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Biomedical subjects

D F Cella

Publications and source records attributed to D F Cella.

At least 19 recordsLinked to original sources
PubMed1996

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↗
PubMed1996

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↗
PubMed1996

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↗
PubMed1996

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↗
PubMed1996

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↗
PubMed1996

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↗
PubMed1996

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↗
PubMed1995

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↗
PubMed1995

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↗
PubMed1995

The Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI): a brief assessment of patients' subjective response to treatment for anorexia/cachexia.

A brief visual analogue instrument was developed and tested in the context of a multicentre randomized double-blinded four-dose trial of megestrol acetate for the treatment of AIDS-related anorexia/cachexia. This nine-item instrument, the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI), was administered every 4 weeks after initiation of study drug (placebo vs 100 mg, 400 mg or 800 mg of drug). The purpose of the instrument was to quantify patient perception of benefit in areas such as decreased concern over weight, decreased concern over appearance, increased pleasure in eating and increase in global perception of quality of life. Post-trial psychometric evaluation of the instrument strongly supported the use of a seven-item index of subjective recovery from symptoms of anorexia/cachexia (BACRI-7) and a single criterion item depicting patient perception of benefit (BACRI-1). The BACRI-7 and BACRI-1 scales showed significant improvement over 12 weeks in patients who received higher dose active drug (400 and 800 mg) compared with the placebo and 100 mg doses. Further differentiation of 400 vs 800 mg arms was seen in the BACRI-7 results, consistent with dose-response improvements in weight and lean body mass changes. Quadratic trends over time in lean body mass change and provider-rated appetite grade suggested peak therapeutic effect at 8 weeks for these endpoints, whereas the absence of these trends in overall weight and patient-reported BACRI scores suggested that these benefits are more persistent. Although subjective (patient-reported) benefit is strongly associated with objective indicators of improvement, there remains the possibility that there is some added, independent benefit of megestrol acetate to subjective well-being.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument.

The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.

Adult↗
PubMed1995

Correlates of stress in HIV disease.

A group of 53 men with HIV disease participated in this correlational study of the relationships among psychological distress, quality of life, uncertainty, coping patterns, stress, and CD4+ T-lymphocyte levels. Meaningful correlations (r > .40, p < .01) indicated that higher levels of negative-impact stressful experiences were associated with more frequent use of emotion-focused coping; both higher levels of negative stress and more frequent use of emotion-focused coping were associated with lower quality of life, higher psychological distress, and more uncertainty; lower quality of life was associated with higher psychological distress and more uncertainty; and lower CD4+ counts were associated with higher levels of positive-impact stressful experiences.

Adaptation, Psychological↗
PubMed1995

Someone to live for: social well-being, parenthood status, and decision-making in oncology.

PURPOSE: Little is known about the influence of social factors on treatment preferences and desire for aggressive cancer therapy. The present study assessed subjective and objective social indicators in patient preferences for treatment. METHODS: Cancer patients (N = 296) with diverse diagnoses and stages read sets of hypothetical vignettes describing patients with early-stage and advanced disease. In the first set, patients made decisions about treatment acceptance given varying levels of either increasing cure or extending survival. In the second set, the point at which patients shifted preferences from mild to severe treatment to improve likelihood of 1-year survival (switch point) was the dependent measure. We assessed the impact of quality-of-life (QL) domains measured by the Functional Assessment of Cancer Therapy-General (FACT-G), having children, marital status, and living arrangements on treatment preferences and switch points. RESULTS: The Social Well-Being (SWB) subscale of the FACT-G predicted both treatment acceptance (P = .007) and switch point (P = .043) in the advanced-disease vignettes, with lower SWB associated with less aggressive preferences. Children living at home was likewise associated with more aggressive intent both in treatment preferences (P = .003, advanced-disease vignette) and switch point (P < .001 and P = .001 for early- and advanced-disease vignettes, respectively). Living with others predicted more aggressive intent in the advanced-disease vignette (P = .03). Marital status did not predict either treatment acceptance or switch point. CONCLUSION: Positive social well-being, as well as having children living at home, predicted patient willingness to accept aggressive treatment. Willingness to receive aggressive treatment may explain or mediate previously reported salutory effects of social support on cancer outcomes.

