Identification of accrual barriers onto breast cancer prevention clinical trials: a case-control study.
BACKGROUND
The purpose of this study was to examine factors influencing a woman's decision to participate in a breast cancer prevention clinical trial. Nine healthcare organizations in Massachusetts cooperated in the present project.


METHODS
The authors performed a case-control study to compare responses between the study group (Study of Tamoxifen and Raloxifene [STAR] trial eligible, but not enrolled) and the control group (STAR trial participants) on 12 factors previously identified as barriers to accrual for clinical trials. Eight hypotheses were tested using multiple logistic regression to estimate the strength of the association for each factor on the dependent variable (study participation).


RESULTS
The study samples were similar to the general population of eligible breast cancer prevention clinical trial subjects in the counties where the participating organizations were located, the state of Massachusetts, and nationally published STAR trial data. Results of a mailed questionnaire showed that when adjusting for subject demographics, and in the presence of other questions, 4 factors significantly influenced a woman's decision to enroll onto a breast cancer prevention clinical trial more than other eligible subjects: 1) clinician expertise and qualifications (P=.012; odds ratio [OR], 4.903; 95% confidence interval [CI], 1.41-17.04); 2) personal desire to participate (P=.033; OR, 3.16; 95% CI, 1.10-9.06); 3) perceived value of the trial (P=.020; OR, 2.92; 95% CI, 1.18-7.21); and 4) level of trial inconvenience (P=.002; OR, 0.10; 95% CI, 0.02-0.44).


CONCLUSIONS
Addressing these issues in the relationship between patients and clinicians should improve accrual to breast cancer prevention clinical trials.
Houlihan
Robert H
RH
Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia 23298-0037, USA. RHHoulihan@vcu.edu
Kennedy
Michael H
MH
Kulesher
Robert R
RR
Lemon
Stephenie C
SC
Wickerham
D Lawrence
DL
Hsieh
Chung-Cheng
CC
Altieri
Dario C
DC
D000328:Adult; D001943:Breast Neoplasms / Q000517:prevention & control* / Q000523:psychology; D016022:Case-Control Studies; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008875:Middle Aged; D018579:Patient Selection; D010817:Physician-Patient Relations; D011795:Surveys and Questionnaires