Implementation and evaluation of an expanded electronic health record-integrated bilingual electronic symptom management program across a multi-site Comprehensive Cancer Center: The NU IMPACT protocol.

BACKGROUND: People with cancer experience symptoms that adversely affect quality of life. Despite existing interventions and clinical guidelines, timely symptom management remains uneven in oncology care. We describe a study to implement and evaluate an electronic health record (EHR)-integrated symptom monitoring and management program in adult outpatient cancer care. METHODS: Our cancer patient-reported outcomes (cPRO) symptom monitoring and management program is a customized EHR-integrated installation. We will implement cPRO across all Northwestern Memorial HealthCare (NMHC) hematology/oncology clinics. We will conduct a cluster randomized modified stepped-wedge trial to evaluate patient and clinician engagement with cPRO. Further, we will embed a patient-level randomized clinical trial to evaluate the impact of an additional enhanced care (EC; cPRO plus web-based symptom self-management intervention) relative to usual care (UC; cPRO alone). The project uses a Type 2 hybrid effectiveness-implementation approach. The intervention will be implemented across seven regional clusters within the healthcare system comprising 32 clinic sites. A 6-month prospective pre-implementation enrollment period will be followed by a post-implementation enrollment period, during which newly enrolled, consenting patients will be randomly assigned (1:1) to EC or UC. We will follow patients for 12 months post-enrollment. Patients randomized to EC will receive evidence-based symptom-management content on cancer-related concerns and approaches to enhance quality of life, using a web-based tool ("MyNM Care Corner"). This design allows for within- and between-site evaluation of implementation plus a group-based comparison to demonstrate effectiveness on patient-level outcomes. DISCUSSION: The project has potential to guide implementation of future healthcare system-level cancer symptom management programs. http://ClinicalTrials.gov # NCT03988543.

Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors.

Patients who have undergone hematopoietic stem cell transplant (HSCT) may experience cognitive impairment that can persist after treatment. Several studies have shown that bright light therapy may improve cognition, potentially due to its effects on the circadian system via brain regions that respond preferentially to light. In this double-blind randomized controlled trial, the efficacy of bright light therapy on cognition was examined in HSCT survivors. Forty-seven HSCT survivors at an urban hospital in the United States were screened for mild cognitive impairment, randomized to either bright white light (BWL) or comparison dim red light (DRL) conditions using a block randomization approach, and instructed to use their assigned light box every morning upon awakening for 30 min for 4 weeks. Assessments occurred at baseline, the end of the second week of the intervention, the end of the intervention, and at follow-up (8 weeks later). The primary outcome was objective cognitive function as measured by a global composite score on neuropsychological tests. Secondary outcomes included cognitive performance in individual domains, self-reported cognitive function, fatigue, sleep and sleep quality, and circadian rhythm robustness. Repeated-measures linear mixed models for both objective and self-reported cognitive function indicated significant main effects for time (ps < 0.05) suggesting significant improvements in both conditions over time. Time by light condition interaction effects were not significant. Models focused on secondary outcomes yielded no significant effects. Both BWL and DRL groups demonstrated significant improvements in objective cognitive and self-reported cognitive function over time, but there was no hypothesized effect of BWL over DRL nor associations with circadian rhythm robustness. Therapeutic effects of both light conditions, practice effects, and/or placebo effects may account for the findings.Trial registration: ClinicalTrials.gov Identifier: NCT02677987 (9 February 2016).

Rationale and usability findings of an e-health intervention to improve oral anticancer adherence among breast cancer survivors: The My Journey mindfulness study.

BACKGROUND: Approximately 80% of breast cancer survivors are prescribed oral endocrine therapy (ET) medication for 5-10 years following primary treatment, making adherence to ET a critical aspect of cancer survivorship care. Despite the benefits of ET, non-adherence is problematic, and up to half of breast cancer survivors ave been documented to discontinue ET early. Our team developed My Journey, an online, mindfulness-based program designed to improve adherence to ET. This manuscript describes the usability testing of My Journey and the protocol development for the My Journey randomized feasibility trial. METHODS: Usability participants were women (N = 15) with a diagnosis of hormone receptor-positive non-metastatic breast cancer who had initiated ET. Participant impressions and feedback were collected qualitatively and quantitatively using items on usefulness, satisfaction, and ease of use. Participants in the 8-week feasibility trial (N = 80) will be randomized to receive the web-based My Journey intervention or a health education comparison condition. RESULTS: Quantitative feedback on the usability trial was favorable, with a mean overall usability score of 106.3 (SD = 7.7; Range: 83-115) indicating above average usability. Qualitative data showed that participants found several strengths in the initial design of the My Journey online tool and that participants liked the layout of My Journey. CONCLUSIONS: Findings indicate that the My Journey online tool is useable. The program's feasibility is being evaluated in a randomized trial.

