"Pathways": A hope-enhancing intervention for patients undergoing treatment for advanced lung cancer.

OBJECTIVE: Observational data suggest hope is associated with the quality of life and survival of people with cancer. This trial examined the feasibility, acceptability, and preliminary outcomes of "Pathways," a hope intervention for people in treatment for advanced lung cancer. METHODS: Between 2020 and 2022, we conducted a single-arm trial of Pathways among participants who were 3-12 weeks into systemic treatment. Pathways consisted of two individual sessions delivered during infusions and three phone calls in which participants discussed their values, goals, and goal strategies with a nurse or occupational therapist. Participants completed standardized measures of hope and goal interference pre- and post-intervention. Feasibility was defined as ≥60% of eligible patients enrolling, ≥70% of participants completing three or more sessions, ≥70% of participants completing post-assessments, and mean acceptability ratings ≥7 out of 10 on intervention relevance, helpfulness, and convenience. Linear regression fixed effects models with covariates modeled pre-post changes in complete case analysis and multiple imputation models. RESULTS: Fifty two participants enrolled: female (59.6%), non-Hispanic White (84.6%), rural (75.0%), and with low educational attainment (51.9% high school degree or less). Except for enrollment (54%), feasibility and acceptability markers were surpassed (77% adherence, 77% retention, acceptability ratings ≥8/10). There was moderate improvement in hope and goal interference from pre-to post-intervention (d = 0.51, p < 0.05 for hope; d = -0.70, p < 0.005 for goal interference). CONCLUSIONS: Strong feasibility, acceptability, and patient-reported outcome data suggest Pathways is a promising intervention to increase hope and reduce cancer-related goal interference during advanced lung cancer treatment.

Characterizing changes in mental health-related outcomes for health service psychology graduate students during the first year of the COVID-19 pandemic.

OBJECTIVES: Health service psychology (HSP) graduate students experienced adverse mental health outcomes during COVID-19. However, little is known about how mental health outcomes changed in this population after the onset of COVID-19. METHODS: N = 496 HSP graduate students reported onset or worsening of mental health outcomes, inability to access mental health care, worry about COVID-19, and stress at two different timepoints during the first year of the COVID-19 outbreak (timepoint 1: May 1 to June 25, 2020; timepoint 2: September 2 to October 17, 2020). This study tested whether mental health outcomes improved, worsened, or stayed stable during this timeframe. The study also examined whether rising COVID-19 case rates in the state where a participant lived moderated changes in mental health outcomes. RESULTS: Overall, HSP graduate students endorsed adverse mental health outcomes at a higher rate during the first survey relative to the second survey. Even still, 62.68% of students reported worsened mental health symptoms, 49.84% reported worsened sleep, and 23.92% reported increased alcohol and substance use in the 2 months leading up to the second survey. CONCLUSION: HSP programs should monitor graduate students' evolving mental health, provide wellness resources, and adopt flexible approaches to support graduate students navigating training during periods of immense disruption.

Development and validation of the positive affect and well-being scale for the neurology quality of life (Neuro-QOL) measurement system.

PURPOSE: To develop and validate an item-response theory-based patient-reported outcomes assessment tool of positive affect and well-being (PAW). This is part of a larger NINDS-funded study to develop a health-related quality of life measurement system across major neurological disorders, called Neuro-QOL. METHODS: Informed by a literature review and qualitative input from clinicians and patients, item pools were created to assess PAW concepts. Items were administered to a general population sample (N = 513) and a group of individuals with a variety of neurologic conditions (N = 581) for calibration and validation purposes, respectively. RESULTS: A 23-item calibrated bank and a 9-item short form of PAW was developed, reflecting components of positive affect, life satisfaction, or an overall sense of purpose and meaning. The Neuro-QOL PAW measure demonstrated sufficient unidimensionality and displayed good internal consistency, test-retest reliability, model fit, convergent and discriminant validity, and responsiveness. CONCLUSION: The Neuro-QOL PAW measure was designed to aid clinicians and researchers to better evaluate and understand the potential role of positive health processes for individuals with chronic neurological conditions. Further psychometric testing within and between neurological conditions, as well as testing in non-neurologic chronic diseases, will help evaluate the generalizability of this new tool.

