Search

Background: Trials of immune checkpoint inhibitors (ICIs) have published patient-reported quality of life (QOL), but the size and heterogeneity of this literature can make patient education difficult. This meta-analysis aimed to describe change in QOL and symptomatology in patients receiving ICIs for cancer., Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, databases were searched through November 2019 for articles or abstracts of prospective, original studies reporting longitudinal QOL in adult cancer patients treated with ICIs. The prespecified primary outcomes were change in global QOL among patients treated with ICIs and difference in change since baseline in global QOL between patients treated with ICI vs non-ICI active treatment. Secondary outcomes included physical functioning and symptomatology. All statistical tests were 2-sided., Results: Of 20 323 publications, 26 met inclusion criteria. Global QOL did not change over time in patients treated with ICIs (k = 26, n = 6974; P = .19). Larger improvements in global QOL was observed in patients receiving ICI vs non-ICI regimens (k = 16, ICI: n = 3588; non-ICI: n = 2948; P < .001). Physical functioning did not change in patients treated with ICIs (k = 14, n = 3169; P = .47); there were no differences in mean change between ICI vs non-ICI regimens (k = 11, n = 4630; P = .94). Regarding symptoms, appetite loss, insomnia, and pain severity decreased, but dyspnea severity increased in patients treated with ICIs (k = 14, n = 3243-3499; P < .001). Insomnia severity was higher in patients treated with ICIs than non-ICI regimens (k = 11, n = 4791; P < .001)., Conclusions: This study is among the first to quantitatively summarize QOL in patients treated with ICIs. Findings suggest ICI recipients report no change in global QOL and higher QOL than patients treated with non-ICI regimens., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Aims: Among people with cancer, dual alcohol and tobacco use increases risk for morbidity and mortality. Most smoking cessation clinical trials with this patient population have excluded individuals with problematic alcohol use. This investigation examined whether problematic alcohol use affects smoking cessation in cancer patients., Methods: Mixed-methods secondary analysis of data from the Smokefree Support Study, a randomized-controlled trial examining the efficacy of Intensive (IT; n = 153) vs. Standard Treatment (ST; n = 150) for smoking cessation in newly diagnosed cancer patients. Problematic alcohol use was assessed at enrollment using the Cut-Down-Annoyed-Guilty-Eye-Opener (CAGE), weekly frequency of alcohol use and binge drinking measures. Alcohol use was categorized as: no current alcohol use, moderate and problematic use. The primary outcome was biochemically-confirmed cigarette abstinence at 6-months. A subset of patients (n = 72) completed qualitative exit-interviews., Results: Among all participants, biochemically-confirmed cigarette abstinence rates were 25% (n = 32), 28% (n = 27), and 36% (n = 20) for participants reporting no current alcohol use, moderate use, and problematic use, respectively (p = 0.33). In logistic regression analysis, neither problematic alcohol use (AOR = 0.96, 95% CI = 0.35-2.67, p = .94) nor the problematic use by study arm interaction (AOR = 2.22, 95% CI = 0.59-8.39, p = .24) were associated with biochemically-confirmed 6-month abstinence. Qualitatively, participants reported that drinking alcohol triggers urges to smoke., Conclusion: Newly diagnosed cancer patients reporting problematic alcohol use were not less likely to quit smoking than those without. Additional research is needed to investigate whether problematic alcohol users may benefit from smoking and alcohol behavior change interventions at the time of cancer diagnosis., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Importance: Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care., Objective: To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking., Design, Setting, and Participants: This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018., Interventions: Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline)., Main Outcome and Measures: The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates., Results: Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2)., Conclusions and Relevance: Among smokers recently diagnosed with cancer in 2 National Cancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research., Trial Registration: ClinicalTrials.gov Identifier: NCT01871506.

