Amy H. Peterman

Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp).

A significant relation between religion and better health has been demonstrated in a variety of healthy and patient populations. In the past several years, there has been a focus on the role of spirituality, as distinct from religion, in health promotion and coping with illness. Despite the growing interest, there remains a dearth of well-validated, psychometrically sound instruments to measure aspects of spirituality. In this article we report on the development and testing of a measure of spiritual well-being, the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), within two samples of cancer patients. The instrument comprises two sub scales—one measuring a sense of meaning and peace and the other assessing the role of faith in illness. A total score for spiritual well-being is also produced. Study 1 demonstrates good internal consistency reliability and a significant relation with quality of life in a large, multiethnic sample. Study 2 examines convergent validity with 5 other measures of religion and spirituality in a sample of individuals with mixed early stage and metastatic cancer diagnoses. Results of the two studies demonstrate that the FACIT-Sp is a psychometrically sound measure of spiritual well-being for people with cancer and other chronic illnesses.

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?

Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales.

Magnitude differences in scores on a measure of quality of life that correspond to differences in function or clinical course are called clinically important differences (CIDs). Anchor-based and distribution-based methods were used to provide ranges of CIDs for five targeted scale scores of the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. Three samples of cancer patients were used: Sample 1 included 50 patients participating in a validation study of the FACT-An; Sample 2 included 131 patients participating in a longitudinal study of chemotherapy-induced fatigue; sample 3 included 2,402 patients enrolled in a community-based clinical trial evaluating the effectiveness and safety of a treatment for anemia. Three clinical indicators (hemoglobin level; performance status; response to treatment) were used to determine anchor-based differences. One-half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Analyses supported the following whole number estimates of a minimal CID for these five targeted scores: Fatigue Scale = 3.0; FACT-G total score = 4.0; FACT-An total score = 7.0; Trial Outcome Index-Fatigue = 5.0; and Trial Outcome Index-Anemia = 6.0. These estimates provide a basis for sample size estimation when planning for a clinical trial or other longitudinal study, when the purpose is to ensure detection of meaningful change over time. They can also be used in conjunction with more traditional clinical markers to assist investigators in determining treatment efficacy.

Fatigue in cancer patients compared with fatigue in the general United States population

Although fatigue is a common symptom among cancer patients, it is also a common experience in the general, healthy population. Its universality has made it difficult to appreciate whether the fatigue experienced by patients with cancer is distinguishable from the fatigue experienced by the general population. Because the etiology of fatigue is multifactorial, it also has been difficult to appreciate fully the relative contribution of anemia to cancer‐related fatigue.

Phase III Trial Comparing a Defined Duration of Therapy Versus Continuous Therapy Followed by Second-Line Therapy in Advanced-Stage IIIB/IV Non–Small-Cell Lung Cancer

PURPOSE To compare four cycles of therapy versus continuous therapy to determine the optimal duration of chemotherapy in advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS Stage IIIB/IV NSCLC patients were randomized to arm A (four cycles of carboplatin at an area under the curve of 6 and paclitaxel 200 mg/m(2) every 21 days) or arm B (continuous treatment with carboplatin/paclitaxel until progression). At progression, all patients on both arms were to receive second-line weekly paclitaxel at 80 mg/m(2)/wk. The primary end points were survival and quality of life (QOL). RESULTS Two hundred thirty patients were randomized. Fifty-seven percent of arm A patients completed four courses of therapy. In the 116 arm B patients, the median number of cycles delivered was four (range, zero to 19 cycles). Forty-two percent received five or more cycles; 18% received eight or more cycles. Overall response rates were 22% and 24% for arms A and B, respectively (P =.80). Median survival time and 1-year survival rates were 6.6 months and 28% for arm A and 8.5 months and 34% for arm B, respectively (log-rank P =.63). Rates of hematologic and nonhematologic toxicity were similar between the two arms, except for neuropathy. The rate of grade 2 to 4 neuropathy increased from 19.9% (95% confidence interval [CI], 13.6% to 26.2%) at cycle 4 to 43% (95% CI, 28.6% to 57.4%) at cycle 8. There were no differences in QOL. Only 45% of patients received second-line therapy (42% in arm A v 47% in arm B, P =.42). CONCLUSION This study shows no overall benefit in survival, response rates, or QOL to continuing treatment with carboplatin/paclitaxel beyond four cycles in advanced NSCLC.

