Patient Navigation Plus Tailored Digital Video Disc Increases Colorectal Cancer Screening Among Low-Income and Minority Patients Who Did Not Attend a Scheduled Screening Colonoscopy: A Randomized Trial.

BACKGROUND: Up to 50% of people scheduled for screening colonoscopy do not complete this test and no studies have focused on minority and low-income populations. Interventions are needed to improve colorectal cancer (CRC) screening knowledge, reduce barriers, and provide alternative screening options. Patient navigation (PN) and tailored interventions increase CRC screening uptake, however there is limited information comparing their effectiveness or the effect of combining them. PURPOSE: Compare the effectiveness of two interventions to increase CRC screening among minority and low-income individuals who did not attend their screening colonoscopy appointment-a mailed tailored digital video disc (DVD) alone versus the mailed DVD plus telephone-based PN compared to usual care. METHODS: Patients (n = 371) aged 45-75 years at average risk for CRC who did not attend a screening colonoscopy appointment were enrolled and were randomized to: (i) a mailed tailored DVD; (ii) the mailed DVD plus phone-based PN; or (iii) usual care. CRC screening outcomes were from electronic medical records at 12 months. Multivariable logistic regression analyses were used to study intervention effects. RESULTS: Participants randomized to tailored DVD plus PN were four times more likely to complete CRC screening compared to usual care and almost two and a half times more likely than those who were sent the DVD alone. CONCLUSIONS: Combining telephone-based PN with a mailed, tailored DVD increased CRC screening among low-income and minority patients who did not attend their screening colonoscopy appointments and has potential for wide dissemination.

Up to half of people scheduled for a screening colonoscopy do not complete this test. There is a need for interventions to improve knowledge about colorectal cancer (CRC) screening, enhance access to screening by offering alternative test options, foster skills for completing screening, and mitigate barriers. The purpose of this study was to compare the effects of two interventions aimed at increasing CRC screening­a mailed tailored digital video disc (DVD) alone versus the mailed DVD plus telephone-based patient navigation (PN)­for patients who had not completed a scheduled screening colonoscopy. We enrolled 371 patients aged 45­75 years who had no CRC risk factors other than age, who were scheduled for a screening colonoscopy but did not attend their appointment. Participants were randomized to receive either: (i) a mailed tailored DVD; (ii) the mailed DVD plus phone-based PN; or (iii) usual care. Those who received the tailored DVD plus PN were four times more likely to complete CRC screening with stool test or colonoscopy compared to usual care. Combining telephone-based PN with a mailed, tailored DVD increased CRC screening among low-income and minority patients who did not attend a scheduled screening colonoscopy appointment.

Characterizing the Effects of Concussion and Head Impact Exposure: Design, Methods, and Participant Traits of the CARE 2.0 Study.

OBJECTIVE: This article describes the design, methods, and participant characteristics of the second phase of the Concussion Assessment, Research, and Education (CARE) Consortium study ("CARE 2.0") of the effects of concussion and repetitive head impact exposure on neuropsychiatric health. METHODS: The authors conducted a prospective multisite observational study of male and female collegiate athletes and military service academy cadets and midshipmen participating in the CARE study. Participants were assessed at three time points: undergraduate baseline (UB), before departure from university or service academy (exit), and up to 6 years following graduation (postgrad) via an online battery of brain health assessments. Participant characteristics were compared across the three time points and four levels of head impact exposure. RESULTS: A total of 4,643 participants completed the exit assessment, and 3,981 completed the postgrad assessment. Relative to the UB assessment cohort, the exit and postgrad assessment cohorts differed with respect to the percentage of women, baseline Wechsler Test of Adult Reading scores, National Collegiate Athletic Association division category, sport contact level, and number of previous concussions. The median standardized difference across balancing variables, assessment time points, and degree of head impact exposure was 0.12 (with 90% of effect sizes ≤0.29). CONCLUSIONS: Although there were some statistically significant differences between participants across assessments, the effect sizes were modest, and overall the data suggest that the exit and postgrad cohorts reflect the characteristics of the baseline cohort. The CARE study design and its large, richly characterized sample provide an opportunity to answer important questions about cumulative and persistent effects of concussion and repetitive head impact exposure on neuropsychiatric health.

Implementation of Research in Community Mental Health Centers: The Challenge of Provider Engagement.