Adaptation, Psychological↗
PubMed1995

Measuring quality of life in palliative care.

In the palliative treatment of chronic illness, attention must extend beyond symptom control to include the overall quality of patients' lives. Symptom relief is highly valued by patients and usually is associated with improvement in general functioning and well-being (ie, overall quality of life). Side effects and costs of therapy, however, also must be included in the equation to fully balance the treatment decision. Patients tend not to think dichotomously in terms of toxicity versus efficacy; rather, they consider the aggregate of their capabilities, circumstances, and somatic sensations. In fact, they often confuse symptoms with side effects. We must therefore survey patients in terms of their disaggregated experience, using a valid self-report questionnaire, and help them make decisions about treatment by estimating which deficiencies or improvements are attributable to disease versus treatment. The dialogue that this demands is challenging, because it can threaten the adaptive suppression that many patients use to protect themselves from negative feelings. Unfortunately, the consequence of avoiding this dialogue often is unnecessary treatment given with misunderstood intentions.

Cost of Illness↗
PubMed1995

Measuring quality of life: 1995 update.

Often, new treatments for cancer are evaluated solely on the basis of increased survival, depriving us of valuable information about other benefits and drawbacks of these treatments. It is important to raise the question of the quality of life as a companion to the question of quantity of life. The trade-off is not always between toxicity vs survival time; sometimes a treatment, however toxic, affords benefit not by virtue of increasing survival, but by palliation of tumor-induced pain or obstruction. Included in this paper is a table that reviews many available quality of life measures that have been designed for, or frequently used with, people with cancer. Proper selection of measures and supplementary questions is an important first step toward a successful evaluation of quality of life. Samples of many of these scales are included in the appendix.

Humans↗
PubMed1994

Age and clinical decision making in oncology patients.

BACKGROUND: Ageism is a cultural bias that might inappropriately steer oncologists away from recommending aggressive treatments for older patients. The extent to which older patients might prefer less aggressive cancer therapies is unknown. Our lack of knowledge about patients' personal preferences for therapy may perpetuate this bias. PURPOSE: We conducted a study to determine 1) if age influences patient acceptance of cancer therapy and 2) if the older patients would be more or less likely to trade increased survival for maintaining quality of life than their younger counterparts. METHODS: Using an interview format, 244 cancer patients of all ages treated at a tertiary care cancer center read two sets of hypothetical vignettes. The first set consisted of four vignettes that varied in terms of stage of disease and treatment toxicity. Patients were asked to make hypothetical decisions about treatment given with respect to varying levels of either increasing cure or extending survival. The second set of vignettes presumed acceptance of cancer therapy. Within each vignette, two hypothetical treatments (mild versus severe) with different probabilities of 1-year survival were contrasted. The point at which patients shifted preferences from a treatment with mild versus severe side effects was the dependent measure. Mixed analysis of variance (ANOVA) procedures (F test) assessed the impact of age (< 65 years versus > or = 65 years) and patient disease stage (early versus advanced) on hypothetical decisions about treatment. All P values are two sided. RESULTS: In the treatment-preference vignettes, there was no effect of either age [F(1,239) = 2.14; P = .14] or patient stage [F(1,239) = .40; P = .53] on treatment acceptance. Older adults were as likely as their younger counterparts to agree to chemotherapy for both curative and control purposes. In the switch-point vignettes, younger adults switched to a more toxic treatment to gain survival advantage at an earlier point than the older patients in both the early-disease vignette [F(1,232) = 3.88; P = .05] and the advanced-disease vignette [F(1,232) = 4.43; P = .036]. There was neither an effect of disease stage on treatment decisions nor an interaction between disease stage and age. CONCLUSIONS AND IMPLICATIONS: In a tertiary care setting, older adults do not differ from their younger counterparts in terms of acceptance of chemotherapy. However, when treatment is presumed, they differ in terms of willingness to trade survival for current quality of life. Generalization of findings is limited by the relatively small sample of older adults (n = 43) and the referral population from which the sample was drawn. Replication with a larger older adult sample in a community setting is needed.

Adult↗