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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 11519-11519
    Abstract: 11519 Background: Doxorubicin has been the traditional standard therapy for treatment of advanced soft tissue sarcoma (STS). The addition of cytotoxic agents leads to increased toxicity with minimal improvement in efficacy. Pembrolizumab monotherapy has demonstrated activity and tolerability in previous study of advanced STS. This study combined pembrolizumab with doxorubicin to determine safety and efficacy in the frontline setting. Methods: This single-center, single-arm, phase 2 trial enrolled subjects with unresectable or metastatic STS and no prior anthracycline therapy. Subjects were treated with pembrolizumab 200 mg IV and doxorubicin 60 mg/m2 (75 mg/m2 dose escalation per investigator discretion) IV every 3 weeks. The primary endpoint of safety, based on Bayesian stopping rules, evaluated if the severe or life-threatening treatment emergent adverse event (TEAE) rate exceeded 0.55. Secondary endpoints included overall survival (OS), objective response rate (ORR), and progression free survival (PFS). Efficacy and safety were based on RECIST 1.1 and CTCAE v 4.0, respectively. Kaplan-Meier methods evaluated time to event outcomes. Results: From 4/2017 to 12/2019, 30 subjects (53% female, median age 61.5 years, 10 patients 〉 70 years (33%)) were enrolled in the study with 6 (20%) patients still on treatment and 27 evaluable for response. The most common histologic subtypes were leiomyosarcoma (33%) and liposarcoma (23%), and a majority of patients demonstrated high grade disease (60%). Current analysis shows a median follow-up of 9.9 months. One subject experienced a stopping rule event (grade 3 autoimmune disorder). ORR was 33% (95% CI 17-54%), with documented disease control in 78% (95% CI 57.7-91.4%) of patients. Eight (30%) patients achieved a partial response, one (4%) patient achieved a complete response and 12 (44%) patients had stable disease. Preliminary results demonstrate median PFS of 6.9 months (PFS-6 mo: 52%) and median OS of 15 months (OS-6 mo: 81%) compared to historical PFS-6mo of 4.6 months and OS of 12.8 months with doxorubicin alone. 1 Most common grade 3+ TEAEs included neutropenia (11 [37%]), febrile neutropenia (6 [20%] ), anemia (5 [17%]), and nausea (4 [13%] ). Molecular and biomarker analysis is currently in progress. Conclusions: The combination of pembrolizumab with doxorubicin has manageable toxicity and preliminary promising activity in the treatment of anthracycline-naive advanced soft tissue sarcomas. Ref: 1. Lancet Oncol. 2014 Apr; 15(4):415-23. Clinical trial information: NCT03056001 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 28_suppl ( 2022-10-01), p. 391-391
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 391-391
    Abstract: 391 Background: While there was broad adoption of telemedicine during the COVID-19 pandemic, optimizing the interaction for patients and the clinical team remained a challenge. We sought to optimize delivery of telemedicine services to provide more efficient and effective patient care. Target areas of concern for improvement were scheduling, staffing, communication, technical challenges with operating the platform, a high cancellation rate, and limited copay collections. Methods: A team of 8 virtual Patient Service Coordinators (VPSCs), 8 virtual Medical Assistants (VMAs), and an RN clinical manager was created to work remotely from home to serve Providers at 8 clinics. VPSCs performed check-in duties, demographics, copay collection and technology trouble-shooting with patients. VMAs performed medical intake (medication reconciliation, depression screenings, and vital signs) with real-time EMR input. VMAs stayed in-touch with patients to communicate Provider delays. Standardized communication pathways connected virtual teams with in-clinic teams. The clinics selected to participate in the TMS program were conducting 29% - 50% of E & M visits by telemedicine. The goal of the TMS program was to reduce stress and burnout, as well as relieve in-clinic staff of telemedicine duties giving them capacity to address in-clinic COVID related staff shortages. Results: The TMS Program supported 15,500 visits (11/15/21 – 5/31/22) and increased upfront expected copay collection from 9% pre-program to 100% post program. The program reduced the time for first contact on video from 18 minutes to 1 minute and reduced the telemedicine cancellation rate by 3%. The supported TM cancellation rate was 7% lower than in-person visit cancellation rate. A geographically distributed work from home team was able to support a 66% increase in visits during inclement weather days which allowed visits to be completed that would have otherwise been canceled due to clinic closures. Additionally, the TMS program relieved workload for in-clinic staff and the VPSC and VMA positions proved highly desirable to the eligible workforce. Conclusions: The TMS Program improved patient connectivity and experience, increased upfront co-pay collection, decreased burden on in-clinic staff, allowed continuity of care during inclement weather, and was an attractive work option for staff. Due to its success, the program moved past pilot phase into an operational program.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 12103-12103
