New Journal of Oncology Practice Early Release articles have been made available
(for the period 7 Jan 2014 to 14 Jan 2014)
(for the period 7 Jan 2014 to 14 Jan 2014)
CLINICAL RESEARCH PRACTICES
Original Contribution
Published 14 January 2014, 10.1200/JOP.2013.001194
- Copyright © 2014 by American Society of Clinical Oncology
Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual
- Diane St Germain, RN, MS⇑,
- Andrea M. Denicoff, MS, RN,
- Eileen P. Dimond, RN, MS,
- Angela Carrigan, MPH,
- Rebecca A. Enos, RN, MPH,
- Maria M. Gonzalez, BS, MPH(C),
- Kathy Wilkinson, RN, OCN,
- Michelle A. Mathiason, MS,
- Brenda Duggan, RN,
- Shaun Einolf,
- Worta McCaskill-Stevens, MD, MS,
- Donna M. Bryant, MSN, ANP-C, OCN, CCRC,
- Michael A. Thompson, MD, PhD,
- Stephen S. Grubbs, MD and
- Ronald S. Go, MD, FACP
+Author Affiliations
- Corresponding author: Diane St. Germain, RN, MS, National Cancer Institute, Division of Cancer Prevention, 9609 Medical Center Dr, 5E508, Rockville MD 20850; e-mail: dstgermain@mail.nih.gov.
Abstract
Purpose: Screening logs have the potential to help oncology clinical trial programs at the site level, as well as trial leaders, address enrollment in real time. Such an approach could be especially helpful in improving representation of racial/ethnic minority and other underrepresented populations in clinical trials.
Methods: The National Cancer Institute Community Cancer Centers Program (NCCCP) developed a screening log. Log data collected from March 2009 through May 2012 were analyzed for number of patients screened versus enrolled, including for demographic subgroups; screening methods; and enrollment barriers, including reasons for ineligibility and provider and patient reasons for declining to offer or participate in a trial. User feedback was obtained to better understand perceptions of log utility.
Results: Of 4,483 patients screened, 18.4% enrolled onto NCCCP log trials. Reasons for nonenrollment were ineligibility (51.6%), patient declined (25.8%), physician declined (15.6%), urgent need for treatment (6.6%), and trial suspension (0.4%). Major reasons for patients declining were no desire to participate in trials (43.2%) and preference for standard of care (39%). Major reasons for physicians declining to offer trials were preference for standard of care (53%) and concerns about tolerability (29.3%). Enrollment rates onto log trials did not differ between white and black (P = .15) or between Hispanic and non-Hispanic patients (P = .73). Other races had lower enrollment rates than whites and blacks. Sites valued the ready access to log data on enrollment barriers, with some sites changing practices to address those barriers.
Conclusion: Use of screening logs to document enrollment barriers at the local level can facilitate development of strategies to enhance clinical trial accrual.
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