Biomedical subjects

D Osoba

Publications and source records attributed to D Osoba.

At least 37 records · Page 2Linked to original sources

PubMed1999

Health-related quality of life in women with metastatic breast cancer treated with trastuzumab (Herceptin).

The measurement of health-related quality of life (HRQL) was an important component of clinical trials of trastuzumab (Herceptin; Genentech, San Francisco, CA) in women with progressive HER2-overexpressing metastatic breast cancer who may or may not have had prior chemotherapy. Health-related quality of life was measured at baseline and specified intervals during therapy using the European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (QLQ-C30, version 1.0). Five domains were chosen a priori for analysis: global quality of life, physical, role and social functioning, and fatigue. In the phase II study, in which trastuzumab was given alone, there was no change in on-treatment QLQ-C30 scores compared with baseline. These results suggest that trastuzumab does not adversely affect HRQL during therapy. In the phase III study, the effects of trastuzumab plus chemotherapy were compared with those of chemotherapy alone. A comparison of QLQ-C30 scores during treatment did not show statistically significant differences between the two groups at the preset level of P = .01. However, comparison of on-treatment scores with baseline in patients receiving chemotherapy alone indicated mild worsening of physical and role functioning and of fatigue throughout the duration of treatment, whereas a similar comparison of those receiving chemotherapy with trastuzumab revealed mild worsening of role functioning at weeks 8 and 20 and of fatigue only at week 8. These results suggest that trastuzumab may be associated with an amelioration of the deleterious effects of chemotherapy alone. In summary, in the doses and schedules used in these studies, trastuzumab is not associated with worsening of HRQL.

Antibodies, Monoclonal↗

PubMed1998

The impact of postchemotherapy nausea and vomiting on quality of life after moderately emetogenic chemotherapy.

The purpose of the study was to assess the impact of postchemotherapy nausea and vomiting (PCNV) after moderately emetogenic chemotherapy on health-related quality of life (HRQOL) in patients with cancer being treated in a routine clinical practice setting. The European Organization for Research and Treatment in Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) was administered on day 2 and day 6 following moderately emetogenic chemotherapy to 119 patients with a variety of cancers. Patients kept daily diaries to record the occurrence and severity of nausea and vomiting. The QLQ-C30 questions were modified, for this study only, to assess the impact of nausea and vomiting on HRQOL in patients who experienced nausea and/or vomiting during the six days following chemotherapy. Those patients who experienced either nausea or vomiting experienced a decrease in HRQOL from prechemotherapy levels on six functioning and five symptom scales at day 2, and on four functioning and four symptom scales on day 6. Comparison of mean scores between the unmodified QLQ-30 and the nausea and vomiting versions demonstrated that the HRQOL rating attributed to nausea and vomiting accounted for much, but not all, of the deterioration in HRQOL scores in patients who experienced these symptoms. It can be concluded that patients who experience PCNV experience a significant negative impact on their HRQOL and that this impact can be attributed in large part to their experience of nausea and vomiting. However, since not all of the deterioration is attributable to these symptoms, other reasons for some of the decrease in HRQOL must also be identified in future studies.

Adult↗

PubMed1998

Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. European Organization for Research and Treatment of Cancer.

INTRODUCTION: The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) was developed to be a pragmatic outcome measure for clinical trials in symptomatic men with advanced hormone-resistant prostate cancer. DESIGN AND SETTING: A comparative assessment of responsiveness was made with longitudinal data from a positive multicenter randomized trial of palliative chemotherapy in 161 symptomatic men with advanced hormone-resistant prostate cancer. INSTRUMENTS: The PROSQOLI, the European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30), and a specific quality of life module for advanced prostate cancer [QLM-P14] were administered every 3 weeks while patients received their allocated treatment. FINDINGS: Sixteen of the 19 health-related quality of life (HRQL) scales demonstrated improvements in palliative responders. All three pain scales detected a beneficial effect of palliative chemotherapy. The relative efficiency statistics favored the PROSQOLI for physical symptoms and physical function but the QLQ-C30 for emotional function, social function, and global perceptions. The PROSQOLI linear analog scale was the most responsive measure of pain. Bootstrap confidence intervals for the relative efficiency statistics were wide. CONCLUSIONS: Both the PROSQOLI and the analogous scales from the QLQ-C30 were responsive to improvements in HRQL. Differences between the instruments were generally subtle. The PROSQOLI is a short, simple, responsive measure of HRQL in men receiving systemic treatment for advanced hormone-resistant prostate cancer.