Racial/ethnic differences in spiritual well-being among cancer survivors.

This study examined racial/ethnic differences in spiritual well-being (SWB) among survivors of cancer. We hypothesized higher levels of Peace and Faith, but not Meaning, among Black and Hispanic survivors compared to White survivors, differences that would be reduced but remain significant after controlling for sociodemographic and medical factors. Hypotheses were tested with data from the American Cancer Society's Study of Cancer Survivors-II. The FACIT-Sp subscale scores, Meaning, Peace, and Faith assessed SWB, and the SF-36 Physical Component Summary measured functional status. In general, bivariate models supported our initial hypotheses. After adjustment for sociodemographic and medical factors, however, Blacks had higher scores on both Meaning and Peace compared to Hispanics and Whites, and Hispanics' scores on Peace were higher than Whites' scores. In contrast, sociodemographic and medical factors had weak associations with Faith scores. The pattern with Faith in bivariate models persisted in the fully adjusted models. Racial/ethnic differences in Meaning and in Peace, important dimensions of SWB, were even stronger after controlling for sociodemographic and medical factors. However, racial/ethnic differences in Faith appeared to remain stable. Further research is needed to determine if racial/ethnic differences in SWB are related to variations in quality of life in survivors of cancer.

Guidelines for psychological practice for people with low-income and economic marginalization: Executive summary.

This is a summary of the guidelines for working with low-income and economically marginalized (LIEM) people developed by the American Psychological Association (APA) task force and approved by the APA Council of Representatives. The task force, consisting of psychologists from a range of psychological specialties and both practice and educational settings, created guidelines in four main categories: Education and Training, Health Disparities, Treatment Considerations, and Career Concerns and Unemployment. Each category includes specific guidelines and recommended interventions. Further, the task force identified two major assumptions that cut across all of the recommendations: (1) The intersection of economic status and other identities is critical to psychological and other aspects of health, and (2) biases and stigma exacerbate the negative experiences of living with LIEM, and must be acknowledged and confronted by psychologists and trainees. Many of the guidelines and corollary interventions reinforce the need for psychologists and trainees to engage in activities that increase their own self-awareness and knowledge of issues and concerns that are exacerbated by economic marginalization, as well as challenge their own implicit and explicit biases related to social class and poverty. The impact of economic marginalization on education, health, and career attainment are addressed, and adaptations to psychological interventions are recommended. The task force concludes with a call to engage psychologists in action that seeks and promotes economic justice. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

An examination of the 3-factor model and structural invariance across racial/ethnic groups for the FACIT-Sp: a report from the American Cancer Society's Study of Cancer Survivors-II (SCS-II).

OBJECTIVES: Recent confirmatory factor analysis (CFA) of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) Scale in a sample of predominantly white women demonstrated that three factors, Meaning, Peace, and Faith, represented a psychometric improvement over the original 2-factor model. The present study tested these findings in a more diverse sample, assessed the stability of the model across racial/ethnic groups, and tested the contribution of a new item. METHODS: In a study by the American Cancer Society, 8805 cancer survivors provided responses on the FACIT-Sp, which we tested using CFA. RESULTS: A 3-factor model provided a better fit to the data than the 2-factor model in the sample as a whole and in the racial/ethnic subgroups (Deltachi(2), p<0.001, for all comparisons), but was not invariant across the groups. The model with equal parameters for racial/ethnic groups was a poorer fit to the data than a model that allowed these parameters to vary (Deltachi(2)(81)=2440.54, p<0.001), suggesting that items and their associated constructs might be understood differently across racial/ethnic groups. The new item improved the model fit and loaded on the Faith factor. CONCLUSIONS: The 3-factor model is likely to provide more specific information for studies in the field. In the construction of scales for use with diverse samples, researchers need to pay greater attention to racial/ethnic differences in interpretation of items.

Development and initial validation of the Perceived Scarcity Scale.

