PURPOSE:GOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL). METHODS:Patients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study. Participants completed baseline (BL) surveys (symptom burden and controllability and QOL) before random assignment. WRITE interventions lasted 8 weeks to develop symptom management plans for three target symptoms. All women received EUC: monthly online symptom assessment with provider reports; online resources; and every 2-week e-mails. Outcomes were evaluated at 8 and 12 weeks after BL. Repeated-measures modeling with linear contrasts evaluated group by time effects on symptom burden, controllability, and QOL, controlling for key covariates. RESULTS:Participants (N = 497) reported mean age of 59.3 ± 9.2 years. At BL, 84% were receiving chemotherapy and reported a mean of 14.2 ± 4.9 concurrent symptoms, most commonly fatigue, constipation, and peripheral neuropathy. Symptom burden and QOL improved significantly over time (P < .001) for all three groups. A group by time interaction (P < .001) for symptom controllability was noted whereby both WRITE intervention groups had similar improvements from BL to 8 and 12 weeks, whereas EUC did not improve over time. CONCLUSION:Both WRITE Intervention groups showed significantly greater improvements in symptom controllability from BL to 8 and BL to 12 weeks compared with EUC. There were no significant differences between Nurse-WRITE and SD-WRITE. SD-WRITE has potential as a scalable intervention for a future implementation study.

BACKGROUND:The NIH consensus statement on cancer-related symptoms concluded the most common and debilitating were depression, pain and fatigue [1-6]. Although the comorbidity of these symptoms is well known and may have similar underlying biological mechanisms no intervention has been developed to reduce these symptoms concurrently. The novel web-based stepped collaborative care intervention delivered by telemedicine is the first to be tested in people diagnosed with cancer. METHODS:We plan to test a web-based stepped collaborative care intervention with 450 cancer patients and 200 caregivers in the context of a randomized controlled trial. The primary endpoint is quality of life with other primary outcomes including patient-reported depression, pain, fatigue. Secondary outcomes include patient serum levels of pro-inflammatory cytokines and disease progression. We also will assess informal caregiver stress, depression, and metabolic abnormalities to determine if improvements in patients' symptoms also relate to improvement in caregiver outcomes. RESULTS:The trial is ongoing and a total of 382 patients have been randomized. Preliminary analyses of the screening tools used for study entry suggest that Center for Epidemiological Studies-Depression (CESD) scale has good sensitivity and specificity (0.81 and 0.813) whereas the scale used to assess pain (0.47 and 0.91) and fatigue (0.11 and 0.91) had poor sensitivity but excellent specificity. Using the AUROC, the best cut point for the CES-D was 19, for pain was 4.5; and for fatigue was 2.5. Outcomes not originally proposed included health care utilization and healthcare charges. The first 100 patients who have been followed a year post-treatment, and who were less than 75 years and randomized to the web-based stepped collaborative care intervention, had lower rates of complications after surgery [χ2 = 5.45, p = 0.02]. For patients who survived 6 months or less and were randomized to the web-based stepped collaborative care intervention, had lower rates of 90-day readmissions when compared to patients randomized to the screening and referral arm [χ2 = 4.0, p = 0.046]. Patients randomized to the collaborative care intervention arm had lower overall health care activity-based costs of $16,758 per patient per year when compared to the screening and referral arm. DISCUSSION:This novel web-based stepped stepped collaborative care intervention, delivered via telemedicine, is expected to provide a new strategy to improve the quality of life in those diagnosed with cancer and their caregivers. TRIAL REGISTRATION:ClinicalTrials.govNCT02939755.

