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.

Identification of cancer care and protocol characteristics associated with recruitment rate in breast cancer clinical trials in Ontario

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17042-17042
Author(s):  
J. Lemieux ◽  
P. J. Goodwin ◽  
K. Pritchard ◽  
K. Gelmon ◽  
L. Bordeleau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Multivariate Analysis ◽  
Relative Risk ◽  
Cancer Care ◽  
Time Frame ◽  
Recruitment Rate ◽  
Pharmaceutical Companies ◽  
Cooperative Groups ◽  
Number Of Patients

17042 Background: Recruitment rate (RR) in clinical trials (CT) has been recognized to be low. Poor accrual may lead to premature closing of CT or decrease of the planned power to detect an effect if present. Methods: Objectives were primarily to identify characteristics of cancer care settings and clinical trials protocols associated with low RR and secondarily (1) to determine the RR and (2) to compare the RR between years. A cross-sectional design was used. Poisson regression was used for multivariate analysis. RR was calculated by CT, hospital and year in Ontario between 1997 and 2002. Number of patients recruited in each CT was obtained from cooperative groups and pharmaceutical companies. Number of patients with breast cancer (BC) was obtained from the Ontario Cancer Registry. Prevalence of women with metastatic BC was calculated from the British Columbia Breast Cancer Outcome Unit database. Characteristics of cancer care and protocols were collected. Results: Response rates were 84% (66/79) for hospitals, 69% (9/13) for cooperative groups and 80% (8/10) for pharmaceutical companies. Recruitment rates varied between 1.3% and 5.5% (median, p=0.0003). Characteristics of cancer care were not associated with RR (number of oncologists, breast oncologists, breast surgeons, investigators, clinical research associates and being a cancer centre or an academic centre). Among protocol characteristics, the following were associated with RR in univariate analysis: phase, randomization, type of intervention, placebo, extent of the trials (local vs. national vs. international), number of sites, population (adjuvant vs. metastatic), menopausal status, premature closing of the trial, time frame for enrolment, extra baseline and follow-up testing. In multivariate analysis, type of control arm and time frame for enrolment were significant. CT using placebo compared to an active control arm were less likely to recruit patients (relative risk 0.57, p=0.0144). CT with a time frame for enrolment greater than 9 weeks were more likely to enrol patients (relative risk 1.43, p=0.0020). Conclusions: RR is very low. No easily modifiable factors have been identified. This project was funded by the Canadian Breast Cancer Foundation, Ontario Chapter. [Table: see text]

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.

scholarly journals Recommendations for Collection and Handling of Specimens From Group Breast Cancer Clinical Trials

2008 ◽  
Vol 26 (34) ◽  
pp. 5638-5644 ◽  
Author(s):  
Brian R. Leyland-Jones ◽  
Christine B. Ambrosone ◽  
John Bartlett ◽  
Matthew J.C. Ellis ◽  
Rebecca A. Enos ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
North American ◽  
Ffpe Tissue ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Specimen Collection ◽  
Frozen Tissue ◽  
Fresh Frozen ◽  
Working Groups

Recommendations for specimen collection and handling have been developed for adoption across breast cancer clinical trials conducted by the Breast International Group (BIG)-sponsored Groups and the National Cancer Institute (NCI)-sponsored North American Cooperative Groups. These recommendations are meant to promote identifiable standards for specimen collection and handling within and across breast cancer trials, such that the variability in collection/handling practices that currently exists is minimized and specimen condition and quality are enhanced, thereby maximizing results from specimen-based diagnostic testing and research. Three working groups were formed from the Cooperative Group Banking Committee, BIG groups, and North American breast cancer cooperative groups to identify standards for collection and handling of (1) formalin-fixed, paraffin-embedded (FFPE) tissue; (2) blood and its components; and (3) fresh/frozen tissue from breast cancer trials. The working groups collected standard operating procedures from multiple group specimen banks, administered a survey on banking practices to those banks, and engaged in a series of discussions from 2005 to 2007. Their contributions were synthesized into this document, which focuses primarily on collection and handling of specimens to the point of shipment to the central bank, although also offers some guidance to central banks. Major recommendations include submission of an FFPE block, whole blood, and serial serum or plasma from breast cancer clinical trials, and use of one fixative and buffer type (10% neutral phosphate-buffered formalin, pH 7) for FFPE tissue across trials. Recommendations for proper handling and shipping were developed for blood, serum, plasma, FFPE, and fresh/frozen tissue.

Temporal trends in protocol-specified adjuvant chemotherapy dosing in obese patients with breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11055-11055
Author(s):  
C. Greenman ◽  
J. J. Griggs
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Adjuvant Chemotherapy ◽  
Cooperative Group ◽  
Obese Patients ◽  
Obese Women ◽  
Optimal Dosing ◽  
Trial Protocols ◽  
Dose Reductions