Aged↗

PubMed1998

Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop.

In recent years, quality of life (QoL) and economic evaluations have become increasingly important as additional outcome measures in cancer clinical trials. However, both fields of research are relatively new and in need of finding solutions to a substantial number of specific methodological problems. This paper reports on the proceedings of a symposium aimed at summarising and discussing some of the most contentious methodological and statistical issues in QoL and economic evaluations. In addition, possible solutions are indicated and the most pertinent areas of research are identified. Issues specific to QoL evaluations that are addressed include clinically meaningful changes in QoL scores; how to analyse QoL data and to handle missing and censored data and integration of length of life and QoL outcomes. Issues specific to economic evaluations are the advantages and disadvantages of various outcome measures; statistical methods to analyse economic data and choice of decision criteria and analytical perspective. How to perform QoL and economic evaluations in large and simple trials and whether the gap between QoL and utility measures can be bridged are also discussed.

Clinical Trials as Topic↗

PubMed1998

Patients' experiences using a computerized program with a touch-sensitive video monitor for the assessment of health-related quality of life.

This study assessed patients' experiences using a computerized program with a touch-sensitive video monitor (TSVM) for the assessment of health-related quality of life (HRQoL). A software program was developed for a computerized form of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, the QLQ-C30. One hundred and seventy-eight patients completed the QLQ-C30, followed by a structured interview designed to assess perceived difficulties with the use of the TSVM. Patients were asked to evaluate the ease of use of different aspects of the TSVM system (using the touch-sensitive screen, entering the patient identification number, reading the screen and following the on-screen instructions). The majority of patients found all aspects of the TSVM system 'very easy' to use. A few patients (1-2%) admitted finding any aspect of the TSVM use 'somewhat difficult' and none ranked any aspect as 'very difficult'. There were no unanswered items in the QLQ-C30. All patients found the amount of time spent on answering the questionnaire acceptable, (the mean time to complete was 6.8 min with a median of 5 min) and 96% stated they were willing to complete a similar questionnaire on a future occasion. From the patients' perspective the TSVM system appears to be a highly acceptable approach for the collection of HRQoL data in clinical practice.

Aged↗

PubMed1998

Effects of altering the time of administration and the time frame of quality of life assessments in clinical trials: an example using the EORTC QLQ-C30 in a large anti-emetic trial.

Previous studies conducted by our group suggested that the ability to demonstrate an impact of emesis control on quality of life might depend upon when an quality of life instrument was administered in relation to chemotherapy and on the time frame of the questionnaire. This study was conducted to address this issue. Six hundred and fifty patients receiving moderately emetogenic chemotherapy in a randomized trial comparing a variety of anti-emetic regimens were allocated to four different modes of administration (days 4 and 8; 3 and 7 day time frames) of the QLQ-C30. Patients who completed the questionnaire at the time of maximal impact of chemotherapy (day 3) were more likely to report deterioration in quality of life. Patients who completed questionnaires at day 8 were more likely to report deterioration in quality of life if their questionnaire had a 7 day time frame rather than a 3 day time frame. Patients receiving more effective anti-emetic therapy had better quality of life. It was concluded that better anti-emetic control improves quality of life after moderately emetogenic chemotherapy. In studying quality of life in situations where the impact of treatment waxes and wanes, careful attention needs to be paid to scheduling the administration of questionnaires and to their time frame.

Adult↗

PubMed1998

Interpreting the significance of changes in health-related quality-of-life scores.