Though socio-economic status (SES) partially explains the experience of stress and health outcomes, most research to date has relied on a small number of traditional indicators that fail to capture the full domain of socioeconomic factors. The recent reconceptualization of perceived scarcity is proposed as a subjective indicator of SES when attempting to predict both stress and health outcomes. Although a conceptualization of perceived scarcity has been advanced, a psychometrically sound scale is needed to assess the utility and scientific import of this concept. No such scale exists. Therefore, the current paper describes the development, psychometric properties, and initial validation of the Perceived Scarcity Scale (PScS). Four studies using traditional scale development processes were employed to develop (Studies 1 and 2) and provide an initial validation (Studies 3 and 4) for the PScS. Results support the existing model of perceived scarcity and indicate that the measure is valid. Moreover, the scale predicted concurrent perceived stress, as well as longitudinal ratings of perceived stress, global health, quality of life, and symptoms of depression and anxiety. The development of the new scale provides clinicians and researchers with a brief, validated measure that can assess the level of perceived scarcity individuals currently experience.

A 3-factor model for the FACIT-Sp.

OBJECTIVE: The 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp) is a popular measure of the religious/spiritual (R/S) components of quality of life (QoL) in patients with cancer. The original factor analyses of the FACIT-Sp supported two factors: Meaning/Peace and Faith. Because Meaning suggests a cognitive aspect of R/S and Peace an affective component, we hypothesized a 3-factor solution: Meaning, Peace, and Faith. METHODS: Participants were 240 long-term female survivors of cancer who completed the FACIT-Sp, the SF-12, and the BSI 18. We used confirmatory factor analysis to compare the 2- and 3-factor models of the FACIT-Sp and subsequently assessed associations between the resulting solutions and QoL domains. RESULTS: Survivors averaged 44 years of age and 10 years post-diagnosis. A 3-factor solution of the FACIT-Sp significantly improved the fit of the model to the data over the original 2-factor structure (Delta chi(2)=72.36, df=2, p<0.001). Further adjustments to the 3-factor model resulted in a final solution with even better goodness-of-fit indices (chi(2)=59.11, df=1, p=0.13, CFI=1.00, SMRM=0.05).The original Meaning/Peace factor controlling for Faith was associated with mental (r=0.63, p<0.000) and physical (r=0.22, p<0.01) health on the SF-12, and the original Faith factor controlling for Meaning/Peace was negatively associated with mental health (r=-0.15, p<0.05). The 3-factor model was more informative. Specifically, using partial correlations, the Peace factor was only related to mental health (r=0.53, p<0.001); Meaning was related to both physical (r=0.18, p<0.01) and mental (r=0.17, p<0.01) health; and Faith was negatively associated with mental health (r=-0.17, p<0.05). CONCLUSION: The results of this study support a 3-factor solution of the FACIT-Sp. The new solution not only represents a psychometric improvement over the original, but also enables a more detailed examination of the contribution of different dimensions of R/S to QoL.

Use of a single-item screening tool to detect clinically significant fatigue, pain, distress, and anorexia in ambulatory cancer practice.

Fatigue, pain, distress, and anorexia are four commonly encountered symptoms in cancer. To evaluate the usefulness of a single-item screening for these symptoms, 597 ambulatory outpatients with solid tumors were administered a self-report screening instrument within the first 12 weeks of chemotherapy. Patients rated the severity of each symptom on a 0-10 scale, at its worst over the past three days, with higher ratings associated with higher symptom levels. From this sample, 148 patients also completed a more comprehensive assessment of these symptoms. Two criteria were used to determine optimal cut-off scores on the screening items: 1) the sensitivity and specificity of each screening item to predict clinical cases using receiver-operating characteristics analysis and 2) the proportion of patients at each screening score who reported that some relief of the target symptom would significantly improve their life. Optimal cut-off scores ranged from 4 to 6 depending on the target symptom (area under the curve range=0.68-0.88). Use of single-item screening instruments for fatigue, pain, distress, and anorexia may assist routine clinical assessment in ambulatory oncology practice. In turn, such assessments may improve identification of those at risk of morbidity and decreased quality of life due to excess symptom burden.

Self-rated health of primary care house officers and its relationship to psychological and spiritual well-being.