11599 Background: There is an urgent need for evidence-based and scalable interventions to reduce depression, pain, and fatigue and improve quality of life in patients diagnosed with cancer. The aims of this study were to share the interim analyses of testing the efficacy of a stepped collaborative care intervention for patients diagnosed with cancers affecting the hepatobiliary and pancreatic system. Methods: Patients were screened for clinical levels of depression, pain, or fatigue and were enrolled in the study if they screened positive for depression, pain, and/or fatigue. After completing a baseline battery of instruments, patients were randomized to the stepped collaborative care intervention or the screening and referral arm. Post-treatment data was collected at 6 months and 12 months to assess efficacy and maintenance of change in depressive symptoms. Results: A total of 100 patients have completed the post-treatment assessment. Interim data analyses revealed that the mean age of patients was 64.0 years (SD = 10.3) and the majority of patient were male (51%), Caucasian (89%), diagnosed with liver cancer (47%) and stage III and IV (60%). Patients randomized to the stepped collaborative care intervention reported significant reductions in depressive symptoms (F(1,92) = 6.22, p = 0.014) and improvements in quality of life (F(1,92) = 7.36, p = 0.008) with moderate effect sizes (Cohen’s d = 0.547 and 0.652, respectively) at 6-months. The mean change in depressive symptoms from randomization to 6-month post- treatment was -4.3 (SD = 9.7) for the patients randomized to the collaborative care intervention and +0.71 (SD = 9.4) for the patients randomized to the screening and referral arm of the study. The mean change in quality of life from randomization to 6-month post-treatment was +4.5 (SD = 16.2) for the patients randomized to the collaborative care intervention and -4.4 (SD = 15.2) for the patients randomized to the screening and referral arm of the study. Conclusions: This promising evidence-based, scalable intervention to treat comorbid cancer and depression was shown to be effective in reducing depressive symptoms and improving quality of life in patients with cancer. Clinical trial information: NCT02939755.

e23128 Background: The aims of this study were to examine the associations between depression and complications, health care utilization and costs in patients with cancer. Methods: Patients diagnosed with cancer were administered a battery of questionnaires, including the Center for Epidemiological Studies-Depression (CES-D) Scale. Health care utilization and costs for patients was collected for one year after the administration of the CES-D. Descriptive statistics, Chi-square and ANOVA, and ordered restricted inference analyses were performed. Results: Of the 100 patients, the mean age was 64.0 years (SD = 10.3), the majority of patients were male (51%), Caucasian (89%), diagnosed with hepatocellular or cholangiocarcinoma (47%) and stage III and IV cancer (60%), and 34% of patients had clinical levels of depressive symptoms (CES-D > 16). No demographic or disease specific variables were associated with depressive symptoms or outcomes. Surgical patients with clinical levels of depression had a greater number of complications [Chi-square = 4.4, p = 0.036] and a greater severity of complications using Clavien-Dindo classification [Chi-square = 4.5, p = 0.033]. Patients undergoing chemotherapy, who reported depressive symptoms in the clinical range, were more likely to require medical intervention for chemotherapy side effects [Chi-square = 4.2, p = 0.04]. Patients with clinical levels of depressive symptoms also had a greater number of emergency room visits [F(1,99) = 8.4, p = 0.005]. Patients who reported clinical levels of depressive symptoms had significantly higher median costs associated with the loss of work force productivity (Median = $7154 versus $2104; p = 0.015), hospital costs (Median = $29,917 versus $8292, p = 0.019), and cost per registration (Median = $3324 versus $1247, p = 0.017) but lower physician costs (Median = $6171 versus $10,821; p = 0.026) than patients with non-clinical levels of depressive symptoms. Conclusions: Depressive symptoms are associated with increased complications and health care utilization and costs. There is an urgent need for effective and scalable interventions to reduce depressive symptoms in patients diagnosed with cancer to improve quality of life and reduce health care utilization and costs.