The increasing value of eHealth in the delivery of patient-centred cancer care.

The increasing use of eHealth has ushered in a new era of patient-centred cancer care that moves beyond the traditional in-person care model to real-time, dynamic, and technology-assisted assessments and interventions. eHealth has the potential to better the delivery of cancer care through improved patient-provider communication, enhanced symptom and toxicity assessment and management, and optimised patient engagement across the cancer care continuum. In this Review, we provide a brief, narrative appraisal of the peer reviewed literature over the past 10 years related to the uses of patient-centred eHealth to improve cancer care delivery. These uses include the addressal of symptom management, health-related quality of life, and other patient-reported outcomes across cancer care. In addition, we discuss the challenges of, and opportunities for, accessibility, scalability, and implementation of these technologies, important areas for further development, and future research directions.

Implementing electronic health record-integrated screening of patient-reported symptoms and supportive care needs in a comprehensive cancer center.

BACKGROUND: Oncology practice can be enhanced by the integration of the assessment of patient-reported symptoms and concerns into the electronic health record (EHR) and clinical workflows. METHODS: Adult oncology outpatients (n = 6825) received 38,422 invitations to complete assessments through the EHR patient portal. Patient-Reported Outcomes Measurement Information System computer adaptive tests were administered to assess fatigue, pain interference, physical function, depression, and anxiety. Checklists identified psychosocial, nutritional, and informational needs. In real time, assessment results were populated in the EHR, and clinicians were notified of elevated symptoms and needs. RESULTS: In all, 3521 patients (51.6%) completed 8162 assessments; approximately 55% of the responding patients completed 2 or more within 32 months. Fatigue, pain, anxiety, and depression scores were comparable to those of the general population (approximately 5% of assessments triggered clinical alerts across those domains); mean scores indicated a lower level of physical function (with severe scores prompting alerts in nearly 5% of assessments). More than half of assessments triggered an alert based on patient endorsement of supportive care needs, with the majority of those being nutritional (41.82% of assessments). Patient endorsement of supportive care needs was associated with significantly higher anxiety, depression, fatigue, and pain interference scores and lower physical function scores. Patients who triggered clinical alerts tended to be younger and more recently diagnosed, to have greater comorbidities, and to be a racial/ethnic minority. Patients who triggered clinical alerts had more health care service encounters in the ensuing month. CONCLUSIONS: EHR integration facilitated the assessment and reporting of patient-reported symptoms and needs within routine oncology outpatient care.

Proposal for an Update of the Definition and Scope of Behavioral Medicine.

PURPOSE: We aim to provide an update of the definition and scope of behavioral medicine in the Charter of ISBM, as the present version was developed more than 25 years ago. METHODS: We identify issues which need clarification or updating. This leads us to propose an update of the definition and scope of behavioral medicine. RESULTS: Issues in need of clarification or updating include the scope of behavioral medicine (biobehavioral mechanisms, clinical diagnosis and intervention, and prevention and health promotion); research as an essential characteristic of all three areas of behavioral medicine; the application of behavioral medicine; the terminology of behavioral medicine as a multidisciplinary field; and the relationship and distinction between behavioral medicine, mental health, health psychology, and psychosomatic medicine. CONCLUSION: We propose the following updated definition and scope of behavioral medicine: "Behavioral medicine can be defined as the multidisciplinary field concerned with the development and integration of biomedical and behavioral knowledge relevant to health and disease, and the application of this knowledge to prevention, health promotion, diagnosis, treatment, rehabilitation, and care. The scope of behavioral medicine extends from biobehavioral mechanisms (i.e., the interaction of biomedical processes with psychological, social, societal, cultural, and environmental processes), to clinical diagnosis and intervention, and to public health."

