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David Cella

Publications and source records attributed to David Cella.

At least 19 recordsLinked to original sources
PubMed2007

Using Q-methodology to understand perceived fatigue reported by adolescents with cancer.

Although fatigue is an unpleasant symptom commonly experienced by pediatric oncology patients, it also tends to be under-recognized and under-treated. A conceptual understanding of how patients perceive fatigue is beneficial for better identification and treatment planning. The purpose of this study was to understand how adolescents with cancer perceive their fatigue and to explore potential factors influencing their perceptions by using Q-methodology. The sample included 15 patients (ages 12-18 years) from the Chicago metropolitan area who were receiving cancer treatment. All participants completed a 37-statement Q-sort task. Data were analyzed by using PQMethod computer software. Results identified three descriptors of perceived fatigues reported by adolescents: energy and related capacity for physical functioning, psychosocial effects, and anemia-specific concerns. Appropriate referral for patients with the latter two descriptors of fatigue was recommended.

Activities of Daily Living↗
PubMed2006

Rapid detection of differential item functioning in assessments of health-related quality of life: The Functional Assessment of Cancer Therapy.

REASON FOR STUDY: Differential item functioning (DIF) occurs when a test item functions differently in different groups when controlling for the level of the underlying construct measured by the test. DIF assessment is a first step in the evaluation of test bias. We sought to demonstrate a rapid hybrid approach to DIF detection by determining the presence and scale-level impact of DIF related to eight covariates in four domains measured by the Functional Assessment of Cancer Therapy (FACT). MAJOR FINDINGS: The number of items found with DIF in each domain depended on the criterion chosen to define the presence of DIF. With a few exceptions, scale-level differential functioning was similar regardless of the criteria chosen. For physical well-being, there was relevant scale-level differential functioning related only to race. For social and family well-being, there was relevant scale-level differential functioning related to each of the covariates. For emotional well-being, there was relevant scale-level differential functioning related to ethnicity, language, and race. For functional well-being, there was relevant scale-level differential functioning related to ethnicity, race, education, and self- vs. interviewer-administration. PRINCIPAL CONCLUSIONS: Our rapid hybrid approach to DIF detection may be broadly applicable in other studies of health-related quality of life.

Adolescent↗
PubMed2006

The impact of literacy on health-related quality of life measurement and outcomes in cancer outpatients.

BACKGROUND: Limited evidence exists regarding the relationship between literacy and health-related quality of life (HRQL). Research is needed to develop measurement techniques for low literacy populations and to evaluate potential literacy-related measurement bias. METHODS: A Talking Touchscreen (TT) was developed for an HRQL study. Low (n = 214) and high literacy (n = 201) adult cancer outpatients participated, 70% of whom were from racial/ethnic minorities. Patients completed three questionnaires by TT: FACT-G (cancer-specific), SF-36 (generic health status), and a standard gamble utility questionnaire. Measurement bias was evaluated using item response theory (IRT). Effects of literacy on HRQL were evaluated using regression models. RESULTS: Most (97%) patients rated the TT easy to use. In IRT analysis, 6/27 FACT-G and 12/31 SF-36 items demonstrated literacy bias; this was relatively balanced (10 items 'biased against' low literacy; 8 'biased against' high literacy). Mean literacy group differences were statistically and clinically non-significant for 9/14 HRQL outcomes. Adjustment for bias and/or covariates eliminated most remaining differences. CONCLUSIONS: The TT is valid and useful for HRQL assessment in low literacy populations. There appears to be no systematic literacy bias in reporting HRQL, and low literacy is not an independent risk factor for poorer HRQL.

Cancer Care Facilities↗
PubMed2006

The SF-36 physical and mental health factors were confirmed in cancer and HIV/AIDS patients.

BACKGROUND AND OBJECTIVE: This study assesses the extent to which the RAND-36/SF-36 items measure physical and mental health (PH and MH), as implied by existing summary scoring systems. METHODS: A total of 1,714 heterogeneous cancer and HIV/AIDS patients were recruited from five institutions. Of these, 56% were women; 81% Caucasians; and about 10% were from each of the major cancer types and HIV/AIDS. RESULTS: Analyses of the SF-36 confirmed the two dimensions of health namely physical and mental. However, item fit statistics and residual factor analysis revealed that some items intended to represent the PH dimension fit better with the MH dimension. CONCLUSION: This paper demonstrated the value of Rasch residual factor analysis for understanding and enhancing interpretation of health.

