The impact of financial toxicity in gastrointestinal cancer patients.

BACKGROUND: Biopsychosocial distress screening is a critical component of comprehensive cancer care. Financial issues are a common source of distress in this patient population. This study uses a biopsychosocial distress screening tool to determine the factors associated with financial toxicity and the impact of these stressors on gastrointestinal cancer patients. METHODS: A 48-question, proprietary distress screening tool was administered to patients with gastrointestinal malignancies from 2009 to 2015. This validated, electronically-administered tool is given to all new patients. Responses were recorded on a 5-point Likert scale from 1 (not a problem) to 5 (very severe problem), with responses rated at ≥3 indicative of distress. Univariate and multivariate logistic regressions were used to analyze the data. RESULTS: Most of the 1,027 patients had colorectal (50%) or hepatobiliary (31%) malignancies. Additionally, 34% of all patients expressed a high level of financial toxicity. Age greater than 65 (odds ratio: 0.63, 95% confidence interval: 0.47-0.86, P < .01), college education (odds ratio: 0.53, 95% confidence interval: 0.38-0.73, P < .0001), being partnered (odds ratio: 0.61, 95% confidence interval: 0.44-0.84, P < .01), and annual income greater than $40,000 (odds ratio: 0.27, 95% confidence interval: 0.19-0.38, P < .0001) were all protective against financial toxicity on univariate analysis. Also, heavy tobacco use was associated significantly with increased distress on univariate analysis (odds ratio: 2.79, 95% confidence interval: 1.38-5.78, P < .01). With the exception of partnered status (odds ratio: 1.18, 95% confidence interval: 0.76-1.85, P = .46), all these variables retained their significant association with financial toxicity in the multivariate model. CONCLUSION: Financial toxicity impacts a large number of cancer patients. Further study of at-risk populations may identify patients who would benefit from pre-emptive education and counseling interventions as part of their routine cancer care.

Economic evaluation of mindfulness group therapy for patients with depression, anxiety, stress and adjustment disorders compared with treatment as usual.

BACKGROUND: A randomised controlled trial found that a structured mindfulness group therapy (MGT) programme was as effective as treatment as usual (mostly cognitive-behavioural therapy) for patients with a diagnosis of depression, anxiety or stress and adjustment disorders in Sweden (ClinicalTrials.gov: NCT01476371). AIMS: To perform a cost-effectiveness analysis of MGT compared with treatment as usual from both a healthcare and a societal perspective for the trial duration (8 weeks). METHOD: The costs from a healthcare perspective included treatment as usual, medication and costs for providing MGT. The societal perspective included costs from the healthcare perspective plus savings from productivity gains for the trial duration. The effectiveness was measured as quality-adjusted life-years (QALY) using the EQ-5D-5L questionnaire and the UK value set. Uncertainty surrounding the incremental costs and effects were estimated using non-parametric bootstrapping with 5000 replications and presented with 95% confidence intervals and cost-effectiveness acceptability curves. RESULTS: The MGT group had significantly lower healthcare and societal costs (mean differences -€115 (95% CI -193 to -36) and -€112 (95% CI -207 to -17), respectively) compared with the control group. In terms of effectiveness, there was no significant difference in QALY gain (mean difference -0.003, 95% CI -0.0076 to 0.0012) between the two groups. CONCLUSIONS: MGT is a cost-saving alternative to treatment as usual over the trial duration from both a healthcare and a societal perspective for patients with a diagnosis of depression, anxiety or stress and adjustment disorders in Sweden.

Developing a laboratory model of smoking lapse targeting stress and brief nicotine deprivation.