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

BACKGROUND: 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. METHODS: Women with metastatic breast cancer (N = 39) were randomized to an in-person intervention, online intervention, or in-person attention-matched control. Psychological well-being (depression [Center for Epidemiologic Studies Depression Scale], positive and negative affect [Differential Emotions Scale], cancer-specific quality of life [Multidimensional Quality of Life Scale-Cancer Version]), and positive coping (mindfulness, positive-affect skill use, and self-compassion [Self-Compassion Scale: Short-Form]) were assessed at baseline, 1 week post-intervention, and 1 month post-intervention follow-up. RESULTS: The LILAC intervention showed good feasibility, acceptability, and retention. Although the study was not adequately powered to detect between-group differences in change on preliminary efficacy outcomes, within-group comparisons revealed that LILAC participants (in-person and online combined) showed reductions in depression and negative affect by the 1 month follow-up (d = -0.81). Notably, LILAC participants fell below the clinical threshold for depression (Center for Epidemiologic Studies Depression Scale = 16) by the 1 month follow-up (t[17] = -2.22, P = .04, d = -0.52), whereas control participants did not differ from threshold (t[9] = 0.45, P = .66, d = 0.14). CONCLUSIONS: The LILAC intervention, regardless of delivery method, shows feasibility, acceptability, and preliminary efficacy for promoting psychological well-being in women with metastatic breast cancer. This research provides support for a larger randomized trial to test more definitively the potential benefits of LILAC. A strength of the LILAC intervention includes its innovative focus on positive affect. The efficacy of the online delivery suggests the potential for widespread Internet dissemination.

Survivorship care planning in a comprehensive cancer center using an implementation framework.

Cancer survivorship care plans (SCPs) have been recommended to improve clinical care and patient outcomes. Research is needed to establish their efficacy and identify best practices. Starting in 2015, centers accredited by the American College of Surgeons Commission on Cancer must deliver SCPs to patients completing primary cancer treatment with curative intent. We describe how we established routine SCP delivery at the Robert H Lurie Comprehensive Cancer Center in Chicago, Illinois, using the Quality Implementation Framework. We evaluated local practices, gathered clinician and patient stakeholder input, developed customized SCP templates within the electronic health record (EHR), and implemented 2 complementary delivery models. Clinician interviews (n = 41) and survey responses (n = 12), along with input from patients (n = 68) and a patient advisory board (n = 15), indicated support for SCPs and survivorship services. To promote feasible implementation and leverage existing workflows, we harmonized 2 SCP delivery models: integrated care within clinics where patients received treatment, and referral to a centralized survivorship clinic. We are implementing SCP delivery with prominent disease sites and will extend services to survivors of other cancers in the future. We developed four electronic disease-specific SCP templates for breast, colorectal, lung, and prostate cancers and a fifth, generic template that can be used for other malignancies. The templates reduced free-text clinician entry by auto-populating 20% of the fields from existing EHR data, and using drop-down menus for another 65%. Mean SCP completion time is 12 minutes (range, 10-15; n = 64). We designed our framework to facilitate ongoing evaluation of implementation and quality improvement. Funding/sponsorship Robert H Lurie Comprehensive Cancer Center, the Coleman Foundation, and the Lynn Sage Cancer Research Foundation.

Implementation of distress screening in an oncology setting.

The recommendations of numerous groups, such as the Institute of Medicine and the National Comprehensive Cancer Network, have resulted in the first regulatory standard on distress screening in oncology implemented in 2015 by the American College of Surgeons Commission on Cancer. This practice-changing standard promises to result in better quality cancer care, but presents unique challenges to many centers struggling to provide high-quality practical assessment and management of distress. The current paper reviews the history behind the CoC standard, identifies the most prevalent symptoms underlying distress, and discusses the importance of distress screening. We also review some commonly used instruments for assessing distress, and address barriers to implementation of screening and management.

The importance of perceived stress management skills for patients with prostate cancer in active surveillance.

Little is known about whether and how stress management skills may improve adjustment for men diagnosed with prostate cancer who opt for active surveillance. This study examined whether two types of perceived stress management skills, specifically the ability to relax and confidence in coping, moderated the relationship between prostate cancer (PC) concerns and psychological distress. Participants were 71 ethnically diverse men in active surveillance. Coping confidence moderated the relationship between PC concerns and intrusive thoughts (p < .01). At low levels of coping confidence, PC concerns was positively related to intrusive thoughts, ß = .95, p < .001, but not when coping confidence was high, ß = .19, p > .05. Coping confidence also moderated the relationship between PC treatment concerns (a subscale of PC concerns) and intrusive thoughts. At low levels of coping confidence, PC treatment concerns was positively associated with intrusive thoughts, ß = .73, p < .001, but not when coping confidence was high, ß = .20, p > .05. Findings underscore the importance of interventions aimed at improving coping in men undergoing active surveillance.

Multilevel modeling in psychosomatic medicine research.