Conducting clinical research in public sector community mental health centers (CMHCs) can be challenging. The purpose of this report is to describe the challenges our research team encountered in engaging CMHC providers in a clinical trial aimed at testing an intervention to improve parent activation and engagement in their child's behavioral healthcare. We discuss the intervention we aimed to test, the challenges we encountered engaging providers, and the barriers to engagement that we identified. The barriers included restrictive inclusion criteria, an ambitious randomized controlled design, a dyadic (provider-parent) recruitment plan, a requirement to record provider-parent sessions, and high day-to-day practice demands on providers. The strategies we used to address the barriers and a discussion of the "trade-offs" these strategies introduced are presented. Improving provider engagement in research in CMHCs can avoid research delays or termination of studies and ultimately mitigate an early blockage in the research-to-practice pipeline.

Factors associated with change in activities of daily living performance in home health care patients with diabetes.

Older adults with diabetes are at risk for impairments in activities of daily living (ADL) performance. Home health (HH) services help patients regain their ability to perform ADLs following hospitalization, but there may be disparities in ADL improvement. We aimed to identify factors associated with change in ADL performance from the start of HH care to discharge in HH patients with diabetes age ≥65. This secondary analysis used Outcome and Assessment Information Set-D data collected by a HH agency. The sample (n = 1350) had a mean age of 76.3 (SD 7.3). Black/African American race and bowel incontinence/ostomy were associated with less ADL improvement. The following factors were associated with greater ADL improvement: having a caregiver who needed training/support, surgical wounds, pain that interfered with activity, confusion, and better scores in prior functioning. Overall, most patients improved their ADL performance while receiving HH care, but there are disparities that should be addressed.

A phase 2 trial of chemotherapy plus pembrolizumab in patients with advanced non-small cell lung cancer previously treated with a PD-1 or PD-L1 inhibitor: Big Ten Cancer Research Consortium BTCRC-LUN15-029.

BACKGROUND: Immunotherapy using a checkpoint inhibitor (CPI) alone or in combination with chemotherapy is the standard of care for treatment-naive patients with advanced non-small cell lung cancer (NSCLC) without driver mutations for which targeted therapies have been approved. It is unknown whether continuing CPI treatment beyond disease progression results in improved outcomes. METHODS: Patients who experienced progressive disease (PD) after a clinical benefit from chemotherapy plus a CPI were enrolled. Patients received pembrolizumab (200 mg every 3 weeks) plus next-line chemotherapy. The primary end point was progression-free survival (PFS) according to the Response Evaluation Criteria in Solid Tumors (version 1.1). Key secondary end points included the overall survival (OS), clinical benefit rate, and toxicity. The authors' hypothesis was that continuing pembrolizumab beyond progression would improve the median PFS to 6 months in comparison with a historical control of 3 months with single-agent chemotherapy alone. RESULTS: Between May 2017 and February 2020, 35 patients were enrolled. The patient and disease characteristics were as follows: 51.4% were male; 82.9% were current or former smokers; and 74.3%, 20%, and 5.7% had adenocarcinoma, squamous cell carcinoma, and NSCLC not otherwise specified, respectively. The null hypothesis that the median PFS would be 3 months was rejected (p < .05). The median PFS was 5.1 months (95% confidence interval [CI], 3.6-8.0 months). The median OS was 24.5 months (95% CI, 15.6-30.9 months). The most common treatment-related adverse events were fatigue (60%), anemia (54.3%), and nausea (42.9%). There were no treatment-related deaths. CONCLUSIONS: Pembrolizumab plus next-line chemotherapy in patients with advanced NSCLC who experienced PD after a clinical benefit from a CPI was associated with statistically significant higher PFS in comparison with historical controls of single-agent chemotherapy alone.

Promoting childbirth in a rural health facility: A quasi-experimental study in western Kenya.

