The cancer care network clinical trials program: Rising from the camp fire ashes.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 168-168
Author(s):  
Ofilio Ramon Vigil ◽  
Dana Ann Little ◽  
Kristin J. Mensonides ◽  
Richard J. Bold
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Rural Communities ◽  
Cancer Care ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Trial Participation ◽  
Care Network ◽  
Research Oversight ◽  
The City

168 Background: The UC Davis Health Cancer Care Network (CCN) in Sacramento improves quality through partnerships with community cancer centers and the UC Davis Comprehensive Cancer Center (UCDCCC). The UCDCCC, as an NCI Lead Academic Participating Site (LAPS) grant recipient, lists Adventist Health Rideout Cancer Center (RCC) in Marysville (42 miles north of Sacramento) as a component. The Adventist Health Feather River Cancer Center (FRCC) and the town of Paradise were devastated by the 2018 Camp Fire, forcing FRCC’s relocation to the city of Chico (49 miles north of Marysville). FRCC was forced to disband its local IRB and unable to continue clinical trials research operations during the aftermath of this natural disaster. The CCN established an affiliation with the FRCC in April 2019. Future plans include establishing an IRB agreement and adding FRCC as a LAPS component. The CCN identified strategies to facilitate the participation of FRCC patients in clinical trials. Methods: The CCN identified 13 NCTN clinical trials with 34 enrolled patients that were in need of appropriate research oversight. Four of these trials were previously never activated at the UCDCCC or its affiliates. CCN staff engaged leaders at the various institutions involved: Quality Assurance (QA) Managers at each NCTN research base, the CIRB, the local IRB, the CTSU, and other leaders within UC Davis and Adventist Health. Results: Stakeholders acknowledged the unusual and urgent nature of our requests and questions, while contributing to the development of a plan allowing patients to continue clinical trial participation. QA managers approved a plan transferring patients to the RCC, allowing research staff to collect and submit data while patients continue receiving care closer to home. Together we developed a notification letter to inform patients of this plan. Conclusions: The relocation of facilities and patients brought rare challenges while conducting clinical research in rural communities. We learned that the cooperation and flexibility of all parties involved was crucial in supporting the continued care for FRCC's clinical trial patients and research contributions.

Stepwise examination of prostate clinical trials participation to reduce accrual barriers.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 157-157
Author(s):  
Dare Olatoye ◽  
Michael Anthony Carducci ◽  
Norma Kanarek
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Oncology ◽  
Local Therapy ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Trial Participation ◽  
Therapeutic Trial ◽  
Clinical Trial Participation

157 Background: Adequate and representative enrollment in therapeutic clinical trials is important to an NCI cancer center. Clinical trial participation is a string of 6 sequential patient and physician decisions beginning with an available therapeutic trial to enrollment in the trial. Opportunities for participation may be lost at any one of these steps. The objective of this study was to calculate transitional probabilities that measure patient, especially minority patient, accrual to clinical trials at the Sidney Kimmel Comprehensive Cancer Center and to describe the barriers for those dropping out at each step. Methods: Records for “first visit” medical oncology patients seen by three SKCCC physicians from January to April 2010 were abstracted. Prostate cancer case reports from the hospital cancer registry and a medical record review provided age, race, Hispanic ethnicity, place of residence, tumor characteristics, and prior treatment history. At each transition step, we calculated the proportion of patients who remained enrollable. Results: Overall, prostate cancer clinical trial participation was 17% (16/94). Minority accrual was similar to Caucasian accrual at 19% and 17% , respectively. Retention at each step of trial participation was highest for “discussed” (98%), “enrolled” (94%), “eligibility” for available trials (79%), and “consented” (71%). Two bottlenecks were qualitatively identified: “trial availability” (65%) and “patient interest” (51%). Forty-two percent of those for whom there was no trial available were older than 70 years and 33% were patients with rising PSA after local therapy and hormone-naïve. The “patient interest” step was shaped primarily by disinterest due to distance to SKCCC (83%). Conclusions: For prostate cancer patients, recruitment to medical oncology clinical trials is robust. Minority patients however are only 17% of all patients seen and half drop out when no trial is available and half of those remaining judged distance to be a problem (hence, no interest). This study approach has clarified which factors are likely to be barriers to participation and is likely useful to making adjustments that can reduce identified barriers by adding to trial portfolio as an example.