The primary purpose of this study is to provide an overview of multilevel modeling for Psychosomatic Medicine readers and contributors. The article begins with a general introduction to multilevel modeling. Multilevel regression modeling at two levels is emphasized because of its prevalence in psychosomatic medicine research. Simulated data sets based on some core ideas from the Familias Unidas effectiveness study are used to illustrate key concepts including communication of model specification, parameter interpretation, sample size and power, and missing data. Input and key output files from Mplus and SAS are provided. A cluster randomized trial with repeated measures (i.e., three-level regression model) is then briefly presented with simulated data based on some core ideas from a cognitive-behavioral stress management intervention in prostate cancer.

Psychosocial and Clinical Characteristics and Psychiatric Co-morbidity Among Men and Women with HIV/AIDS under Medical Treatment at a Tertiary Health Care Center in Cali, Colombia

Introduction: Better understanding of psychosocial and health care needs of complex HIV/AIDS patients may facilitate disease management and virologic control. Objectives: To examine the behavioral, psychosocial, and co-morbid characteristics of HIV/AIDS illness in men and women being followed at a tertiary health care center in Colombia. Methods: A sample of HIV+ patients, 114 men and 29 women, was selected for review of clinical records. Results: Men were older (40 vs. 32 yrs.) and more likely to be employed (83 vs. 50%). Of those reporting sexual preference, 33% of men and 100% of women indicated being heterosexual. A higher percentage of men (34%) had CD4 count < 200 cells/mm2 when compared with the women (21%). More men than women had opportunistic infections (75 vs. 48%) and more men tended to be on complex medication regimens (68 vs. 48%). Viral load data was available for 53% of the cases, half of which had > 400 copies/ml. Only 40% of patients attended every scheduled 3-month visit. Less than one-quarter (22%) of the sample was diagnosed by a psychiatrist with a mental disorder and only a small proportion (one-fifth) had a psychiatric follow-up. Conclusions: Our study reveals several important findings among this sample of HIV patients attending a tertiary care private hospital in Cali: (1) the epidemic is rising among women, (2) undetected and under-treated psychiatric illness is highly prevalent, and (3) adherence to scheduled clinical visits is low among patients with a viral load >400 copies/ml. Thus, integrating psychosocial care with behavioral interventions to improve adherence is warranted to counteract these critical issues. An important weakness of this study was that clinical records did not include complete documentation of all variables...

Introducción: Una mejor comprensión de las necesidades psicosociales y de salud de pacientes con VIH/sida de mayor complejidad puede facilitar su manejo y control virológico. Objetivo: Estudiar las características de comportamiento, psicosociales y de comorbilidad en la enfermedad por VIH/sida en hombres y mujeres de un centro de atención nivel tres en Colombia. Método: Revisión de una muestra de pacientes con VIH+ de 114 hombres y 29 mujeres y de sus historias clínicas. Resultados: Los hombres eran de mayor edad (40 vs. 32 años) y estaban empleados (83% vs. 50%). En los que reportaron preferencia sexual, 33% de los hombres y 100% de las mujeres refirieron heterosexualidad. Un mayor porcentaje de hombres (34%) que de mujeres (21%) tuvo un recuento de CD4 <200 células/mm2. Más hombres tenían infecciones oportunistas (75% vs. 48%) y estaban en tratamientos médicos de mayor complejidad (68% vs. 48%). Datos de carga viral estaban disponibles en el 53% de los casos. Solamente 40% asistieron a cada una de las citas trimestrales. El 22% tenía un diagnóstico de enfermedad mental realizado por un psiquiatra, y sólo una quinta parte, seguimiento por psiquiatra. Conclusiones: Nuestro estudio revela tres hallazgos importantes para la población que acude a un hospital privado de nivel tres en la ciudad de Cali: (i) la epidemia está aumentando en mujeres, (ii) la enfermedad psiquiátrica no detectada y no tratada es altamente prevalente y (iii) la adherencia a las visitas programadas fue baja en los pacientes con carga viral >400 copias/ml. Por lo tanto, para mejorar adherencia es prioritario integrar el cuidado psicosocial con las intervenciones sobre el comportamiento y así controlar estos críticos aspectos...

Perceived stress mediates the effects of coping on the quality of life of HIV-positive women on highly active antiretroviral therapy.

This study examined the relationship between three HIV-specific coping strategies (cognitive coping strategies, denial, and religious coping) and quality of life (QoL) in 90 HIV+, predominately minority women on highly active antiretroviral therapy. Religious coping was unrelated to QoL; however, use of cognitive coping strategies was related to greater QoL, and denial was related to poorer QoL. Baron and Kenny's model of mediation was then used to test perceived stress as a mediator of the relationships between denial and cognitive coping strategies and QoL. These relationships were both mediated by perceived stress. Results suggest that utilization of certain coping strategies may lessen or heighten perceptions of life stressfulness, thereby influencing QoL in this understudied population.