BACKGROUND: The high maternal and neonatal mortality rate in sub-Saharan Africa could be reduced by using navigation by means of mobile devices to increase the number of women who choose to give birth in a health center (HC) with a skilled healthcare practitioner. METHODS: A quasi-experimental design was used to test a midwife-delivered navigation by means of mobile phone. A total of 208 women were randomized to two groups (intervention and control). Women in the intervention group received up to three navigation calls from midwives. Women in the control group received usual antenatal education during prenatal visits. Data were collected using semistructured questionnaires. Childbirth location was determined through medical records. RESULTS: Overall, 180 (87%) women gave birth in a HC with a 3% advantage for the intervention group. A total of 86% (88/102) of the control group gave birth in a HC versus 89% (92/103) for the intervention group (Χ2 = 0.44, p-value = 0.51), with an unadjusted odds ratio of 1.33 (95% CI: 0.57, 3.09). Among those with personal phones, 91% (138/152) had a birth in a HC versus 79% (42/53) in those without a personal phone (Χ2 = 4.89, p-value = 0.03). CONCLUSIONS: The results of this study indicate that it is feasible to deliver phone-based navigation to support birth in a HC; personal phone ownership may be a factor in the success of this strategy.

Risk factors for inpatient facility admission among home health care patients with diabetes.

BACKGROUND: Home health care (HHC) patients with diabetes are at high risk for inpatient admissions. PURPOSE: To identify variables associated with inpatient admissions among adults age ≥50 with diabetes receiving HHC in the community and in assisted living (AL). METHODS: Retrospective HHC data (collected October 2021 to March 2022 in the Southern United States) from the Outcome and Assessment Information Set D were analyzed with logistic regression (n = 5,308 patients). DISCUSSION: The inpatient admission rate was 29.5%. For community-dwelling patients, multiple hospitalizations, depression, limited cognitive function, decreased activities of daily living (ADL) performance, and unhealed pressure ulcer or injury ≥stage 2 were significantly associated with inpatient admission. For those in AL, multiple prior hospitalizations and decreased ability to perform ADLs were associated with inpatient admission. CONCLUSION: Understanding risk factors for inpatient admissions among patients with diabetes can support the identification of at-risk patients and inform interventions.

Ranking Important Factors for Using Postoperative Chemotherapy in Nonmuscle Invasive Bladder Cancer: Conjoint Analysis Results From the Michigan Urological Surgery Improvement Collaborative (MUSIC).

PURPOSE: National and international guidelines recommend the use of 1 dose of intravesical chemotherapy immediately following surgery for nonmuscle invasive bladder cancer, which is performed infrequently on a population level. We sought to understand the importance of potential environmental and clinical dimensions involved in the decision to offer this therapy. MATERIALS AND METHODS: Urologists from the Michigan Urological Surgery Improvement Collaborative (MUSIC) rated 8 distinct clinical vignettes involving patients with nonmuscle invasive bladder cancer. A ratings-based conjoint analysis method was used to evaluate the clinical vignette responses. Each vignette included 4 clinical dimensions and 2 environmental dimensions, with each dimension consisting of 2 possible attributes. The relative importance of each attribute was derived from the regression model and ranked in order. RESULTS: A total of 58 urologists answered the clinical vignettes which represents >75% of MUSIC sites. The median age of urologists was 53, most were male, and median years in practice was 20 years post residency. An environmental attribute, having a recovery room protocol for instilling and disposing of the chemotherapy, ranked as the most influential attribute for giving postoperative chemotherapy (utility=8.6). The clinical attribute yielding the strongest preference for giving chemotherapy was tumor grade (utility=4.9). These preferences varied by different subgroups of urologists, particularly regarding the type of practice a urologist was in. CONCLUSIONS: This study demonstrates that urologists have clear preferences for when they offer postoperative immediate chemotherapy. Factors beyond just clinical variables play a role in this decision making process such as the structure of the recovery room.

Hyperglycemia, symptoms, and symptom clusters in colorectal cancer survivors with type 2 diabetes.