Metastatic colorectal cancer (mCRC) patterns of care: Implications for clinical trial design

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4079-4079 ◽  
Author(s):  
C. S. Denlinger ◽  
M. A. Collins ◽  
Y. Wong ◽  
S. Litwin ◽  
N. J. Meropol
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
New Drugs ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Treatment Change ◽  
Therapy Regimen

4079 Background: New approaches have expanded options for patients (pts) with mCRC. To characterize current practice paradigms that might bear on clinical trial design, we analyzed decision-making and treatment patterns in pts treated at a Comprehensive Cancer Center since the introduction of cetuximab (CET), and bevacizumab (BV). Methods: A retrospective review of all pts diagnosed with mCRC between 3/1/04 and 8/28/06 treated at Fox Chase Cancer Center. Results: 160 pts were treated, with 157 pts receiving at least one therapy regimen by 10 attending oncologists. There were 350 changes in therapy with 246 (70%) including continuation of at least one prior drug (92 BV, 111 fluoropyrimidines, 43 other). The most common reasons for treatment change were toxicity (33%), progressive disease (PD) (29%), treatment breaks (15%), and metastasectomy (11%) ( Table ). PD was a more common cause for treatment discontinuation in later phases of treatment (18% initial regimen vs. 36% subsequent regimens, p=0.0002). 24% of pts treated with oxaliplatin (OX) discontinued due to neuropathy. Hypersensitivity caused discontinuation in 5% of pts with OX and 7% of pts with CET. Resection of metastases was undertaken in 38% of pts. 43% of these pts received neoadjuvant therapy, and 56% received adjuvant therapy. 30% of pts have died, 29% remain on active treatment, 28% are on a treatment break, 3% are on hospice, and 11% are lost to follow-up. Conclusions: PD is no longer the primary reason for change of therapy in pts with mCRC. Metastasectomy is common and OX neuropathy is often treatment-limiting. These findings have important implications for endpoint selection and design of clinical trials in mCRC. Future clinical trials in mCRC must recognize treatment complexities and capture key components of decision-making that may result in prolonged survival. Furthermore, treatment breaks represent a potential window for the evaluation of new drugs. [Table: see text] No significant financial relationships to disclose.

scholarly journals Monitoring Twitter Conversations for Targeted Recruitment in Cancer Trials in LA County: Protocol for a Mixed-Methods Pilot Study (Preprint)

2018 ◽  
Author(s):  
Katja Reuter ◽  
Praveen Angyan ◽  
NamQuyen Le ◽  
Alicia MacLennan ◽  
Sarah Cole ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Social Media ◽  
Clinical Trials ◽  
Pilot Study ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Translational Science ◽  
The Social ◽  
Media Intervention ◽  
Twitter Users

BACKGROUND Insufficient recruitment of participants remains a critical roadblock to successful clinical research, in particular clinical trials. Social media (SM) provides new ways for connecting potential participants with research opportunities. Researchers suggested that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues and increasing enrollment in cancer clinical trials. However, there is a lack of evidence that Twitter offers practical utility and impact. OBJECTIVE The objective of this pilot study is to examine the feasibility and impact of using Twitter monitoring data (i.e., user activity and their conversations about cancer-related conditions and concerns expressed by Twitter users in LA County) as a tool for enhancing clinical trial recruitment at a comprehensive cancer center. METHODS We will conduct a mixed-methods interrupted time series study design with a before and after SM recruitment intervention. Based on a preliminary analysis of eligible trials, we plan to onboard at least 84 clinical trials across six disease categories: breast cancer, colon cancer, kidney cancer, lymphoma, non-small cell lung cancer, and prostate cancer that are open to accrual at the USC Norris Comprehensive Cancer Center (USC Norris). We will monitor messages about the six cancer conditions posted by Twitter users in LA County. Recruitment for the trials will occur through the Twitter account (@USCTrials). Primary study outcomes include, first, feasibility and acceptance of the social media intervention among targeted Twitter users and the study teams of the onboarded trials, which will be assessed using qualitative interviews and 4-point Likert scale, and calculating the proportion of targeted Twitter users who engaged with outreach messages. Second, impact of the social media intervention will be measured by calculating the proportion of people who enrolled in trials. The enrollment rate will be compared between the active intervention period and the prior 10 months as historical control for each disease trial group. RESULTS This study has been funded by the National Center for Advancing Translational Science (NCATS) through a Clinical and Translational Science Award (CTSA) award. Study approval was obtained from the Clinical Investigations Committee (CIC) at USC Norris and the Institutional Review Board (IRB) at USC. Recruitment on Twitter started in February 2018. Data collection will be completed in November 2018. CONCLUSIONS This pilot project will provide preliminary data and practical insight into the application of publicly available Twitter data to identify and recruit clinical trial participants center across six cancer disease types. We will shed light on the acceptance of the SM intervention among Twitter users and study team members of the onboarded trials. If successful, the findings will inform a multisite, randomized controlled trial to determine the efficacy of the social media intervention across different locations and populations.

