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  • Author: Joanne Buzaglo x
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Neal J. Meropol, Joanne S. Buzaglo, Jennifer Millard, Nevena Damjanov, Suzanne M. Miller, Caroline Ridgway, Eric A. Ross, John D. Sprandio and Perry Watts

Although clinical trial research is required for the development of improved treatment strategies, very few cancer patients participate in these studies. The purpose of this study was to describe psychosocial barriers to clinical trial participation among oncologists and their cancer patients. A survey was distributed to all medical oncologists in Pennsylvania and a subset of their patients. Relevant background information and assessment of practical and psychosocial barriers to clinical trial participation were assessed. Among 137 oncologists and 170 patients who completed the surveys, 84% of patients were aware of clinical trials, and oncologists and patients generally agreed that clinical trials are important to improving cancer treatment. However, oncologists and patients were more likely to consider clinical trials in advanced or refractory disease. When considering 7 potential barriers to clinical trials, random assignment and fear of receiving a placebo were ranked highly by both patients and oncologists. Patients identified fear of side effects as the greatest barrier to clinical trial participation, whereas oncologists ranked this psychosocial barrier as least important to their patients. Overall, the study found that although oncologists and patients are aware of clinical trials and have favorable attitudes toward them, psychosocial barriers exist for patients that may impact participation in clinical trials. Furthermore, important discrepancies exist between the perceptions of oncologists and those of patients regarding what the psychosocial barriers are. We concluded that characterizing oncologist and patient perceived barriers can help improve communication and decision making about clinical trials, such that participation may be optimized.

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Shauna McManus, Alexandra K. Zaleta, Melissa F. Miller, Joanne S. Buzaglo, Julie S. Olson, Sara Goldberger and Kevin Stein

Background: CancerSupportSource (CSS) is a 25-item distress screening tool implemented at community-based cancer support organizations and hospitals nationwide. CSS assesses distress over 5 domains: (1) emotional concerns (including depression and anxiety risk screening subscales), (2) symptom burden, (3) body and healthy lifestyle, (4) healthcare team communication, and (5) relationships. This study developed a short form of CSS and examined its psychometric properties. Methods: 2,379 cancer survivors enrolled in the Cancer Support Community’s Cancer Experience Registry. Participants provided demographic and clinical background and completed CSS-25 and PROMIS-29, a measure of health-related quality of life. Item reduction was conducted with a subsample of 1,435 survivors and included external item quality (correlations between items and PROMIS-29 scales), internal item quality (inter-item and inter-factor correlations, factor loadings and structure, and item communalities from an exploratory factor analysis of CSS-25), and professional judgement (ranking/prioritization of items by CSS-25 developers, accounting for theoretical and practical implications). Pearson correlations and confirmatory factor analysis were conducted on a separate subsample of 944 survivors to corroborate psychometric properties and dimensionality of the shortened scale. Results: Scale refinement resulted in a 15-item short form of CSS (CSS-15). At least 1 item from each of the 5 CSS-25 domains was retained to preserve multidimensionality, including anxiety and depression risk screening subscale items. Additionally, 1 item about tobacco/substance use was kept due to clinical significance for risk assessment. In confirmatory factor analysis, the model explained 59% of the variance and demonstrated good fit (RMSEA=0.068, 90% CI=0.061–0.075; SRMR=0.033; CFI=0.959; χ 2(68)=334.75, P<.001). Correlation between CSS-15 and CSS-25 was 0.986, P<.001. Total distress was associated with PROMIS subscales (rs=−.65–.75, ps<.001); internal consistency reliability was excellent (α=.92). Conclusions: CSS-15 is a brief, reliable, and valid multidimensional measure of distress. The reduced measure retained excellent internal consistency and a stable factor structure, while correlating well with CSS-25 and PROMIS-29. CSS-15 can serve as a practical tool to efficiently screen for distress among cancer patients and survivors.

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Jamie M. Jacobs, Molly E. Ream, Nicole Pensak, Lauren E. Nisotel, Joel N. Fishbein, James J. MacDonald, Joanne Buzaglo, Inga T. Lennes, Steven A. Safren, William F. Pirl, Jennifer S. Temel and Joseph A. Greer

Background: Oral therapies are increasingly common in oncology care. However, data are lacking regarding the physical and psychologic symptoms patients experience, or how these factors relate to medication adherence and quality of life (QoL). Materials and Methods: From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center. Patients completed baseline assessments of adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment. Relationships among these factors were examined using Pearson product-moment correlations and multivariable linear regression. Results: At baseline, the mean electronic pill cap adherence rate showed that patients took 85.57% of their oral therapy. The most commonly reported cancer-related symptoms were fatigue (88.60%), drowsiness (76.50%), disturbed sleep (68.20%), memory problems (63.10%), and emotional distress (60.80%). Patients who reported greater cancer-related symptom severity had lower adherence (r= −0.20). In a multivariable regression, greater depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction with clinicians and treatment, and higher symptom burden were associated with worse QoL (F[10, 146]=50.53; adjusted R 2=0.77). Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= −7.10; SE=0.22). Conclusions: Patients prescribed oral therapies struggle with adherence, and cancer-related symptom burden is high and related to worse adherence and QoL. Given perceptions that oral therapies are less impairing, these data underscore the strong need to address adherence issues, symptom burden, and QoL for these patients.

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Alexandra K. Zaleta, Shauna McManus, Joanne S. Buzaglo, Eva Y. N. Yuen, Julie S. Olson, Melissa F. Miller, Karen Hurley, Lillie D. Shockney, Sara Goldberger, Mitch Golant and Kevin Stein

Background: Despite growing recognition that patient preferences and values should inform cancer care, patients’ views continue to be under-represented. We developed a quantitative tool, Valued Outcomes in the Cancer Experience (VOICE), to measure patient priorities and to understand discrepancies between what matters most to patients and what patients believe they can control. This study presents VOICE development and initial validation. Methods: 459 cancer patients completed an online survey and rated level of importance and perceived control for 54 value items (0=not at all; 4=very much). Items were derived from patient and caregiver focus groups and included themes such as independence, functional abilities, planning for the future, symptom management, health knowledge, and social support. Participants also completed validated measures of hope, optimism, quality of life, financial toxicity, spiritual well-being, illness perceptions, social support, self-efficacy, intolerance of uncertainty, and cancer-related distress. Iterative exploratory factor analysis (EFA) with direct oblique rotation, magnitude of importance and control ratings, and Pearson correlations between items and validation measures were used to inform scale refinement. Results: Participants were 86% non-Hispanic white; mean age=60 years, SD=10; 38% breast cancer, 18% blood, 9% lung, 9% prostate; mean time since diagnosis=6.5 years, SD=6; 22% metastatic. Items that did not load in the EFA, or were not associated with conceptually relevant validation measures, were removed or reworded. The final EFA explained over half of the variance in the data and demonstrated good fit, with absolute and relative fit indices in established acceptable ranges (P<.001). The refined VOICE measure addresses diverse themes including access to care, maintaining independence, longevity, shared decision making, illness understanding, symptom management, emotional support, connection to illness community, spirituality, and end of life preparation. Conclusions: The study results demonstrate a framework for developing a quantitative, multidimensional measure of patient values. By understanding what matters most to patients, VOICE is positioned to bring patient preferences to the foreground of cancer care, contribute to shared decision making, and enhance care. Next steps include further validation of this tool in diverse settings, including oncology practices and community-based organizations.