e18348 Background: The aims of this study were to test the efficacy of a stepped collaborative care intervention for comorbid cancer and depression on outcomes including complication rates, health care utilization and costs. Methods: Patients diagnosed with cancer were enrolled in a randomized controlled trial testing the efficacy of a stepped collaborative care intervention. Patients were administered a battery of questionnaires prior to randomization. Rates and severity of surgical complications, health care utilization and costs were collected for a one-year period after randomization. Descriptive statistics, Chi-square analyses, and Ordered Restricted Inference analyses were performed. Results: Of the 100 patients, the mean age was 64.0 (SD = 10.3), the majority of the patients were male (51%), Caucasian (89%), diagnosed with hepatocellular or cholangiocarcinoma (47%) and stage III and IV (60%). For patients less than 75 years, patients randomized to the collaborative care intervention had lower rates of complications after surgery [Χ2= 5.45, P = 0.02]. We observed that 16% of patients randomized to the collaborative care intervention had complications versus 66.7% of the patients in the screening and referral arm. For patients who survived 6 months or less, those who were randomized to the collaborative care intervention had lower rates of 90-day readmissions than patients randomized to the screening and referral arm [Χ2= 4.0, P = 0.046]. The patients randomized to the collaborative care intervention did not have any readmissions while 2 patients in the screening and referral arm were readmitted. Patients randomized to the collaborative care intervention arm had lower median costs associated with the loss of workforce productivity ($2340 versus $3001; P = 0.07), hospital costs ($13,008 versus $21,109, P = 0.09), and cost per hospital registration ($1158 versus $2219, P = 0.07) when compared to the screening and referral arm. Conclusions: The stepped collaborative care intervention not only reduced depressive symptoms, but patients randomized to this intervention had lower complication rates, health care utilization, loss of work productivity, and hospital related costs. Clinical trial information: NCT02939755.

e23174 Background: Cancer caregivers are at increased risk for cardiovascular disease. The aims of the present study were to develop an instrument to identify cancer caregivers at risk for the development of cardiovascular disease. Methods: Cancer caregivers were enrolled in a prospective study examining predictors of metabolic syndrome. Predictors included perceived stress, caregiver stress, depression, hostility, physical activity, diet, alcohol and tobacco use, social support and relationship with the patient. Regression analyses and factor analyses was performed to reduce the number of items to develop an instrument that would identify cancer caregivers at risk for cardiovascular disease. Internal consistency and Area Under the Receiver Operator Curve was also performed to test the new instrument. Results: A total of 111 caregivers were included in the analyses. The mean age of caregivers was 59.6 ( SD= 12.7) and the majority of caregivers were female (74.8%), Caucasian (94.6%), and were the spouse of the cancer patient (65.8%).Using regression analyses, the items from the caregiver stress, hostility, and social support questionnaires were most likely to predict metabolic syndrome. Preliminary findings suggest that a 35-item instrument was predictive of metabolic syndrome [B = 0.067, HR = 1.07, p = 0.001]. The reliability of the instrument was good with a Cronbach Alpha = 0.83. The Area Under the Receiver Operator Curve was also fair (AUROC = 0.703; 95% CI = 0.597-0.808, p = 0.001). Based on the AUROC, the best cut point to detect metabolic syndrome would be a score of 24 (Sensitivity = 0.75 and Specificity = 0.55). Conclusions: Preliminary findings suggest that this 35-item questionnaire may be useful in identifying cancer caregivers at risk for metabolic syndrome, an intermediate endpoint for cardiovascular disease. The questionnaire may be used to screen cancer caregivers for interventions to reduce metabolic syndrome.

More than 25 years ago we developed a data visualization system called Vibe. During this same period we developed a system for collaborative authoring – CASCADE – that made heavy use of visualization. These were but a few of many efforts at that time to develop new methods for understanding data, stimulated by improved hardware - faster CPUs, more memory and high resolution graphical displays that made it possible to perform advanced visualization on ordinary PCs. In this paper we revisit some of these efforts and then discuss where visualization is today. We briefly examine big data and scientific visualization where many of the issues we explored 25 years ago are being revisited. Our focus however is on general visualization. What we find is that advanced visualization systems for data presentations have not come into general use. We explore some of the reasons this may be the case.