PURPOSE: The purpose of the study was to compare the individual and total number of symptoms and explore symptom clusters by hyperglycemia status in colorectal cancer survivors (CRCS) with diabetes (type 2). METHODS: A retrospective cohort study was conducted, whereby symptom data were extracted from clinical notes in electronic health records. CRCS (stage II or III) diagnosed between 2007 and 2017 who had diabetes and at least one HbA1c within 8 months of initial chemotherapy were included. Zero-inflated negative binomial regression analysis was used to examine total symptoms by hyperglycemia status (hyperglycemia versus no hyperglycemia). Exploratory factor analysis was conducted to identify symptom clusters. RESULTS: Two hundred forty-three CRCS met inclusion criteria. CRCS with hyperglycemia (HbA1c ≥ 6.5%) had greater individual symptoms (fatigue and depression) and total number of symptoms than those with no hyperglycemia. Two distinct symptom clusters, with five (nausea, vomiting, constipation, fatigue, and peripheral neuropathy) and two symptoms (anxiety and depression), were identified among CRCS with hyperglycemia. CONCLUSION: These findings indicate that CRCS with diabetes and hyperglycemia had more symptoms and two distinct symptom clusters compared to those with no hyperglycemia. Prospective research studies are needed to examine the role of hyperglycemia in symptoms among CRCS with diabetes. Understanding hyperglycemia's influence is important as it is a modifiable risk factor towards which prevention and intervention can be directed, potentially mitigating symptoms and symptom clusters and improving outcomes for CRCS with diabetes.

Process Evaluation of a Mailed Interactive Educational DVD in a Comparative Effectiveness Trial to Promote Colorectal Cancer Screening.

A process evaluation was conducted as part of a comparative effectiveness trial of a mailed interactive educational DVD intervention to promote colorectal cancer screening among average-risk patients who did not attend a scheduled colonoscopy. Participants (n = 371) for the trial were randomized to (1) mailed DVD, (2) mailed DVD plus patient navigation, or (3) usual care. Participants (n = 243) randomized to the two DVD intervention arms were called 2 weeks after mailing materials to complete a process evaluation interview about the DVD (September 2017-February 2020). Forty-nine (20%) participants were not reached, and 194 (80%) participants watched the DVD and completed the interview. The process evaluation assessed whether (1) the DVD content was helpful, (2) any new information was learned by participants, (3) the appropriate amount of information was included in the DVD, (4) participants were engaged when watching the DVD, (5) the DVD content was relevant, (6) participants were satisfied with the DVD (7) participants would recommend the DVD to others, and (8) their opinion about colorectal cancer screening was changed by watching the DVD. Among participants who watched the DVD, 99% reported the screening information was very or somewhat helpful, 47% learned new information, 75% said the DVD included the right amount of information, they were engaged (M = 3.35 out of 4, SD = 0.49), 87% reported all or most information applied to them, they were satisfied (M = 3.42 out of 4, SD = 0.39) with DVD content, 99% would recommend the DVD to others, and 45% reported changing their opinion about screening. To understand the effects of interventions being tested in trials and to plan the dissemination of evidence-based interventions, process evaluation is critical to assess the dose received and acceptability of behavioral interventions.

Phase II trial of brentuximab vedotin in relapsed/refractory germ cell tumors.

Background CD-30 is highly expressed in some patients with non-seminomatous germ-cell tumors. Brentuximab vedotin is an antibody-drug conjugate directed to CD-30. We report a phase 2 trial of brentuximab vedotin in patients with chemo-refractory GCT. Patients and methods This is a single arm, two cohort phase 2 trial investigating brentuximab vedotin 1.8 mg/kg IV every 3 weeks until disease progression or intolerable toxicities in patients with relapsed GCT who have no curative options. Patients with mGCT who progressed after first line cisplatin-based chemotherapy and after at least 1 salvage regimen (high-dose or standard-dose chemotherapy) were eligible. CD30 expression was assessed and two cohorts defined: CD30 positive and CD30 negative/unknown. Results 18 patients were enrolled. Median age 34.7 (range, 23-56). All patients had non-seminoma. Median AFP 4.9 (range, 1-219,345) and hCG 282 (range, 0.6-172,064). Five patients had late relapse (> 2 years). Median number of previous chemotherapy regimens was 3 (range, 2-7). Ten patients received prior high-dose chemotherapy. Seven patients had positive CD30 staining. There were two grade 3 treatment-related adverse events. No partial or complete responses were observed. 6 patients achieved radiographic stable disease (range, 9-14.9 weeks), 5 had elevated AFP or hCG at trial entry and all 5 had transient > 50% decline in baseline AFP/hCG: 4 had CD30 -ve and 2 had CD30 + ve staining; 10 patients had progression of disease as their best response; 2 were not evaluable for response. Conclusion Brentuximab vedotin does not appear to have clinically meaningful single-agent activity in patients with refractory GCT.

Computer-tailored intervention increases colorectal cancer screening among low-income African Americans in primary care: Results of a randomized trial.