    Abstract: 12103 Background: Among patients receiving chemotherapy, symptomatic adverse event monitoring with electronic patient-reported outcomes (ePRO) is associated with improved clinical outcomes, satisfaction, and compliance with therapy. Standard approaches for ePRO implementation are not established warranting evaluation in community cancer practices. Objective: Evaluate implementation of ePRO symptom monitoring across a large multi-site community oncology practice network. Methods: Patients initiating a new systemic therapy at one of 210 practice sites in the Texas Oncology Practice were invited to use in the Navigating Cancer ePRO platform, with rolling implementation from July-December 2020. Participating patients received a weekly prompt by text message or email (patient choice) to self-report common symptoms and well-being via web or smartphone. Severe self-reported symptoms triggered a real-time notification alert to nursing triage to address the symptom. Enrollment and compliance were systematically tracked weekly with evaluation of barriers and facilitators to adoption and sustainability. Results: 4375 patients planning systemic treatment enrolled and participated, with baseline characteristics are shown in Table 1. 73% (1841/2522) of enrolled patients with follow up completed at least one ePRO assessment, and among these individuals, 65% (8762/25061) of all available weekly ePRO assessments were completed. Over a 10-week period, compliance with weekly symptom reporting declined from 72% to 52%. Patients on oral therapy had higher compliance rates overall. Barriers currently being addressed include lack of a second reminder text/email prompt, inconsistent discussion of reported ePROs by clinicians at visits, and COVID-related changes in workflow. Facilitators included patient and staff engagement on the importance of PROs for symptom management. Conclusions: ePROs can be effectively implemented in community oncology practice. Utilization of ePROs is high, but diminishes over time without attention to barriers. Ongoing work to address barriers and optimize compliance are underway.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 1507-1507
    Abstract: 1507 Background: There is a priority to accelerate the delivery of digital health solutions (DHS) to provide patients with enhanced means for accessing care, but lack of understanding of their utility in certain populations. There are concerns that equitable adoption translate into disparities. We sought to implement a portfolio of DHS across a large practice and characterize engagement across populations to enhance clinical informatics solutions that support care delivery. Methods: This is a retrospective evaluation of cancer patients who engaged with a portfolio of DHS between March 1, 2019 and January 15, 2022. We included four tools with opt-in and opt-out functionality: (1) a care management (CM) platform utilized by clinical staff to manage patient activities, (2) an electronic patient-reported outcomes (ePRO) remote monitoring program for tracking symptoms and oral adherence, (3) a patient portal (PP) for securely accessing patient health records, and (4) digital education (DE) for patients regarding disease and treatments. The engaged population was defined as the number of enrolled patients with at least one (1) record of triage activity, (2) completed ePRO assessment, (3) PP login, and (4) DE read activity, for each tool, respectively. The start of the index period was adjusted based on the first go-live date of each tool. We evaluated factors (age, gender, race/ethnicity, preferred-language, marital status, and distance from clinic) associated with patient engagement using Chi-Square test and multivariate logistic regression. Results: This analysis included a total of 267,375 unique patients. Of the enrolled population per tool, 172,840 (73.6%), 9,938 (67.7 %), 49,771 (79.2%), and 12,044 (56.9%) patients were engaged in CM, ePRO, PP and DE, respectively. The majority ( 〉 50%) of engaged patients were female, White and non-Hispanic/Latino, English-language, and aged 61-80 yrs. After adjusting for covariates, we observed that White and non-Hispanic/Latino [(CM: OR 1.15, ePRO OR 1.46, PP: OR 1.48, and DE: OR 1.36) and English-language (CM: OR 1.2, ePRO OR 1.67, PP: OR 1.8 and DE: OR 1.89) patients were significantly (p-value 〈 0.001) more engaged compared to their counterparts. Male patients were less likely to be engaged in CM (OR: 0.79) and ePRO (OR: 0.65) but more engaged in PP (OR: 1.1) compared to females. No significant difference was observed in engagement between non-rural ( 〈 20 mile) vs. rural (≥ 20 miles) and in all age groups 21-40, 41-60, 61-80 and 〉 80 years as compared to reference age of 0-20 years for any digital tools except CM. Conclusions: DHS can be used to support the cancer patient journey and we demonstrated high utilization in an array of sociodemographic variables in our population. However, tools designed and implemented with different populations in mind to reduce staff burden and lessen the digital divide should be further explored.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 23 ( 2022-08-10), p. 2612-2635