This chapter explores opportunities to manage standards and standardization with a particular focus on the information and communication technologies (ICT) sector. It looks at the historical “management” of standards primarily in the United States, highlighting government and industrial approaches and the forces that have shaped the management process. It then turns to the current pressures and forces facing the management of ICT standards and standardization and makes some suggestions for activities that might enhance the management of standards.

Importance Collaborative care for depression and anxiety is superior to usual care from primary care physicians for these conditions; however, challenges limit its provision in routine practice and at scale. Advances in technology may overcome these barriers but have yet to be tested. Objective To examine the effectiveness of combining an internet support group (ISG) with an online computerized cognitive behavioral therapy (CCBT) provided via a collaborative care program for treating depression and anxiety vs CCBT alone and whether providing CCBT in this manner is more effective than usual care. Design, Setting, and Participants In this 3-arm randomized clinical trial with blinded outcome assessments, primary care physicians from 26 primary care practices in Pittsburgh, Pennsylvania, referred 2884 patients aged 18 to 75 years in response to an electronic medical record prompt from August 2012 to September 2014. Overall, 704 patients (24.4%) met all eligibility criteria and were randomized to CCBT alone (n = 301), CCBT+ISG (n = 302), or usual care (n = 101). Intent-to-treat analyses were conducted November 2015 to January 2017. Interventions Six months of guided access to an 8-session CCBT program provided by care managers who informed primary care physicians of their patients’ progress and promoted patient engagement with our online programs. Main Outcomes and Measures Mental health–related quality of life (12-Item Short-Form Health Survey Mental Health Composite Scale) and depression and anxiety symptoms (Patient-Reported Outcomes Measurement Information System) at 6-month follow-up, with treatment durability assessed 6 months later. Results Of the 704 randomized patients, 562 patients (79.8%) were female, and the mean (SD) age was 42.7 (14.3) years. A total of 604 patients (85.8%) completed our primary 6-month outcome assessment. At 6-month assessment, 254 of 301 patients (84.4%) receiving CCBT alone started the program (mean [SD] sessions completed, 5.4 [2.8]), and 228 of 302 patients (75.5%) in the CCBT+ISG cohort logged into the ISG at least once, of whom 141 (61.8%) provided 1 or more comments or posts (mean, 10.5; median [range], 3 [1-306]). Patients receiving CCBT+ISG reported similar 6-month improvements in mental health–related quality of life, mood, and anxiety symptoms compared with patients receiving CCBT alone. However, compared with patients receiving usual care, patients in the CCBT alone cohort reported significant 6-month effect size improvements in mood (effect size, 0.31; 95% CI, 0.09-0.53) and anxiety (effect size, 0.26; 95% CI, 0.05-0.48) that persisted 6 months later, and completing more CCBT sessions produced greater effect size improvements in mental health–related quality of life and symptoms. Conclusions and Relevance While providing moderated access to an ISG provided no additional benefit over guided CCBT at improving mental health–related quality of life, mood, and anxiety symptoms, guided CCBT alone is more effective than usual care for these conditions. Trial Registration clinicaltrials.gov Identifier: NCT01482806

Objective: GOG-259 was a 3-arm randomized controlled trial of 2 web-based symptom management interventions (WRITE Symptoms) for women with recurrent ovarian cancer. The primary aims of the study were to compare the efficacy of nurse-guided (ND) WRITE and self-directed (SD) WRITE to enhanced usual care (EUC) in improving symptoms and quality of life (QOL).

