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D F Cella

Publications and source records attributed to D F Cella.

At least 19 recordsLinked to original sources

Comparison of psychosocial adaptation of advanced stage Hodgkin's disease and acute leukemia survivors. Cancer and Leukemia Group B.

BACKGROUND: The purpose of this study was to compare the long-term psychosocial adaptation of Hodgkin's disease and adult acute leukemia survivors. PATIENTS AND METHODS: Two hundred seventy-three Hodgkin's disease (HD) and 206 adult acute leukemia (AL) survivors were interviewed by telephone concerning their psychosocial adjustment and problems they attributed to having been treated for cancer, using identical research procedures and a common set of instruments. The following measures were used: Psychosocial Adjustment to Illness Scale (PAIS); Brief Symptom Inventory (BSI); current Conditioned Nausea and Vomiting triggered by treatment-related stimuli (CNVI); Indices of Employment, Insurance and Sexual Problems Attributed to Cancer; Negative Socioeconomic Impact of Cancer Index (NSI). All participants had been treated on one of nine Hodgkin's disease or 13 acute leukemia Cancer and Leukemia Group B (CALGB) clinical trials from 1966-1988, and had been off treatment for one year or more (mean years: HD = 5.9; AL = 5.6). RESULTS: HD survivors' risk of having a high distress score on the BSI was almost twice that found for AL survivors (odds ratio = 1.90), with 21% of HD vs. 14% of AL survivors (P < 0.05) having scores that were 1.5 standard deviations above the norm, suggestive of a possible psychiatric disorder. HD survivors reported greater fatigue (POMS Fatigue, P = 0.01; Vigor Subscales, P = 0.001), greater conditioned nausea (CNVI, P < 0.05), greater impact of cancer on their family life (PAIS Domestic Environment, P = 0.004) and poorer sexual functioning (PAIS Sexual Relationships, P = 0.0001), than AL survivors. CONCLUSIONS: Treatment-related issues may have placed HD survivors at a greater risk for problems in long-term adaptation than AL survivors.

Adaptation, Psychological

The influence of personal expectations on cancer patients' reports of health-related quality of life.

The role of personal expectations on reports of health-related quality of life (HRQL) in the context of a set of other variables commonly thought to affect patient report of HRQL was examined. The complete set of predictor variables included: (1) patient factors including age, gender, race, education, income, insurance type, living arrangement and expectations; and (2) clinical factors namely performance status rating (PSR), diagnosis and disease stage. The outcome measures included five dimensions of HRQL (relationship with physician, physical, social, emotional and functional well being) and an overall measure of HRQL. Five variables (PSR, expectation rating, age, living arrangement and managed care enrollment) exerted significant effects on the summated rating of HRQL. Older cancer patients, those living with others, those enrolled in managed care organizations and those who report better-than-expected experience are more likely to have a higher overall HRQL. In addition to treating the disease itself, quality of life can possibly be enhanced by narrowing the disparities between individuals' expectations and what actually occurs. Patients would likely therefore benefit from being encouraged to set and maintain realistic goals concerning their cancer prognosis and treatment process.

Activities of Daily Living

Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system.

This paper reports the development and validation of a questionnaire assessing fatigue and anemia-related concerns in people with cancer. Using the 28-item Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire as a base, 20 additional questions related to the symptoms and concerns of patients with anemia were developed. Thirteen of these 20 questions dealt with fatigue, while the remaining 7 covered other concerns related to anemia. Using semi-structured interviews with 14 anemic oncology patients and 5 oncology experts, two instruments were produced: The FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items, and the FACT-Anemia (FACT-An), consisting of the FACT-F plus 7 nonfatigue items. These measures were, in turn, tested on a second sample of 50 cancer patients with hemoglobin levels ranging from 7 to 15.9 g/dL. The 41-item FACT-F and the 48 item FACT-An scores were found to be stable (test-retest r = 0.87 for both) and internally consistent (coefficient alpha range = 0.95-0.96). The symptom-specific subscales also showed good stability (test-retest r range = 0.84-0.90), and the Fatigue subscale showed strong internal consistency (coefficient alpha range = 0.93-0.95). Internal consistency of the miscellaneous nonfatigue items was lower but acceptable (alpha range = 0.59-0.70), particularly in light of their strong relationship to patient-rated performance status and hemoglobin level. Convergent and discriminant validity testing revealed a significant positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and a predicted lack of relationship with social desirability. The total scores of both scales differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < 0.0001). The 13-item Fatigue subscale of the FACT-F and the 7 nonfatigue items of the FACT-An also differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < or = 0.001). The FACT-F and FACT-An are useful measures of quality of life in cancer treatment, adding more focus to the problems of fatigue and anemia. The Fatigue Subscale may also stand alone as a very brief, but reliable and valid measure of fatigue.