Activities of Daily Living↗
PubMed2006

Responsiveness and minimal important differences for patient reported outcomes.

Patient reported outcomes provide the patient's perspective on the effectiveness of treatment. The draft Food and Drug Administration guidance on patient reported outcomes for labeling and promotional claims raises a number of method and measurement issues that require further clarification, including methods of determining responsiveness and minimal important differences. For clinical trials, instruments need to be based on a clear conceptual framework, have evidence supporting content validity and acceptable psychometric qualities. The measures must also have evidence documenting responsiveness and interpretation guidelines (i.e., minimal important difference) to be most useful as effectiveness endpoints in clinical trials. The recommended approach is to estimate the minimal important difference based on several anchor-based methods, with relevant clinical or patient-based indicators, and to examine various distribution-based estimates (i.e., effect size, standardized response mean, standard error of measurement) as supportive information, and then to triangulate on a single value or small range of values for the MID. Confidence in a specific MID value evolves over time and is confirmed by additional research evidence, including clinical trial experience. The MID may vary by population and context, and no one MID will be valid for all study applications involving a PRO instrument. Responsiveness and MID must be demonstrated and documented for the particular study population, and these measurement characteristics are needed for PRO labeling and promotional claims.

Clinical Trials as Topic↗
PubMed2006

A brief symptom index for advanced renal cell carcinoma.

BACKGROUND: Our objective was to test a brief, symptom index for advanced renal cell carcinoma, a disease affecting over 38,000 Americans each year and often diagnosed in late stages. METHODS: We conducted secondary data analyses on patient-reported outcomes of 209 metastatic renal cell carcinoma patients participating in a Phase III clinical trial. Patient-reported outcomes, obtained from the FACT-Biological Response Modifier (FACT-BRM) scale, were available at baseline, 2, and 8 weeks. We analyzed data from eight FACT-BRM items previously identified by clinical experts to represent the most important symptoms of advanced renal cell carcinoma. Items comprising this index assess nausea, pain, appetite, perceived sickness, fatigue and weakness, with higher scores indicating fewer symptoms. We determined reliability and validity of the index and estimated a minimally important difference. RESULTS: The index had excellent internal reliability at all three time points (alphas > or = 0.83). Baseline scores were able to discriminate patients across Karnofsky performance status, number of metastatic sites, and risk group categories (ps < .01). Mean index scores declined over time likely indicative of the toxic nature of the administered treatments. Distribution- and anchor-based methods converged on a minimally important difference estimate of 2 to 3 points. CONCLUSION: The 8-item index of patient-reported symptoms of renal cell carcinoma appears to be a psychometrically sound measure. It is a brief, reliable, and valid measure that can easily be adapted for use in clinical trials and observational studies.

Antineoplastic Agents↗
PubMed2006

Factor analysis techniques for assessing sufficient unidimensionality of cancer related fatigue.

BACKGROUND: Fatigue is the most common unrelieved symptom experienced by people with cancer. The purpose of this study was to examine whether cancer-related fatigue (CRF) can be summarized using a single score, that is, whether CRF is sufficiently unidimensional for measurement approaches that require or assume unidimensionality. We evaluated this question using factor analysis techniques including the theory-driven bi-factor model. METHODS: Five hundred and fifty five cancer patients from the Chicago metropolitan area completed a 72-item fatigue item bank, covering a range of fatigue-related concerns including intensity, frequency and interference with physical, mental, and social activities. Dimensionality was assessed using exploratory and confirmatory factor analysis (CFA) techniques. RESULTS: Exploratory factor analysis (EFA) techniques identified from 1 to 17 factors. The bi-factor model suggested that CRF was sufficiently unidimensional. CONCLUSIONS: CRF can be considered sufficiently unidimensional for applications that require unidimensionality. One such application, item response theory (IRT), will facilitate the development of short-form and computer-adaptive testing. This may further enable practical and accurate clinical assessment of CRF.

Aged↗
PubMed2006

Developing a health-related quality of life instrument for childhood brain tumor survivors.