BACKGROUND: The stress associated with residency training may place house officers at risk for poorer health. We sought to determine the level of self-reported health among resident physicians and to ascertain factors that are associated with their reported health. METHODS: A questionnaire was administered to house officers in 4 residency programs at a large Midwestern medical center. Self-rated health was determined by using a health rating scale (ranging from 0 = death to 100 = perfect health) and a Likert scale (ranging from "poor" health to "excellent" health). Independent variables included demographics, residency program type, post-graduate year level, current rotation, depressive symptoms, religious affiliation, religiosity, religious coping, and spirituality. RESULTS: We collected data from 227 subjects (92% response rate). The overall mean (SD) health rating score was 87 (10; range, 40-100), with only 4 (2%) subjects reporting a score of 100; on the Likert scale, only 88 (39%) reported excellent health. Lower health rating scores were significantly associated (P < 0.05) with internal medicine residency program, post-graduate year level, depressive symptoms, and poorer spiritual well-being. In multivariable analyses, lower health rating scores were associated with internal medicine residency program, depressive symptoms, and poorer spiritual well-being. CONCLUSION: Residents' self-rated health was poorer than might be expected in a cohort of relatively young physicians and was related to program type, depressive symptoms, and spiritual well-being. Future studies should examine whether treating depressive symptoms and attending to spiritual needs can improve the overall health and well-being of primary care house officers.

Religion, spirituality, and depressive symptoms in patients with HIV/AIDS.

BACKGROUND: Depression has been linked to immune function and mortality in patients with chronic illnesses. Factors such as poorer spiritual well-being has been linked to increased risk for depression and other mood disorders in patients with HIV. OBJECTIVE: We sought to determine how specific dimensions of religion, spirituality, and other factors relate to depressive symptoms in a contemporary, multi-center cohort of patients with HIV/AIDS. DESIGN: Patients were recruited from 4 medical centers in 3 cities in 2002 to 2003, and trained interviewers administered the questionnaires. The level of depressive symptoms was measured with the 10-item Center for Epidemiologic Studies Depression (CESD-10) Scale. Independent variables included socio-demographics, clinical information, 8 dimensions of health status and concerns, symptoms, social support, risk attitudes, self-esteem, spirituality, religious affiliation, religiosity, and religious coping. We examined the bivariate and multivariable associations of religiosity, spirituality, and depressive symptoms. MEASUREMENTS AND MAIN RESULTS: We collected data from 450 subjects. Their mean (SD) age was 43.8 (8.4) years; 387 (86.0%) were male; 204 (45.3%) were white; and their mean CD4 count was 420.5 (301.0). Two hundred forty-one (53.6%) fit the criteria for significant depressive symptoms (CESD-10 score > or = 10). In multivariable analyses, having greater health worries, less comfort with how one contracted HIV, more HIV-related symptoms, less social support, and lower spiritual well-being was associated with significant depressive symptoms (P<.05). CONCLUSION: A majority of patients with HIV reported having significant depressive symptoms. Poorer health status and perceptions, less social support, and lower spiritual well-being were related to significant depressive symptoms, while personal religiosity and having a religious affiliation was not associated when controlling for other factors. Helping to address the spiritual needs of patients in the medical or community setting may be one way to decrease depressive symptoms in patients with HIV/AIDS.

Modeling the effects of spirituality/religion on patients' perceptions of living with HIV/AIDS.

BACKGROUND: Spirituality/religion is an important factor in health and illness, but more work is needed to determine its link to quality of life in patients with HIV/AIDS. OBJECTIVE: To estimate the direct and indirect effects of spirituality/religion on patients' perceptions of living with HIV/AIDS. DESIGN: In 2002 and 2003, as part of a multicenter longitudinal study of patients with HIV/AIDS, we collected extensive demographic, clinical, and behavioral data from chart review and patient interviews. We used logistic regression and path analysis combining logistic and ordinary least squares regression. SUBJECTS: Four hundred and fifty outpatients with HIV/AIDS from 4 sites in 3 cities. MEASURES: The dependent variable was whether patients felt that life had improved since being diagnosed with HIV/AIDS. Spirituality/religion was assessed by using the Duke Religion Index, Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being-Expanded, and Brief RCOPE measures. Mediating factors included social support, self-esteem, healthy beliefs, and health status/health concerns. RESULTS: Approximately one-third of the patients felt that their life was better now than it was before being diagnosed with HIV/AIDS. A 1-SD increase in spirituality/religion was associated with a 68.50% increase in odds of feeling that life has improved--29.97% due to a direct effect, and 38.54% due to indirect effects through healthy beliefs (29.15%) and health status/health concerns (9.39%). Healthy beliefs had the largest effect on feeling that life had improved; a 1-SD increase in healthy beliefs resulted in a 109.75% improvement in feeling that life changed. CONCLUSIONS: In patients with HIV/AIDS, the level of spirituality/religion is associated, both directly and indirectly, with feeling that life is better now than previously. Future research should validate our new conceptual model using other samples and longitudinal studies. Clinical education interventions should focus on raising awareness among clinicians about the importance of spirituality/religion in HIV/AIDS.