Adult

Health status assessment for the twenty-first century: item response theory, item banking and computer adaptive testing.

Health status assessment is frequently used to evaluate the combined impact of human immunodeficiency virus (HIV) disease and its treatment on functioning and well-being from the patient's perspective. No single health status measure can efficiently cover the range of problems in functioning and well-being experienced across HIV disease stages. Item response theory (IRT), item banking and computer adaptive testing (CAT) provide a solution to measuring health-related quality of life (HRQoL) across different stages of HIV disease. IRT allows us to examine the response characteristics of individual items and the relationship between responses to individual items and the responses to each other item in a domain. With information on the response characteristics of a large number of items covering a HRQoL domain (e.g. physical function, and psychological well-being), and information on the interrelationships between all pairs of these items and the total scale, we can construct more efficient scales. Item banks consist of large sets of questions representing various levels of a HRQoL domain that can be used to develop brief, efficient scales for measuring the domain. CAT is the application of IRT and item banks to the tailored assessment of HRQoL domains specific to individual patients. Given the results of IRT analyses and computer-assisted test administration, more efficient and brief scales can be used to measure multiple domains of HRQoL for clinical trials and longitudinal observational studies.

Diagnosis, Computer-Assisted

Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale.

We developed a 12-item bone marrow transplant subscale (BMTS) for the general Functional Assessment of Cancer Therapy (FACT) measure. The subscale combined with the FACT, (FACT-BMT) is a 47-item, valid and reliable measure of five dimensions of quality of life in bone marrow transplant patients. The three-step validation process involved the generation and selection of BMT-specific items and the testing of the overall measure. Items were selected from a list produced by seven oncology experts and 15 patients and were designed to assess content not represented in the general FACT items. A total of 182 patients completed the FACT-BMT at baseline, prior to BMT. An analysis measuring sensitivity to change was performed with 74 patients after transplantation and 60 patients over the three time-points of baseline, hospital discharge and 100 days. The FACT-BMT and all subscales were correlated, sensitivity to change was measured, and the internal consistency for each scale was calculated. Coefficients of reliability and validity ranged from 0.86 to 0.89 for the entire FACT-BMT and 0.54 to 0.63 for the BMTS. The BMTS was able to discriminate patients on the basis of performance status rating and also demonstrated sensitivity to change over time. The FACT-BMT has good psychometric properties for use in assessing quality of life in bone marrow transplant patients. The addition of the bone marrow transplant subscale to the general FACT measure makes it an excellent choice for use in BMT clinical trials.

Adolescent

Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument.

PURPOSE: This is the first published report on the validation of the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer. The FACT-B consists of the FACT-General (FACT-G) plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to QL in breast cancer. The FACT-B was developed with an emphasis on patients' values and brevity and is available in nine languages. METHODS AND RESULTS: Two validation samples were used for this report. The first (n = 47) was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample (n = 295). The alpha coefficient (internal consistency) for the FACT-B total score was high (alpha = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. CONCLUSION: The FACT-B is appropriate for use in oncology clinical trials, as well as in clinical practice. It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change.

Adult

The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity.