OBJECTS: With improved treatment, many childhood brain tumor survivors live through adulthood. A psychometrically sound instrument, which can capture their unique experiences through the lifetime, is needed. This paper documents the development of the Pediatric Functional Assessment of Cancer Therapy-Childhood Brain Tumor Survivor (PedsFACT-BrS) for use with survivors for at least 1 year posttreatment. METHODS: The PedsFACT-BrS was developed in two phases. In phase I, items were generated via interviewing 20 survivors, 20 caregivers, and 12 clinicians/teachers. In phase II, Rasch analysis and classical test theory were used to evaluate the responses of 46 survivors and 46 caregivers. CONCLUSION: The 34-item PedsFACT-BrS covers four domains: physical well-being, emotional well-being and illness experiences, social well-being, and brain tumor-specific concerns. Its scalability is supported by Rasch analysis and its content validity and reliability is documented. It is now ready to be validated to other subpopulations across the disease trajectory.

Brain Neoplasms↗
PubMed2006

Measuring the concerns of cancer patients with low platelet counts: the Functional Assessment of Cancer Therapy--thrombocytopenia (FACT-Th) questionnaire.

PURPOSE: The specific concerns of people with low platelet counts (thrombocytopenia) have not been characterized well in the literature and as a result proper measurement of patient-reported concerns is lacking. We report on the development and validation of questions specifically targeted to patients with thrombocytopenia that can be added to the more general concerns in the Functional Assessment of Cancer Therapy-General. MATERIALS AND METHODS: An 18-item FACT-Thrombocytopenia Subscale (ThS) was rated and evaluated by thrombocytopenic patients at baseline during a validation study of 40 thrombocytopenic and 43 nonthrombocytopenic cancer patients. To evaluate responsiveness, patients completed a battery of self-report measures including the FACT-Th and were followed up for change in platelet count over 2 weeks. RESULTS: All subscales and aggregated scores showed high internal consistency at initial assessment and at retesting. Convergent and divergent validity were demonstrated by predicted relationships between FACT-Th subscales and mood, mental and physical component scores of the SF-36, and social desirability. The ThS differentiated patients with low platelets from those with normal platelet counts and good performance from poor performance status patients. CONCLUSION: The FACT-Th is a reliable and valid measure for assessing the impact of thrombocytopenia on patients' lives. It can distinguish cancer patients with and without thrombocytopenia and is responsive to increase in platelet count over time. The FACT-Th may therefore prove useful as a measure of self-reported symptoms and concerns related to thrombocytopenia in clinical trials evaluating new pharmacologic agents and/or platelet transfusion practice.

Adult↗
PubMed2006

Psychometric evaluation of the Osteoporosis Patient Treatment Satisfaction Questionnaire (OPSAT-Q), a novel measure to assess satisfaction with bisphosphonate treatment in postmenopausal women.

BACKGROUND: The Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) is a new measure of patient satisfaction with bisphosphonate treatment for osteoporosis. The objective of this study was to evaluate the psychometric characteristics of the OPSAT-Q. METHODS: The OPSAT-Q contains 16 items in four subscales: Convenience, Confidence with Daily Activities, Side Effects, and Overall Satisfaction. All four subscale scores and an overall composite satisfaction score (CSS) can be computed. The OPSAT-Q, Osteoporosis Targeted Quality of Life (OPTQoL), and sociodemographic/clinical questionnaires, including 3 global items on convenience, functioning and side effects, were self-administered to women with osteoporosis or osteopenia recruited from four US clinics. Analyses included item and scale performance, internal consistency reliability, reproducibility, and construct validity. Reproducibility was measured using the intraclass correlation coefficient (ICC) via a follow-up questionnaire completed by participants 2 weeks post baseline. RESULTS: 104 women with a mean age of 65.1 years participated. The majority were Caucasian (64.4%), living with someone (74%), and not currently employed (58.7%). 73% had osteoporosis and 27% had osteopenia. 80% were taking weekly bisphosphonates and 18% were taking daily medication (2% missing data). On a scale of 0-100, individual patient subscale scores ranged from 17 to 100 and CSS scores ranged from 44 to 100. All scores showed acceptable internal consistency reliability (Cronbach's alpha > 0.70) (range 0.72 to 0.89). Reproducibility ranged from 0.62 (Daily Activities) to 0.79 (Side Effects) for the subscales; reproducibility for the CSS was 0.81. Significant correlations were found between the OPSAT-Q subscales and conceptually similar global measures (p < 0.001). CONCLUSION: The findings from this study confirm the validity and reliability of the OPSAT-Q and support the proposed composition of four subscales and a composite score. They also support the use of the OPSAT-Q to examine the impact of bisphosphonate dosing frequency on patient satisfaction.