    Abstract: To update evidence-based guideline recommendations to practicing oncologists and others on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer. METHODS An Expert Panel conducted a targeted systematic literature review (for both systemic treatment and CNS metastases) and identified 545 articles. Outcomes of interest included efficacy and safety. RESULTS Of the 545 publications identified and reviewed, 14 were identified to form the evidentiary basis for the guideline recommendations. RECOMMENDATIONS HER2-targeted therapy is recommended for patients with HER2-positive advanced breast cancer, except for those with clinical congestive heart failure or significantly compromised left ventricular ejection fraction, who should be evaluated on a case-by-case basis. Trastuzumab, pertuzumab, and taxane for first-line treatment and trastuzumab deruxtecan for second-line treatment are recommended. In the third-line setting, clinicians should offer other HER2-targeted therapy combinations. There is a lack of head-to-head trials; therefore, there is insufficient evidence to recommend one regimen over another. The patient and the clinician should discuss differences in treatment schedule, route, toxicities, etc during the decision-making process. Options include regimens with tucatinib, trastuzumab emtansine, trastuzumab deruxtecan (if either not previously administered), neratinib, lapatinib, chemotherapy, margetuximab, hormonal therapy, and abemaciclib plus trastuzumab plus fulvestrant, and may offer pertuzumab if the patient has not previously received it. Optimal duration of chemotherapy is at least 4-6 months or until maximum response, depending on toxicity and in the absence of progression. HER2-targeted therapy can continue until time of progression or unacceptable toxicities. For patients with HER2-positive and estrogen receptor–positive or progesterone receptor–positive breast cancer, clinicians may recommend either standard first-line therapy or, for selected patients, endocrine therapy plus HER2-targeted therapy or endocrine therapy alone. Additional information is available at www.asco.org/breast-cancer-guidelines .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 6
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 28_suppl ( 2022-10-01), p. 390-390
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 390-390
    Abstract: 390 Background: In our team-based approach to care delivery, Advanced Practice Providers (APPs) are a critical component of the care delivery team. In our statewide oncology practice APPs are not available at each site, limiting our ability to provide program visits that enhance patient care and limiting our flexible staffing capacity. APP program visits - Advance Care Planning (ACP), Treatment Review and Coordination (TRC) and Genetics – had limited availability due to the capacity of existing APP staff. We sought to provide both enhancements in patient care with program visits and offer flexible staffing capacity across our statewide practice by using a centralized virtual care clinic model providing high quality specialty care via Telemedicine. Methods: Four APPs were identified and trained to provide full-time telemedicine services statewide under a single collaboration agreement with the Virtual APP Medical Director. Local sites went through a brief onboarding process with the Virtual APP clinic and then submitted requests for appointment coverage by the Virtual APP (VAPP) team. The VAPPs had the same core oncology training, with a few differentiated skills which were matched with coverage requests aligning with their skill sets. To ensure continuity of care, virtual APP clinic notes were visible statewide in the practice EHR, and local providers were alerted by chart message of significant patient concerns. Results: In the first 3 months of service, the VAPPs completed 1,040 appointments for 12 clinics. The VAPPs conducted 50% Program visits and 50% established patient visits (follow-up, on treatment and urgent care). Conducting the Program visits virtually allowed patients to invite family members from any location to join the appointments virtually. The Urgent Care capability was not used frequently in the first 90 days of service, but may still grow in the future. Conclusions: The Virtual APP program ensured oncology patients received high quality, timely care through 1,040 completed visits. This prevented delays in care, resolved staffing challenges, expanded care, and supports virtual care in oncology. This program ensures APPs are available when and where needed and allows them to efficiently serve multiple clinics. The VAPPs provided education, assessment, prevention, and management of toxicities in a flexible manner.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 28_suppl ( 2022-10-01), p. 297-297
