Patients’ perceptions of care coordination among NCORP therapeutic clinical trial participants: A matched case-control study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13504-e13504
Author(s):  
Izumi Okado ◽  
Ian Pagano ◽  
Jessica Rhee ◽  
Jeffrey L. Berenberg ◽  
Randall F. Holcombe
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Care Coordination ◽  
Cancer Care ◽  
Healthcare Delivery ◽  
Cancer Clinical Trials ◽  
Cancer Type ◽  
Oncology Research ◽  
Domain Scores

e13504 Background: Effective coordination of care (CC) is a critical component of high-quality cancer care; however, many patients with cancer continue to receive poorly coordinated care. CC experiences among therapeutic clinical trial (CT) participants are relatively unknown. We examined cancer patients’ perceptions of CC among CT participants using a validated Care Coordination Instrument (CCI). Methods: The study sample (N = 90) consisted of 45 CT participants and 45 matched non-participants from archival data from our prior CC studies. 171 patients who participated in therapeutic cancer clinical trials through the Hawaii Minority/Underserved NCI Community Oncology Research Program (NCORP) between 2015 and 2020 were contacted for study participation, and 26% completed the CCI. The CCI measures overall perceptions of CC and across 3 domains (Communication, Navigation, Operational). Paired t-tests were used to compare overall and domain scores between CT participants and non-participants. The two groups were matched by age, gender, cancer type (breast, GI, other), and clinical stage. Results: Among CT participants, the mean age was 61.7 ( SD = 9.4), and the majority were female (67%) and Asian (56%). The most common cancer types were breast (27%) and GI (16%), with 24% with stage III disease. CT participants reported significantly higher total CC scores than non-participants (62.5 vs. 55.8; p = .0008). Similar trends were found for Navigation ( p = .007) and Operational ( p = .001) domain scores. 29% of CT participants reported receiving high-intensity CC assistance from their clinical research associates (CRAs), and 27% indicated receiving moderate-level CC assistance. Responses to open-ended questions regarding CC revealed that CT participants received assistance with a variety of CC activities from their CRAs, including scheduling appointments and explaining test results and procedures. Conclusions: Patients who participate in therapeutic cancer clinical trials report more positive perceptions of CC compared to non-participants. Qualitative data suggest that significant care coordination support is provided by the clinical research associate. The results underscore the importance of CC support provided by CRAs who may be an unrecognized component of the healthcare delivery team. CC provided by CRAs may contribute to improved quality and value of cancer care for patients enrolled on therapeutic clinical trials.

Practical Aspects of Implementing and Applying Health Care Cloud Computing Services and Informatics to Cancer Clinical Trial Data

2021 ◽  
pp. 826-832
Author(s):  
Jay G. Ronquillo ◽  
William T. Lester
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Cancer Research ◽  
Cloud Computing ◽  
Clinical Trials ◽  
Laboratory Tests ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Precision Oncology ◽  
Oncology Research

PURPOSE Cloud computing has led to dramatic growth in the volume, variety, and velocity of cancer data. However, cloud platforms and services present new challenges for cancer research, particularly in understanding the practical tradeoffs between cloud performance, cost, and complexity. The goal of this study was to describe the practical challenges when using a cloud-based service to improve the cancer clinical trial matching process. METHODS We collected information for all interventional cancer clinical trials from ClinicalTrials.gov and used the Google Cloud Healthcare Natural Language Application Programming Interface (API) to analyze clinical trial Title and Eligibility Criteria text. An informatics pipeline leveraging interoperability standards summarized the distribution of cancer clinical trials, genes, laboratory tests, and medications extracted from cloud-based entity analysis. RESULTS There were a total of 38,851 cancer-related clinical trials found in this study, with the distribution of cancer categories extracted from Title text significantly different than in ClinicalTrials.gov ( P < .001). Cloud-based entity analysis of clinical trial criteria identified a total of 949 genes, 1,782 laboratory tests, 2,086 medications, and 4,902 National Cancer Institute Thesaurus terms, with estimated detection accuracies ranging from 12.8% to 89.9%. A total of 77,702 API calls processed an estimated 167,179 text records, which took a total of 1,979 processing-minutes (33.0 processing-hours), or approximately 1.5 seconds per API call. CONCLUSION Current general-purpose cloud health care tools—like the Google service in this study—should not be used for automated clinical trial matching unless they can perform effective extraction and classification of the clinical, genetic, and medication concepts central to precision oncology research. A strong understanding of the practical aspects of cloud computing will help researchers effectively navigate the vast data ecosystems in cancer research.