Activities of Daily Living↗
PubMed2006

The clinical significance of quality of life assessments in oncology: a summary for clinicians.

BACKGROUND: A series of six manuscripts with an introduction appeared in the Mayo Clinic Proceedings, based upon the collective effort of 30 individuals with an interest and expertise in assessing the clinical significance of quality of life (QOL) assessments. The series of manuscripts described the state of the science of QOL assessments in oncology clinical research and practice and included extensive literature and theoretical justification for the continued inclusion of QOL in oncology clinical research and practice. OBJECTIVES: The purpose of this paper is to produce a summary of these articles and to supplement these works with additional information that was gleaned from subsequent meetings and discussions of this material. The primary aim of this paper is to present a cogent and concise description for clinicians to facilitate the incorporation of QOL assessments into oncology clinical research and practice. The theoretical discussion is supplemented with an example of how the various ideas can be operationalized in an oncology clinical trial.

Clinical Competence↗
PubMed2006

Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer.

The impact of treatment on health-related quality of life (HRQoL) is an important consideration in the adjuvant treatment of operable breast cancer. Here we report mature HRQoL outcomes from the ATAC trial, comparing anastrozole with tamoxifen as primary adjuvant therapy for postmenopausal women with localized breast cancer. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire plus endocrine subscale (ES) at baseline, 3 and 6 months, and every 6 months thereafter. Baseline characteristics in the HRQoL sub-protocol were well balanced between the anastrozole (n = 335) and tamoxifen (n = 347) groups in the primary analysis population. As with previously published results at 2 years, there was no statistically significant difference in the Trial Outcome Index of the FACT-B, the primary endpoint of the study, between treatments at 5 years. There were no statistically significant differences between treatment groups in ES total scores. Consistent with the 2-year analysis, there were differences between treatment groups in patient-reported side effects: diarrhea (anastrozole 3.1% vs. tamoxifen 1.3%), vaginal dryness (18.5% vs. 9.1%), diminished libido (34.0% vs. 26.1%), and dyspareunia (17.3% vs. 8.1%) were significantly more frequent with anastrozole compared to tamoxifen. Dizziness (3.1% vs. 5.4%) and vaginal discharge (1.2% vs. 5.2%) were significantly less frequent with anastrozole compared to tamoxifen. In this, the first report of HRQoL over 5 years of initial adjuvant therapy with an aromatase inhibitor, we conclude that anastrozole and tamoxifen had similar impacts on HRQoL, which was maintained or slightly improved during the treatment period for both groups.

Anastrozole↗
PubMed2006

The role of maintenance therapy and novel taxanes in ovarian cancer.

OBJECTIVES: Despite several studies reporting various degrees of success, the role of maintenance chemotherapy in ovarian cancer remains controversial. This article reviews the available data and the controversy surrounding maintenance therapy. In addition, the role of novel taxanes, which may offer an improved therapeutic index and reduced toxicity relative to conventional therapies in this setting, is discussed. METHODS: The available randomized clinical data on extended or maintenance therapy in ovarian cancer are reviewed. RESULTS: Available data indicate that patients with ovarian cancer undergoing taxane maintenance chemotherapy exhibit a reduced recurrence rate and a longer progression-free survival. CONCLUSIONS: While an additional randomized trial is needed to confirm these benefits and establish maintenance therapy as the standard of care, the authors conclude that maintenance therapy is a valuable option that should be discussed with patients until further data are available. The Gynecologic Oncology Group 212 trial is a randomized clinical trial that is designed to answer whether taxane maintenance therapy offers a survival advantage as well as to determine the impact of such a therapeutic regimen on a patient's quality of life. This trial is also designed to address some of the questions regarding the role of a novel taxane in maintenance therapy in ovarian cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Metaanalysis of the correlation between radiographic tumor response and patient-reported outcomes.

