scholarly journals The Impact of Insurance on Access to Cancer Clinical Trials at a Comprehensive Cancer Center

2010 ◽  
Vol 16 (24) ◽  
pp. 5997-6003 ◽  
Author(s):  
Justin F. Klamerus ◽  
Suanna S. Bruinooge ◽  
Xiaobu Ye ◽  
Mandi L. Klamerus ◽  
Dorothy Damron ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
The Impact

Health care worker attitudes about clinical trials at a comprehensive cancer center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20633-e20633
Author(s):  
Erica Leigh Campagnaro ◽  
Seunghee Margevicius ◽  
Barbara J. Daly ◽  
Jennifer Rachel Eads ◽  
Tyler G. Kinzy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Small Sample Size ◽  
Educational Interventions ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Normative Beliefs ◽  
The Impact

e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.

Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

2006 ◽  
Vol 24 (28) ◽  
pp. 4545-4552 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler
Keyword(s):  
Clinical Trials ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Home Office ◽  
Scientific Review ◽  
Oncology Research ◽  
Oncology Clinical Trials ◽  
The Impact

Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

The impact of the COVID-19 pandemic on oncology clinical trial recruitment in an Irish cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18756-e18756
Author(s):  
Ronan Andrew McLaughlin ◽  
Valerie Madigan ◽  
Maureen O'Grady ◽  
Thamir Andrew Mahgoub ◽  
Roshni Andrew Kalachand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Treatment Options ◽  
Cancer Clinical Trial ◽  
University Hospital ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Number Of Patients ◽  
The Impact

e18756 Background: The COVID-19 pandemic has created unprecedented disruptions to cancer clinical trial research across the world due to a temporary global suspension of patients’ recruitment to cancer clinical trials. Access to clinical trials permits better treatment options and best clinical practice standards for patients with cancer. We present the impact of the COVID-19 pandemic on cancer clinical trial activity at the Cancer Clinical Trials Unit (CCTU) at the Mid-Western Cancer Centre, University Hospital Limerick (UHL). Over the last 4 years 28 clinical trials, both interventional and translational, have opened here, across a variety of primary disease sites, with 5 trials opened in 2017, 11 in 2018, 7 in 2019 but only 2 in the first 10 months of 2020 until 3 further trials were opened in December. Methods: CCTU records were reviewed to identify the number of patients screened and consented to participate in cancer clinical trials at UHL in 2020, which were compared directly with corresponding numbers for 2019. Results: In 2019, 17 clinical trials were open and recruiting at the CCTU, UHL. During 2020, 19 trials were recruiting although during the 1st surge of the COVID-19 pandemic recruitment was essentially suspended and CCTU staff were redeployed throughout the hospital. 1st Six months 2020 vs 2019 In the six months from January 2020 until the end of June 2020, 99 patients were screened and only 15 (15.2%) signed informed consent to participate in a cancer clinical trial. When these figures are directly compared with the first six months of 2019, there is a 33% reduction in patients screened for participation (147 vs 99) and a 60% reduction in patients consented (37 vs 15) to clinical trials. 12 Months 2020 vs 2019 In total during 2019, 376 patients were screened for inclusion to participate and 49 (13%) patients signed informed consent to participate in a clinical trial within CCTU at UHL. In 2020, 914 patients were screened for participation with 51 patients consented to participate (5.6%). The majority (45/51 (88%)) of patients consented to cancer clinical trials in 2020 at the CCTU, UHL were recruited to translational based studies and only 6 (12%) consented to interventional studies compared with 2019 when 30/49 (61%) consented to translational and 30/49 (39%) to interventional studies. Conclusions: During the COVID-19 pandemic, the percentage of patients consented to participation in a clinical trial reduced significantly, as compared to the previous year (5.6% vs 13%). Fewer interventional studies have recruited patients during 2020. As we enter the third surge of COVID-19 infections in Ireland, we must continue to monitor and identify effective strategies to navigate the ever-changing situation for cancer clinical trials, in an attempt to maintain access to high quality cancer clinical trial opportunities for our patients.

