John M. Salsman

Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma.

In a phase 3, randomized, open‐label trial (Pazopanib versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma, COMPARZ; NCT00720941), pazopanib was found to be noninferior to sunitinib in terms of progression‐free survival in patients with metastatic renal cell carcinoma with no prior therapy. Overall treatment differences were evaluated in a post hoc analysis with a quality‐adjusted time without symptoms or toxicity (Q‐TWiST) methodology.

Advancing our understanding of religion and spirituality in the context of behavioral medicine

Recognizing and understanding the potentially powerful roles that religiousness and spirituality (RS) may serve in the prevention and amelioration of disease, as well as symptom management and health related quality of life, significantly enhances research and clinical efforts across many areas of behavioral medicine. This article examines the knowledge established to date and suggests advances that remain to be made. We begin with a brief summary of the current knowledge regarding RS as related to three exemplary health conditions: (a) cardiovascular disease; (b) cancer; and, (c) substance abuse. We then focus on particular concerns for future investigations, emphasizing conceptual issues, possible mediators and moderators of relationships or effects, and methodology. Our discussion is framed by a conceptual model that may serve to guide and organize future investigations. This model highlights a number of important issues regarding the study of links between RS and health: (a) RS comprise many diverse constructs, (b) the mechanisms through which RS may influence health outcomes are quite diverse, and (c) a range of different types of health and health relevant outcomes may be influenced by RS. The multidimensional nature of RS and the complexity of related associations with different types of health relevant outcomes present formidable challenges to empirical study in behavioral medicine. These issues are referred to throughout our review and we suggest several solutions to the presented challenges in our summary. We end with a presentation of barriers to be overcome, along with strategies for doing so, and concluding thoughts.

Clinical research participation among adolescent and young adults at an NCI-designated Comprehensive Cancer Center and affiliated pediatric hospital

PurposeMinimal clinical trial participation among adolescents and young adults (AYAs) with cancer limits scientific progress and ultimately their clinical care and outcomes. These analyses examine the current state of AYA clinical research participation at a Midwestern comprehensive cancer center and affiliated pediatric hospital to advise program development and increase availability of trials and AYA participation. Enrollment is examined across all diagnoses, the entire AYA age spectrum (15–39), and both cancer therapeutic and supportive care protocols.Methodshis study was a retrospective review of electronic medical records via existing databases and registries for all AYAs. Data were collected for AYAs seen by an oncologist at the adult outpatient cancer center or at the pediatric hospital between the years 2010 and 2014. Descriptive statistics and logistic regression analyses were conducted to characterize this sample.ResultsIn the pediatric setting, 42.3% of AYAs were enrolled in a study compared to 11.2% in the adult setting. Regression analyses in the pediatric setting revealed that AYAs with private insurance or Caucasian race were more likely to participate. Within the adult setting, ethnicity, race, insurance, and diagnosis were associated with study participation; 54.8% of study enrollments were for cancer therapeutic and 43.4% for supportive care studies.ConclusionsThese results are comparable to previously published data and support the need for new local and national AYA initiatives to increase the availability of and enrollment in therapeutic clinical trials. The same is true for supportive care studies which play a crucial role in improving quality of life.

A randomized pilot trial of a positive affect skill intervention (lessons in linking affect and coping) for women with metastatic breast cancer.

We conducted a randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of a 5 week positive affect skills intervention (LILAC: lessons in linking affect and coping) for women with metastatic breast cancer. Additionally, we examined whether online delivery of the intervention would offer comparable benefits as in‐person delivery.

Refining and supplementing candidate measures of psychological well-being for the NIH PROMIS®: qualitative results from a mixed cancer sample

PurposeThe Patient-Reported Outcomes Measurement Information System (PROMIS) is a National Institutes of Health initiative designed to improve patient-reported outcomes using state-of-the-art psychometric methods. The aim of this study is to describe qualitative efforts to identify and refine items from psychological well-being subdomains for future testing, psychometric evaluation, and inclusion within PROMIS.MethodSeventy-two items from eight existing measures of positive affect, life satisfaction, meaning & purpose, and general self-efficacy were reviewed, and 48 new items were identified or written where content was lacking. Cognitive interviews were conducted in patients with cancer (n = 20; 5 interviews per item) to evaluate comprehensibility, clarity, and response options of candidate items.ResultsA Lexile analysis confirmed that all items were written at the sixth grade reading level or below. A majority of patients demonstrated good understanding and logic for all items; however, nine items were identified as “moderately difficult” or “difficult” to answer. Patients reported a strong preference for confidence versus frequency response options for general self-efficacy items.ConclusionsAltogether, 108 items were sufficiently comprehensible and clear (34 positive affect, 10 life satisfaction, 44 meaning & purpose, 20 general self-efficacy). Future research will examine the psychometric properties of the proposed item banks for further refinement and validation as PROMIS measures.