Stress plays a significant role in the maintenance of, and relapse to, smoking. The current study aims to develop a human laboratory model examining stress-precipitated tobacco lapse following brief nicotine deprivation. Daily smokers (N = 48; 50% female) who were nicotine deprived for 3 hr received a personalized imagery induction (stress or neutral, within-subject, counterbalanced) on 2 separate days. Following imagery induction, participants were instructed that they could smoke or receive monetary reinforcement ($0.25, $0.50, $1.00; between-subjects) for every 5 min they chose to delay tobacco self-administration during a 50-min delay period. After the delay period, participants engaged in a 1-hr ad libitum smoking period. Tobacco craving and mood were assessed throughout. The primary aim was to determine whether stress imagery would reduce the ability to resist following a brief nicotine deprivation in a laboratory setting. A secondary goal identified which level of monetary reinforcement highlighted the effect of stress on reduced ability to resist smoking (i.e., resisting ∼25 min of the 50-min window). Overall, stress versus neutral imagery decreased the ability to resist smoking, increased craving and negative mood states, decreased positive mood, but did not change ad libitum smoking. Increased monetary reinforcement increased the ability to resist smoking. Planned comparisons examining lapse behavior within each monetary condition demonstrated that $0.50 produced the only significant difference between stress and neutral imagery, demonstrating target model behavior. Findings highlight that stress negatively impacts smoking lapse behavior and can be effectively modeled in the human laboratory with a brief, 3-hr deprivation window. (PsycINFO Database Record

The financial burden and distress of patients with cancer: Understanding and stepping-up action on the financial toxicity of cancer treatment.

"Financial toxicity" has now become a familiar term used in the discussion of cancer drugs, and it is gaining traction in the literature given the high price of newer classes of therapies. However, as a phenomenon in the contemporary treatment and care of people with cancer, financial toxicity is not fully understood, with the discussion on mitigation mainly geared toward interventions at the health system level. Although important, health policy prescriptions take time before their intended results manifest, if they are implemented at all. They require corresponding strategies at the individual patient level. In this review, the authors discuss the nature of financial toxicity, defined as the objective financial burden and subjective financial distress of patients with cancer, as a result of treatments using innovative drugs and concomitant health services. They discuss coping with financial toxicity by patients and how maladaptive coping leads to poor health and nonhealth outcomes. They cover management strategies for oncologists, including having the difficult and urgent conversation about the cost and value of cancer treatment, availability of and access to resources, and assessment of financial toxicity as part of supportive care in the provision of comprehensive cancer care. CA Cancer J Clin 2018;68:153-165. © 2018 American Cancer Society.

Cost-effectiveness of Mindfulness-based Stress Reduction Versus Cognitive Behavioral Therapy or Usual Care Among Adults With Chronic Low Back Pain.

STUDY DESIGN: Economic evaluation alongside a randomized trial of cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) versus usual care alone (UC) for chronic low back pain (CLBP). OBJECTIVE: To determine 1-year cost-effectiveness of CBT and MBSR compared to 33 UC. SUMMARY OF BACKGROUND DATA: CLBP is expensive in terms of healthcare costs and lost productivity. Mind-body interventions have been found effective for back pain, but their cost-effectiveness is unexplored. METHODS: A total of 342 adults in an integrated healthcare system with CLBP were randomized to receive MBSR (n = 116), CBT (n = 113), or UC (n = 113). CBT and MBSR were offered in 8-weekly 2-hour group sessions. Cost-effectiveness from the societal perspective was calculated as the incremental sum of healthcare costs and productivity losses over change in quality-adjusted life-years (QALYs). The payer perspective only included healthcare costs. This economic evaluation was limited to the 301 health plan members enrolled ≥180 days in the years pre-and postrandomization. RESULTS: Compared with UC, the mean incremental cost per participant to society of CBT was $125 (95% confidence interval, CI: -4103, 4307) and of MBSR was -$724 (CI: -4386, 2778)-that is, a net saving of $724. Incremental costs per participant to the health plan were $495 for CBT over UC and -$982 for MBSR, and incremental back-related costs per participant were $984 for CBT over UC and -$127 for MBSR. These costs (and cost savings) were associated with statistically significant gains in QALYs over UC: 0.041 (0.015, 0.067) for CBT and 0.034 (0.008, 0.060) for MBSR. CONCLUSION: In this setting CBT and MBSR have high probabilities of being cost-effective, and MBSR may be cost saving, as compared with UC for adults with CLBP. These findings suggest that MBSR, and to a lesser extent CBT, may provide cost-effective treatment for CLBP for payers and society. LEVEL OF EVIDENCE: 2.

