Lessons learned from implementing the first Alliance NCORP Research Base Cancer Care Delivery Research (CCDR) trial A191402CD.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 175-175
Author(s):  
Joel E Pacyna ◽  
Jeff A. Sloan ◽  
Simon P. Kim ◽  
Hillary Sedlacek ◽  
Jon Charles Tilburt
Keyword(s):  
Clinical Trials ◽  
Cancer Care ◽  
Early Stage ◽  
Care Delivery ◽  
Decision Aids ◽  
Symptom Control ◽  
Cluster Randomized Trial ◽  
Lessons Learned ◽  
Oncology Research ◽  
Minority Men

175 Background: Biomedical research focused on the experiences of cancer patients in care delivery has progressed remarkably in recent years, including the emergence of Cancer Care Delivery Research (CCDR) within the NCI Community Oncology Research Program (NCORP). CCDR is a relatively new mechanism with the NCORP to support protocols that test questions beyond standard clinical trials for treatment or symptom control interventions. CCDR leverages the NCORP infrastructure to develop and test care delivery interventions in community hospital settings and in settings serving underserved and minority populations. CCDR enables researchers to conduct care delivery studies in critical places and in niche populations. Methods: We will describe our experience coordinating the first Alliance NCORP Research Base Cancer CCDR trial. Our trial – a four arm, cluster-randomized trial of decision aids among sites capable of oversampling minority men with a diagnosis of early stage prostate cancer – was the first CCDR trial in the Alliance NCORP Research Base. We will describe the opportunities and challenges we encountered. Results: We implemented a CCDR protocol even as the oversight for CCDR was being worked out in parallel. Curating partnerships outside of established channels of clinical trials, engaging minority serving institutions, and engaging surgical practices like urology illustrate some of the challenges of implementing a care-delivery trial in a diverse multi-site network. Research staff must learn the art of mitigating the disruption of care delivery research procedures within clinics. Additionally, the researcher’s skills are drawn upon at multiple points— establishing relationships, advocating for flexibility in implementing rules, cheerleading, connecting dots, and directing traffic. Conclusions: Our “lessons learned” presentation will provide an experiential account that will inform aspiring care delivery researchers in their work and describe some of the emerging aspects of the institutional implementation of new initiatives in modern cooperative group research. Our presentation will also inform key stakeholders about how to best facilitate this type of research.

Decision aids for localized prostate cancer: Initial outcomes from NCI Community Oncology Research Program Alliance Research Base Cancer Care Delivery Research (CCDR) Protocol - A191402CD - A Cluster-Randomized Trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24176-e24176
Author(s):  
Jon Charles Tilburt ◽  
Joel E Pacyna ◽  
Daniel G. Petereit ◽  
Judith Salmon Kaur ◽  
Bruce D. Rapkin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Usual Care ◽  
Care Delivery ◽  
Decision Aids ◽  
Clinical Stage ◽  
Cluster Randomized Trial ◽  
Relative Effect ◽  
Oncology Research ◽  
Cluster Randomized ◽  
Cluster Correlation