PURPOSE: To determine the significance to patients of changes in health-related quality-of-life (HLQ) scores assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). PATIENTS AND METHODS: A subjective significance questionnaire (SSQ), which asks patients about perceived changes in physical, emotional, and social functioning and in global quality of life (global QL) and the QLQ-C30 were completed by patients who received chemotherapy for either breast cancer or small-cell lung cancer (SCLC). In the SSQ, patients rated their perception of change since the last time they completed the QLQ-C30 using a 7-category scale that ranged from "much worse" through "no change" to "much better." For each category of change in the SSQ, the corresponding differences were calculated in QLQ-C30 mean scores and effect sizes were determined. RESULTS: For patients who indicated "no change" in the SSQ, the mean change in scores in the corresponding QLQ-C30 domains was not significantly different from 0. For patients who indicated "a little" change either for better or for worse, the mean change in scores was about 5 to 10; for "moderate" change, about 10 to 20; and for "very much" change, greater than 20. Effect sizes increased in concordance with increasing changes in SSQ ratings and QLQ-C30 scores. CONCLUSION: The significance of changes in QLQ-C30 scores can be interpreted in terms of small, moderate, or large changes in quality of life as reported by patients in the SSQ. The magnitude of these changes also can be used to calculate the sample sizes required to detect a specified change in clinical trials.

Breast Neoplasms↗

PubMed1998

Use of dexamethasone and granisetron in the control of delayed emesis for patients who receive highly emetogenic chemotherapy. National Cancer Institute of Canada Clinical Trials Group.

PURPOSE: To evaluate the roles of granisetron and dexamethasone for emesis control on days 2 through 7 after the administration of cisplatin in doses of 50 mg/m2 or greater to patients who had not previously received chemotherapy. PATIENTS AND METHODS: Four hundred thirty-five eligible and assessable patients were randomized to one of two arms in a double-blind fashion: arm A; granisetron 3 mg intravenous (i.v.) plus dexamethasone 10 mg i.v. prechemotherapy followed by granisetron 1 mg orally at 6 and 12 hours, then granisetron 1 mg orally and dexamethasone 8 mg orally twice daily on days 2 through 7 (219 patients); arm B; as in arm A but with placebo substituted for granisetron on days 2 through 7 (216 patients). All patients completed diaries in which episodes of emesis and severity of nausea were recorded. RESULTS: The addition of granisetron on days 2 through 7 had no discernable impact on nausea and vomiting during this period. CONCLUSION: The administration of a 5-hydroxytryptamine3, receptor (5-HT3) antagonist, in this case granisetron, after 24 hours conferred no benefit. This negative result needs to be assessed in light of conflicting literature, but at present it does not appear that the routine use of these drugs in this setting is justified.

Antiemetics↗

PubMed1997

Current applications of health-related quality-of-life assessment in oncology.

The past 5 years have seen increasing application of health-related quality-of-life (HRQOL) assessment in oncology. Most commonly, HRQOL has been studied in patients with metastatic cancer and in trials involving the use of antiemetics to control postchemotherapy nausea and vomiting. These studies have produced interesting and, in some cases, counterintuitive results. Thus far, HRQOL assessment appears to be important in clinical trials involving control of symptoms (disease-related or treatment-related), cancers with a poor prognosis, treatment arms with similar survivals, supportive care interventions, and ways of determining prognosis.

Antineoplastic Agents↗

PubMed1997

Effect of postchemotherapy nausea and vomiting on health-related quality of life. The Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group.