11055 Purpose: Dosing of breast cancer adjuvant chemotherapy in obese women varies substantially, with up to 40% of obese women receiving reduced (compared to full weight-based) doses. Such variation indicates uncertainty about best practices. This study reports changes over time in protocol-specified dose determinations in heavy patients. Methods: The National Cancer Institute database of cooperative group trials was used to identify completed clinical trials of non-myeloablative breast cancer adjuvant chemotherapy. Dose determinations specified in each protocol were categorized into one of four groups: 1) full weight-based dosing, 2) dose reduction in heavy patients (ideal or corrected body weight used to calculate body surface area, BSA), 3) dosing in heavy patients left to physician’s discretion, or 4) no specific instructions. Results: Of 110 eligible clinical trial protocols identified, 61 (55%) were retrieved. Of the 16 protocols initiated before 1985, 15 (94%) either did not address dose determination (n = 6) or specified dose reduction (n = 9) in heavy patients. Of the 45 protocols initiated after 1985, 26 (58%) specified full weight-based dosing, 13 (29%) specified dose reductions, 4 (9%) left dosing in heavy women to the physician’s discretion, and 3 (7%) had no specific instructions for dose determinations in heavy patients. The difference in the use of full weight based doses before and after 1985 was statistically significant (p value = 0.0003, 2-sided Fisher’s exact test). One of the cooperative groups, which contributed 10 of the 45 (22%) clinical trial protocols since 1985, specifies a maximum BSA of 2.0 m2 for cyclophosphamide and doxorubicin in all protocols. Conclusions: Over the last two decades, dose determinations in clinical trial protocols have, with the exception of one cooperative group, specified use of actual body weight. Present-day dose reductions in obese patients who are not participating in clinical trials suggest a lack of diffusion of information about optimal dosing in obesity. The continued practice of limiting the doses of cyclophosphamide and doxorubicin in patients with a BSA over 2.0 m2 in the protocols of one cooperative group may contribute to persistent uncertainty about optimal dosing in heavy patients. No significant financial relationships to disclose.

Proposal for Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials: The STEEP System

2007 ◽  
Vol 25 (15) ◽  
pp. 2127-2132 ◽  
Author(s):  
Clifford A. Hudis ◽  
William E. Barlow ◽  
Joseph P. Costantino ◽  
Robert J. Gray ◽  
Kathleen I. Pritchard ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Cancer Death ◽  
End Points ◽  
Breast Cancer Death ◽  
End Point ◽  
Adjuvant Breast Cancer

Purpose Standardized definitions of breast cancer clinical trial end points must be adopted to permit the consistent interpretation and analysis of breast cancer clinical trials and to facilitate cross-trial comparisons and meta-analyses. Standardizing terms will allow for uniformity in data collection across studies, which will optimize clinical trial utility and efficiency. A given end point term (eg, overall survival) used in a breast cancer trial should always encompass the same set of events (eg, death attributable to breast cancer, death attributable to cause other than breast cancer, death from unknown cause), and, in turn, each event within that end point should be commonly defined across end points and studies. Methods A panel of experts in breast cancer clinical trials representing medical oncology, biostatistics, and correlative science convened to formulate standard definitions and address the confusion that nonstandard definitions of widely used end point terms for a breast cancer clinical trial can generate. We propose standard definitions for efficacy end points and events in early-stage adjuvant breast cancer clinical trials. In some cases, it is expected that the standard end points may not address a specific trial question, so that modified or customized end points would need to be prospectively defined and consistently used. Conclusion The use of the proposed common end point definitions will facilitate interpretation of trial outcomes. This approach may be adopted to develop standard outcome definitions for use in trials involving other cancer sites.

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.

scholarly journals ReCAP: Impact of the National Cancer Institute Community Cancer Centers Program on Clinical Trial and Related Activities at a Community Cancer Center in Rural Nebraska

2016 ◽  
Vol 12 (1) ◽  
pp. 67-68 ◽  
Author(s):  
Mehmet Sitki Copur ◽  
Ryan Ramaekers ◽  
Mithat Gönen ◽  
Mary Gulzow ◽  
Rebecca Hadenfeldt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Positive Impact ◽  
Tissue Samples ◽  
Cancer Centers ◽  
Care Services ◽  
Cancer Program ◽  
Number Of Patients ◽  
And Storage

QUESTION ASKED: What is the impact of participating in the National Cancer Institute Community Cancer Centers Program (NCCCP) on the number of clinical trials available, number of patients enrolled in trials, and trial-related services provided to patients at a rural community-based cancer program? SUMMARY ANSWER: Significant increases in the number and percentage of patients enrolled in clinical trials, in the number of available treatment and non-treatment (eg, prevention, biospecimen, cancer control) trials, in clinical trial staffing, and in the number of tissue samples collected and/or stored were observed during the 5-year period of NCCCP. Biospecimen trials helped promote standardization of collection and storage processes in our community cancer program. Employment and utilization of a genetic counselor, smoking cessation counselor, outreach project coordinator, and two nurse navigators enabled delivery of improved cancer care continuum services to our rural patient population. METHODS: SFCTC clinical trial activities data from July 2002 to June 2007, the 5 years before participation in the NCCCP, and from July 2007 to June 2012, the 5 years during the program, were gathered and compared. Data capture included information on the number and percentage of patients on clinical trials, number and type of available clinical trials, percentage of underserved patients in clinical trials, clinical trial staffing, collection and storage of tissue samples, organizational infrastructure, linkage to NCI-designated cancer centers, and availability of new cancer care services. Percentages of patients in clinical trials were calculated as the ratio of the number of patients enrolled onto clinical trials over the number of analytic new patient cases of cancer through our tumor registry per year. Percentages of tissue samples collected and/or stored were similarly measured as the number of biospecimens collected over the number of analytic new patient cases of cancer per year. Statistical analyses were performed using chi-square and Wilcoxon tests. BIAS, CONFOUNDING FACTOR(S), DRAWBACKS: Data 5 years prior to and 5 years during NCCCP were prospectively collected. Analysis of data was performed after the completion of NCCCP. REAL-LIFE IMPLICATIONS: Improving access of all adult cancer patients to clinical trials in the communities where they live is crucial to provide the best cancer care. Participation in the NCCCP had a positive impact on our clinical trial and related activities, providing our rural Nebraska population with enhanced access to both clinical trials and cancer care services. Implementing programs and policies that facilitate the delivery of high-quality care in the community setting is feasible and greatly needed. The NCCCP had a positive impact by providing expanded spectrum of clinical trial types and programs to the population of patients in our cancer program service area. [Table: see text]

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