e24176 Background: Decision aids for prostate cancer treatment can improve knowledge, but the relative effect of pre-consultation and within-consultation DAs is not known. Methods: We conducted a parallel design, 2-by-2 factorial, 4-arm, cluster-RCT in urology practices affiliated with the NCI’s Alliance research base. We compared patient knowledge immediately after consultation (%12-item% correct) intervention arms compared to usual care. We used mixed effects regression modeling to assess effect of interventions on knowledge adjusting for site-clustering, race/ethnicity (non-Hispanic White; Other), age (years), clinical stage (T1-3), PSA, and Gleason score. Results: 15 of 21 randomized centers accrued 158 pts from Nov 2017 to June 2019. The arm delivering both DAs (n = 3 sites) recruited 25 pts. The pre-consultation DA arm (n = 4 sites) recruited 39 pts. The within-consultation DA arm (n = 4 sites) recruited 44 pts. The no DA arm (n = 4 sites) accrued 50 pts. Overall, mean age was 64; 54% were AA; 73% had T1 stage; median Gleason = 7; and median PSA = 7. The combined DAs group, followed by pre-consultation reported higher median knowledge (75% and 67%, respectively). The within-consultation and no DA arms both reported median knowledge scores (58%). Within arm, inter-site standard deviations in mean knowledge scores ranged from 0.164 in in the pre-consultation arm to 0.232 in the usual care arm. Neither pre-consultation nor within-consultation DAs had statistically significant effects (p = .15 and p = .99, respectively). Pre-specified adjusted difference [97.5% CIs], comparing the pre-consultation DA and the within-consultation DA with the control was 9.4% [-7.3%, 26.2%] and -0.4% [-16.9%, 16.1%], respectively. Intra-cluster correlation (ICC) coefficient was high (.24). No interaction effects were identified (p = .98). A post-hoc analysis comparing any DA vs usual care found a mean adjusted difference [95% CI] of 5.6% [-8.5%, 19.8%] (p = 0.40), 63.9% for any DA and 58.3% for usual care. Conclusions: Possible knowledge gains associated with some DAs for early prostate cancer were obscured by larger-than-expected intra-cluster correlation effects associated with the primary outcome. How interventions were used was not measured. Support:UG1CA189823; https://acknowledgments.alliancefound.org ; R01 MD008934-06. Clinical trial information: NCT03103321 .

scholarly journals Evolution of Cancer Care Delivery Research in the NCI Community Oncology Research Program

2019 ◽  
Vol 112 (6) ◽  
pp. 557-561 ◽  
Author(s):  
Ann M Geiger ◽  
Ann M O’Mara ◽  
Worta J McCaskill-Stevens ◽  
Brenda Adjei ◽  
Priyanga Tuovenin ◽  
...  
Keyword(s):  
Research Program ◽  
National Cancer Institute ◽  
Cancer Care ◽  
Care Delivery ◽  
Well Being ◽  
Practice Change ◽  
Evidence Based ◽  
Oncology Research ◽  
Community Oncology ◽  
Robust Portfolio

Abstract Research seeking to improve patient engagement with decision-making, use of evidence-based guidelines, and coordination of multi-specialty care has made important contributions to the decades-long effort to improve cancer care. The National Cancer Institute expanded support for these efforts by including cancer care delivery research in the 2014 formation of the National Cancer Institute Community Oncology Research Program (NCORP). Cancer care delivery research is a multi-disciplinary effort to generate evidence-based practice change that improves clinical outcomes and patient well-being. NCORP scientists and community-based clinicians and organizations rapidly embraced the addition of this type of research into the network, resulting in a robust portfolio of observational studies and intervention studies within the first 5 years of funding. This commentary describes the initial considerations in conducting this type of research in a network previously focused on cancer prevention, control, and treatment studies; characterizes the protocols developed to date; and outlines future directions for cancer care delivery research in the second round of NCORP funding.

Treatment of Lung Cancer in Medically Compromised Patients

2016 ◽  
pp. e484-e491
Author(s):  
Jeffrey Crawford ◽  
Paul Wheatley-Price ◽  
Josephine Louella Feliciano
Keyword(s):  
Lung Cancer ◽  
Socioeconomic Status ◽  
Clinical Trials ◽  
Molecular Mechanisms ◽  
Early Stage ◽  
Care Delivery ◽  
Advanced Lung Cancer ◽  
Early Stage Disease ◽  
Major Barrier ◽  
The Impact