BACKGROUND: The goal of this investigation was to examine the relationship between, and application of, two disease specific quality of life (QL) measures currently being employed for head and neck cancer patients: the Functional Assessment of Cancer Therapy-Head and Neck Scale (FACT-H&N) and the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN). METHODS: The FACT-H&N and PSS-HN were administered to 151 head and neck cancer patients with a range of disease sites, treatment status (on vs. off treatment), and treatment modalities (surgery, radiation, and chemotherapy). RESULTS: FACT-H&N subscale and total scores and PSS-HN subscale scores proved sensitive to patients groups (showed significant and clinically meaningful differences) on the basis of treatment status (on vs. off treatment) and global performance status (Karnofsky scores). The pattern of correlations between FACT-H&N and PSS-HN subscales supported the scales' construct (convergent vs. divergent) validity. The strongest and most significant associations were observed between PSS-HN Normalcy of Diet and Eating in Public, and the head and neck subscale (HNS) of FACT-H&N, both of which were designed to measure the unique problems of head and neck cancer patients. More modest associations were observed between subscales measuring physical and functional areas of performance, social functioning, and emotional well-being. CONCLUSIONS: The FACT-HNS was found to be reliable and valid when applied to head and neck cancer patients. It clearly adds information to that collected by the parent (core) instrument. The PSS-HN also provides unique information, independent of that provided by the Karnofsky or the FACT-H&N. This study supported the multidimensional nature of QL for head and neck cancer patients, and thus the importance of assessing disease specific concerns in addition to general health status when assessing functional and QL outcome.

Adolescent

Psychological symptoms and disease-free and overall survival in women with stage II breast cancer. Cancer and Leukemia Group B.

BACKGROUND: The possible link between psychological factors and length of cancer survival has generated a literature of contradictory findings. Associations usually have not been found when general psychological symptoms are assessed. Associations usually have been found for predictors related to expressive versus repressive emotional coping (e.g., depression, "fighting spirit," hostility, and type C personality); however, even these associations have been relatively small, when compared with those for medical factors. Yet few studies have adequately controlled for medical and treatment-related factors. PURPOSE: Within a Cancer and Leukemia Group B (CALGB) national clinical trial of four adjuvant therapy regimens for stage II breast cancer (CALGB 8082), this study prospectively examined the contribution of potential psychological predictors to length of disease-free and overall survival over a 15-year period. METHODS: Subjects were 280 women with stage II breast cancer, out of a total of 899, who were randomly assigned to receive CMFVP (cyclophosphamide-methotrexate-fluorouracil-vincristine-prednisone) for two 6-week cycles or six 4-week cycles, then subsequently randomly assigned to receive or not to receive VATH (vinblastine-doxorubicin-thiotepa-fluoxymesterone). Subjects were recruited during the period between October 1980 and August 1984, inclusive, and followed until January 1996. Prior to chemotherapy, psychological symptoms were assessed using the Symptom Check List-90-Revised (SCL-90-R). SCL-90-R scores were trichotomized into categories representing high, medium, and low distress. Basic base-line sociodemographic data (including age, ethnicity, education, and marital status) and medical data (including lymph node status, estrogen receptor status, menopausal status, and performance status) were collected. Subjects with psychosocial data differed from those without psychosocial data solely in their higher percentage of classification in the mild limitation category of the Zubrod (Eastern Cooperative Oncology Group) performance status rating (subjects with psychosocial data: 14%; subjects without psychosocial data: 8%). RESULTS: In stepwise Cox regression analyses that controlled for sociodemographic and medical variables, there was no significant predictive effect of the level of distress (as measured by the SCL-90-R trichotomized scores) on length of disease-free and overall survival of the study subjects. Risk ratios for low versus high distress were 1.01 (95% confidence interval [CI] = 0.62-1.66) for disease-free survival and 1.03 (95% CI = 0.58-1.82) for overall survival. CONCLUSIONS: This study failed to provide evidence that psychological factors contributed to length of disease-free or overall survival of women who received adjuvant chemotherapy (either CMFVP alone or CMFVP followed by VATH) for treatment of stage II breast cancer. IMPLICATIONS: In the context of far more potent medical factors, the contribution of psychological factors to disease-free and overall survival is likely to be relatively small. Future research should focus on specific theory-driven predictors rather than on general psychological symptoms. Moreover, it should be based on clinical studies using a controlled, prospective design, in which the effects of medical factors may be distinguished and psychological predictors are clear antecedents of survival outcomes.