Identification of Cancer Care and Protocol Characteristics Associated With Recruitment in Breast Cancer Clinical Trials

2008 ◽  
Vol 26 (27) ◽  
pp. 4458-4465 ◽  
Author(s):  
Julie Lemieux ◽  
Pamela J. Goodwin ◽  
Kathleen I. Pritchard ◽  
Karen A. Gelmon ◽  
Louise J. Bordeleau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Primary Objective ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Number Of Patients ◽  
Trial Protocols ◽  
Few Data

Purpose It is estimated that only 5% of patients with cancer participate in a clinical trial. Barriers to participation may relate to available protocols, physicians, and patients, but few data exist on barriers related to cancer care environments and protocol characteristics. Methods The primary objective was to identify characteristics of cancer care environments and clinical trial protocols associated with a low recruitment into breast cancer clinical trials. Secondary objectives were to determine yearly recruitment fraction onto clinical trials from 1997 to 2002 in Ontario, Canada, and to compare recruitment fraction among years. Questionnaires were sent to hospitals requesting characteristics of cancer care environments and to cooperative groups/pharmaceutical companies for information on protocols and the number of patients recruited per hospital/year. Poisson regression was used to estimate the recruitment fraction. Results Questionnaire completion rate varied between 69% and 100%. Recruitment fraction varied between 5.4% and 8.5% according to year. More than 30% of patients were diagnosed in hospitals with no available trials. In multivariate analysis, the following characteristics were associated with recruitment: use of placebo versus not (relative risk [RR] = 0.80; P = .05), nonmetastatic versus metastatic trial (RR = 2.80; P < .01), and for nonmetastatic trials, protocol allowing an interval of 12 weeks or longer versus less than 12 weeks (from diagnosis, surgery, or end of therapy) before enrollment (RR = 1.36; P < .01). Conclusion Allowable interval of 12 weeks or longer to randomly assign patients in clinical trials could help recruitment. In our study, absence of an available clinical trial represented the largest barrier to recruitment.

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.

REACT: A feasibility study to test the integration of a cancer registry early case ascertainment process via electronic pathology reporting with an online clinical trial matching tool.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 207-207
Author(s):  
Hala Borno ◽  
Christine Duffy ◽  
Sylvia Zhang ◽  
Zinnia Loya ◽  
Todd Golden ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Feasibility Study ◽  
Cancer Registry ◽  
Cancer Clinical Trials ◽  
Case Ascertainment ◽  
Early Case ◽  
Diverse Patient Populations