Context: The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure commonly used to screen for symptoms of anxiety and depression in cancer patients. The HADS has demonstrated validity in over 100 languages, including Spanish. However, validation studies have largely used European Spanish-speaking samples with a variety of medical diagnoses., Objectives: The aim of this study was to examine the psychometric properties of the Spanish version of the HADS in a sample of Spanish-speaking Latina women with cancer in the U.S., Methods: Participants (N = 242) completed self-report measures of anxiety and depression (HADS), quality of life (Functional Assessment of Cancer Therapy-General Version), cancer-related distress (Impact of Events Scale-Revised Version Intrusion Subscale), and cancer symptomatology (Memorial Symptom Assessment Scale-Short Form) before initiating chemotherapy and five to seven weeks later. Analyses evaluated internal consistency and test-retest reliability, construct validity, and convergent validity., Results: Factor analysis supported a two-factor structure as proposed by the original HADS developers (X 2 [76, N = 242] = 143.3, P < 0.001, comparative fit index = 0.94, root-mean-square error of approximation = 0.06, and standardized root-mean-square residual = 0.06). The HADS and its subscales demonstrated good internal consistency (α = 0.83-0.88) and test-retest reliability (intraclass correlation coefficient = 0.76-0.82). Construct validity was evidenced by factor analysis and item-subscale, item-total, and subscale-total correlations. Convergent validity was demonstrated by strong positive correlations with cancer-related distress (r = 0.51-0.71) and symptom severity (r = 0.54-0.62) and strong negative correlations with quality of life (r = -0.63 to -0.76) (all P's < 0.001)., Conclusion: The Spanish version of the HADS evidenced sound psychometric properties in Latinas with cancer in the U.S., supporting its use in clinical oncology research and practice., (Copyright © 2019 American Academy of Hospice and Palliative Medicine. All rights reserved.)

Purpose: Chemotherapy-induced nausea and vomiting (CINV) is common among cancer patients. Early identification of patients at risk for CINV may help to personalize anti-emetic therapies. To date, few studies have examined the combined contributions of patient-reported and genetic risk factors to CINV. The goal of this study was to evaluate these risk factors., Methods: Prior to their first chemotherapy infusion, participants completed demographic and risk factor questionnaires and provided a blood sample to measure genetic variants in ABCB1 (rs1045642) and HTR3B (rs45460698) as well as CYP2D6 activity score. The M.D. Anderson Symptom Inventory was completed at 24 h and 5-day post-infusion to assess the severity of acute and delayed CINV, respectively., Results: Participants were 88 patients (55% female, M = 60 years). A total of 23% experienced acute nausea and 55% delayed nausea. Younger age, history of pregnancy-related nausea, fewer hours slept the night prior to infusion, and variation in ABCB1 were associated with more severe acute nausea; advanced-stage cancer and receipt of highly emetogenic chemotherapy were associated with more severe delayed nausea (p values < 0.05). In multivariable analyses, ABCB1 added an additional 5% predictive value beyond the 13% variance explained by patient-reported risk factors., Conclusions: The current study identified patient-reported and genetic factors that may place patients at risk for acute nausea despite receipt of guideline-consistent anti-emetic prophylaxis. Additional studies examining other genetic variants are needed, as well as the development of risk prediction models including both patient-reported and genetic risk factors.

Purpose Survivors of childhood cancer may experience financial burden as a result of health care costs, particularly because these patients often require long-term medical care. We sought to evaluate the prevalence of financial burden and identify associations between a higher percentage of income spent on out-of-pocket medical costs (≥ 10% of annual income) and issues related to financial burden (jeopardizing care or changing lifestyle) among survivors of childhood cancer and a sibling comparison group. Methods Between May 2011 and April 2012, we surveyed an age-stratified, random sample of survivors of childhood cancer and a sibling comparison group who were enrolled in the Childhood Cancer Survivor Study. Participants reported their household income, out-of-pocket medical costs, and issues related to financial burden (questions were adapted from national surveys on financial burden). Logistic regression identified associations between participant characteristics, a higher percentage of income spent on out-of-pocket medical costs, and financial burden, adjusting for potential confounders. Results Among 580 survivors of childhood cancer and 173 siblings, survivors of childhood cancer were more likely to have out-of-pocket medical costs ≥ 10% of annual income (10.0% v 2.9%; P < .001). Characteristics of the survivors of childhood cancer that were associated with a higher percentage of income spent on out-of-pocket costs included hospitalization in the past year (odds ratio [OR], 2.3; 95% CI, 1.1 to 4.9) and household income < $50,000 (OR, 5.5; 95% CI, 2.4 to 12.8). Among survivors of childhood cancer, a higher percentage of income spent on out-of-pocket medical costs was significantly associated with problems paying medical bills (OR, 8.9; 95% CI, 4.4 to 18.0); deferring care for a medical problem (OR, 3.0; 95% CI, 1.6 to 5.9); skipping a test, treatment, or follow-up (OR, 2.1; 95% CI, 1.1 to 4.0); and thoughts of filing for bankruptcy (OR, 6.6; 95% CI, 3.0 to 14.3). Conclusion Survivors of childhood cancer are more likely to report spending a higher percentage of their income on out-of-pocket medical costs, which may influence their health-seeking behavior and potentially affect health outcomes. Our findings highlight the need to address financial burden in this population with long-term health care needs.