Spirituality and religion in patients with HIV/AIDS.

BACKGROUND: Spirituality 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. METHODS: We 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. RESULTS: The 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 least 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. CONCLUSIONS: Most 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.

Religion, spirituality, and depressive symptoms in primary care house officers.

OBJECTIVE: The arduous nature of residency training places house officers at risk for depression. We sought to determine the prevalence of depressive symptoms in pediatric (PED), internal medicine (IM), family medicine (FM), and combined internal medicine-pediatric (IMPED) house staff, and spiritual/religious factors that are associated with prevalence of depressive symptoms. METHODS: PED, IM, FM, and IMPED residents at a major teaching program were asked to complete a questionnaire during their In-Training Examination. Depressive symptoms were measured with the 10-item Center for Epidemiologic Studies Depression Scale. Independent variables included demographics, residency program type, postgraduate level, current rotation, health status, religious affiliation, religiosity, religious coping, and spirituality. RESULTS: We collected data from 227 subjects. Their mean (SD) age was 28.7 (3.8) years; 131 (58%) were women; 167 (74%) were white; and 112 (49%) were PED, 62 (27%) were IM, 27 (12%) were FM, and 26 (12%) were IMPED residents. Fifty-seven house officers (25%) met the criteria for having significant depressive symptoms. Having depressive symptoms was significantly associated (P< .05) with residency program type, inpatient rotation status, poorer health status, poorer religious coping, and worse spiritual well-being. In multivariable analyses, having significant depressive symptoms was associated with program type, poorer religious coping, greater spiritual support seeking, and worse spiritual well-being. CONCLUSIONS: Depressive symptoms are prevalent among house officers and are associated with certain residency program types and with residents' spiritual and religious characteristics. Identifying residents with depressive symptoms and potentially attending to their spiritual needs may improve their well-being.

Beliefs of primary care residents regarding spirituality and religion in clinical encounters with patients: a study at a midwestern U.S. teaching institution.

PURPOSE: To assess primary care residents' beliefs regarding the role of spirituality and religion in the clinical encounter with patients. METHOD: In 2003, at a major midwestern U.S. teaching institution, 247 primary care residents were administered a questionnaire adapted from that used in the Religion and Spirituality in the Medical Encounter Study to assess whether primary care house officers feel they should discuss religious and spiritual issues with patients, pray with patients, or both, and whether personal characteristics of residents, including their own spiritual well-being, religiosity, and tendency to use spiritual and religious coping mechanisms, are related to their sentiments regarding spirituality and religion in health care. Simple descriptive, univariate, and two types of multivariable analyses were performed. RESULTS: Data were collected from 227 residents (92%) in internal medicine, pediatrics, internal medicine/pediatrics, and family medicine. One hundred four (46%) respondents felt that they should play a role in patients' spiritual or religious lives. In multivariable analysis, this sentiment was associated with greater frequency of participating in organized religious activity (odds ratio [OR] 1.55, 95% confidence interval [CI] 1.20-1.99), a higher level of personal spirituality (OR 1.05, 95% CI 1.02-1.08), and older resident age (OR 1.11, 95% CI 1.02-1.21; C-statistic 0.76). In general, advocating spiritual and religious involvement was most often associated with high personal levels of spiritual and religious coping and with the family medicine training program. Residents were more likely to agree with incorporating spirituality and religion into patient encounters as the gravity of the patient's condition increased (p < .0001). CONCLUSIONS: Approximately half of primary care residents felt that they should play a role in their patients' spiritual or religious lives. Residents' agreement with specific spiritual and religious activities depended on both the patient's condition and the resident's personal characteristics.