101 Background: The purpose of this study is to recommend a core set of priority symptoms to be assessed in research and clinical settings for women with recurrent ovarian cancers. Methods: We used baseline data of 497 women with recurrent ovarian, fallopian, or primary peritoneal cancer participating in a symptom management randomized clinical trial (GOG-0259) to identify a core index of patient-reported priority symptoms. We used the Symptom Representation Questionnaire to assess priority rankings of 28 symptoms based on four criteria: (1) symptom prevalence, (2) patient-reported symptom severity, (3) percentage of women identifying each symptom as one of top three symptoms “I would like to get better control over”, and (4) the association between symptom severity and functional wellbeing as measured by the Functional Assessment of Cancer Therapy - Ovarian. Final priority ranking included all symptoms that were ranked in the top 10 for any of the four criteria. Results: Of the original 28 symptoms, 19 were ranked in the top 10 for at least one criterion: fatigue, sleep disturbance, pain, anxiety, peripheral neuropathy, constipation, abdominal bloating, drowsiness, mood swings, memory problems, weight gain, nausea, sexual concerns, vomiting, hair loss, lymphedema, lack of appetite, shortness of breath, and depression. Fatigue, sleep disturbance, and pain were each ranked one of the top 10 symptoms for all four criteria. Anxiety, peripheral neuropathy, and constipation were each ranked in the top 10 for three of the 4 criteria. Conclusions: We propose a core index of 19 patient-reported symptoms to be systematically assessed among patients with recurrent ovarian cancer. These symptoms are common, severe, poorly managed, and/or interfere with survivors’ functioning and can be efficiently assessed in 1-2 minutes. Systematic assessment in clinical and research settings could advance understanding about the predictors and consequences of poorly managed symptoms and could lead to more proactive, personalized interventions to improve functional well-being in this at-risk patient population.

BACKGROUND The aim of this study was to examine the efficacy of a collaborative care intervention in reducing depression, pain, and fatigue and improve quality of life. METHODS A total of 261 patients with advanced cancer and 179 family caregivers were randomized to a web‐based collaborative care intervention or enhanced usual care. The intervention included the following: 1) a web site with written and audiovisual self‐management strategies, a bulletin board, and other resources; 2) visits with a care coordinator during a physician's appointment every 2 months; and 3) telephone follow‐up every 2 weeks. Primary patient outcomes included measures of depression, pain, fatigue, and health‐related quality of life. Secondary outcomes included Interleukin (IL)‐1α, IL‐1β, IL‐6, and IL‐8 levels, Natural Killer (NK) cell numbers, and caregiver stress and depression. RESULTS At the baseline, 51% of the patients reported 1 or more symptoms in the clinical range. For patients who presented with clinical levels of symptoms and were randomized to the intervention, reductions in depression (Cohen's d = 0.71), pain (Cohen's d = 0.62), and fatigue (Cohen's d = 0.26) and improvements in quality of life (Cohen's d = 0.99) were observed when compared to those in the enhanced usual car arm at 6 months. Reductions in IL‐6 (φ = 0.18), IL‐1β (φ = 0.35), IL‐1α (φ = 0.19), and IL‐8 (φ = 0.15) and increases in NK cell numbers (φ = 0.23) were observed in comparison with enhanced usual care arm at 6 months. Reductions in caregiver stress (Cohen's d = 0.75) and depression (Cohen's d = 0.37) were observed at 6 months for caregivers whose loved ones were randomized to the intervention arm. CONCLUSIONS The integration of screening and symptom management into cancer care is recommended. Cancer 2016;122:1270–82 . © 2016 American Cancer Society .

The recent proliferation of information and communications technology standards and their accompanying ad hoc standards bodies could lead to a decentralization of standardization, which will affect privacy and security in the Internet of Things.

The history of modern standards development provides support for the argument that the process of standardization has evolved in response to crises and opportunities. In the information and communication technologies (ICT) sector, many new groups have become involved in standards setting. In a period of rapid change, standards development in these areas has focused primarily on the provision of functionality. That is, there are few overarching roadmaps for development and issues such as security and interoperability are of less concern for many of the new standards developers. In addition, new oversight structures have emerged that appear to be more responsive to the particular needs of developers in the ICT arena. It may be important for nation states to consider assisting in roadmap development in the ICT arena to insure security and privacy issues are addressed such that these increasingly essential systems are less vulnerable.

