Statewide cancer clinical trial navigation service.
OBJECTIVE
Realizing that education and awareness are paramount in making clinical trials available to improve overall accrual rates, we sought to create a clinical trial navigation service to improve the accessibility of cancer clinical trials in Florida for physicians and patients. This study was undertaken to evaluate this service. We hoped to identify characteristics of our service that were effective in promoting clinical trial enrollment and to better understand barriers that prevented enrollment.


METHODS
Qualitative and quantitative data were gathered to inform the evaluation. This information was drawn from semistructured interview and focus groups as well as data from 6,350 patient questionnaires capturing diagnosis, stage, and treatment history. Quantitative data were analyzed by computing indices of central tendency and dispersion as well as frequency distributions. Qualitative data were analyzed using open coding to identify major themes representing the information.


RESULTS
Our navigation system increased patient awareness of trials; however, this did not lead to an increase in trial enrollment. A key barrier to enrollment was the timing of the patient's awareness of a clinical trial opportunity. Often trial options were realized after a treatment course was initiated. This frequently disqualified the patient from trial consideration. We identified factors underlying the critical role of how physician attitudes toward trials affect enrollment. We also found that government databases were incomplete. Twenty-five percent of clinical trials open in Florida were not listed with Physician Data Query or clinicaltrials.gov, and 15% to 22% were erroneously listed as having sites in Florida. Media efforts to increase patient awareness and use of the navigation service were transient. One-time educational programs did not have a long-term impact on clinical trial inquiries. Patients who spoke with clinical trial navigators were four times more likely to contact a matched trial site. Sharing a common database platform with various organizations increased the likelihood of patients finding trials near home. More than 82% of patients seeking information started their search on other Web sites.


CONCLUSIONS
Although we were able to overcome the barriers most commonly cited by patients, we found that taking a strictly patient-focused approach was not enough. Our results underline the critical role of health professionals in guiding patients to clinical trials, by including these options at a time when patients are likely to be eligible.
Moffitt
Karen
K
University of South Florida; Moffitt Cancer Center and Research Institute; Florida Dialogue on Cancer, Tampa; M. D. Anderson Cancer Center Orlando, Orlando; Lynn Cancer Center, Boca Raton Community Hospital, Boca Raton; Sylvester Comprehensive Cancer Center, University of Miami, Miami; and Mayo Clinic in Florida, Jacksonville, FL.
Brogan
Frank
F
Brown
Clarence
C
Kasper
Michael
M
Rosenblatt
Joseph
J
Smallridge
Robert
R
Sullivan
Daniel
D
Kromrey
Jeffrey
J
J Clin Oncol. 2002 Apr 15;20(8):2109-17
11956272
J Clin Oncol. 2003 Mar 1;21(5):830-5
12610181
J Clin Oncol. 2003 Apr 1;21(7):1383-9
12663731
Lancet. 2004 Jan 24;363(9405):263-70
14751698
Cancer. 2006 Jan 15;106(2):426-33
16353206
J Clin Oncol. 2005 Dec 20;23(36):9282-9
16361626
JAMA. 2004 Jun 9;291(22):2720-6
15187053
J Am Coll Surg. 2004 Oct;199(4):644-51
15454152