scholarly journals Trial Prospector: Matching Patients with Cancer Research Studies Using an Automated and Scalable Approach

2014 ◽  
Vol 13 ◽  
pp. CIN.S19454 ◽  
Author(s):  
Satya S. Sahoo ◽  
Shiqiang Tao ◽  
Andrew Parchman ◽  
Zhihui Luo ◽  
Licong Cui ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Survival Rates ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Dramatic Improvement ◽  
Multiple Sources ◽  
Eligibility Criteria ◽  
Physician Participation ◽  
Time Required

Cancer is responsible for approximately 7.6 million deaths per year worldwide. A 2012 survey in the United Kingdom found dramatic improvement in survival rates for childhood cancer because of increased participation in clinical trials. Unfortunately, overall patient participation in cancer clinical studies is low. A key logistical barrier to patient and physician participation is the time required for identification of appropriate clinical trials for individual patients. We introduce the Trial Prospector tool that supports end-to-end management of cancer clinical trial recruitment workflow with (a) structured entry of trial eligibility criteria, (b) automated extraction of patient data from multiple sources, (c) a scalable matching algorithm, and (d) interactive user interface (UI) for physicians with both matching results and a detailed explanation of causes for ineligibility of available trials. We report the results from deployment of Trial Prospector at the National Cancer Institute (NCI)-designated Case Comprehensive Cancer Center (Case CCC) with 1,367 clinical trial eligibility evaluations performed with 100% accuracy.

Comparison of the demographics of patients enrolled (E) versus those not enrolled (NE) on therapeutic clinical trials at a comprehensive cancer center

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17065-17065
Author(s):  
S. Goodin ◽  
D. C. Vamos ◽  
M. P. Kane ◽  
J. Nishioka ◽  
S. Lisi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Demographic Data ◽  
Private Insurance ◽  
Univariate Analysis ◽  
The Elderly ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Chi Square ◽  
Enrollment Rates

17065 Background: In the U.S., representation of minorities and the elderly in clinical trials has been low yet few reports have evaluated this potential barrier to enrollment by comparing the demographics of patients E vs NE within an institution. Therefore, we compared these groups to determine if there were significant differences in demographics at our center. Methods: For all E patients, demographic data is collected in a clinical trial database. For evaluated NE patients, data was captured through a ‘non-protocol’ form. A univariate analysis was performed on the demographic data, including gender, age, race, and insurance status, for each year to determine if there were differences in patients E vs NE on a therapeutic clinical trial. Results: From June 2003 through December 2005, there were 912 E patients and data available on 474 NE patients. The results were consistent for each year from 2003 to 2005, and therefore combinable, with no statistical difference in any parameter for E patients versus NE patients during any year with the exception of gender (p=0.05; Chi-square). The distribution of patients E by gender is 52% (474/912) female vs 48% (438/912) male and NE is 69% (325/474) female vs 31% (149/474) male. The mean age of E patients was 55 vs 56 years for NE patients, with 32% vs 33% representing those >65years, respectively. For the E patients, 84% were white, 7.2% black, 4.6% Asian, 4.2% unknown, and 0.4% Hawaiian/Pacific Islander (H/PI). For the NE patients, where race was not consistently available, 65% were white, 9.3% black, 3.2% Asian, 20.5% unknown, and 2.1% H/PI. In both groups, most patients had private insurance (E 60%, NE 54%), followed by Medicare (E 27.5%, NE 29%), Medicaid (E 4%, NE 9%), self pay (E 7.5%, NE 7.4%), and unknown (E 1.3%, NE 0.4%). Conclusions: When comparing E vs NE patients, gender was the only factor that differed significantly. Although this result suggests that males were more likely to be E in a clinical trial, this finding should be interpreted with caution, since this difference might relate to differences in trial availability. While lower enrollment rates for the elderly and minority patients have been identified nationally, enrolling this group of patients does not appear to be a barrier at our center. No significant financial relationships to disclose.