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 297-297
    Abstract: 297 Background: Investments in infrastructure to enhance care delivery are often partnered with practice participation in alternative payment model contracts and innovative care delivery models. Oncology nurses routinely are physically located in a cancer practice. We sought to understand the impact of centralizing resources to work remotely building upon triage pathways already in place on staffing and symptom call resolution with the goal of optimizing outpatient symptom management and patient satisfaction. Due to a national RN shortage and a historical high number of RN vacancies in oncology, we thought this this innovative staffing solution may attract, retain, and elevate the role of RNs. Methods: A needs assessment was conducted to evaluate call volumes, staff levels and duties. A gap analysis was performed to determine which duties would be assigned to remote triage versus in person staffing. Some sites had triage; all sites upgraded to new optimization of assessment and management. Standardized evidence based care and communication pathways were implemented. RNs were trained to follow structured workflows for call ticket resolution. A regional pool supported primary triage RNs who were assigned to each site. The model allowed for flexible staffing while building and maintaining relationships with local providers. Additionally, remote triage RNs were given the opportunity to augment their assessment with audio/visual telehealth as needed. Results: In the first 4 months, 9 pilot sites decreased symptom management time by 50%; 1 site decreased by 70% (over 120 minutes down to 27 minutes). Since remote triage began, average resolution times reduced from 2.52 hours to 1.31 hours. One pilot site had an in-person triage position posted and attracted 4 applicants over 4 weeks. When the position was converted to a remote role, 38 applications were received in 1 week. Offering remote triage positions allowed RN recruitment from other states and gave tenured RNs within the organization an attractive new work model. Conclusions: Remote RN work is an attractive opportunity for RNs allowing for broader recruitment of candidates. Removing triage RNs from the clinic site allows them to focus on triage resolution and as a result call resolution times decreased substantially. Standardized communication pathways were developed, rolled out, and optimized in both virtual and in-person Triage RN roles statewide. Adherence to these communication pathways is critical to ensuring timely symptom management resolution and a sustainable workforce.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 8
    In: Methods of Information in Medicine, Georg Thieme Verlag KG
    Abstract: Background Patient-generated health data (PGHD) are data collected through technologies such as mobile devices and health apps. The integration of PGHD into health care workflows can support the care of chronic conditions such as multiple sclerosis (MS). Patients are often willing to share data with health care professionals (HCPs) in their care team; however, the benefits of PGHD can be limited if HCPs do not find it useful, leading patients to discontinue data tracking and sharing eventually. Therefore, understanding the usefulness of mobile health (mHealth) solutions, which provide PGHD and serve as enablers of the HCPs' involvement in participatory care, could motivate them to continue using these technologies. Objective The objective of this study is to explore the perceived utility of different types of PGHD from mHealth solutions which could serve as tools for HCPs to support participatory care in MS. Method A mixed-methods approach was used, combining qualitative research and participatory design. This study includes three sequential phases: data collection, assessment of PGHD utility, and design of data visualizations. In the first phase, 16 HCPs were interviewed. The second and third phases were carried out through participatory workshops, where PGHD types were conceptualized in terms of utility. Results The study found that HCPs are optimistic about PGHD in MS care. The most useful types of PGHD for HCPs in MS care are patients' habits, lifestyles, and fatigue-inducing activities. Although these subjective data seem more useful for HCPs, it is more challenging to visualize them in a useful and actionable way. Conclusion HCPs are optimistic about mHealth and PGHD as tools to further understand their patients' needs and support care in MS. HCPs from different disciplines have different perceptions of what types of PGHD are useful; however, subjective types of PGHD seem potentially more useful for MS care.
