Search PubMed⌕ Search

Biomedical subjects

David Cella

Publications and source records attributed to David Cella.

At least 73 records · Page 4Linked to original sources
PubMed2004

Physicians' attitudes about quality-of-life issues in hematopoietic stem cell transplantation.

Studies investigating quality of life (QOL) after hematopoietic stem cell transplantation demonstrate the spectrum of QOL outcomes awaiting survivors. Nevertheless, how transplantation physicians interpret and apply QOL information to clinical practice is poorly understood. We conducted a cross-sectional survey of transplantation physicians to address these issues and received 180 (24%) responses from physicians in 29 countries. Seventy-two percent reported that their patients are willing to accept poor QOL for a small chance of cure. Only 28% said that QOL considerations "often" or "almost all the time" enter into patients' decisions about transplantation. This contrasted with physicians' reported attention to QOL in their discussions with patients. Although 53% of physicians reported using QOL results to modify practice, 55% would be more likely to use these data if they were more understandable. To ensure generalizability of the results, a validation sample was randomly selected, and these 85 physicians (response rate, 76%) confirmed the findings of the original survey. Given the extensive data regarding posttransplantation QOL, resources should be devoted to exploring how patients and physicians use these data in clinical care and in devising methods to ensure that QOL results are interpretable and relevant to patients and physicians.

Adaptation, Psychological↗
PubMed2004

Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study.

PURPOSE: To determine whether the addition of paclitaxel to doxorubicin plus cisplatin improves overall survival (OS) in women with advanced or recurrent endometrial carcinoma. Secondary comparisons included progression-free survival (PFS), response rate (RR), and toxicities. PATIENTS AND METHODS: Eligible, consenting patients received doxorubicin 60 mg/m(2) and cisplatin 50 mg/m(2) (AP), or doxorubicin 45 mg/m(2) and cisplatin 50 mg/m(2) (day 1), followed by paclitaxel 160 mg/m(2) (day 2) with filgrastim support (TAP). The initial doxorubicin dose in the AP arm was reduced to 45 mg/m(2) in patients with prior pelvic radiotherapy and those older than 65 years. Both regimens were repeated every 3 weeks to a maximum of seven cycles. Patients completed a neurotoxicity questionnaire before each cycle. RESULTS: Two hundred seventy-three women (10 ineligible) were registered. Objective response (57% v 34%; P <.01), PFS (median, 8.3 v 5.3 months; P <.01), and OS (median, 15.3 v 12.3 months; P =.037) were improved with TAP. Treatment was hematologically well tolerated, with only 2% of patients receiving AP, and 3% of patients receiving TAP experiencing neutropenic fever. Neurologic toxicity was worse for those receiving TAP, with 12% grade 3, and 27% grade 2 peripheral neuropathy, compared with 1% and 4%, respectively, in those receiving AP. Patient-reported neurotoxicity was significantly higher in the TAP arm following two cycles of therapy. CONCLUSION: TAP significantly improves RR, PFS, and OS compared with AP. Evaluation of this regimen in the high-risk adjuvant setting is warranted, but close attention should be paid to the increased risk of peripheral neuropathy.

Aged↗
PubMed2004

The talking touchscreen: a new approach to outcomes assessment in low literacy.

PURPOSE: Cancer patients who are deficient in literacy skills are particularly vulnerable to experiencing different outcomes due to disparities in care or barriers to care. Outcomes measurement in low literacy patients may provide new insight into problems previously undetected due to the challenges of completing paper-and-pencil forms. DESCRIPTION OF STUDY: A multimedia program was developed to provide a quality of life assessment platform that would be acceptable to patients with varying literacy skills and computer experience. One item at a time is presented on the computer touchscreen, accompanied by a recorded reading of the question. Various colors, fonts and graphic images are used to enhance visibility, and a small picture icon appears near each text element allowing patients to replay the sound as many times as they wish. Evaluation questions are presented to assess patient burden and preferences. RESULTS: An ethnically diverse group of 126 cancer patients with a range of literacy skills and computer experience reported that the 'talking touchscreen' (TT) was easy to use, and commented on the usefulness of the multimedia approach. CLINICAL IMPLICATIONS: The TT is a practical, user-friendly data acquisition method that provides greater opportunities to measure self-reported outcomes in patients with a range of literacy skills.

Adult↗
PubMed2004

A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale.