INTRODUCTION: Although African Americans have the highest colorectal cancer (CRC) incidence and mortality rates of any racial group, their screening rates remain low. STUDY DESIGN/PURPOSE: This randomized controlled trial compared efficacy of two clinic-based interventions for increasing CRC screening among African American primary care patients. METHODS: African American patients from 11 clinics who were not current with CRC screening were randomized to receive a computer-tailored intervention (n = 335) or a non-tailored brochure (n = 358) designed to promote adherence to CRC screening. Interventions were delivered in clinic immediately prior to a provider visit. Univariate and multivariable logistic regression models analyzed predictors of screening test completion. Moderators and mediators were determined using multivariable linear and logistic regression analyses. RESULTS: Significant effects of the computer-tailored intervention were observed for completion of a stool blood test (SBT) and completion of any CRC screening test (SBT or colonoscopy). The colonoscopy screening rate was higher among those receiving the computer-tailored intervention group compared to the nontailored brochure but the difference was not significant. Predictors of SBT completion were: receipt of the computer-tailored intervention; being seen at a Veterans Affairs Medical Center clinic; baseline stage of adoption; and reason for visit. Mediators of intervention effects were changes in perceived SBT barriers, changes in perceived colonoscopy benefits, changes in CRC knowledge, and patient-provider discussion. Moderators of intervention effects were age, employment, and family/friend recommendation of screening. CONCLUSION: This one-time computer-tailored intervention significantly improved CRC screening rates among low-income African American patients. This finding was largely driven by increasing SBT but the impact of the intervention on colonoscopy screening was strong. Implementation of a CRC screening quality improvement program in the VA site that included provision of stool blood test kits and follow-up likely contributed to the strong intervention effect observed at that site. The trial is registered at ClinicalTrials.gov as NCT00672828.

Negative Attribution Bias and Related Risk Factors After Brain Injury.

OBJECTIVE: In participants with traumatic brain injury (TBI) and peer controls, examine (1) differences in negative attributions (interpret ambiguous behaviors negatively); (2) cognitive and emotional factors associated with negative attributions; and (3) negative attribution associations with anger responses, life satisfaction, and participation. SETTING: Two TBI outpatient rehabilitation centers. PARTICIPANTS: Participants with complicated mild to severe TBI (n = 105) and peer controls (n = 105). DESIGN: Cross-sectional survey study. MAIN MEASURES: Hypothetical scenarios describing ambiguous behaviors were used to assess situational anger and attributions of intent, hostility, and blame. Executive functioning, perspective taking, emotion perception and social inference, alexithymia, aggression, anxiety, depression, participation, and life satisfaction were also assessed. RESULTS: Compared with peer controls, participants with TBI rated behaviors significantly more intentional, hostile, and blameworthy. Regression models explained a significant amount of attribution variance (25%-43%). Aggression was a significant predictor in all models; social inference was also a significant predictor of intent and hostility attributions. Negative attributions were associated with anger responses and lower life satisfaction. CONCLUSION: People with TBI who have higher trait aggression and poor social inferencing skills may be prone to negative interpretations of people's ambiguous actions. Negative attributions and social inferencing skills should be considered when treating anger problems after TBI.

Associations between COVID-19 perceptions, anxiety, and depressive symptoms among adults living in the United States.

BACKGROUND: Associations among illness perceptions of viruses, anxiety and depression symptoms, and self-management decisions, such as mask-wearing, are critical to informing public health practices to mitigate the short- and long-term consequences of the SARS-CoV-2 viral pandemic. PURPOSE: Guided by the common-sense model of self-regulation, this observational study examined associations among illness perceptions of COVID-19, anxiety, and depression symptoms among community-dwelling adults. METHOD: Data were collected from 1380 adults living in the United States early in the pandemic (03-23-2020 to 06-02-2020). Participants completed online surveys. Analyses were conducted using descriptive statistics and correlations. FINDINGS: While increased anxiety symptoms were associated with less perceived personal control, greater concern, and higher emotional responsiveness, increased depression symptoms were related to lower concern as well as greater emotional responsiveness and perceived consequences of the pandemic. DISCUSSION: Associations among illness perceptions, anxiety, and depression symptoms may impact viral spread mitigation behavior adoption.