Spirituality and Religion in Patients with HIV/AIDS

BackgroundSpirituality and religion are often central issues for patients dealing with chronic illness. The purpose of this study is to characterize spirituality/religion in a large and diverse sample of patients with HIV/AIDS by using several measures of spirituality/religion, to examine associations between spirituality/religion and a number of demographic, clinical, and psychosocial variables, and to assess changes in levels of spirituality over 12 to 18 months.MethodsWe interviewed 450 patients from 4 clinical sites. Spirituality/religion was assessed by using 8 measures: the Functional Assessment of Chronic Illness Therapy—Spirituality-Expanded scale (meaning/peace, faith, and overall spirituality); the Duke Religion Index (organized and nonorganized religious activities, and intrinsic religiosity); and the Brief RCOPE scale (positive and negative religious coping). Covariates included demographics and clinical characteristics, HIV symptoms, health status, social support, self-esteem, optimism, and depressive symptoms.ResultsThe patients’ mean (SD) age was 43.3 (8.4) years; 387 (86%) were male; 246 (55%) were minorities; and 358 (80%) indicated a specific religious preference. Ninety-five (23%) participants attended religious services weekly, and 143 (32%) engaged in prayer or meditation at last daily. Three hundred thirty-nine (75%) patients said that their illness had strengthened their faith at least a little, and patients used positive religious coping strategies (e.g., sought God’s love and care) more often than negative ones (e.g., wondered whether God has abandoned me; P<.0001). In 8 multivariable models, factors associated with most facets of spirituality/religion included ethnic and racial minority status, greater optimism, less alcohol use, having a religion, greater self-esteem, greater life satisfaction, and lower overall functioning (R2=.16 to .74). Mean levels of spirituality did not change significantly over 12 to 18 months.ConclusionsMost patients with HIV/AIDS belonged to an organized religion and use their religion to cope with their illness. Patients with greater optimism, greater self-esteem, greater life satisfaction, minorities, and patients who drink less alcohol tend to be both more spiritual and religious. Spirituality levels remain stable over 12 to 18 months.

Measuring the side effects of taxane therapy in oncology: The Functional Assessment of Cancer therapy-taxane (FACT-taxane)

Cancer chemotherapy with some of the taxane class of agents can be associated with significant neurotoxicity, arthralgias, myalgias, and skin changes that may offset the therapeutic benefits of taxane use.

A brief assessment of concerns associated with genetic testing for cancer: the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire.

The Multidimensional Impact of Cancer Risk Assessment (MICRA) is a new tool to measure the specific impact of result disclosure after genetic testing. The authors compared its performance with that of questionnaires measuring general and cancer-specific distress. Participants (158 women) responded 1 month after they received genetic test results. The women were divided into 4 standard clinical test result groups: BRCA1/2 positive, BRCA1/2 negative, panel negative, and true negative. Factor analysis supported the formation of 3 subscales: Distress (6 items, alpha = .86), Uncertainty (9 items, alpha = .77), and Positive Experiences (4 items, alpha = .75). All 3 MICRA subscales differentiated participants who were BRCA1/2 positive from the other 3 groups. MICRA thus helps identify subgroups of vulnerable genetic testing participants.

Neuro-QOL Brief measures of health-related quality of life for clinical research in neurology

Objective: To address the need for brief, reliable, valid, and standardized quality of life (QOL) assessment applicable across neurologic conditions. Methods: Drawing from larger calibrated item banks, we developed short measures (8–9 items each) of 13 different QOL domains across physical, mental, and social health and evaluated their validity and reliability. Three samples were utilized during short form development: general population (Internet-based, n = 2,113); clinical panel (Internet-based, n = 553); and clinical outpatient (clinic-based, n = 581). All short forms are expressed as T scores with a mean of 50 and SD of 10. Results: Internal consistency (Cronbach α) of the 13 short forms ranged from 0.85 to 0.97. Correlations between short form and full-length item bank scores ranged from 0.88 to 0.99 (0.82–0.96 after removing common items from banks). Online respondents were asked whether they had any of 19 different chronic health conditions, and whether or not those reported conditions interfered with ability to function normally. All short forms, across physical, mental, and social health, were able to separate people who reported no health condition from those who reported 1–2 or 3 or more. In addition, scores on all 13 domains were worse for people who acknowledged being limited by the health conditions they reported, compared to those who reported conditions but were not limited by them. Conclusion: These 13 brief measures of self-reported QOL are reliable and show preliminary evidence of concurrent validity inasmuch as they differentiate people based upon number of reported health conditions and whether those reported conditions impede normal function.

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, α = 0.91), function and global well-being (13 items, α = 0.86), emotional well-being/living with HIV (10 items, α = 0.82), social well-being (eight items, α = 0.73), and cognitive functioning (three items; α = 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, α =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.