A virtual tumor board-driven synaptic knowledge network.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 89-89
Author(s):  
Laurence J. Heifetz ◽  
Ahrin B. Koppel ◽  
Elaine Melissa Kaime ◽  
Daphne Palmer ◽  
Thomas John Semrad ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rural Areas ◽  
Cancer Care ◽  
Knowledge Network ◽  
Tumor Board ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Hospital District ◽  
Number Of Patients ◽  
Tumor Boards

89 Background: In 2006, Tahoe Forest Hospital District—a 25-bed hospital in Truckee, CA, a mountain resort community one hour from regional and two hours from academic cancer services—designed and implemented an oncology program utilizing effective telecommunications with a committed academic partner, the UC Davis Comprehensive Cancer Center in Sacramento. Methods: The UC Davis Cancer Care Network was established with four remote cancer programs, enabling participation in daily virtual tumor boards, clinical trial enrollment, and quality assurance assistance. (Richard J. Bold, et. al., Virtual tumor boards: community-university collaboration to improve quality of care. Community Oncol 10(11):310-315, November 2013.; Laurence J. Heifetz, MD, et. al., A Model for Rural Oncology. J Oncol Pract, 7:168-171, May 2011.). An increasing number of patients were observed to in-migrate to Truckee from even more remote rural areas in the mountains. In 2013, the now Gene Upshaw Memorial Tahoe Forest Cancer Center developed four remote telemedicine clinics to allow even more physically distant patients the capacity to be followed locally. Results: Since we opened the remote telemedicine clinics, our Sullivan-Luallin patient satisfaction scores have averaged 4.82/5.00 for “overall satisfaction with the practice” and 4.90/5.00 for “recommending your provider to others”; our in-migration rate of patients from outside our primary catchment area increased from 43% to 52%: and clinical trial accrual rate averaged 10%. Conclusions: Reducing cancer health disparities is an ASCO mission. (cover, ASCO Connection, July 2014; Laurence J. Heifetz, MD. Country Docs with City Technology Can Address Rural Cancer Care Disparities. Oncol, 29(9):641-644, September 2015.). We believe this synaptic knowledge network effectively addresses that mission for rural communities. This model can be scaled in many configurations to address the inherent degradation of quality care as a function of physical distance to an academic center that rural doctors and patients deal with on a daily basis. The key is to insist on a cultural shift – Do something smart at lunch every day. Attend a virtual tumor board.

scholarly journals Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials

2016 ◽  
Vol 12 (6) ◽  
pp. 556-563 ◽  
Author(s):  
Mona N. Fouad ◽  
Aras Acemgil ◽  
Sejong Bae ◽  
Andres Forero ◽  
Nedra Lisovicz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
African American ◽  
African Americans ◽  
Patient Navigation ◽  
Comprehensive Cancer Center ◽  
Trial Participation ◽  
Cancer Clinical Trials ◽  
Minority Participation ◽  
Navigation Support

Purpose: Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute–designated comprehensive cancer center. Methods: Lay individuals were hired and trained to serve as PNs for clinical trials. African American patients potentially eligible for clinical trials were identified through chart review or referrals by clinic nurses, physicians, and social workers. PNs provided two levels of services: education about clinical trials and tailored support for patients who enrolled in clinical trials. Results: Between 2007 and 2014, 424 African American patients with cancer were referred to the Increasing Minority Participation in Clinical Trials project. Of those eligible for a clinical trial (N = 378), 304 (80.4%) enrolled in a trial and 272 (72%) consented to receive patient navigation support. Of those receiving patient navigation support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support. The difference in retention rates between the two groups was statistically significant (P < .001). Participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%. Conclusion: Patient navigation for clinical trials successfully retained African Americans in therapeutic trials compared with non–patient navigation trial participation. The model holds promise as a strategy to reduce disparities in cancer clinical trial participation. Future studies should evaluate it with racial/ethnic minorities across cancer centers.