A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale.

OBJECTIVE: To determine distribution- and anchor-based minimal important difference (MID) estimates for four scores from the Functional Assessment of Cancer Therapy-Breast (FACT-B): the breast cancer subscale (BCS), Trial Outcome Index (TOI), FACT-G (the general version), and FACT-B. STUDY DESIGN AND SETTING: We used data from a Phase III clinical trial in metastatic breast cancer (ECOG study 1193; n=739) and a prospective observational study of pain in metastatic breast cancer (n=129). One third and one half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Clinical indicators used to determine anchor-based differences included ECOG performance status, current pain, and response to treatment. RESULTS: FACT-B scores were responsive to performance status and pain anchors, but not to treatment response. By combining the results of distribution- and anchor-based methods, MID estimates were obtained: BCS=2-3 points, TOI=5-6 points, FACT-G=5-6 points, and FACT-B=7-8 points. CONCLUSION: Distribution- and anchor-based estimates of the MID do show convergence. These estimates can be used in combination with other measures of efficacy to determine meaningful benefit and provide a basis for sample size estimation in clinical trials.

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.

Measuring meaning and peace with the FACIT-spiritual well-being scale: distinction without a difference?

The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp; Peterman, Fitchett, Brady, Hernandez, & Cella, 2002) has become a widely used measure of spirituality; however, there remain questions about its specific factor structure and the validity of scores from its separate scales. Specifically, it remains unclear whether the Meaning and Peace scales denote distinct factors. The present study addresses previous limitations by examining the extent to which the Meaning and Peace scales relate differentially to a variety of physical and mental health variables across 4 sets of data from adults with a number of chronic health conditions. Although a model with separate but correlated factors fit the data better, discriminant validity analyses indicated limited differences in the pattern of associations each scale showed with a wide array of commonly used health and quality-of-life measures. In total, the results suggest that people may distinguish between the concepts of Meaning and Peace, but the observed relations with health outcomes are primarily due to variance shared between the 2 factors. Additional research is needed to better understand the separate and joint role of Meaning and Peace in the quality of life of people with chronic illness.

A retrospective analysis of VeriStrat status on outcome of a randomized phase II trial of first-line therapy with gemcitabine, erlotinib, or the combination in elderly patients (age 70 years or older) with stage IIIB/IV non-small-cell lung cancer.

PURPOSE: In a multicenter randomized phase II trial of gemcitabine (arm A), erlotinib (arm B), and gemcitabine and erlotinib (arm C), similar progression-free survival (PFS) and overall survival (OS) were observed in all arms. We performed an exploratory, blinded, retrospective analysis of plasma or serum samples collected as part of the trial to investigate the ability of VeriStrat (VS) to predict treatment outcomes. METHODS: Ninety-eight patients were assessable, and the majority had stage IV disease (81%), adenocarcinoma histology (63%), reported current or previous tobacco use (84%), and 26% had a performance status (PS) of 2. RESULTS: In arm A, patients with VS Good (n = 20) compared with VS Poor status (n = 8) had similar PFS (hazard ratio [HR]: 1.21; p = 0.67) and OS (HR: 0.82; p = 0.64). In arm B, patients with VS Good (n = 26) compared with VS Poor (n = 12) had a statistically significantly superior PFS (HR: 0.33; p = 0.002) and OS (HR: 0.40; p = 0.014). In arm C, patients with VS Good (n = 17) compared with Poor (n = 1 5) had a superior PFS (HR: 0.42; p = 0.027) and a trend toward superior OS (HR: 0.48; p = 0.051). In the multivariate analysis for PFS, VS status was statistically significant (p = 0.011); for OS, VS status (p = 0.017) and PS (p = 0.005) were statistically significant. A statistically significant VS and treatment interaction (gemcitabine versus erlotinib) was observed for PFS and OS. CONCLUSIONS: Gemcitabine is the superior treatment for elderly patients with VS Poor status. First-line erlotinib for elderly patients with VS Good status may warrant further investigation.