Outcomes for patients with lung cancer have been improved substantially through the integration of surgery, radiation, and systemic therapy for patients with early-stage disease. Meanwhile, advances in our understanding of molecular mechanisms have substantially advanced our treatment of patients with advanced lung cancer through the introduction of targeted therapies, immune approaches, improvements in chemotherapy, and better supportive care. However, the majority of these advances have occurred among patients with good functional status, normal organ function, and with the social and economic support systems to be able to benefit most from these treatments. The aim of this article is to bring greater attention to management of lung cancer in patients who are medically compromised, which remains a major barrier to care delivery. Impaired performance status is associated with poor outcomes and correlates with the high prevalence of cachexia among patients with advanced lung cancer. CT imaging is emerging as a research tool to quantify muscle loss in patients with cancer, and new therapeutics are on the horizon that may provide important adjunctive therapy in the future. The benefits of cancer therapy for patients with organ failure are poorly understood because of their exclusion from clinical trials. The availability of targeted therapy and immunotherapy may provide alternatives that may be easier to deliver in this population, but clinical trials of these new agents in this population are vital. Patients with lower socioeconomic status are disproportionately affected by lung cancer because of higher rates of tobacco addiction and the impact of socioeconomic status on delay in diagnosis, treatment, and outcomes. For all patients who are medically compromised with lung cancer, multidisciplinary approaches are particularly needed to evaluate these patients and to incorporate rapidly changing therapeutics to improve outcomes.

scholarly journals Current models, challenges and best practices for work conducted between European academic cooperative groups and industry

ESMO Open ◽  
2020 ◽  
Vol 5 (2) ◽  
pp. e000628
Author(s):  
Rolf A Stahel ◽  
Denis Lacombe ◽  
Fatima Cardoso ◽  
Paolo G Casali ◽  
Anastassia Negrouk ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Working Group ◽  
Early Stage ◽  
Data Access ◽  
Cooperative Groups ◽  
Effective Strategies ◽  
Patients With Cancer ◽  
Oncology Research ◽  
Industry Partnerships ◽  
Multi Stakeholder

BackgroundThe academia-industry interface is important, and, despite challenges that inevitably occur, bears the potential for positive synergies to emerge. Perceived barriers to wider collaboration in academia-industry oncology research in Europe need to be addressed, current academic cooperative group and industry models for collaboration need to be discussed, and a common terminology to facilitate understanding of both sectors’ concerns needs to be established with an eye towards improving academia-industry partnerships on clinical trials for the benefit of patients with cancer.MethodologyCAREFOR (Clinical Academic Cancer Research Forum), a multi-stakeholder platform formed to improve the direction for academic clinical trials in the field of oncology in Europe, formed the CAREFOR-Industry Working Group comprised of experienced professionals from European academic cooperative groups joined by industry representatives selected based on their activities in the area of medical oncology. They jointly discussed academic cooperative groups, clinical trials conducted between academic cooperative groups and industry, examples of successful collaborative models, common legal negotiation points in clinical trial contracts, data access, and principles of interaction.ResultsFour principles of interaction between the academia and industry are proposed: (1) clarify the roles and responsibilities of all partners involved in the study, (2) involve legal teams from an early stage; (3) acknowledge that data is an important output of the study, (4) agree on the intent of the trial prior to its start.ConclusionsThe CAREFOR-Industry Working Group describes current models, challenges, and effective strategies for academia-industry research in Europe with an eye towards improving academia-industry partnerships on clinical trials for patients with cancer. Current perceived challenges are explained, and future opportunities/recommendations for improvement are described for the areas of most significant impact. Challenges are addressed from both the academic and industry perspectives, and principles of interaction for the optimal alignment between academia and industry in selected areas are proposed.

First Results of the Interdisciplinary Comprehensive Cancer Center Freiburg (CCCF) Tumor Board (TB) Multiple Myeloma (MM) Assessing TB-Questions, TB-Advice Adherence, TB-Satisfaction of Patients, Participants and Referring Physicians, Inclusion of Difficult-to-Treat-MM Pts in Clinical Trials (CT) and Patient Outcome

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2635-2635
Author(s):  
Ricarda Selder ◽  
Masa Pandurevic ◽  
Mandy-Deborah Möller ◽  
Johannes Waldschmidt ◽  
Milena Pantic ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Care ◽  
Clinical Pathways ◽  
Symptom Control ◽  
Tumor Board ◽  
Comprehensive Cancer Center ◽  
Stream Line ◽  
Line Treatment ◽  
Tumor Boards ◽  
Referring Physicians