The purpose was to measure the effects of postchemotherapy nausea and vomiting (PCNV) on health-related quality of life (HQL) in patients receiving either moderately or highly emetogenic chemotherapy. The study sample consisted of 832 chemotherapy-naive patients with cancer who received either moderately or highly emetogenic chemotherapy as part of multicenter trials of new antiemetics. The patients completed the self-report European Organization for Research and Cancer (EORTC) core Quality of Life Questionnaire (QLQ-C30) before chemotherapy (baseline) and 1 week (day 8) and 2-4 weeks after chemotherapy. They also completed a self-report nausea and vomiting (NV) diary for 5-7 days after chemotherapy. To determine the effects of PCNV on HQL, the change in scores between the baseline and day 8 HQL assessments was calculated for each domain and symptom in the QLQ-C30 and compared in four subgroups of patients: those with both nausea and vomiting, those with nausea but no vomiting, those with no nausea but with vomiting, and those with neither nausea nor vomiting. The group with both nausea and vomiting showed statistically significantly worse physical, cognitive and social functioning, global quality of life, fatigue, anorexia, insomnia and dyspnea as compared to the group with neither nausea nor vomiting (0.0001 < P < 0.05). Patients with only nausea but no vomiting tended to have less worsening in functioning and symptoms than those having both nausea and vomiting. Increased severity of vomiting (> 2 episodes) was associated with worsening of only global quality of life and anorexia as compared with 1-2 episodes of vomiting (0.0001 < P < 0.01). By 2-4 weeks after chemotherapy all HQL scores had either returned to their baseline levels or were better than baseline. PCNV adversely affects several quality-of-life domains, but patients with only nausea experience less disruption than do those with both nausea and vomiting. Patients with 1-2 episodes of vomiting experience almost the same degree of disruption of HQL as do patients with more than 2 episodes of vomiting.

Analysis of Variance↗

PubMed1997

Fatigue in patients with cancer: results with National Cancer Institute of Canada Clinical Trials Group studies employing the EORTC QLQ-C30.

The purpose of this study was to examine the factors which affect the level of fatigue among patients participating in clinical trials in which this symptom had been assessed with the EORTC QLQ-C30. Data were assembled from 2390 patients in ten clinical trials in which the QLQ-C30 had been used to assess baseline and on-study quality of life. The relationship between the level of fatigue reported by the patients on the fatigue scale of this questionnaire and patient and disease characteristics was assessed in univariate and multivariate cross-sectional analyses. In addition, changes in fatigue scores were compared in a longitudinal analysis among patients on two arms of an anti-emetic trial whose emesis control was markedly different. Baseline fatigue levels differed substantially among patients taking part in the different trials. Factors associated with greater fatigue severity on univariate analysis included: female gender, presence of metastatic disease, and poorer performance status. In addition, on multivariate analyses the oldest patients were found to have less fatigue, as were patients with breast cancer, while patients with ovarian and lung cancer experienced greater fatigue. Patients on the arm of the anti-emetic trial in which emesis was better controlled showed significantly less increase in fatigue after receiving chemotherapy. The fatigue scale of the QLQ-C30 appears to provide a useful approach to assessing this important symptom. The relationships found between fatigue and patient and disease characteristics need further exploration as does the degree to which the QLQ-C30 fully captures this dimension of quality of life.

Adult↗

PubMed1997

Quality of life in oncology practice: prognostic value of EORTC QLQ-C30 scores in patients with advanced malignancy.

Quality of life (QL) scores may be used to assess the impact of disease and treatment, and to predict survival of cancer patients in prospective clinical trials. The aim of this study was to evaluate the prognostic association of QL scores among patients with advanced malignancies in routine practice. Adult patients with advanced malignancy from 12 institutions in 10 countries completed the EORTC QLQ-C30 questionnaire, in their native language, once at study entry. Baseline patient and disease characteristics were recorded. We used a proportional hazards model stratified on diagnostic category to test whether QL scores from the QLQ-C30 were significantly and independently predictive of overall survival duration from the time of QL measurement. In all, 735 eligible patients were entered between November 1989 and September 1995. On 1 October 1995, follow-up information was obtained on 656 patients, of whom 411 had died. Patient and disease factors predictive of worse survival were age and performance status. The global scale and the scales of physical, role, emotional, cognitive and social function were each significantly predictive of subsequent survival duration in univariate analyses. Single-item QL scores for overall physical condition (question 29), overall quality of life (question 30), and the global and social functioning scales remained independently prognostic after allowing for performance status and age, and, among solid tumour patients, metastatic site. QL can be measured in an international setting based on routine oncology practice. QL scores carry prognostic information independent of other recorded factors.

Age Factors↗

PubMed1997

Effect of neurological dysfunction on health-related quality of life in patients with high-grade glioma.