Bridging the gaps between tertiary and community care networks: Results from a southern California survey research analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1538-1538
Author(s):  
Alex Chehrazi-Raffle ◽  
Nicholas Salgia ◽  
Joann Hsu ◽  
Zeynep Busra Zengin ◽  
Sabrina Salgia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Los Angeles ◽  
Southern California ◽  
Medical Center ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Electronic Data Capture System ◽  
Tertiary Center

1538 Background: Although many tertiary cancer centers offer access to myriad research protocols, the majority of patients nevertheless receive treatment at community practices. We sought to examine the barriers that hamper clinical collaboration between tertiary and community practice environments in Southern California. Methods: A 31-item survey was distributed to community and tertiary oncologists using REDCap, a browser-based electronic data capture system. Survey questions assessed the following attributes: demographics and features of clinical practice, referral patterns, availability and knowledge pertaining to clinical trials, strategies for knowledge acquisition, and integration of community and tertiary practices. Results: The survey was distributed to 98 oncologists, 85 (87%) of whom completed it in full. The most common institutional affiliations were City of Hope Comprehensive Cancer Center (58%), University of California, Los Angeles (10%), and Cedars Sinai Medical Center (8%). In total, 52 (61%) respondents were community practitioners and 33 (38%) were tertiary oncologists. A majority (56%) of community oncologists defined themselves as general oncologists whereas almost all (97%) tertiary oncologists reported a subspecialty. Clinical trial availability was the most common reason for pt referrals to tertiary centers (73%). The most frequent barrier to tertiary referral was financial considerations (59%). Clinical trials were offered by 97% of tertiary practitioners as compared to 67% of community oncologists (p = 0.001). Of note, while a majority of tertiary center providers (52%) described the primary value of community practices to be a source of referrals for clinical trials, most community oncologists (82%) reported only a minimal-to-moderate understanding of clinical trials available at regional tertiary centers. Conclusions: Community oncologists refer patients to tertiary centers primarily with the intent of clinical trial enrollment; however, significant gaps exist in their knowledge of trial availability. Our results identify the need for enhanced communication and collaboration between community and tertiary providers to expand patients’ access to clinical trials.

Medication safety in cancer clinical trials: An analysis of medication error reports at a comprehensive cancer center

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6547-6547 ◽  
Author(s):  
M. P. Kane ◽  
K. Fessele ◽  
J. Gordilis-Perez ◽  
S. Schwartz ◽  
S. Lisi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medication Errors ◽  
Education And Training ◽  
Standards Of Care ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Healthcare Team ◽  
Improvement Project ◽  
And Training

6547 Background: Although medication errors comprise 10–25% of all medical errors, little is known concerning the occurrence or types of medication errors occurring while treating patients on a clinical trial. Therefore, we retrospectively reviewed the medication errors reported in patients enrolled on clinical trials at our center. Methods: As part of a multidisciplinary continuous quality improvement project, from January 2003 through December 2006, we collected voluntary reports of medication errors in adult and pediatric patients on clinical trials involving both oral and intravenous chemotherapy. All reports were classified prospectively regarding clinical trial involvement, severity category (A to I) per the National Coordination Council on Medical Error Reporting and Prevention, type, cause, and where in the medication use process the error occurred. Results: There were 163 reports involving patients treated on clinical trials. The most common errors were those corrected prior to reaching the patient in 68% of events (Category A&B), while 31% reached the patient but did not result in harm (Category C&D), with 1% resulting in temporary patient harm (Category E&F). The most common type of errors were prescribing (66%), improper dose (42%), and omission errors (9%). Not following an institutional procedure or the protocol was the primary cause for these errors (39%), followed by the written order (30%), and poor communication involving both the healthcare team and the patient (26%). The processes where the errors initiated were in prescribing 47%, administration 10%, dispensing 6%, and monitoring 5%. Conclusion: Medication errors do occur in clinical trials, however the majority of these are corrected prior to reaching the patient or do not result in harm. Not following an institutional procedure or the protocol was the most common cause of error. This is most likely due to the protocol procedures differing from existing standards of care. Protocol-specific education through the Centralized Education and Training Service, a shared resource within our cancer center, addresses this issue enhancing the quality and safety of clinical trials through the education and training of healthcare professionals. No significant financial relationships to disclose.

Sign in / Sign up

Export Citation Format

Share Document