More complex research questions are being posed in early-phase oncology clinical trials, necessitating design strategies tailored to contemporary study objectives. This paper describes the proposed design of a Phase I trial concurrently evaluating the safety of a hematopoietic progenitor kinase-1 inhibitor (Agent A) as a single agent and in combination with an anti-PD-1 agent in patients with advanced malignancies. The study’s primary objective was to concurrently determine the maximum tolerated dose (MTD) of Agent A with and without anti-PD-1 therapy among seven possible study dose levels.

Our solution to this challenge was to apply a continual reassessment method shift model to meet the research objectives of the study.

The application of this method is described herein, and a simulation study of the design’s operating characteristics is conducted. This work was developed through collaboration and mentoring between the authors at the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) annual AACR/ASCO Methods in Clinical Cancer Research Workshop.

The aim of this manuscript is to highlight examples of novel design applications as a means of augmenting the implementation of innovative designs in the future and to demonstrate the flexibility of adaptive designs in satisfying modern design conditions. Although the design is presented using an investigation of Agent A with and without anti-PD-1 therapy as an illustrative example, the approach described is not specific to these agents and could be applied to other concurrent monotherapy and combination therapy studies with well-defined binary safety endpoints.

Caregivers of patients with primary brain tumor (PBT) describe feeling preoccupied with the inevitability of their loved one's death. However, there are currently no validated instruments to assess death anxiety in caregivers. This study sought to examine (1) the psychometric properties of the Death and Dying Distress Scale (DADDS), adapted for caregivers (DADDS-CG), and (2) the prevalence and correlates of death anxiety in caregivers of patients with PBT.

Caregivers (N = 67) of patients with PBT completed the DADDS-CG, Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), Fear of Cancer Recurrence (FCR-7), and God Locus of Health Control (GLHC). Caregivers’ sociodemographic information and patients’ medical characteristics were also collected. Preliminary examination of the psychometric properties of the DADDS-CG was conducted using exploratory factor analysis, Cronbach's alpha, and correlations. The prevalence and risk factors of death anxiety were assessed using frequencies, pair-wise comparisons, and correlations.

Factor analysis of the DADDS-CG revealed a two-factor structure consistent with the original DADDS. The DADDS-CG demonstrated excellent internal consistency, convergent validity with the PHQ-9, GAD-7, and FCR-7, and discriminant validity with the GLHC. Over two-thirds of caregivers reported moderate-to-severe symptoms of death anxiety. Death anxiety was highest in women and caregivers of patients with high-grade PBT.

The DADDS-CG demonstrates sound psychometric properties in caregivers of patients with PBT, who report high levels of death anxiety. Further research is needed to support the measure's value in clinical care and research — both in this population and other caregivers — in order to address this unmet, psychosocial need.

Water plays a critical role in the production of food and preparation of nutritious meals, yet few studies have examined the relationship between water and food insecurity. The primary objective of this study, therefore, was to examine how experiences of household water insecurity (HWI) relate to experiences of household food insecurity (HFI) among a pastoralist population living in an arid, water-stressed region of northern Kenya.

We implemented the twelve-item Household Water Insecurity Experiences (HWISE, range 0–36) Scale and the nine-item Household Food Insecurity Access Scale (HFIAS, range 0–27) in a cross-sectional survey to measure HWI and HFI, respectively. Data on socio-demographic characteristics and intake of meat and dairy in the prior week were collected as covariates of interest.

Northern Kenya, June–July 2019.

Daasanach pastoralist households (n 136) from seven communities.

In the prior 4 weeks, 93·4 % and 98·5 % of households had experienced moderate-to-severe HWI and HFI, respectively. Multiple linear regression analyses indicated a strong association between HWI and HFI. Each point higher HWISE score was associated with a 0·44-point (95 % CI: 0·22, 0·66, P = 0·003) higher HFIAS score adjusting for socio-economic status and other covariates.

These findings demonstrate high prevalence and co-occurrence of HWI and HFI among Daasanach pastoralists in northern Kenya. This study highlights the need to address HWI and HFI simultaneously when developing policies and interventions to improve the nutritional well-being of populations whose subsistence is closely tied to water availability and access.

This study investigated death anxiety in patients with primary brain tumor (PBT). We examined the psychometric properties of two validated death anxiety measures and determined the prevalence and possible determinants of death anxiety in this often-overlooked population.