OBJECTIVE: To determine distribution- and anchor-based minimal important difference (MID) estimates for four scores from the Functional Assessment of Cancer Therapy-Breast (FACT-B): the breast cancer subscale (BCS), Trial Outcome Index (TOI), FACT-G (the general version), and FACT-B. STUDY DESIGN AND SETTING: We used data from a Phase III clinical trial in metastatic breast cancer (ECOG study 1193; n=739) and a prospective observational study of pain in metastatic breast cancer (n=129). One third and one half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Clinical indicators used to determine anchor-based differences included ECOG performance status, current pain, and response to treatment. RESULTS: FACT-B scores were responsive to performance status and pain anchors, but not to treatment response. By combining the results of distribution- and anchor-based methods, MID estimates were obtained: BCS=2-3 points, TOI=5-6 points, FACT-G=5-6 points, and FACT-B=7-8 points. CONCLUSION: Distribution- and anchor-based estimates of the MID do show convergence. These estimates can be used in combination with other measures of efficacy to determine meaningful benefit and provide a basis for sample size estimation in clinical trials.

Adult↗
PubMed2004

Predictors of cognitive appraisals following genetic testing for BRCA1 and BRCA2 mutations.

The objectives of this study were (1) to describe perceptions of stress and confidence following genetic testing for BRCA1 and BRCA2 (BRCA1/2) mutations and (2) to identify predictors of these processes. Participants were 130 high-risk women affected with cancer who received BRCA1/2 test results. Individual difference characteristics and interpersonal factors were measured by self-report before genetic counseling and perceptions of stress and confidence were evaluated by self-report 1 month following disclosure of test results. BRCA1/2 test results had a significant effect only on perceptions of stress (beta = 0.38, p = 0.0001), while trait anxiety had a significant effect on both perceptions of stress (beta = 0.44, p = 0.0001) and confidence (beta = -0.41, p = 0.001). These results suggest that interventions designed to address perceptions of stress related to medical decision-making and familial concerns may need to be targeted to BRCA1/2 mutation carriers and individuals who are highly anxious.

Adaptation, Psychological↗
PubMed2004

The Functional Assessment of Cancer Therapy-Lung and Lung Cancer Subscale assess quality of life and meaningful symptom improvement in lung cancer.

Treatment options for patients with advanced lung cancer who have received prior chemotherapy are largely palliative, with little hope for cure. Current therapies may provide only modest survival benefits to patients while potentially adding treatment-related toxicities to lung cancer-related symptoms. However, new treatments have been developed that may improve disease-related symptoms and quality of life with only mild toxicities. The Functional Assessment of Cancer Therapy-Lung, a validated, disease-specific quality-of-life instrument, effectively correlates quality-of-life changes with clinical outcomes in patients with non-small-cell lung cancer. In a large randomized trial from the Eastern Cooperative Oncology Group study 5592, a change of two to three points in the Lung Cancer Subscale of the Functional Assessment of Cancer Therapy-Lung was found to be clinically meaningful and correlated well with patient symptom differences at baseline, changes in symptoms after treatment, tumor response, and time to disease progression. Results from trials that include symptom improvement and quality of life as end points, in addition to the more standard outcomes of tumor response and survival, will provide meaningful information in evaluating the clinical benefits of new cancer treatments.

Clinical Trials as Topic↗
PubMed2004

Quality of life considerations in patients with advanced lung cancer.

Quality of life (QOL) is an important consideration in the treatment of patients with advanced lung cancer because treatment is largely palliative. Moreover, QOL predicts survival in non-small cell lung cancer, and there is increasing acceptance by clinicians and regulatory authorities of symptoms and QOL as primary or coprimary endpoints in clinical trials. This article reviews the signs and symptoms of advanced lung cancer that commonly affect QOL, and the prevalence, emergence, and decline of symptoms in patients with good performance status during and after treatment. Next, it details the various tools for measuring QOL in patients with lung cancer and data that support the use of QOL data to guide individual treatment decisions. Finally, it discusses the need for a better understanding of the QOL and treatment preferences of patients with poor performance status.

Clinical Trials as Topic↗
PubMed2004

Normative data for functional assessment of cancer therapy--general scale and its use for the interpretation of quality of life scores in cancer survivors.

The aims of this study were to derive population-based reference values for the Functional Assessment of Cancer Therapy Scale-General (FACT-G) and to investigate the impact of sociodemographic variables (e.g. age, sex, health status) on these quality of life (QOL) scores, and to compare the normative QOL scores with those of various groups of cancer survivors. A random sample of 2 000 members of the Austrian public were sent questionnaires containing the FACT-G and questions relating to demographic data and health status. A total of 968 questionnaires were returned giving an overall response rate of 50.6% (females 48.3%, age 49.3 +/- 16.8). Subjects with higher education reported higher QOL values; divorced and widowed persons had significantly lower QOL scores. Higher age was also associated with lower QOL scores. After bone marrow transplantation, patients generally showed lower QOL scores than the age- and sex-matched population-based sample, whilst in breast cancer survivors there was reduced QOL regarding social well-being. Survivors of Hodgkin's disease were found to have higher functional and social well-being scores than those of the general population sample. Sociodemographic variables should always be taken into consideration when interpreting QOL scores. Furthermore, unless patient data are compared with normative values, phenomena such as adaptation and response shift might be missed or misinterpreted.