Abstract Introduction: Tumor boards have become a crucial institution in oncology practice to provide paramount interdisciplinary cancer treatment, stream-line patient (pt) entries and to ensure treatment according to clinical pathways (CP). We initiated a weekly MM-TB at our institution in 6/2012. Participating experts are hematologist-oncologists, pathologists/cytogenetic specialists, orthopedists, radiotherapists, immunologists/rheumatologists and, if needed, nephrologists, cardiologists and others. Pt applications to be discussed are centrally organized through our CCCF, with the TB advice being centrally stored within our electronic pt information system. Recommended TB advice is made according to best current literature/knowledge and international CP. The development of mandatory CCCF-CP and transparency of decision making are key quality criteria. Methods: This first analysis focused on a) discussed TB questions, b) given recommendations, c) pt characteristics, d) pts’, referring- and participating-physicians' satisfaction with the TB, e) inclusion of these challenging-to-treat pts in clinical trials (CT) and f) PFS/OS of TB pts as compared to the literature (Kumar SK. Leukemia 2012). Grades of recommendations were assigned using the GRADE criteria (Engelhardt M. Haematologica 2014) and meticulously assessed, as well as whether TB recommendations were pursued. Pts’, referring- and participating-physicians' satisfaction with the TB was evaluated via standardized questionnaires, the aimed sample size being n=100 for consecutive pts and ~n=30 each for participating and referring physicians. Results: From 6/2012-5/2014, 483 pts have been discussed within 90 MM-TB sessions, substantially increasing these from 2011 to 2012, 2013 and 2014 by 12-fold. Of the entire MM cohort seen at our institution, 60% of these challenging-to-treat pts were discussed within the TB in 2012, increasing to 71% in 2013. We have currently assessed 200 TB-protocols for pt characteristics, clinical outcome and adherence to TB decisions. Of those, 2% were presented for explicit diagnosis-finding, 17% had newly diagnosed MM, 41% relapsed/refractory MM and 40% had attained stable disease or better with their last-line therapy and were discussed to resolve their ongoing treatment. Expectedly, most pts (89%) were discussed for their next-line treatment, 43% due to strains with comorbidities, symptom control, side effects, diagnosis finding and MM-staging, and 11% due to various other reasons (multiple entries possible). Mean treatment lines of pts discussed in the TB was 2 (range 0-10), deciding on their 3rd-line-treatment. Within the TB cohort, 70% were presented once, but 30% several times (mean 2, range 2-4). Of these multiple presentations, most pts had relapsed or refractory MM, this rate further increasing towards the 3rd and 4th TB-presentation. The adherence to TB-recommendations was excellent with 93% of decisions being pursued. Reasons for adapted approaches were practicable issues or disagreement of the pt, family or referring physician. Of currently 80/100 interviewed pts, 95% were entirely satisfied with their care, treating oncologists/MM-expert team and very supportively perceived the MM-TB. Of note, 94% considered their cancer care ideally achieved by the TB, 92% that their local physician profited greatly and 88% that their personal preferences were also accounted for. Of 30 interviewed participating physicians, 97% considered themselves well-educated and their time well-spent. Of currently 18 referring physicians, 73% were unconditionally satisfied with all TB-diagnostics and -therapies, with the university centers' cooperation and 65% acknowledged no information loss. Of 288 pts assessed for their CT suitability, 28% were suggested by the TB to be included, with 53% actually being able to enter therein. Thus, 15% of our MM-TB cohort could be included in a CT, which is considerable since these were challenging-to-treat pts who had received extensive prior therapies and showed several comorbidities. This also confirms current CT accrual rates for cancer pts of 5-15%, which can be increased with well-structured TB. Conclusions: Our preliminary results suggest that this MM-TB is a highly relevant exchange platform and allows physicians from different disciplines to intensely and rewardingly collaborate for state-of-the-art cancer care. Disclosures No relevant conflicts of interest to declare.

