineoplastic Agents↗