Assessing Negative Attributions After Brain Injury With the Ambiguous Intentions Hostility Questionnaire.

OBJECTIVES: (1) To explore the construct validity of the Ambiguous Intentions Hostility Questionnaire (AIHQ) in participants with traumatic brain injury (TBI) (ie, confirm negative attributions are associated with anger and aggression); and (2) use the AIHQ to examine negative attribution differences between participants with and without TBI. SETTING: Two rehabilitation hospitals. PARTICIPANTS: Eighty-five adults with TBI and 86 healthy controls (HCs). DESIGN: Cross-sectional survey. MAIN MEASURES: The AIHQ, a measure of negative attributions (intent, hostility, and blame), anger, and aggressive responses to hypothetical scenarios. RESULTS: Attributions were significantly correlated with anticipated anger and aggressive responses to AIHQ scenarios. Compared with HCs, participants with TBI reported stronger negative attributions (P ≤ .001), anger (P = .021), and aggressive responses (P = .002) to the scenarios. CONCLUSION: Negative attributions were associated with anger and aggression responses, demonstrating construct validity of the AIHQ in the TBI population. Participants with TBI judged others' behaviors more severely than HCs, similar to prior research using a different attribution measure. The AIHQ has promise as a practical instrument for assessing negative attributions after TBI.

Phase 1 study of EUS-guided photodynamic therapy for locally advanced pancreatic cancer.

BACKGROUND AND AIMS: Locally advanced pancreatic cancer (LAPC) has a poor prognosis. There are limited data describing the use of photodynamic therapy (PDT) for pancreatic cancer in humans. We hypothesized that EUS-guided PDT for LAPC is safe, technically feasible, and produces a dose- and time-dependent increasing degree of image-defined tumor necrosis. METHODS: In a single-center, prospective, dose-escalation phase 1 study, patients with treatment-naïve LAPC received intravenous porfimer sodium (Concordia Laboratories Inc, St Michael, Barbados) followed 2 days later by EUS-PDT. EUS-PDT was performed by puncture with a 19-gauge needle and insertion of a 1.0-cm light diffuser (Pioneer Optics, Bloomfield, Conn) and illumination with a 630-nm light (Diomed Inc, Andover, Mass). A CT scan 18 days after PDT was done to assess for change in pancreatic necrosis. Nab-paclitaxel (125 mg/ m2 intravenously) and gemcitabine (1000 mg /m2 intravenously) were initiated 7 days after CT and given weekly for 3 of 4 weeks (1 cycle) until disease progression or unacceptable toxicity. RESULTS: Twelve patients (mean age, 67 ± 6 years; 8 male) with tumors (mean diameter, 45.2 ± 12.9 mm) in the head and/or neck (8) or body and/or tail (4) underwent EUS-PDT. Compared with baseline imaging, increased volume and percentage of tumor necrosis were observed in 6 of 12 patients (50%) after EUS-PDT. The mean overall increases in volume and percentage necrosis were 10 ± 26 cm3 (P = .20) and 18% ± 22% (P = .016), respectively. After a median follow-up of 10.5 months (range, 1.0-37.4 months), median progression-free (PFS) and overall survival (OS) were 2.6 months (95% confidence interval, 0.7, not estimable) and 11.5 months (95% confidence interval, 1.1, 16.9), respectively. Surgical resection was attempted in 2 patients, and pathology showed a complete response (n = 1) and residual 2-mm tumor (n = 1). There were 8 serious adverse events and none related to EUS or EUS-PDT. CONCLUSION: EUS-PDT for LAPC appears to be safe and produces measurable imaged-defined tumor necrosis. Phase 2 studies are warranted. (Clinical trial registration number: NCT01770132.).

Plasma-derived proteomic biomarkers in human leukocyte antigen-haploidentical or human leukocyte antigen-matched bone marrow transplantation using post-transplantation cyclophosphamide.