Designing comprehensive patient and family centered oncology care to achieve value based quality outcomes: Lessons learned from the field in creating sustainable change.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18225-e18225
Author(s):  
Tamira Harris ◽  
Lalan S. Wilfong
Keyword(s):  
Cancer Care ◽  
Gap Analysis ◽  
Care Delivery ◽  
Strong Relationship ◽  
Lessons Learned ◽  
Care Team ◽  
Need To Evaluate ◽  
Oncology Care ◽  
Value Based Care ◽  
Family Centered

e18225 Background: Of all clinical specialties cancer care is often thought of as one of the most patient and family centered due to the nature of the disease and course of treatment. Traditionally a strong relationship is held among the physicians, office practice staff and patients and family. Cancer care requires multidisciplinary collaboration and alignment for the optimized patient experience. Comparatively speaking this has been the case. The office based oncology care team has worked side by side to move the patient through the system during various treatments and settings. Most often the relationships and bonds that are formed are long lasting as cancer is a life changing experience. Opportunities for change however do exist and are needed in today’s increasingly complex healthcare environment. As demographics shift, and treatment methodologies continue to be discovered costs have escalated giving rise to the need to evaluate different care delivery models such as value based care. The Centers for Medicaid and Medicare Innovation Center (CMMI) Oncology Care Model (OCM) initiative has addressed this in their 5 year OCM pilot. Methods: Using qualitative and six sigma lean techniques practices redesigned patient throughput and experience based on data from gap analysis assessments, observation and collaboration. Results: The session will highlight lessons learned from the practice setting in initiating the changes required to meet CMS objectives and change the face of oncology care. Learn how practices designed patient navigation, created care team huddles, designed technology that facilities decision making, identified new models and partnerships for care, and standardized approaches across practice sites among other successes. Conclusions: This interactive session will explore what worked well, what physicians would change, and next steps planned.

Community and academic partnerships: Moving a new generation of clinical trials in NCI Community Oncology Research Program (NCORP) into community oncology practices.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2551-2551
Author(s):  
Worta J. McCaskill-Stevens ◽  
Ann M. Geiger
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Cost Of Care ◽  
Community Practice ◽  
Effective Strategies ◽  
Oncology Research ◽  
Research Activities ◽  
Community Oncology ◽  
Catchment Areas

2551 Background: NCORP is a model program that bridges academic and community oncology practices and research. Over the past decade, community cancer investigators have adopted new technology, encountered new treatment sequalae, and faced rising cost of care with its financial toxicity imposed upon individuals seeking care. Opportunities are abundant for community investigators to assess feasibility and uptake of research advances into community practice settings, yet these opportunities are met with the challenges of dynamic changes in types of organizations delivering cancer care and diversity of populations within their catchment areas. Little information is shared about how and to what extent the health environment influences this partnership and the implementation of a broad cancer research portfolio. Methods: This abstract reports on the continued interest and participation of community oncologists in research which is demonstrated by 987 practices with over 4000 investigators in NCORP. Since 2014, over 30,000 individuals enrolled in symptom management, screening, surveillance, quality of life, and treatment trials. An additional 4500 patients and clinicians have enrolled in care delivery studies. Results: NCORP has been central in evaluating the most effective strategies for investigators to effectively communicate to patients the science of genomically-driven trials. It has also provided ways of bringing the pediatric and AYA patients access to the most up-to-date treatment strategies and new therapies in their community. This creates the least disruption on family structure/dynamics, diminished traveling requirements/costs, and reduced the financial burden. NCORP promotes involvement of treating oncologists in research activities. This also improves care for patients not enrolled in clinical trials. Therefore, NCORP serves as a laboratory to determine the most effective strategies for co-management of cancer patients and survivors. Conclusions: Several questions however remain to be addressed using this clinical trial model. These include: how to continue to reduce disparities in cancer care and clinical trial participation; and, what are the best strategies for fostering implementation of cancer care models in community practice.

