ABSTRACT
BACKGROUND: Enrollment rates onto cancer clinical trials are low and reflect a small subset of the population of which even fewer participants come from populations of racial or ethnic diversity or low socioeconomic status. There is a need to increase enrollment onto cancer clinical trials with a focus on recruitment of a diverse, underrepresented patient population. OBJECTIVE: To use the electronic medical record (EMR) to understand the eligibility and enrollment rates for all available cancer trials in the ambulatory care setting at an urban safety net hospital to identify specific strategies for enhanced accrual onto cancer clinical trials of diverse and underserved patients. METHODS: A clinical trial screening note was created for the EMR by the clinical trials office at an urban safety net hospital. 847 cancer clinical trial screening notes were extracted from the EMR between January 1, 2010 and December 31, 2010. During that time, 99 cancer trials were registered for accrual, including clinical treatment, survey, data repository, imaging, and symptom management trials. Data on eligibility, enrollment status, and relationship to sociodemographic status were compared. LIMITATIONS: This is a single-institution and retrospective study. CONCLUSIONS: The findings demonstrate that a formal process of tracking cancer clinical trial screens using an EMR can document baseline rates of institution-specific accrual patterns and identify targeted strategies for increasing cancer clinical trial enrollment among a vulnerable patient population. Offering nontreatment trials may be an important and strategic method of engaging this vulnerable population in clinical research.
ABSTRACT
The purpose of this study was to evaluate the rate of change (RoC) in the size of the lumpectomy cavity (LC) before and during breast radiotherapy (RT) using cone-beam computed tomography (CBCT), relative to the initial LC volume at CT simulation (CTVLC) and timing from surgery. A prospective institutional review board-approved study included 26 patients undergoing breast RT: 20 whole breast irradiation (WBI) patients and six partial breast irradiation (PBI) patients, with surgical clips outlining the LC. The patients underwent CT simulation (CTsim) followed by five CBCTs during RT, once daily for PBI and once weekly for WBI. The distance between surgical clips and their centroid (D) acted as a surrogate for LC size. The RoC of the LC size, defined as the percentage change of D between two scans divided by the time interval in days between the scans, was calculated before (CTsim to CBCT1) and during RT (CBCT1 to CBCT5). The mean RoC of D for all patients before starting RT was -0.25%/day (range, -1.3 to 1.4) and for WBI patients during RT was -0.15%/day (range, -0.45 to 0.40). Stratified by median CTVLC, the RoC before RT for large CTVLC group (≥ 25.7 cc) was 15 times higher (-0.47%/day) than for small CTVLC group (< 25.7 cc) (-0.03%/day), p = 0.06. For patients undergoing CTsim < 42 days from surgery, the RoC before RT was -0.43%/day compared to -0.07%/day for patients undergoing CTsim ≥ 42 days from surgery, p = 0.12. For breast cancer RT, the rate of change of the LC is affected by the initial cavity size and the timing from surgery. Resimulation closer to the time of boost treatment should be considered in patients who are initially simulated within six weeks of surgery and/or with large CTVLC.