207 Background: Representation of diverse patient populations in prostate cancer clinical trials is essential to ensure results are applicable to all men. However, underrepresentation among underserved populations remains a critical problem. Population-based cancer registries provide a potential platform to overcome problems with inclusion of diverse patient populations in clinical research when used as a source for recruitment. Methods: Leveraging statewide implementation of early-case ascertainment (ECA) via electronic pathology for cancer case identification, we performed a feasibility study within the Greater Bay Area Cancer Registry to (1) test a process using ECA to identify new cases of advanced prostate cancer for potential enrollment into clinical trials and (2) test the utility of an online clinical trial matching tool to improve matching of underrepresented patients into clinical trials. All study materials were translated into Spanish, and recruiters were Spanish-speaking. Results: A total of 419 cases were identified from 19 reporting facilities through ECA and sent invitation letters; 18 cases were excluded due to physician contraindication, and 68 (16%) declined participation. All enrolled participants (N=54) completed baseline surveys. To date, 40 participants completed follow-up surveys after using the online matching tool. Most participants were White (80%), of higher income (>$150,000; 41%), and college-educated (70%). Thirty-seven percent indicated awareness of cancer clinical trials, 69% stated interest in participating in clinical research, and 72% held a positive attitude towards cancer clinical trials. However, 46% indicated they would not participate in a randomized study. To assess utility of the matching tool, 65% indicated it increased their interest in participating in a clinical trial. Conclusions: ECA needs to ensure sociodemographic data are available to make it useful as a tool for clinical trials. Preliminary results indicate ECA used in combination with an online clinical trial matching tool may serve as an important recruitment vehicle for prostate cancer clinical trials.

Evaluation of drug cost avoidance resulting from conduct of cancer clinical trials in a community-based oncology practice.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 66-66
Author(s):  
Amit Sanyal ◽  
James M. Heun ◽  
Brittany Glynn ◽  
Ryan Porter ◽  
Daniel Wellner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Health Plan ◽  
Cost Savings ◽  
Investigational Drug ◽  
Cancer Clinical Trials ◽  
Community Based ◽  
Hospital System ◽  
Cost Avoidance

66 Background: Aim: To prospectively evaluate cost avoidance during routine conduct of cancer clinical trials in a community based integrated delivery network (IDN) consisting of a health services provider group, a health insurance plan and a hospital system. Only 2%–7% of adult cancer patients participate in clinical trials nationwide [1]. Inadequate funding and concerns about financial viability have been identified as factors that impede clinical trial accrual in the community oncology setting. ‘Cost-avoidance’, defined as dollars that would have been spent to purchase medications but were not spent because of study-related interventions [3] has been proposed as one mechanism to overcome this. Methods: Anti-cancer and hematology drugs provided by intergroup as well as pharmaceutical industry-based trial sponsors to patients enrolled in oncology clinical research were tabulated. Analysis of cost avoidance was restricted to patients covered by the IDNs health plan. Additionally, drugs provided by the trial sponsor were included in the analysis only if they represented a normal standard of care for the disease state. Cost avoidance was defined as the net ingredient cost of the drugs that would have been spent by the health plan for patient care if drugs provided by trial sponsors were not available. Results: Between January 2020 and April 2021, 25 patients covered by the IDN were recruited into clinical trials. Cost savings resulted from 7 targeted and immuno-oncology medications. Net cost avoidance in 2020 was $1,229,798 while that in 2021 till date has been $892,783. The realized cost savings has allowed recruitment of additional clinical research staff as well as expansion of clinical research to rural regional sites served by the IDN. Conclusions: Anticancer drugs provided free of charge by clinical trial sponsors render significant cost savings, ensuring viability and even expansion of oncology clinical research in community based IDNs. References: National Health Expenditure Data. 2018, U.S. Centers for Medicare & Medicaid Services: Baltimore, MD 21244. McDonagh MS, M.S., Naden E., Costs and savings of investigational drug services. American Journal of Health-Systems Pharmacy, 2000. 57: p. 40-43.[Table: see text]

Impact of nontreatment oncology research trials on physician engagement in clinical research in an oncology community practice setting.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 44-44
Author(s):  
Susan S. Night ◽  
Juston S. Roemisch ◽  
David A. Smith
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Negative Impact ◽  
Rapid Development ◽  
Treatment Options ◽  
Community Practice ◽  
Oncology Research ◽  
Community Oncology ◽  
Physician Engagement