Early comprehensive care of preterm infants-effects on quality of life, childhood development, and healthcare utilization: study protocol for a cohort study linking administrative healthcare data with patient reported primary data.

BACKGROUND: About 9 % of all children in Germany are born preterm. Despite significant improvements of medical care, preterm infants are at a greater risk to develop short and long term health complications. Negative consequences of preterm birth include neurodevelopmental disabilities, behavioral problems or learning disorders. Most data on effects of prematurity are derived from single or multi-center studies and not population-based. Since some of the long term problems of preterm delivery are associated with a disturbed parent-child interaction originating in the neonatal period, several intervention programs became available aiming to strengthen the early parent-child relationship. However, there is insufficient knowledge regarding the psychosocial and socioeconomic impact of these interventions. Prior to introducing them into routine care, those effects have to be rigorously evaluated. The population-based cohort study EcoCare-PIn (Early comprehensive Care of Preterm Infants-effects on quality of life, childhood development, and healthcare utilization) will investigate the following primary research questions: 1) What are the short- and long-term consequences of preterm birth with regard to parental stress, parent-child relationship, childhood development, quality of life and healthcare utilization including costs? 2) Does early family-centered psychosocial care prevent the hypothesized negative consequences of preterm birth on the above mentioned outcomes? METHODS/DESIGN: EcoCare-PIn examines the research questions by means of a linkage of a) pseudonymized administrative individual-level claims data from the German statutory health insurance AOK PLUS on approximately 140,000 children born between 2007 and 2013 in Saxony, and b) primary data collected from the parents/caregivers of all very low birth weight (<1,500 g; n = 1,000) and low birth weight infants (1,500 to 2,500 g; n = 5,500) and a matched sample of infants above 2,500 g birth weight (n = 10,000). DISCUSSION: In Saxony, approximately 50 % of all individuals are insured at the AOK PLUS. The linkage of patient-level administrative and primary data is a novel approach in neonatal research and probably the only way to overcome shortcomings of studies solely relying on one data source. The study results are based on an observation period of up to 8 years and will directly inform perinatal healthcare provision in Saxony and Germany as a whole.

Racial/ethnic and sociodemographic factors associated with micronutrient intakes and inadequacies among pregnant women in an urban US population.

OBJECTIVE: To assess sociodemographic correlates of micronutrient intakes from food and dietary supplements in an urban, ethnically diverse sample of pregnant women in the USA. DESIGN: Cross-sectional analyses of data collected using a validated semi-quantitative FFQ. Associations between racial, ethnic and sociodemographic factors and micronutrient intakes were examined using logistic regression controlling for pre-pregnancy BMI, maternal age and smoking status. SETTING: Prenatal clinics, Boston, MA, USA. SUBJECTS: Analyses included pregnant women (n 274) in the PRogramming of Intergenerational Stress Mechanisms (PRISM) study, an urban longitudinal cohort designed to examine how stress influences respiratory health in children when controlling for other environmental exposures (chemical stressors, nutrition). RESULTS: High frequencies of vitamin E (52 %), Mg (38 %), Fe (57 %) and vitamin D (77 %) inadequacies as well as suboptimal intakes of choline (95 %) and K (99 %) were observed. Factors associated with multiple antioxidant inadequacies included being Hispanic or African American, lower education and self-reported economic-related food insecurity. Hispanics had a higher prevalence of multiple methyl-nutrient inadequacies compared with African Americans; both had suboptimal betaine intakes and higher odds for vitamin B6 and Fe inadequacies compared with Caucasians. Nearly all women (98 %) reported Na intakes above the tolerable upper limit; excessive intakes of Mg (35 %), folate (37 %) and niacin (38 %) were also observed. Women reporting excessive intakes of these nutrients were more likely Caucasian or Hispanic, more highly educated, US-born and did not report food insecurity. CONCLUSIONS: Racial/ethnic and other sociodemographic factors should be considered when tailoring periconceptional dietary interventions for urban ethnic women in the USA.

Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study.

BACKGROUND: Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners. METHODS/DESIGN: A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed. DISCUSSION: This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.

How best to assess the quality of life in long-term survivors after surgery for NSCLC? Comparison between clinical predictors and questionnaire scores.

BACKGROUND: The determinants and predictors of QOL in lung cancer survivors who have received surgery remain defined vaguely and still debated. We evaluate clinical, surgical, and pulmonary function characteristics as predictors of QOL in long-term lung cancer survivors who received surgery. METHODS: Quality of life was evaluated 5 years after surgery in 67 lung cancer patients using the European Organization for Research and Treatment of Cancer (EORTC) QOL Core Questionnaire, its lung cancer-specific module QLQ LC-13, and the Hospital Anxiety and Depression Scale questionnaire. Preoperative clinical, surgical, and pathologic data were matched with the questionnaire scores. RESULTS: Sex was associated with role functioning and symptoms, with males more often reporting fatigue and pain, appetite loss, coughing, and hemoptysis (P < .05). Lower education was associated with better cognitive functioning (P < .05). Symptoms were worse for younger patients and for those with major comorbidity. Histology marginally influenced the global health status (P < .10) and the cognitive functioning (P < .05). Patients receiving complementary therapy more easily suffered from fatigue and insomnia (P < .05), and to a lesser extent from nausea and vomiting, constipation, and stress related to financial difficulties (P < .10). Higher values of forced expiratory volume at the first second (FEV(1)) and forced vital capacity (FVC) were significantly (P < .05) associated with a lower frequency of nausea and vomiting and appetite loss, while low percentage levels of FEV(1) and FVC were associated with lower global function and a greater severity of specific and nonspecific symptoms (P < .10 and P < .05). CONCLUSIONS: Several preoperative features, particularly those reflecting pulmonary function, were moderately associated with QOL in long-term survivors and may be useful to address therapeutic strategies in lung cancer patients after surgery.

The effect of 90 day administration of a high dose vitamin B-complex on work stress.

OBJECTIVE: Occupational stress is increasing in Western societies and the impact is significant at a personal, organisational and community level. The present study examined for the first time the efficacy of 3 months administration of two forms of high dose vitamin B complex on mood and psychological strain associated with chronic work stress. METHOD: Sixty participants completed the 3-month, double-blind, randomised, placebo-controlled trial in which personality, work demands, mood, anxiety and strain were assessed. RESULTS: After individual differences in personality and work demands were statistically controlled, the vitamin B complex treatment groups reported significantly lower personal strain and a reduction in confusion and depressed/dejected mood after 12 weeks. There were no treatment-related changes in other measures of mood and anxiety. DISCUSSION: The results of the study are consistent with two previous studies examining multivitamin supplementation and personal (non-work) feelings of strain and suggestive of significant decreases in the experience of workplace stress after 90 day supplementation of a B multivitamin. CONCLUSION: Given the direct and indirect costs of workplace stress, these findings point to the utility of a cost-effective treatment for the mood and psychological strain effects of occupational stress. These findings may have important personal health, organisational and societal outcomes given the rising cost and incidence of workplace stress.

Life satisfaction in chronic pain patients: the stress-buffering role of the centrality of religion.

Chronic pain (CP) is a stressful condition that severely impacts individuals' lives. Researchers have begun to explore the role of religion for CP patients, but the literature is scarce, especially for West European populations. Drawing from the transactional theory of stress, this study examined the associations between the religious meaning system and the life satisfaction for a group of CP patients who were members of a Flemish patients' association. To take into account the religious landscape of West European countries, the centrality of one's religious meaning system, rather than religious content, was the focus. Results from the questionnaires completed by 207 patients suggest that the centrality of a meaning system is an important factor in the promotion of life satisfaction for this group, above and beyond the influence of several control variables. Furthermore, the centrality of the religious meaning system moderated or buffered the detrimental influence of pain severity on life satisfaction.