Adolescent↗
PubMed2004

Measurement and management of health-related quality of life in lung cancer.

The 5-year survival rate for lung cancer has been and remains very low, and patient experience is characterized by a heavy symptom burden leading to poorer health-related quality of life (HRQL). In light of these facts, treatment remains primarily palliative with a focus on improving quality of life, particularly through symptom management. Increasingly, clinical research has evaluated both traditional clinical endpoints as well as quality of life as primary outcome variables. This is due in part to recent data in which patient-reported health data have been found to have prognostic value in lung cancer. This paper reviews the literature to date about lung cancer survivors, HRQL conclusions from recent clinical trials, and several barriers to the incorporation of HRQL information into daily clinical practice. Finally, we describe some recent clinical applications of the integration of HRQL information into routine clinical practice with advanced lung cancer patients.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation.

The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The measurement system, under development since 1987, began with the creation of a generic CORE questionnaire called the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-G (now in Version 4) is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is appropriate for use with patients with any form of cancer, and extensions of it have been used and validated in other chronic illness condition (e.g., HIV/AIDS; multiple sclerosis; Parkinson's disease; rheumatoid arthritis), and in the general population. The FACIT Measurement System now includes over 400 questions, some of which have been translated into more than 45 languages. Assessment of any one patient is tailored so that the most-relevant questions are asked and administration time for any one assessment is usually less than 15 minutes. This is accomplished both by the use of specific subscales for relevant domains of HRQOL, or computerized adaptive testing (CAT) of selected symptoms and functional areas. FACIT questionnaires can be administered by self-report (paper or computer) or interview (face-to-face or telephone). Available scoring, normative data and information on meaningful change now allow one to interpret results in the context of a growing literature base.

Chronic Disease↗
PubMed2003

Deep vein thrombosis: validation of a patient-reported leg symptom index.

INTRODUCTION: Deep vein thrombosis (DVT) is a serious health problem that affects more than 2 million people annually in the United States. Many of these patients develop asymptomatic DVT, but months to years later may experience symptomatic post-thrombotic syndrome (PTS). It is not known how many cases of PTS can be traced to "asymptomatic" DVT because venography is no longer routinely done and ultrasonography (US) may miss some asymptomatic clots. As a result, a clinical tool in addition to US to detect symptom emergence or exacerbation in patients after DVT would be of value. METHODS: Seventy-seven patients hospitalized with an acute DVT interviewed by telephone at 3-7 days, 30-40 days, and 12-months following discharge were included in this report. All were treated with a standard anticoagulation "Clinical Pathway Protocol" between April 1999 and January 2000. Using a 14-item Deep Vein Thrombosis Leg Symptom Index (DVT-LSI), patients were queried regarding leg pain, swelling, skin discoloration, cosmetic appearance, activity tolerance, emotional distress, and leg-related sleep problems. RESULTS: The DVT-LSI for each leg was reliable at all assessments, with instrument reliability (alpha coefficients) greater than 0.70 at all time points (range 0.71-0.87). DVT-LSI scores, and the percentage of patients exhibiting symptoms, were higher in the DVT-affected leg at all time points. Among patients with unilateral disease, symptom severity ratings were significantly worse for patients in the affected leg compared to the normal leg at all time points, with the exception of those with a right-leg DVT at 12 months. Patients with bilateral thrombi did not have different scores on one leg compared to the other. CONCLUSION: The DVT-LSI is useful in assessing symptomatic clinical outcomes in patients after diagnosis of DVT, and may represent a surrogate marker for DVT otherwise presumed to be asymptomatic.

Anticoagulants↗
PubMed2003

Brief assessment of priority symptoms in hormone refractory prostate cancer: the FACT Advanced Prostate Symptom Index (FAPSI).