Reply to the association between religion/spirituality and mental health in cancer

We thank Drs. Garssen and Visser for their constructive comments on our meta-analysis of the relationship between R/S and mental health in cancer. We are in agreement with several of their recommendations for strengthening this research and provide detailed responses below. Before doing so, however, it is worth noting that the other meta-analyses they cited were not focused on cancer and were published 10 years ago in social science journals. Thus, a meta-analytic summary and synthesis specifically within the context of cancer was warranted and valuable, and presented a more nuanced, comprehensive, and up-to-date view of the data than was previously reported. First, the authors asked why we included what they termed “meaningless studies” (ie, studies of spiritual wellbeing [SWB] and mental health associations) “in the first place only to reject them later?” Reporting effect sizes both with and without SWB measures enabled us to clearly characterize the problem of confounding SWB predictors with mental health outcomes. Using this approach, the degree to which the overall relation between affective measures of R/S and mental health outcomes is inflated by SWB measures could be more clearly delineated. We also discussed this problem in our commentary. Second, in our article, space did not permit for subanalyses of associations between specific R/S measures and specific measures of mental health. Excluding both SWB and spiritual distress leaves only 3 studies (all of which were cross-sectional, with 8 effect size estimates) that included an affective R/S measure, which were too little data with which to say anything meaningful. However, Garssen and Visser raised an important concern regarding the relationship between spiritual distress and general distress. Evidence from 2 longitudinal studies conducted with patients with cancer suggested that R/S struggle may be a predictor of emotional distress. Among 94 recipients of stem cell transplantation, Sherman et al found that greater pretransplant negative RCOPE (religious coping) predicted greater posttransplant anxiety and depression. A similar pattern was found among 284 women with breast cancer who were followed for 8 to 12 months in the study by Hebert et al. In models adjusted for demographic factors, religiosity, and personality, baseline anger with God predicted a poorer mental quality of life and greater depressive symptoms. Further research is obviously needed to determine the nature and direction of the relationship between R/S distress and other types of distress among patients with cancer, but evidence suggests that spiritual distress constitutes more than simply general distress and may contribute to negative wellbeing. Third, Drs. Garssen and Visser correctly pointed out that we did not perform a subanalysis of studies that only used psychometrically robust scales for R/S. Given space constraints, we could include only a limited number of subanalyses and thus we chose to focus on providing a broad overview of the findings for R/S and mental health relationships as well as a more nuanced summary of these relationships as a function of the type of R/S dimension, type of mental health outcome, and potential moderating variables. We acknowledged the need for greater attention to the selection of psychometrically strong R/S measures in the accompanying commentary. Fourth, Drs. Garssen and Visser argued that our investigation should have focused more heavily on the subset of longitudinal studies. For the 7 longitudinal studies that provided data regarding the predictive relationship between R/S and mental health, the average effect size (including 73 unique effect size estimates) was a z of 0.119 (95% confidence interval [95% CI], 0.0170.221). Four studies included affective measures of R/S, with an average z of 0.229 (95% CI, 0.150-0.307 [43 effect sizes]); 4 studies included behavioral measures of R/S, with an average z of -0.040 (95% CI, -0.203 to 0.122 [13 effect sizes]); 1 study included cognitive measures of R/S (4 effect sizes); and 3 studies included other measures of R/S (13 effect sizes). Excluding measures of SWB reduces the sample to only 5 studies (35 unique effect size estimates), with an average z of 0.037 (95% CI, -0.058 to 0.132). Further longitudinal studies are needed before any strong conclusions are drawn regarding the predictive relationship between R/S and mental health.

Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.

