A randomized phase II trial comparing every 3-weeks carboplatin/paclitaxel with every 3-weeks carboplatin and weekly paclitaxel in advanced non-small cell lung cancer.

BACKGROUND: The optimal schedule of taxane administration has been an area of active interest in several recent clinical trials. METHODS: To address a pure schedule question, we randomized 161 patients with advanced stage IIIB or IV non-small-cell lung cancer (NSCLC) to either paclitaxel 225 mg/m2 every 3 weeks x 4 cycles or 75 mg/m2/week x 12 (cumulative dose on each arm = 900 mg/m2). Both arms received concurrent carboplatin AUC 6 every 3 weeks x 4 cycles. RESULTS: The two arms were well-balanced in terms of known prognostic factors. The overall response rate and survival outcomes were similar on the two arms. There was significantly more grade 3/4 thrombocytopenia and grade 2-4 anemia on the weekly arm but less severe myalgias/arthralgias and alopecia. No difference in the rates of peripheral neuropathy was observed; however, patients on the every 3 weeks arm reported significantly more taxane therapy-related side-effects on the functional assessment of cancer therapy taxane subscale. CONCLUSIONS: This randomized trial exploring schedule-related issues with carboplatin/paclitaxel confirms the versatility of this regimen.

A case for including spirituality in quality of life measurement in oncology.

Most of the commonly used quality of life (QOL) instruments in oncology do not include spirituality as a core domain. However, previous research suggests that spirituality might be an important aspect of QOL for cancer patients and that it may, in fact, be especially salient in the context of life-threatening illness. This study used a large (n=1610) and ethnically diverse sample to address three questions relevant to including spirituality in QOL measurement: (1) Does spirituality demonstrate a positive association with QOL?; (2) Is this association unique?; and (3) Is there clinical utility in including spirituality in QOL measurement? Spirituality, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), was found to be associated with QOL to the same degree as physical well-being, a domain unquestioned in its importance to QOL. The significant association between spirituality and QOL was unique, remaining after controlling for core QOL domains as well as other possible confounding variables. Furthermore, spiritual well-being was found to be related to the ability to enjoy life even in the midst of symptoms, making this domain a potentially important clinical target. It is concluded that these results support the move to the biopsychosocialspiritual model for QOL measurement in oncology.

Relationship between quality of life and depression in patients with head and neck cancer.

OBJECTIVE: This study describes the relationship between health-related quality of life (HRQOL) and depression in patients following major surgery for head and neck cancer. DESIGN: Cross-sectional study using medical chart review, patient interview, and test administration. METHOD: Fifty patients were evaluated 6 months to 6 years following surgery using one global HRQOL measure (The Functional Assessment of Cancer Therapy-General [FACT-G]); three disease-specific measures of HRQOL (the HN module of the FACT [FACT-HNS], The University of Washington Quality of Life Scale [UWQOL], and The Performance Status Scale for Head and Neck Cancer); and one measure of depression (The Beck Depression Inventory [BDI]). RESULTS: The study population showed a high occurrence of depressive symptoms (22%). A negative correlation existed between the BDI and HRQOL as measured by the FACT-G (r = -0.49, P < .001) and the UWQOL (r = -0.44, P = .003). When somatic symptoms of depression were removed, the BDI remained correlated with HRQOL and was most highly correlated with the Emotional Well-Being (EWB) subscale of the FACT-G (r = -0.42, P = .003). There was no correlation between clinician judgments of EWB and any patient-rated measures of HRQOL or depression. CONCLUSIONS: Results demonstrate an inverse relationship between patient-reported HRQOL and depression. The lack of correlation between physician and patient ratings of HRQOL and EWB stresses the importance of obtaining patient ratings in addition to traditional clinician ratings when assessing outcomes. Finally, the multidimensional construction of the FACT with its specific subscales may make it a useful clinical tool for assessing patient status and augmenting patient interviews.

The effects of the social environment on stress-related cardiovascular activation: current findings, prospects, and implications.

Social relationships have been shown to be health-protective and to improve cardiovascular disease prognosis. One of the mechanisms by which social relationships may alter health status is through altering patterns of neuroendocrine or hemodynamic responding to ongoing activity. For example, research with non-human primates suggests that disrupted social relationships may increase cardiovascular risk through their effects on sympathetic nervous system activation. In humans, a number of recent reports have shown that the presence of an affiliative companion can reduce cardiovascular activity during psychologically challenging tasks, results which are consistent with this proposed mechanism of effect. We review the recent human literature which has examined the effects of the social environment on stress-related cardiovascular activity. Although findings in this literature are generally consistent, recent anomalous results are reviewed which shed light on some of the context-dependent effects of social affiliation. Additional areas for further investigation are examined, including possible mechanisms for explaining these social affiliation effects, individual differences which may moderate these effects, and emerging methodological advances for examining how these effects may generalize to the natural environment.

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

The revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life (QoL) instrument has been updated and expanded to provide more complete and accurate coverage of human immune deficiency virus/acquired immune deficiency syndrome (HIV/AIDS)-related QoL. Factor analysis and the Rasch measurement model were used to determine a new subscale structure for the FAHI. The content of these subscales, including physical well-being (ten items, alpha = 0.91), function and global well-being (13 items, alpha = 0.86), emotional well-being/living with HIV (10 items, alpha = 0.82), social well-being (eight items, alpha = 0.73), and cognitive functioning (three items; alpha = 0.75), reflect both general illness- and HIV/AIDS-specific QoL concerns: a total QoL score can also be calculated for the FAHI (44 items, alpha = 0.91). Psychometric evaluation revealed good internal consistency reliability for the FAHI and its subscales. In addition, construct validity, known groups validity and sensitivity to change were demonstrated by significant associations between the FAHI and additional indicators of functional status, psychological symptoms, stress and illness severity. In summary, the FAHI is a psychometrically sound instrument that captures multiple important dimensions of HIV/AIDS-related QoL. It is brief, easy to administer and score, has been translated into nine languages other than English and is appropriate for use in clinical trials and clinical practice.

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.