BACKGROUND: The objective of this study was to construct and validate a brief, clinically-relevant symptom index for advanced prostate cancer. METHODS: Questions were extracted from a commonly-used multi-dimensional cancer quality of life instrument with prostate-specific items, the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Surveys of disease-related symptoms were presented to an international sample of 44 expert physicians. Each expert narrowed the list to no more than five of the most important symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. Symptoms/concerns endorsed at a frequency greater than chance probability (17%) were retained for the symptom index and called the FACT Advanced Prostate Symptom Index-8 (FAPSI-8): pain (three items), fatigue, weight loss, urinary difficulties (two items), and concern about the condition becoming worse. The FAPSI-8 was validated using data from a clinical trial of 288 men being treated for hormone refractory prostate cancer. RESULTS: The FAPSI-8 showed good internal consistency (r = 0.67-0.80); association with existing FACT scales (e.g., FACT-P, Physical Well-being, Functional Well-being; r = 0.44-0.85, p <.0001), responsiveness to clinical change (Guyatt's Responsiveness statistic = 1.29), and ability to differentiate patients by performance status (p <.0001). A six-item alternate version of the FAPSI was also evaluated with comparable results. CONCLUSIONS: This project produced a reliable and valid list of the eight most important clinician-rated targets of drug therapy for advanced prostate cancer. These questions perform comparably to the longer derivative questionnaire. Examination of patient agreement with this priority list and the extent to which changes in these 8 targets are related to meaningful clinical benefit to the patient are important next steps for future research.

Aged↗
PubMed2003

Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial.

CONTEXT: More persons in the United States die from non-small cell lung cancer (NSCLC) than from breast, colorectal, and prostate cancer combined. In preclinical testing, oral gefitinib inhibited the growth of NSCLC tumors that express the epidermal growth factor receptor (EGFR), a mediator of cell signaling, and phase 1 trials have demonstrated that a fraction of patients with NSCLC progressing after chemotherapy experience both a decrease in lung cancer symptoms and radiographic tumor shrinkages with gefitinib. OBJECTIVE: To assess differences in symptomatic and radiographic response among patients with NSCLC receiving 250-mg and 500-mg daily doses of gefitinib. DESIGN, SETTING, AND PATIENTS: Double-blind, randomized phase 2 trial conducted from November 2000 to April 2001 in 30 US academic and community oncology centers. Patients (N = 221) had either stage IIIB or IV NSCLC for which they had received at least 2 chemotherapy regimens. INTERVENTION: Daily oral gefitinib, either 500 mg (administered as two 250-mg gefitinib tablets) or 250 mg (administered as one 250-mg gefitinib tablet and 1 matching placebo). MAIN OUTCOME MEASURES: Improvement of NSCLC symptoms (2-point or greater increase in score on the summed lung cancer subscale of the Functional Assessment of Cancer Therapy-Lung [FACT-L] instrument) and tumor regression (>50% decrease in lesion size on imaging studies). RESULTS: Of 221 patients enrolled, 216 received gefitinib as randomized. Symptoms of NSCLC improved in 43% (95% confidence interval [CI], 33%-53%) of patients receiving 250 mg of gefitinib and in 35% (95% CI, 26%-45%) of patients receiving 500 mg. These benefits were observed within 3 weeks in 75% of patients. Partial radiographic responses occurred in 12% (95% CI, 6%-20%) of individuals receiving 250 mg of gefitinib and in 9% (95% CI, 4%-16%) of those receiving 500 mg. Symptoms improved in 96% of patients with partial radiographic responses. The overall survival at 1 year was 25%. There were no significant differences between the 250-mg and 500-mg doses in rates of symptom improvement (P =.26), radiographic tumor regression (P =.51), and projected 1-year survival (P =.54). The 500-mg dose was associated more frequently with transient acne-like rash (P =.04) and diarrhea (P =.006). CONCLUSIONS: Gefitinib, a well-tolerated oral EGFR-tyrosine kinase inhibitor, improved disease-related symptoms and induced radiographic tumor regressions in patients with NSCLC persisting after chemotherapy.

Administration, Oral↗
PubMed2003

Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane).