Background: Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence-based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers., Methods/design: A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST., Discussion: This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients., (Copyright © 2016. Published by Elsevier Inc.)

Background: Sexual health concerns in cancer survivors are often unaddressed by providers. Study objectives were to assess cancer survivors' reported rates of communication with oncology providers about sexual health, preference for such communication with their oncology or primary care providers (PCPs), and factors associated with these communication rates and preferences., Methods: Sixty-six patients attending a cancer survivorship clinic were asked how often their oncologist addressed and initiated discussion about sexual functioning and whether they wanted their oncologist or PCP to ask about their sexual health. We also assessed whether various sociodemographic characteristics and levels of depression, anxiety, and sexual satisfaction were associated with survivors' sexual health communication rates and preferences., Results: 41% of patients wanted their oncologist to ask about sexual health and 58% of patients wanted their PCP to ask about sexual health. Over 90% of patients reported that their oncologist infrequently addressed sexual health concerns and that their oncologist was unlikely to initiate such discussions. Education level influenced whether patients wanted their oncologist to ask about sexual health. Age, education level, and insurance type influenced whether patients wanted their PCP to ask about sexual health. Levels of depression, anxiety, and sexual satisfaction were not associated with communication rates or preferences., Conclusions: Patients attending a survivorship clinic reported infrequent communication about sexual health with their oncology providers, despite wanting their providers to ask about sexual health concerns., (Copyright © 2014 John Wiley & Sons, Ltd.)

Purpose: The Patient Protection and Affordable Care Act (ACA) established provisions intended to increase access to affordable health insurance and thus increase access to medical care and long-term surveillance for populations with pre-existing conditions. However, childhood cancer survivors' coverage priorities and familiarity with the ACA are unknown., Methods: Between May 2011 and April 2012, we surveyed a randomly selected, age-stratified sample of 698 survivors and 210 siblings from the Childhood Cancer Survivor Study., Results: Overall, 89.8% of survivors and 92.1% of siblings were insured. Many features of insurance coverage that survivors considered "very important" are addressed by the ACA, including increased availability of primary care (94.6%), no waiting period before coverage initiation (79.0%), and affordable premiums (88.1%). Survivors were more likely than siblings to deem primary care physician coverage and choice, protections from costs due to pre-existing conditions, and no start-up period as "very important" (P < .05 for all). Only 27.3% of survivors and 26.2% of siblings reported familiarity with the ACA (12.1% of uninsured v 29.0% of insured survivors; odds ratio, 2.86; 95% CI, 1.28 to 6.36). Only 21.3% of survivors and 18.9% of siblings believed the ACA would make it more likely that they would get quality coverage. Survivors' and siblings' concerns about the ACA included increased costs, decreased access to and quality of care, and negative impact on employers and employees., Conclusion: Although survivors' coverage preferences match many ACA provisions, survivors, particularly uninsured survivors, were not familiar with the ACA. Education and assistance, perhaps through cancer survivor navigation, are critically needed to ensure that survivors access coverage and benefits., (© 2015 by American Society of Clinical Oncology.)