44 Background: The rapid development of new oncology drugs has created a significant increase in the number of clinical research studies. This underscores the need for greater participation in research by physicians as well as patients. Many physicians hesitate to participate in oncology clinical trials that provide treatment options for their patients given the complexity of the protocols. Non-treatment clinical trials may serve as a bridge for engaging physicians in clinical research and enhance the culture of research in community oncology practices. Methods: A large non-treatment oncology clinical trial was opened in a network of community oncology practices with approximately 1,000 physicians. We evaluated the number of physicians who did not enroll a patient onto a clinical trial in Year 1 but did enroll patients onto the non-treatment study. We further examined the number of physicians who enrolled a patient onto the non-treatment study that also enrolled patients onto a treatment clinical trial. Overall physician engagement in clinical research was measured by comparing practices where non-treatment study was offered to locations that did not participate in the non-treatment study. Negative impact on treatment accruals was also evaluated. Results: There were 105 physicians that practice at a site with the non-treatment study who had 0 accruals in Year 1 but enrolled a patient to any clinical trial in Year 2. Ninety-two of those physicians were responsible for enrolling over 900 patients to the non-treatment study in Year 2. Additionally, 46 of the 0 accruing physicians in Year 1, enrolled a patient to the non-treatment study also enrolled a patient to a treatment clinical trial. We also found that 24 physicians who did not did not enroll a patient in Year 1 and did not enroll a patient to the non-treatment study did enroll patients to a treatment clinical trial in Year 2. Conclusions: Participation in oncology treatment clinical trials can be difficult in the community oncology setting. Participation in a non-treatment study may serve as a bridge to engage more physicians in clinical research and enhance the culture of research within a community oncology practice.

Role of oncology-advanced practitioners to enhance clinical research.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 95-95
Author(s):  
Christa Marie Braun-Inglis ◽  
Leigh Boehmer ◽  
Laura J Zitella ◽  
Brianna Hoffner ◽  
Jessica Rhee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Health Care Providers ◽  
Nurse Practitioners ◽  
Cancer Care ◽  
Treatment Options ◽  
Physician Assistants ◽  
Full Potential ◽  
Care Providers

95 Background: Oncology Advanced Practitioners (APs), including Nurse Practitioners, Physician Assistants, Clinical Nurse Specialists, and Pharmacists are highly trained health care providers that contribute significantly to quality cancer care. Given low clinical trial enrollment among adult oncology patients, understanding current research responsibilities of APs could lead to identification of opportunities to leverage this workforce to enhance accrual and conduct of clinical trials. Methods: A 65-item validated survey addressing attitudes, beliefs and responsibilities of oncology APs participating in clinical research was distributed from January 22 through March 6, 2020. Outreach via the Association of Community Cancer Centers (ACCC) and Harborside was utilized to reach a sample set of 14,601 oncology APs’ emails. The survey was administered and data were analyzed using Survey Monkey. Results: 408 U.S. oncology APs completed the survey. Respondents were primarily white (83%), female (92%) and nurse practitioners (71%). Thirty-five percent practiced in an academic setting and 62% practiced in a community setting. Nearly all respondents believed that clinical trials are important to improve oncology care standards and more than 90% reported that clinical trials were available at their practice. Nearly 80% reported that they are comfortable discussing treatment options with patients, discussing clinical trials in general, and know where to find clinical trials. Furthermore, 80% participate in the care of patients enrolled on clinical trials. Only 60%, however, are comfortable discussing trials available at their practice and only 38% routinely explore whether a clinical trial is available for their patients. While 70% of APs approach eligible patients about clinical trials at their practice, only 20% reported doing so “a great deal” or “a lot”. Ninety percent of APs reported that they should play a role in clinical research and 75% would like to be more involved in the clinical trial process. Barriers to greater involvement in clinical trials include lack of time, inadequate awareness of clinical trial specifics, and under-representation on research committees. Conclusions: The majority of oncology APs are engaged and interested in clinical trials and believe that research is important to improve cancer care. However, they are not being utilized to their full scope. Multidisciplinary team integration, trials-related education, and policy change is needed to allow this group of skilled professionals to realize their full potential within cancer clinical trials.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Sign in / Sign up

Export Citation Format

Share Document