Increasing Clinical Trials Accrual at a Comprehensive Cancer Center

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1266-1266
Author(s):  
Bayard L. Powell ◽  
Debbie Olson ◽  
Robert M. Morrell ◽  
Terry L. Hales ◽  
Kevin P High ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Critical Role ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Point System ◽  
Cancer Clinical Trials ◽  
Treatment Trials ◽  
Academic Year ◽  
Year 2013

Abstract Background: During the academic year 2013 (July 2012-June 2013) our accrual to cancer clinical trials, a critical measure of success for a Comprehensive Cancer Center (CCC), was lower than prior years and below the desired level for CCC core grant renewal. Academic physicians were faced with increasing pressures to meet clinical demands, often at the expense of academic productivity, including clinical research. Methods: Our Dean and clinical leadership committed to support our efforts to increase accrual to clinical trials by providing salary support for our Section on Hematology and Oncology for specific milestones of 5%, 10%, and 15% increases in accrual to all clinical trials and in accrual to treatment (NCI definition) trials. The goal of the faculty was to increase accrual by > 15% to all trials and to treatment trials to maximize the “pool”. To determine how to divide the pool among investigators we developed a point system recognizing clinical investigators for roles as a) PI for trials (with additional points for all accrual to their trials) and b) for entering patients on clinical trials. The point system for both roles (PI and entering patients) was weighted relative to the value of the trial to the CCC, e.g. investigator initiated > cooperative group > industry initiated, and treatment trials >> non-treatment trials. In addition, we awarded points for publications (first and senior author > co-author) and presentations (oral > poster; major national meeting > other meetings). Results: During academic year 2014 (July 2013-June 2014) accrual to all cancer clinical trials increased by 140% (276 to 663) and accrual to treatment trials increased 40% (114 to 160). These increases occurred in both hematologic malignancies (95% all; 16% treatment) where we had a strong track record for accruals, and in solid tumors (200% all; 76% treatment) where our prior record was not as strong. Discussion: Accrual to clinical trials, both treatment and non-treatment improved dramatically. Interpretation of cause and effect is complex. The baseline year (2013) included implementation of a new EMR and the recent year (2014) included recruitment of additional faculty. However, 2014 was complicated by implementation of a new practice plan heavily weighted toward individual RVU production, and a decrease in available co-operative group trials to historically low levels. However, we can conclude that attention to this critical role of clinical investigators is important and can influence behavior. We cannot determine whether financial incentives are needed or whether the funding is one of several potential methods of recognition of the importance of clinical trials. It is possible that the commitment to provide financial support for clinical research demonstrated to clinical investigators that the leadership valued clinical trials activity and this recognition was more important than the actual funds. Future efforts will also need to find ways to recognize/reward clinical trials productivity of groups of investigators for their multidisciplinary contributions to the care of patients on clinical trials, without generating internal competition within the groups. Disclosures No relevant conflicts of interest to declare.

Factors Associated With Breast Cancer Clinical Trials Participation and Enrollment at a Large Academic Medical Center

2004 ◽  
Vol 22 (11) ◽  
pp. 2046-2052 ◽  
Author(s):  
Michael S. Simon ◽  
Wei Du ◽  
Lawrence Flaherty ◽  
Philip A. Philip ◽  
Patricia Lorusso ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Medical Center ◽  
Performance Status ◽  
Academic Medical Center ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Poor Performance Status ◽  
Cancer Clinical Trials ◽  
Factors Associated