The purpose of the study was to assess health-related quality of life (HQL) in patients with high-grade malignant glioma of the brain. The EORTC core Quality of Life Questionnaire (QLQ-C30) and a Brain Cancer Module (BCM20) were administered at baseline and several weeks later (follow-up) to 105 patients with either recently-diagnosed (n = 41) or recurrent (n = 64) malignant glioma. In addition, the attending neurologists completed a standard neurological examination, a modified Barthel Activities of Daily Living Index (BADLI) and the Karnofsky Performance Scale (KPS). In a preliminary step, the QLQ-C30 was found to have acceptable reliability (internal consistency and test-retest reliability). Newly-diagnosed patients and those with a KPS of 80-100 had significantly better physical, role and cognitive functioning and global quality of life with less fatigue, visual disorder, motor dysfunction, communication deficit, weakness of both legs and trouble controlling the bladder than did those with recurrent disease and those with a KPS of 50-70. Similarly, those capable of independent activities of daily living, as reported on the BADLI, had higher functioning scores and less fatigue than did those who were not independent. Patients with dysphasia, mental confusion or motor deficit on neurological examination reported significantly lower levels of physical, role, cognitive, emotional and social functioning and global quality of life than did patients not having these difficulties. They also had significantly more symptoms. In patients with deteriorating neurological status between baseline and follow-up, there was a marked decline in cognitive, physical, role, emotional and social functioning and global quality of life and an increase in fatigue. Thus, there are significant differences in HQL between patients with newly-diagnosed and recurrent brain cancer and between patients with differing KPS and BADLI scores. In addition, the HQL scores provide details not provided by the KPS and the BADLI. Deterioration in neurological function is accompanied by significant deterioration in a range of HQL domains and in global quality of life.

Adolescent↗

PubMed1997

Modification of the EORTC QLQ-C30 (version 2.0) based on content validity and reliability testing in large samples of patients with cancer. The Study Group on Quality of Life of the EORTC and the Symptom Control and Quality of Life Committees of the NCI of Canada Clinical Trials Group.

A revision of the Quality of Life Questionnaire (QLQ-C30) of the European Organization for Research and Treatment of Cancer (EORTC) was undertaken to improve low internal consistency estimates (Cronbach's alpha) and content validity for the role functioning scale and a conceptual difficulty (undue emphasis on physical functioning) in the global quality of life (QOL) scale. The role functioning items were reworded and a four-category response format was substituted for the previous dichotomous format. A new item asking about 'overall health' was substituted for the 'overall physical condition' item in the global QOL domain. The original and new versions were tested at three time points in a total of 1,181 patients with cancer in Canada (n = 696) and the Netherlands (n = 485). In both samples there was a marked improvement in internal consistency for the role functioning scale (Cronbach's alpha s ranging from 0.78-0.88) in the new version. In the global QOL scale, the substitution of the new item for the previous one did not alter internal consistency (Cronbach's alpha's ranging from 0.81-0.92). The revised versions of the role functioning and global QOL domains have been incorporated into the QLQ-C30 (version 2.0).

Adult↗

PubMed1997

Quality of life scores: an independent prognostic variable in a general population of cancer patients receiving chemotherapy. The National Cancer Institute of Canada Clinical Trials Group.

This report examines the prognostic associations between QOL scores measured by the EORTC QLQ-C30 and survival in a large heterogeneous population of cancer patients. Eight hundred and fifty-one cancer patients who were to receive chemotherapy were enrolled in two National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) antiemetic trials. All patients completed the EORTC QLQ-C30 immediately prior to their first chemotherapy. Survival data were available and obtained for 474 of 639 patients (74%). Cox's proportional hazards model was used to assess the independent impact of QOL and demographic variables on survival. Presence of metastatic disease, diagnosis of lung or ovarian cancer, ECOG performance status, global quality of life and emotional functioning were significantly associated with survival. Global QOL was predictive in all patients, in subgroups of patients with metastatic disease, with breast and lung cancer and other tumour types. In patients with low global quality of life scores, patients with low emotional functioning ratings lived longer than did patients with high emotional functioning ratings. Patients with high global QOL live significantly longer than do patients with low global QOL. The relationship between emotional functioning in patients with low global QOL and survival needs confirmation.