Two cross-sectional studies in neuro-oncology were conducted. In Study 1, 81 patients with PBT completed psychological questionnaires, including the Templer Death Anxiety Scale (DAS). In Study 2, 109 patients with PBT completed similar questionnaires, including the Death and Dying Distress Scale (DADDS). Medical and disease-specific variables were collected across participants in both studies. Psychometric properties, including construct validity, internal consistency, and concurrent validity, were investigated. Levels of distress were analyzed using frequencies, and determinants of death anxiety were identified using logistic regression.

The DADDS was more psychometrically sound than the DAS in patients with PBT. Overall, 66% of PBT patients endorsed at least one symptom of distress about death and dying, with 48% experiencing moderate-severe death anxiety. Generalized anxiety symptoms and the fear of recurrence significantly predicted death anxiety.

The DADDS is a more appropriate instrument than the DAS to assess death anxiety in neuro-oncology. The proportion of patients with PBT who experience death anxiety appears to be higher than in other advanced cancer populations. Death anxiety is a highly distressing symptom, especially when coupled with generalized anxiety and fears of disease progression, which appears to be the case in patients with PBT. Our findings call for routine monitoring and the treatment of death anxiety in neuro-oncology.

Few studies have examined burnout in psychosocial oncology clinicians. The aim of this systematic review was to summarize what is known about the prevalence and severity of burnout in psychosocial clinicians who work in oncology settings and the factors that are believed to contribute or protect against it.

Articles on burnout (including compassion fatigue and secondary trauma) in psychosocial oncology clinicians were identified by searching PubMed/MEDLINE, EMBASE, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature, and the Web of Science Core Collection.

Thirty-eight articles were reviewed at the full-text level, and of those, nine met study inclusion criteria. All were published between 2004 and 2018 and included data from 678 psychosocial clinicians. Quality assessment revealed relatively low risk of bias and high methodological quality. Study composition and sample size varied greatly, and the majority of clinicians were aged between 40 and 59 years. Across studies, 10 different measures were used to assess burnout, secondary traumatic stress, and compassion fatigue, in addition to factors that might impact burnout, including work engagement, meaning, and moral distress. When compared with other medical professionals, psychosocial oncology clinicians endorsed lower levels of burnout.

This systematic review suggests that psychosocial clinicians are not at increased risk of burnout compared with other health care professionals working in oncology or in mental health. Although the data are quite limited, several factors appear to be associated with less burnout in psychosocial clinicians, including exposure to patient recovery, discussing traumas, less moral distress, and finding meaning in their work. More research using standardized measures of burnout with larger samples of clinicians is needed to examine both prevalence rates and how the experience of burnout changes over time. By virtue of their training, psychosocial clinicians are well placed to support each other and their nursing and medical colleagues.

We aimed to evaluate emergency medical services (EMS) data as disaster metrics and to assess stress in surrounding hospitals and a municipal network after the closure of Bellevue Hospital during Hurricane Sandy in 2012.

We retrospectively reviewed EMS activity and call types within New York City’s 911 computer-assisted dispatch database from January 1, 2011, to December 31, 2013. We evaluated EMS ambulance transports to individual hospitals during Bellevue’s closure and incremental recovery from urgent care capacity, to freestanding emergency department (ED) capability, freestanding ED with 911-receiving designation, and return of inpatient services.

A total of 2,877,087 patient transports were available for analysis; a total of 707,593 involved Manhattan hospitals. The 911 ambulance transports disproportionately increased at the 3 closest hospitals by 63.6%, 60.7%, and 37.2%. When Bellevue closed, transports to specific hospitals increased by 45% or more for the following call types: blunt traumatic injury, drugs and alcohol, cardiac conditions, difficulty breathing, “pedestrian struck,” unconsciousness, altered mental status, and emotionally disturbed persons.

EMS data identified hospitals with disproportionately increased patient loads after Hurricane Sandy. Loss of Bellevue, a public, safety net medical center, produced statistically significant increases in specific types of medical and trauma transports at surrounding hospitals. Focused redeployment of human, economic, and social capital across hospital systems may be required to expedite regional health care systems recovery. (Disaster Med Public Health Preparedness. 2016;10:333–343)