Coherence and health care cost--RCA actuarial study: a cost-effectiveness cohort study.

Chronic stress is among the most costly health problems in terms of direct health costs, absenteeism, disability, and performance standards. The Reformed Church in America (RCA) identified stress among its clergy as a major cause of higher-than-average health claims and implemented HeartMath (HM) to help its participants manage stress and increase physiological resilience. The 6-week HM program Revitalize You! was selected for the intervention including the emWave Personal Stress Reliever technology. From 2006 to 2007, completion of a health risk assessment (HRA) provided eligible clergy with the opportunity to participate in the HM program or a lifestyle management program (LSM). Outcomes for that year were assessed with the Stress and Well-being Survey. Of 313 participants who completed the survey, 149 completed the Revitalize You! Program, and 164 completed the LSM. Well-being, stress management, resilience, and emotional vitality were significantly improved in the HM group as compared to the LSM group. In an analysis of the claims costs data for 2007 and 2008, 144 pastors who had participated in the HM program were compared to 343 non-participants (control group). Adjusted medical costs were reduced by 3.8% for HM participants in comparison with an increase of 9.0% for the control group. For the adjusted pharmacy costs, an increase of 7.9% was found compared with an increase of 13.3% for the control group. Total 2008 savings as a result of the HM program are estimated at $585 per participant, yielding a return on investment of 1.95:1. These findings show that HM stress-reduction and coherence-building techniques can reduce health care costs.

Resources, stressors and psychological distress among older adults in Chennai, India.

Scant information exists on the complex interaction between resources and stressors and their subsequent influence on the psychological distress of older adults in India. Within the framework of resource theory, the present study examined the various pathways through which resources and stressors influence psychological distress by testing four models - the independence model, the stress-suppression model, the counteractive model and the resource-deterioration model. The independence model posits that resources and stressors have a direct relationship with psychological distress. The stress-suppression model hypothesizes that stressors mediate the influence of resources on psychological distress. The counteractive model postulates that stressors mobilize resources, which in turn influence psychological distress. The resource-deterioration model states that stressors deplete resources and subsequently exacerbate distress. In the present study, resources include social support, religiosity and mastery; stressors include life events, abuse and health problems. Psychological distress was measured using the Center for Epidemiological Studies Depression scale and Geriatric Depression Scale. Interviews were conducted among 400 adults aged 65 years and above, randomly selected from the electoral list of urban Chennai, India. The battery of instruments was translated into Tamil (local language) by back-translation. Structural Equation Modeling was conducted to test the three models. The results supported the stress-suppressor model. Resources had an indirect, negative relationship with psychological distress, and stressors had a direct, positive effect on distress. As such there is a need to identify and strengthen the resources available to older adults in India.

A cross cultural review of the ethical issues in dementia care in Kerala, India and The Netherlands.

BACKGROUND: The paper explores the diverse ethical issues in the care of persons with dementia, in the Netherlands and Kerala, India. These cross-cultural data are used to suggest newer ways for addressing the ethical issues in a mutually enhancing manner. METHODS: A thorough review of the literature focusing on ethical aspects of the care for persons with dementia. RESULTS: The medical paradigm is dominant in the Netherlands and awareness of dementia as an organic brain disease is low in Kerala. Institutionalized care is more common in the Netherlands and home-based care is the norm in Kerala. Institutional care is costly, whereas home-based care is stressful for caregivers. The advanced directive plays an influential role in the Netherlands, but this mechanism is yet to evolve in Kerala. The legal and social setting of the Netherlands has a strong influence on physician decision-making concerning end of life issues. In Kerala, discussion of these matters is nearly unknown. CONCLUSION: Limited awareness of dementia in Kerala should be addressed in public forums, which can then be used to garner governmental support. The predominantly institutional model of care-giving in the Netherlands and home-based care-giving in Kerala, each have their strengths; policy makers in both societies can usefully apply the values and merits inherent in both models. A culturally appropriate implementation of the advanced directive will have beneficial medical, social, and economic impacts in Kerala. The remarkable disparity between the Netherlands and Kerala in dealing with end-of-life issues will allow more philosophically and socially informed ways of addressing the ethical questions that arise in those situations.