Purpose The practice patterns of medical oncologists at a large National Cancer Institute Comprehensive Cancer Center in Detroit, MI were evaluated to better understand factors associated with accrual to breast cancer clinical trials. Patients and Methods From 1996 to 1997, physicians completed surveys on 319 of 344 newly evaluated female breast cancer patients. The 19-item survey included clinical data, whether patients were offered clinical trial (CT) participation and enrollment, and when applicable, reasons why they were not. Multivariate analyses using logistic regression were performed to evaluate predictors of an offer and enrollment. Results The patients were 57% white, 32% black, and 11% other/unknown race. One hundred six (33%) were offered participation and 36 (34%) were enrolled. In multivariate analysis, CTs were less likely offered to older women (mean age, 52 years for those offered v 57 years for those not offered; P = .0005) and black women (21% of blacks offered v 42% of whites; P = .0009). Women with stage 1 disease, poor performance status, and those who were previously diagnosed were also less likely to be offered trials. None of these factors were significant predictors of enrollment. Women were not offered trials because of ineligibility (57%), lack of available trials (41%), and noncompliance (2%). Reasons for failed enrollment included patient refusal (88%) and failed eligibility (12%). Conclusion It is important for cooperative groups to design studies that will accommodate a broader spectrum of patients. Further work is needed to assess ways to improve communication about breast cancer CT participation to all eligible women.

scholarly journals Cancer-Related Internet Use and Online Social Networking Among Patients in an Early-Phase Clinical Trials Clinic at a Comprehensive Cancer Center

2018 ◽  
pp. 1-14 ◽  
Author(s):  
Goldy C. George ◽  
Adrianna Buford ◽  
Kenneth Hess ◽  
Sarina A. Piha-Paul ◽  
Ralph Zinner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Internet Use ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cancer Information ◽  
The Internet ◽  
Phase I Clinical Trials ◽  
Experimental Drugs ◽  
The Impact

Purpose We examined patterns, correlates, and the impact of cancer-related Internet use among patients with advanced cancer in a phase I clinical trials clinic for molecularly targeted oncologic agents. Methods An anonymous questionnaire on Internet use for cancer-related purposes that incorporated input from phase I clinical trial oncologists and patients was self-administered by patients age ≥ 18 years in a phase I clinic. Multivariable modeling was used. Data were analyzed for the overall sample and by generation, which was defined by year of birth. Results Of 291 patients (52% women, 82% non-Hispanic white, 50% age ≤ 60 years), 62% were cancer-related Internet users (CIUs). Cancer-related Internet use was associated with an income of ≥ $60,000 (odds ratio, 2.42; P = .004). CIUs used the Internet to learn about their cancer (85%), treatment adverse effects (65%), clinical trials (52%), new alternative treatments (42%), and symptom management (41%). CIUs most frequently used the hospital Web site (70%) to learn about clinical trials, followed by ClinicalTrials.gov (42%) and search engines (41%). The emotional impact of Internet-derived cancer information on CIUs varied—56% felt empowered, 34% anxious, 29% relieved, and 17% confused. Cancer-related Internet information made 51% of patients from the Millennial (born after 1990) and Generation X/Y (born 1965 to 1990) CIU populations anxious compared with < 29% of CIUs from older generations (born 1964 and before). Most CIUs desired more online information about new experimental drugs (91%) and US Food and Drug Administration–approved drugs for cancer (72%). Conclusion As most phase I patients use the Internet for cancer-related purposes, the Internet overall and hospital Web sites should provide more extensive, pertinent, and helpful information on clinical trials and cancer treatment to phase I patients.

scholarly journals Barriers to Enrollment of Elderly Adults in Early-Phase Cancer Clinical Trials

2008 ◽  
Vol 4 (4) ◽  
pp. 162-168 ◽  
Author(s):  
Michele Basche ◽  
Anna E. Barón ◽  
S. Gail Eckhardt ◽  
Lodovico Balducci ◽  
Martha Persky ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Age Groups ◽  
Experimental Treatment ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Sources Of Information ◽  
Barriers To Participation ◽  
University Center ◽  
Barriers To Enrollment

Purpose: To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age ≥ 65 years, and to identify influences on their decisions to participate. Participants and Methods: In-person surveys were administered to subjects age ≥ 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks. Results: Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%). Conclusion: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.

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