BACKGROUND: The primary aim of the current study was to determine whether radiographic tumor response is associated with patient-reported outcomes such as symptom response or health-related quality of life. METHODS: A metaanalysis was conducted of 21 available studies from 1995-2003 that provided data sufficient for examining the association between tumor response and patient-reported outcomes, including symptom response and health-related quality of life. A second aim was to examine the influence of possible moderating study variables on effect size variation. RESULTS: As hypothesized, patient-reported outcome improvement rates were most frequently associated with patients classified as a complete or partial response (CR/PR), followed by those with stable disease (SD) and progressive disease (PD). Moderate effect sizes were observed between the CR/PR and SD (effect size of 0.35) and CR/PR and PD categories (effect size of 0.43). A weak effect size was found between SD and PD (effect size of 0.16), raising concern over the meaningfulness of the SD category. No significant correlations were found between effect size and patient or study characteristics. Significant associations existed between treatment duration and age, study duration, survival, and symptom response rates, especially among PD patients. CONCLUSION: Despite significant study-to-study heterogeneity, an important association exists in the correlation between tumor response and formal measures of change in patient-reported outcomes. A better understanding of this relation would be enhanced if future reports included estimates of effect size in patient-reported outcome change by tumor response category. Practical implications, limitations, and directions for future research are provided.

Disease Progression↗
PubMed2006

Role of quality of life in men with metastatic hormone-refractory prostate cancer: how does atrasentan influence quality of life?

OBJECTIVE: Progression of hormone-refractory prostate cancer (HRPC) is associated with skeletal complications and bone pain, which contribute to deterioration in quality of life (QOL). The effects of new HRPC therapies on patients' QOL need to be studied. Patient-based assessments that help quantify the risk-benefit profile of HRPC therapies are warranted. This review summarizes the known QOL literature and estimates the potential effect of atrasentan, a novel, selective endothelin A receptor antagonist (SERA), on the QOL of HRPC patients. METHODS: Published studies were identified through a structured, detailed literature review. Clinical studies that report QOL data were reviewed, along with recent QOL data from atrasentan studies. RESULTS: HRPC studies have begun to use QOL assessments as primary endpoints, but different assessments and therapies are not comparable. Very few data integrate QOL with clinical endpoints. Atrasentan clinical trials demonstrated a statistically significant difference in the prostate cancer-specific QOL in favor of atrasentan (p=.032) and an increased quality-adjusted time to progression in men with HRPC. CONCLUSIONS: Atrasentan provides QOL benefits relevant to HRPC. The quality-adjusted analyses applied in the atrasentan studies have begun to lay the foundation for interpreting clinical endpoints in conjunction with QOL. These analyses will facilitate better QOL comparisons within studies and across trials. Further evaluation of atrasentan in HRPC is warranted.

Atrasentan↗
PubMed2006

Quality of life (QOL) outcomes from a randomized trial of cisplatin versus cisplatin plus paclitaxel in advanced cervical cancer: a Gynecologic Oncology Group study.

OBJECTIVE: Chemotherapy can profoundly affect patients' quality of life (QOL), yet few clinical trials in advanced cervical cancer have included QOL outcomes. Our purpose was to assess the impact of cisplatin (C) versus cisplatin plus paclitaxel (CP) on overall QOL and pain in cervical cancer patients. METHODS: QOL was assessed using FACT-Cx, consisting of the Functional Assessment of Cancer Therapy (FACT-G) plus a cervix cancer-specific subscale, the Brief Pain Inventory-Short Form (BPI-SF), and a neurotoxicity subscale. Time points were: baseline (prior to randomization) and prior to chemotherapy cycles 2, 3, and 4. RESULTS: Overall (FACT-G) scores did not differ significantly between arms at the fourth assessment (C = 70.3 (19.6); CP = 72.8 (17.4)). Scores were stable over time and considerably lower than the general population norms. The BPI-SF revealed a decline in pain scores in both arms from the first to fourth assessments. The CP arm produced a significantly higher response rate and progression-free survival (PFS) but not overall survival (OS). Greater myelosuppression was reported in the combination arm. The rate of QOL drop-out for any reason was higher for C (53%) compared to CP (38%) (P < 0.05). At the fourth time point, 60% of living patients in both arms completed a QOL assessment. CONCLUSION: There was no significant difference in overall QOL scores between treatment arms or serially. Combined with QOL results, the significant increase in response and PFS in the CP arm and the higher drop-out rate in the C arm suggest a better outcome for the combination regimen despite its increased myelosuppression.

Adult↗
PubMed2006

Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial.

BACKGROUND: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. METHODS: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with with the identifier NCT00111449. FINDINGS: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p<0.0001; difference 42%, 95% CI 36-48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5.0 vs 1.9; p<0.0001, difference 3.0, 95% CI 1.6-4.5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. INTERPRETATION: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.

Anti-Inflammatory Agents, Non-Steroidal↗