Objective: E-health applications are becoming integral components of general medical care delivery models and emerging for mental health care. Few exist for treatment of those with severe mental illness (SMI). In part, this is due to a lack of models to design such technologies for persons with cognitive impairments and lower technology experience. This study evaluated the effectiveness of an e-health design model for persons with SMI termed the Flat Explicit Design Model (FEDM). Methods: Persons with schizophrenia ( n = 38) performed tasks to evaluate the effectiveness of 5 Web site designs: 4 were prominent public Web sites, and 1 was designed according to the FEDM. Linear mixed-effects regression models were used to examine differences in usability between the Web sites. Omnibus tests of between-site differences were conducted, followed by post hoc pairwise comparisons of means to examine specific Web site differences when omnibus tests reached statistical significance. Results: The Web site designed using the FEDM required less time to find information, had a higher success rate, and was rated easier to use and less frustrating than the other Web sites. The home page design of one of the other Web sites provided the best indication to users about a Web site’s contents. The results are consistent with and were used to expand the FEDM. Conclusions: The FEDM provides evidence-based guidelines to design e-health applications for person with SMI, including: minimize an application’s layers or hierarchy , use explicit text, employ navigational memory aids, group hyperlinks in 1 area, and minimize the number of disparate subjects an application addresses.

This paper describes a standard education development project that endeavors to provide accessible and engaging modules that can be used in a variety of educations settings. The project looks at the standards process and standards organizations.

9522 Background: According to the NIH consensus statement, the three most common and debilitating symptoms for cancer patients are depression, pain and fatigue. The aims of this study were to test the efficacy of a web-based collaborative care intervention to reduce cancer-related symptoms and improve quality of life in advanced cancer patients. Methods: Patients with advanced cancer were randomized to a web-based stepped collaborative care intervention or usual care arm. The primary outcomes of the intervention included the Center for Epidemiological Studies-Depression (CES-D), Brief Pain Inventory, the Functional Assessment of Cancer Therapy (FACT)-Fatigue, and the FACT-Hepatobiliary. Secondary outcomes included Interleukin (IL)-1b, IL-6 and Natural Killer cells and the Caregiver Quality of Life Index and Caregiver CES-D. An intent to treat analyses was performed and effect sizes were reported using the Cohen’s d (Small<0.20; Medium=0.30-0.70; Large>0.80) or Phi (Small=0.10; Medium=0.30; Large=0.50). Results: A total of 261 patients and 179 caregivers were enrolled in the study. Patients with clinical levels of symptoms, who were randomized to the intervention arm, reported reductions in depression (Cohen’s d=0.32), pain (Cohen’s d=0.74), fatigue (Cohen’s d=0.48) and improvements in quality of life (Cohen’s d =0.38) when compared to patients randomized to the usual care arm at 6-months. Patients randomized to the intervention arm also had reductions in IL-6 (Phi=0.34), IL-1b (Phi=0.38) and increases in NK cell numbers (Phi=0.49). The family caregivers of patients randomized to the intervention arm also had lower levels of stress (Cohen’s d=0.75) and depressive symptoms (Cohen’s d=0.37) when compared to the usual care arm at 6-months. Conclusions: The web-based collaborative care intervention was found to be effective in reducing cancer-related symptoms, immune system dysregulation, and improving quality of life in both the patients and family caregivers. Clinical trial information: NCT01640522.

Introduction There are a variety of approaches to teaching standards. Historically, there have been a number of efforts to include standards as economic tools and much of the very early research on standards was from this perspective. Standards may also be viewed as social efforts to provide for the common good. They may also be viewed as a component of business activity—an approach that has been championed by much of the more recent work in Europe and Asia. Finally, they may be viewed from a “standards” perspective in which various disciplines are combined to study the social dynamics of the process, the technical evolution of the standards and the economic and business impacts of the standards. This article examines an effort at the University of Pittsburgh that was funded by a contract from the National Institute of Standards and Technology (Project 70NANB13H206). We begin with a history of standards education efforts at the University of Pittsburgh and conclude with a description of the effort under the grant.