BACKGROUND: Cancer chemotherapy with some of the taxane class of agents can be associated with significant neurotoxicity, arthralgias, myalgias, and skin changes that may offset the therapeutic benefits of taxane use. METHODS: The authors developed and tested a set of questions to assess these important side effects of taxane therapy from the patient's perspective. The current study evaluated the taxane subscale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Reliability, validity, and responsiveness to expected change were evaluated in the context of an ongoing clinical trial comparing four cycles of carboplatin plus paclitaxel with a strategy of carboplatin plus paclitaxel until disease progression in patients with advanced nonsmall cell lung carcinoma (NSCLC). RESULTS: The 16-item Taxane subscale score and the 11-item peripheral neuropathy subset both demonstrated excellent internal consistency and concurrent validity, and the scores worsened as one would predict during a 12-week treatment course of taxane therapy. Results of the psychometric analyses supported the use of this subscale for measuring the unwanted adverse consequences of effective cancer therapies. Measuring the patient perception of treatment side effects also allowed a preliminary exploration of the relative quality of life (QOL) impact of symptom relief and treatment toxicity. The results indicated that toxicity and symptom improvement may make relatively equivalent contributions to total QOL as measured by the summary score from a multidimensional QOL instrument, the Functional Assessment of Cancer Therapy-General. However, symptom status and improvement appear to play a stronger role than taxane toxicity in patients' global rating of their QOL. CONCLUSIONS: Future research might examine this question of competing benefits as a potential aid to decision-making regarding the administration of toxic therapies in the setting of advanced disease.

Antineoplastic Agents, Phytogenic↗
PubMed2003

Evaluation of pain associated with oral mucositis during the acute period after administration of high-dose chemotherapy.

BACKGROUND: No single oral mucositis (OM) assessment scale is universally accepted; the most commonly used scales are deficient because they combine subjective and objective measures and do not capture the patient's perspective. Because pain is the hallmark symptom of OM, the authors sought to determine whether a simple measure of patient-reported pain was correlated with objective, physician-assessed measures of OM. The findings of the current study may provide a clinical context for understanding the relation between objective indicators and patients' perceptions of OM. METHODS: Three hundred twenty-three patients receiving stomatotoxic chemotherapy and randomized to receive either iseganan or placebo for treatment of OM underwent periodic objective and subjective evaluations of OM. Objective measures included clinician scoring of stomatitis and dysphagia using the National Cancer Institute Common Toxicity Criteria scales. A subjective measure was obtained by having patients complete a questionnaire (with questions based on an 11-point numeric scale) regarding oral pain. RESULTS: More than 90% of scheduled oral assessments were obtained. Mouth pain scores were closely related to stomatitis and dysphagia; peak mouth pain coincided with peak stomatitis and dysphagia. Analgesic use increased by 0.7 days for each unit rise on the pain scale. Patients receiving iseganan had a significantly lower level of peak mouth pain than did patients receiving placebo (P=0.041). CONCLUSIONS: A separate measurement of patient-reported pain was useful for capturing the patient's perspective on OM and was correlated with the physician's objective assessment. These findings support the use of a simple, patient-reported rating of mouth pain as a clinically relevant and responsive endpoint in clinical trials. This rating system also may provide a straightforward method of following OM in clinical practice.

Adolescent↗
PubMed2003

Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: results from the IRIS Study.

PURPOSE: Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study. PATIENTS AND METHODS: Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy-Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over. RESULTS: Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P <.001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P <.001) differences were observed between patients who did and did not cross over in favor of imatinib. CONCLUSION: Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC.

Adolescent↗
PubMed2003

Early change in patient-reported health during lung cancer chemotherapy predicts clinical outcomes beyond those predicted by baseline report: results from Eastern Cooperative Oncology Group Study 5592.

PURPOSE: To determine the ability of longitudinal patient-reported health (PRH) scores to enhance prediction of clinical outcomes beyond baseline scores. PATIENTS AND METHODS: In 573 advanced non-small-cell lung cancer patients enrolled in a phase III clinical trial, we used baseline and 6-week follow-up PRH scores to predict best response to treatment, disease progression, and survival. Using regression analyses, we tested the predictive ability of the five subscales of the Functional Assessment of Cancer Therapy-Lung (physical, functional, social/family, emotional well-being, and the lung cancer subscale) as well as the trial outcome index (TOI) aggregate score. RESULTS: After clinical factors were controlled for, baseline physical well-being (PWB) and TOI scores predicted all three clinical outcomes. A higher baseline PWB score was associated with a better response to treatment (odds ratio, 1.09; P <.001) and lower risk of death (risk ratio, 0.95; P <.001). Higher baseline TOI score was associated with a lower risk of disease progression (risk ratio, 0.98; P <.001). These two baseline predictors (PWB and TOI) were then used along with 6-week change scores to classify patients into four groups: low baseline-declined, low baseline-improved, high baseline-declined, and high baseline-improved. Patients with low baseline-declined PWB scores showed the worst responses to treatment and survived the shortest duration. Patients with low baseline-declined TOI scores had the shortest time to progression. CONCLUSION: The physical aspects of baseline PRH and PRH change during chemotherapy are significant predictors of clinical outcomes in lung cancer. This has implications for patient stratification in clinical trials and may aid decision-making in clinical practice.

Adult↗