Female↗

PubMed1997

The use of significant others as proxy raters of the quality of life of patients with brain cancer.

OBJECTIVES: The use of self-report questionnaires for the assessment of health-related quality of life (HRQOL) is increasingly common in clinical research. This method of data collection may be less suitable for patient groups who suffer from cognitive impairment, however, such as patients with brain cancer. In such cases, one can consider employing the patients' significant others as proxy raters of the patients' health-related quality of life. The authors examined the response agreement between patients with brain cancer and their significant others on a health-related quality of life instrument commonly used in cancer clinical trials, the EORTC QLQ-C30, and on a brain cancer-specific questionnaire module, the QLQ-BCM. METHODS: The study sample consisted of 103 pairs of patients, with either recently diagnosed or recurrent brain cancer, and their significant others (75% spouses, 22% relatives, and 3% friends). Patients and proxies independently completed the EORTC QLQ-C30 and the QLQ-BCM at three different times. RESULTS: Approximately 60% of the patient and proxy scores were in exact agreement, with more than 90% of scores being within one response category of each other. For most HRQOL dimensions assessed, moderate to good agreement was found. Statistically significant differences in mean scores were noted for several dimensions, with proxies tending to rate the patients as having a lower quality of life than the patients themselves. With the exception of fatigue ratings, this response bias was of a limited magnitude. Less agreement and a more pronounced response bias was observed for the more impaired patients, and particularly for patients exhibiting mental confusion. This finding was confirmed by longitudinal analyses, which indicated lower levels of patient-proxy agreement at follow-up for those patients whose physical or neurologic condition had deteriorated over time. CONCLUSIONS: In general, patients and their significant others provide similar ratings of the patients' quality of life. Lower levels of agreement and more biased ratings can be expected among those patients for whom the need for proxies is most salient. It is argued, however, that discrepancies between patient-proxy ratings should not be interpreted, a priori, as evidence of the inaccuracy or biased nature of proxy-generated data. Future studies are needed to examine the relative validity and reliability of patient-versus proxy-generated health-related quality of life scores.

Adolescent↗

PubMed1997

Determinants of postchemotherapy nausea and vomiting in patients with cancer. Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group.

PURPOSE: To assess whether prechemotherapy health-related quality-of-life (HQL) variables are associated with postchemotherapy nausea and vomiting (PCNV), and to determine their relationship to patient and treatment variables. PATIENTS AND METHODS: Eight hundred thirty-two chemotherapy-naive patients scheduled to receive antiemetic regimens containing a 5-hydroxytryptamine (5-HT3) antagonist with or without dexamethasone for moderately or highly emetogenic chemotherapy were enrolled. HQL was measured by the self-report European Organization for Research and Treatment of Cancer (EORTC) Care Quality of Life Questionnaire (QLQ-C30) within 7 days before chemotherapy. Prechemotherapy HQL scores, as well as other patient, disease, and treatment variables were compared in the groups of patients who had PCNV and those who did not have PCNV. All variables were assessed initially in a univariate analysis and then together in a multivariate analysis using step-wise logistic regression. The final model generated by the multivariate analyses was used in a risk factor analysis to predict PCNV. RESULTS: Univariate analyses identified 10 HQL variables and five patient and treatment characteristics that were associated with PCNV. In the multivariate analysis, the variables remaining in the final model included low social functioning, prechemotherapy nausea, female gender, highly emetogenic chemotherapy, and the lack of maintenance antiemetics (5-HT3 antagonists with or without dexamethasone) after chemotherapy. A history of low alcohol use was also associated with PCV, whereas increased fatigue and lower performance status were associated with PCN. In the risk factor analysis, the incidence of PCV increased from 20% in those having no risk factors to 76% in those having any four of the six risk factors. CONCLUSION: Several pretreatment HQL, patient, and treatment characteristics are associated with the occurrence of PCNV. Patients about to receive moderately or highly emetogenic chemotherapy should be screened for these factors and additional measures, such as behavior modification and modification of antiemetic therapy, should be considered in attempts to improve the control of PCNV.

Analysis of Variance↗

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↗