Contributive compared with subsidized insurance in colorectal cancer in the Colombian National Administrative Cancer Registry.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18136-e18136
Author(s):  
Robert Hsu ◽  
Paula Ramirez ◽  
Lizbeth Acuña ◽  
Gilberto Lopes
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Therapy ◽  
Neoadjuvant Therapy ◽  
Cancer Care ◽  
Nutritional Support ◽  
Early Stage ◽  
Care Delivery ◽  
Tnm Staging ◽  
Wait Times ◽  
Curative Surgery

e18136 Background: Colombia has gone to great lengths to provide nearly universal health care insurance for its patients, as 96.6% of its constituents now have health insurance as of 2014 compared to 23.5% in 1993. Most Colombians are associated with either contributive insurance (CI) in which employees and employers contribute to the insurance or subsidized insurance (SI) in which government funds cover the insurance cost. Colorectal cancer (CRC) has the 5th highest incidence of all malignancies in Colombia. This abstract aims to compare CRC care delivery metrics between CI and SI. Methods: We used the Colombian National Administrative Cancer Registry (NACR) data compiled from the Department of Health Ministry from January 2, 2016- January 1, 2017 consisting of 32 departments and 1122 municipalities. CRC cases were investigated by incidence, mortality, percentage of cases with early stage detection, stage I-III with curative surgery intent, nutritional support, and TNM staging, and days between suspicion to diagnosis, diagnosis to first treatment, neoadjuvant therapy to surgery, and surgery to adjuvant therapy. Results: There were 2605 new CRC cases in the NACR in 2017, with 1691 CI cases and 823 SI cases. There was a noticeably higher incidence in CI (7.2 new cases per 100,000 people) than in SI (3.7 new cases per 100,000), and a higher mortality rate (5.0 deaths per 100,000) in CI compared with SI cases (2.6 deaths per 100,000). There was a significant increase in average wait time for SI CRC cases from diagnosis to first treatment (77.7 days vs. 57.3 days, p = .027) and in average time to neoadjuvant therapy to surgery in CI cases (123.1 days vs. 92.5 days, p = .054) with longer but statistically insignificant wait times in SI cases in average time to adjuvant therapy (83.6 days vs. 73.9 days, p = .0168) and suspicion to diagnosis (56.1 days vs. 46.9 days, p = .811). Similar percentages of CI and SI cases had early stage detection (37.2% in SI vs. 34.3% in CI, p = 0.311), TNM staging (50.7% in CI vs. 49.3% in SI, p = 0.146), stage I-III cases with curative surgery intent (23.3% in CI vs. 21.8% in SI, p = 0.833), and nutritional support (10.5% in CI vs. 8.5% in SI, p = 0.942). Conclusions: The NACR represents a model for developing countries to improve cancer care delivery efficiently. As evidenced by higher incidence and mortality in CI cases and longer wait times before treatment in SI cases, there are differences in cancer care delivery between major modes of healthcare delivery in Colombia. More investigation needs to be done with a goal of streamlining cancer care delivery.

scholarly journals Lessons in Integrating Shared Decision-Making Into Cancer Care

2018 ◽  
Vol 14 (4) ◽  
pp. 229-235 ◽  
Author(s):  
Karina Dahl Steffensen ◽  
Mette Vinter ◽  
Dorthe Crüger ◽  
Kathrina Dankl ◽  
Angela Coulter ◽  
...  
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Cancer Care ◽  
Care Delivery ◽  
Decision Aids ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Shared Decision ◽  
Care Needs ◽  
Patient Reported

The benefits of shared decision-making (SDM) in health care delivery are well documented, but implementing SDM at the institutional level is challenging, particularly when patients have complex illnesses and care needs, as in cancer. Denmark’s Lillebaelt Hospital, in creating The Patient’s Cancer Hospital in Vejle, has learned key lessons in implementing SDM so that the organization’s culture is actually being transformed. In short, SDM is becoming part of the fabric of care, not a mere add-on to it. Specifically, the hospital chose and structured its leadership to ensure that SDM is constantly championed. It organized multiple demonstration projects focused on use of decision aids, patient-reported outcome measures, and better communication tools and practices. It designed programs to train clinicians in the art of doctor-patient communication. It used research evidence to inform development of the decision aids that its clinicians use with their patients. And it rigorously measured SDM performance in an ongoing fashion so that progress could be tracked and refined to ensure continuous improvement. Initial data on the institution’s SDM initiatives from the Danish national annual survey of patients’ experiences show substantial progress, thereby motivating Lillebaelt to reassert its commitment to the effort, to share what it has learned, and to invite dialogue among all cancer care organizations as they seek to fully integrate SDM in daily clinical practice.

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