Financial stress and strain associated with terminal cancer--a review of the evidence.

Financial circumstances are a significant influence on the quality of life for older people and may be important to health and wellbeing at the end of life. The aim of this study is to review the evidence for the existence and consequences of financial stress and strain at the end of life for people dying with cancer. We conducted a systematic search of four electronic databases for studies, providing data on illness-related financial burden (stress), or perception of financial hardship (strain), from patients with terminal cancer or their caregivers. Twenty-four papers were identified from 21 studies published in English between 1980 and 2006, the majority (14) of cross-sectional design. Financial stress was reported in all 13 studies from the USA (median 33%, range 10-66%), but only four sought measures of financial strain. In the USA, specific social consequences, such as moving house or change in employment to cope with caregiving, were reported in four of these studies; one of these also noted changes in treatment choices and avoidance of care for other family members. In studies from outside the USA, there is a dearth of data on financial stresses and the consequences of this for the household, despite widespread reporting of financial strain. To fill a gap in our understanding and improve holistic palliative care, researchers need to ask the questions about the consequences of financial stresses and strain for the health and wellbeing of the household.

Psychosocial stress and cardiovascular disease. Part 3: Clinical and policy implications of research on the transcendental meditation program.

Cardiovascular disease (CVD) remains the leading cause of death in the United States today and a major contributor to total health care costs. Psychosocial stress has been implicated in CVD, and psychosocial approaches to primary and secondary prevention are gaining research support. This third article in the series on psychosocial stress and CVD continues the evaluation of one such approach, the Maharishi Transcendental Meditation program, a psychophysiological approach from the Vedic tradition that is systematically taught by qualified teachers throughout the world. Evidence suggests not only that this program can provide benefits in prevention but also that it may reduce CVD-related and other health care expenses. On the basis of data from the studies available to date, the Transcendental Meditation program may be responsible for reductions of 80% or greater in medical insurance claims and payments to physicians. This article evaluates the implications of research on the Transcendental Meditation program for health care policy and for large-scale clinical implementation of the program. The Transcendental Meditation program can be used by individuals of any ethnic or cultural background, and compliance with the practice regimen is generally high. The main steps necessary for wider adoption appear to be: (1) educating health care providers and patients about the nature and expected benefits of the program, and (2) adjustments in public policies at the state and national levels to allow this program to be included in private and public health insurance plans.

The influence of income on the experience of informal caregiving: policy implications.

Examining the need for an eldercare policy is relevant and timely because the population is aging, a focus of care has shifted from institutional to community based, and informal caregivers, primarily women, are increasingly pressured to be responsible for eldercare. The purpose of the study is to examine the differences in the experiences of low-income and those who are not low-income informal caregivers. Three hundred questionnaires were mailed to past and present home care clients and 58 questionnaires were returned (19% response rate). This research revealed that low-income caregivers have increased needs for support and education from those who can afford to pay for their support services. Low-income caregivers experience significantly greater caregiver distress than do caregivers who are not low income. The unique needs of low-income caregivers must be considered in the formation of Canadian eldercare policy as increased health care privatization promotes the growing inequality in health care provision.

Case management at what expense? A case study of the emotional costs of case management.

Case management, which has its historical roots in community and public health, seeks to coordinate care, decrease costs, and promote access to appropriate levels of service. The case management system in this case study underscores the potential negative outcomes that can result from ignoring the holistic approach represented by an implemented case management system as a cost control mechanism. These negative outcomes not only include those expenditures of resources usually included when describing costs of care, but include those emotional costs of the system, patient, and care managers. Several needed system changes are identified and recommendations provided.