259 Background: Cancer anorexia-cachexia syndrome (CACS) is common in advanced cancer patients and associated with weight loss, fatigue, impaired quality of life (QoL), and poor prognosis. The goal of this project was to identify the most responsive items and evaluate their validity from two QoL measures in the ROMANA 2 (NCT01387282) Phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer (NSCLC) cachexia: the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Functional Assessment of Anorexia/ Cachexia Therapy (FAACT). METHODS In the ROMANA 2 trial, 477 patients with unresectable Stage III or IV NSCLC and cachexia were to be enrolled and randomized (2:1) to receive anamorelin HCl or placebo once daily for 12 weeks. All 383 patients who reached the Week 12 visit at the time of this blinded data analysis were included. Co-primary endpoints were change from baseline in lean body mass and handgrip strength. QoL was a key secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3, 6, 9, and 12. RESULTS Two 4-item scales (referred to as the Simplified Evaluation of Fatigue [SEF] & Simplified Evaluation of Appetite [SEA]) from the FACIT-F and FAACT, respectively, demonstrated good internal consistency reliability with Cronbachs alphas >0.70. In analysis of known group validity, scores significantly differed between groups defined by performance status and appetite (with effect sizes ≥0.34). Convergent validity analysis showed significant correlations with general QoL/functioning scales (correlation coefficients 0.41-0.77), further demonstrating validity. In terms of responsiveness, changes from baseline to week 12 in SEF and SEA scores were associated with changes in general QoL/ functioning, appetite, weight, and lean body mass (correlations >0.20). The estimated important difference for each scale was ~1-2 points. CONCLUSIONS These brief scales are valid and responsive measures that provide psychometric properties necessary to promote future research in NSCLC patients with CACS. Additional work should examine clinical utility of these scales and their impact on treatment decision-making.

Symptom burden among young adults with breast or colorectal cancer: Symptom Burden in Young Adult Oncology

Cancer incidence has increased among young adults (YAs) and survival rates have not improved compared with other age groups. Patient‐reported outcomes may enhance our understanding of this vulnerable population.

Symptom Burden Among Young Adults with Breast or Colorectal Cancer (ECOG E2Z02)

Cancer incidence has increased among young adults (YAs) and survival rates have not improved compared with other age groups. Patient‐reported outcomes may enhance our understanding of this vulnerable population.

Symptom burden and change among adolescent/young adult (AYA) patients with breast, lung, colorectal, or prostate cancer.

9064 Background: Little is known about the symptoms experienced by AYA cancer patients (pts) with common solid tumors in outpatient adult oncology clinics. We compared AYA to cancer pts greater than 40 years old in a cohort by severity of cancer, treatment status, symptom burden, symptom changes, and difficulty in caring for them. METHODS In the ECOG E2Z02 Symptom Outcomes and Practice Patterns Study, pts with invasive cancer (ca) of the breast, prostate, colon/rectum, or lung were enrolled from multiple academic (n=6) and community sites (n=32). At study enrollment and 4-5 weeks later pts rated their symptoms on a 0-10 numerical rating scale with the MDASI-ECOG. Descriptive statistics, Fishers exact test, and logistic regression models were used to summarize the findings. RESULTS Of the 3106 evaluable pts, 168 (5.4%) were 40 years old or younger, and were more likely to be female (81.6% vs. 69.2%, P=0.001), and Hispanic (17.3% vs. 9.5%, P=0.001). There were 114 pts with breast ca (mean age 37.5 yrs, 25%-75% quartile 34.0-39.5), 44 colon ca( 36.2 yrs, 34.3-39.6), 9 pts with lung ca, and 1 with prostate ca. African-American pts were more likely to have advanced cancer at baseline (OR=1.40, 95% CI 1.07-1.83). Multivariate logistic regression analysis showed that AYA cancer pts were more likely to suffer moderate/severe fatigue (OR=1.62, 1.15-2.29), distress (OR=1.82, 1.19-2.78), drowsiness (OR=1.82, 1.31-2.51), cognitive difficulties (OR=1.68, 0.98-2.89) and hair loss (OR=1.55, 1.03-2.33). While the number of symptoms was similar, interference with function was more severe for AYA cancer pts for mood (OR=1.61, 1.11-2.34) and relations with others (OR=1.93, 1.24-2.98). Symptoms were less likely to improve in AYA pts, and this reached significance for distress (OR=0.56, 0.33-0.95). There were no significant differences in cancer stage, current treatment status and clinicians perception of difficulty in caring for AYA cancer pts. CONCLUSIONS AYA cancer pts with primarily breast and colon ca report higher symptom severity and less improvement for many common symptoms compared to older cancer pts. These data provide direction in developing supportive care programs for AYA cancer pts.