    Type of Medium: Online Resource
    ISSN: 0026-1270 , 2511-705X
    RVK:
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2023
    detail.hit.zdb_id: 3500-2
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  • 9
    In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 27, No. 11 ( 2021-06-01), p. 3061-3068
    Abstract: As monotherapies, eribulin (chemotherapy) and pembrolizumab (immunotherapy) have shown promise for patients with metastatic triple-negative breast cancer (mTNBC). This phase Ib/II study examined eribulin plus pembrolizumab as a potential mTNBC treatment in first-line and later-line settings. Patients and Methods: In this open-label, single-arm, phase Ib/II study, eligible patients had mTNBC, measurable disease, and ≤2 prior systemic anticancer therapies in the metastatic setting. Patients were enrolled by number of prior systemic anticancer therapies (stratum 1: 0 vs stratum 2: 1–2) in the metastatic setting and further analyzed by tumor programmed death-ligand 1 (PD-L1) expression status. All patients received intravenous eribulin 1.4 mg/m2 on day 1 and day 8, plus intravenous pembrolizumab 200 mg on day 1, of 21-day cycles. The primary objectives were the safety, tolerability, and objective response rate (ORR) of this combination. Results: The study included 167 patients (phase Ib, n = 7; phase II, n = 160). The most common treatment-emergent adverse events were fatigue (66%), nausea (58%), peripheral sensory neuropathy (41%), alopecia (40%), and constipation (37%). ORRs were 25.8% [95% confidence interval (CI): 15.8–38.0] for stratum 1 (n = 66) and 21.8% (95% CI: 14.2–31.1) for stratum 2 (n = 101). Patients with PD-L1–positive tumors (combined positive score ≥1) had numerically higher ORR than those with PD-L1–negative tumors, particularly in stratum 1 [stratum 1: 34.5% (95% CI: 17.9–54.3) vs 16.1% (95% CI: 5.5–33.7); stratum 2, 24.4% (95% CI: 12.9–39.5) vs 18.2% (95% CI: 8.2–32.7)] . Conclusions: Eribulin plus pembrolizumab was generally well tolerated and showed promising antitumor activity in mTNBC. Efficacy outcomes appeared influenced by line of therapy and PD-L1 status.
    Type of Medium: Online Resource
    ISSN: 1078-0432 , 1557-3265
    RVK:
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2021
    detail.hit.zdb_id: 1225457-5
    detail.hit.zdb_id: 2036787-9
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  • 10
    In: Biological Psychiatry, Elsevier BV, Vol. 93, No. 12 ( 2023-06), p. 1081-1088
    Type of Medium: Online Resource
    ISSN: 0006-3223
    RVK:
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
    detail.hit.zdb_id: 1499907-9
    SSG: 12
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