Adaptation, Psychological

Quality of life and functional status measures in patients with head and neck cancer.

OBJECTIVE: To assess the relationship among three validated head and neck-specific measures of functional status and a general measure of quality of life in patients with head and neck cancer. DESIGNS: Cross-sectional study using medical chart review, patient interview, and test administration. SETTING: Academic tertiary referral center. PARTICIPANTS: Fifty adults patients 3 months to 6 years after major surgery for head and neck cancer. MAIN OUTCOME MEASURE: Scores from a general measure of quality of life (the Functional Assessment of Cancer Therapy), a subscale specific to head and neck cancer, the University of Washington Quality of Life Questionnaire, and the Performance Status Scale for Head and Neck Cancer Patients. RESULTS: The disease-specific measures of functional status correlate well with one another. However, there were low correlations between the Functional Assessment of Cancer Therapy and the disease-specific measures, indicating that general and disease-specific instruments contribute unique information about quality of life. CONCLUSION: A general measure of quality of life augments information obtained by disease-specific instruments by interpreting functional status in the broader scope of the patient's life.

Activities of Daily Living

Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system.

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29-49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.

Activities of Daily Living

Functional Assessment of Cancer Therapy (FACT-G): non-response to individual questions.

The purpose of this investigation is to examine methods of scoring the FACT-G when there is non-response to individual questions. Using completed questionnaires from 350 patients, random and non-random missing responses where simulated. Seven methods of scoring the FACT-G are compared on the basis of accuracy (bias and precision) of both population estimates and prediction of individual scores. Substituting the mean of the completed items in the subscale when more than 50% are completed is generally the most unbiased and precise approach. Case deletion is the worst approach and results in clinically significant bias when the missing responses were non-random and a lack of precision when the rate of non-response was high.

Activities of Daily Living

Development and validation of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument.

The Functional Assessment of Human Immuno-deficiency Virus (HIV) Infection (FAHI) quality of life instrument was developed using a combination of conceptual and empirical strategies. The core, general health-related quality of life instrument is the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The FACT-G was selected to enable comparison of data across two similar, life-threatening conditions and because of its desirable psychometric properties. Initial data on both the relevance (applicability) of the FACT-G to the HIV population and the generation and testing of questions for an HIV-specific subscale were encouraging. Consequently, the FACT-G and a 9-item HIV-specific subscale were combined and tested in 196 patients in three categories: an English-speaking stress management sample from Chicago, illinois (n = 110); an English-speaking urban, mixed race sample from Chicago (n = 71); and a Spanish-speaking urban sample from Chicago and San Juan, Puerto Rico (n = 64). With the exception of the Social Well-being subscale, the subscales of the FACT-G demonstrated good internal consistency reliability across all three samples (alpha range = 0.72-0.88). Total FAHI scores produced consistently high alpha coefficients (0.89-0.91). Concurrent validity data included moderately strong associations with other measures of similar concepts and an ability to distinguish groups of patients by activity level and disease severity. Sensitivity to change in mood disturbance and responsiveness to a stress management intervention were also evident. The 9-item HIV-specific subscale demonstrated relatively low alpha coefficients (range = 0.53-0.71) and marginal sensitivity to change, leading to supplementation of content with an additional 11 items, creating a 20-item HIV-specific subscale that is currently being tested. Clinical trial and clinical practice investigators are encouraged to use the FACT-G in its current (version 3) form when evaluating group differences and within-group change over time. It should prove particularly useful when comparing clinical trial and clinical practice data for cancer vs. HIV-infected patients and in the evaluation of treatments for HIV disease and HIV-related malignancy. The supplemental 20 questions comprising the revised HIV-specific subscale are undergoing further testing, and may ultimately enhance the value of this measurement system.

Adolescent

Validation of the functional assessment of multiple sclerosis quality of life instrument.