Recent studies have suggested that plasma-derived proteins may be potential biomarkers relevant for graft-versus-host disease and/or non-relapse mortality occurring after allogeneic blood or marrow transplantation. However, none of these putative biomarkers have been assessed in patients treated either with human leukocyte antigen-haploidentical blood or marrow transplantation or with post-transplantation cyclophosphamide, which has been repeatedly associated with low rates of severe acute graft-versus-host disease, chronic graft-versus-host disease, and non-relapse mortality. We explored whether seven of these plasma-derived proteins, as measured by enzyme-linked immunosorbent assays, were predictive of clinical outcomes in post-transplantation cyclophosphamide-treated patients using plasma samples collected at serial predetermined timepoints from patients treated on prospective clinical studies of human leukocyte antigen-haploidentical (n=58; clinicaltrials.gov Identifier: 00796562) or human leukocyte antigen-matched-related or -unrelated (n=100; clinicaltrials.gov Identifiers: 00134017 and 00809276) T-cell-replete bone marrow transplantation. Day 30 levels of interleukin-2 receptor α, tumor necrosis factor receptor 1, serum STimulation-2 (IL1RL1 gene product), and regenerating islet-derived 3-α all had high areas under the curve of 0.74-0.97 for predicting non-relapse mortality occurrence by 3 months post-transplant in both the human leukocyte antigen-matched and human leukocyte antigen-haploidentical cohorts. In both cohorts, all four of these proteins were also predictive of subsequent non-relapse mortality occurring by 6, 9, or 12 months post-transplant and were significantly associated with non-relapse mortality in univariable analyses. Furthermore, day 30 elevations of interleukin-2 receptor α were associated with grade II-IV and III-IV acute graft-versus-host disease occurring after day 30 in both cohorts. These data confirm that plasma-derived proteins previously assessed in other transplantation platforms appear to retain prognostic and predictive utility in patients treated with post-transplantation cyclophosphamide.

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

Objectives: To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. Methods: A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n = 9) or attention control ( n = 7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Results: Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Conclusions: Despite child benefit, findings do not support parent delivery of AME + P.

Potential Impact of Amantadine on Aggression in Chronic Traumatic Brain Injury.

OBJECTIVE: To assess the effects of amantadine on anger and aggression among individuals with a chronic traumatic brain injury (TBI). METHODS: A cohort of 118 persons with chronic TBI (>6 months postinjury) and moderate-severe aggression selected from a larger cohort of 168 participants enrolled in a parallel-group, randomized, double-blind, placebo-controlled trial of amantadine 100 mg twice daily (n = 82) versus placebo (n = 86) for treatment of irritability were studied. Anger and aggression were measured at treatment days 0, 28, and 60 using observer-rated and participant-rated State-Trait Anger Expression Inventory-2 (STAXI-2) and Neuropsychiatric Inventory-Agitation/Aggression domain (NPI-A) Most Problematic and Distress scores. RESULTS: Participant-rated day 60 NPI-A Most Problematic (adjusted P = .0118) and NPI-A Distress (adjusted P = .0118) were statistically significant between the 2 groups, but STAXI-2 differences were not significant after adjustment for multiple comparisons. Substantial improvements were noted in both amantadine and placebo groups (70% vs 56% improving at least 3 points on day 60 Observer NPI-A; P = .11). CONCLUSION: Amantadine 100 mg twice daily in this population with chronic TBI appears to be beneficial in decreasing aggression from the perspective of the individual with TBI. No beneficial impact on anger was found. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00779324; http://www.clinicaltrials.gov/ct2/show/NCT00779324?term=irritability&rank=6.

Evaluation of interprofessional relational coordination and patients' perception of care in outpatient oncology teams.

This pilot study was designed to measure teamwork and the relationship of teamwork to patient perceptions of care among 63 members of 12 oncology teams at a Cancer Centre in the Midwest. Lack of teamwork in cancer care can result in serious clinical errors, fragmentation of care, and poor quality of care. Many oncology team members, highly skilled in clinical care, are not trained to work effectively as members of a care team. The research team administered the Relational Coordination survey to core oncology team members-medical oncologists, nurse coordinators, and clinical secretaries-to measure seven dimensions of team skills (four relating to communication [frequency, timeliness, accuracy, and problem solving] and three relating to relationship [shared goals, shared knowledge, and mutual respect]) averaged to create a Relational Coordination Index. The results indicated that among the team member roles, nurse coordinator relational coordination indices were the strongest and most positively correlated with patient perception of care. Statistically significant correlations were intra-nurse coordinator relational coordination indices and two patient perception of care factors (information and education and patient's preferences). All other nurse coordinator intra-role as well as inter-role correlations were also positively correlated, although not statistically significant.