Based on scientific literature and interviews with clinicians and patients, we developed a quality of life instrument for use with people with MS called the Functional Assessment of Multiple Sclerosis (FAMS). The initial item pool consisted of 88 questions: 28 from the general version of the Functional Assessment of Cancer Therapy quality of life instrument, plus 60 generated by patients, providers, and literature review. The validation samples comprised a mail survey cohort (N = 377) and a clinical cohort (N = 56). Both cohorts provides evidence for internal consistency of the derived subscales, test-retest reliability, content validity, concurrent validity, and construct validity. Principal components and Rasch measurement model analyses were applied sequentially to survey sample data, reducing test length to 44 questions, divided into six subscales: mobility, symptoms, emotional well-being (depression), general contentment, thinking/fatigue, and family/social well-being. Fifteen initially rejected questions were added back as miscellaneous (unscored) questions for their potential clinical and empirical value. The mobility subscale was strongly predictive of the Kurtzke Extended Disability Status Scale and the Scripps Neurologic Rating Scales. The other five subscales were not, indicating they measure aspects of patient quality of life not captured by the neurologic exam. The final 59-item English language instrument (FAMS version 2) is available for inclusion in clinical trials and clinical practice.

Adult

Quality of life outcomes: measurement and validation.

New treatments for cancer often are evaluated solely on the basis of increased survival, and thus, lack valuable information about other benefits and drawbacks of these treatments. It is important to raise the issue of the quality of life as a companion to the issue of quantity of life. The trade-off is not always between toxicity and survival time; sometimes a treatment, however toxic, affords benefit not by virtue of increasing survival, but rather, by palliating tumor-induced pain or obstruction. Proper selection of measures and supplementary questions is an important first step toward a successful evaluation of QOL. Included in this article is a table that reviews many available QOL measures that have been designed for, or are frequently used with, people with cancer. One cancer-specific questionnaire, the Functional Assessment of Cancer Therapy (FACT), also is reproduced.

Humans

The Functional Assessment of Cancer Therapy (FACT) scale. Development of a brain subscale and revalidation of the general version (FACT-G) in patients with primary brain tumors.

BACKGROUND: This report describes the development and validation of a brain subscale for the Functional Assessment of Cancer Therapy (FACT) scale, and the revalidation of the subscales of the general version (FACT-G), which measure physical, social, family, emotional, and functional well-being and the quality of the relationship with the physician. METHODS: 101 patients with primary brain tumors, after giving informed consent, participated in the last two phases of a four-phase validation process: item generation, item reduction, validation, and reliability testing. In the validation phase, FACT-G subscale and total scores as well as the brain subscale scores were correlated with other tests of mood, response, bias, and quality of life (QOL). Test-retest reliability testing was performed with 46 patients who had primary brain tumors. RESULTS: Validity and reliability coefficients were high for the FACT-G and brain subscale, except for the comparison with a second QOL measure (FP-QLI) and the Karnofsky Performance Status (KPS). The lower scores were the result of inherent differences in the two QOL instruments and the relatively high performance status of the brain tumor patients, which restricted the KPS score range. CONCLUSION: The FACT-G has good psychometric properties supporting its broad generalizability and the brain subscale tests substantially different QOL issues than the core instrument. Use of this scale with the addition of the brain subscale provides a well rounded view of the various aspects of QOL from the patient's perspective. With modifications and further psychometric testing, the brain subscale may have broader applicability to subpopulations of patients with other brain disorders.

Adult

Methods and problems in measuring quality of life.

The US health-care transition demands increased accountability for medical care. This has contributed to increased interest in documenting valued medical outcomes, including improvements in health-related quality of life and treatment satisfaction. These data can only be obtained validly by asking patients directly about their current health state, perception of well-being, and satisfaction with care. A core set of well-validated instruments have been developed to measure health-related quality of life in patients with cancer. As these are employed with increasing frequency, rigorous quality assurance of data collection is critical. Because of the necessity of quality control, patient-reported data collection can be labor-intensive and prohibitively costly. However, time and cost-saving methods, such as centralized telephone survey methods or on-site direct data entry via interactive computer, can guarantee high-quality data while minimizing costs. Justification of the need for these methods and a brief description are provided.

Data Interpretation, Statistical