Identification of accrual barriers to cancer clinical trials in Massachusetts

According to the National Cancer Institute, breast cancer is a critical public health problem and accrual onto cancer clinical trials is low. The purpose of this study was to examine factors influencing the decision to participate or not to participate in a breast cancer prevention clinical trial conducted in Massachusetts. To date there have been no identified studies investigating the barriers experienced by subjects that are deemed eligible to participate in a Phase III breast cancer prevention clinical trial, but choose not to join, in comparison with those subjects that actually enroll onto the trial.;Nine health care organizations in Massachusetts participated in the research project. A total of 242 study eligible women were identified at the cooperating sites for participation in a mailed survey instrument. Ultimately, 111 (45.9%) women completed the mailed questionnaire.;Three research questions were posed as part of the research project. The first two questions sought to determine the comparability of the study population to the demographic characteristics of local populations, the state of Massachusetts, and to the national demographic characteristics of women both study eligible and those enrolled onto the STAR study, a national Phase III breast cancer prevention trial. Using a case-control study, the third research question sought to compare responses between the two study groups on 12 factors that are identified barriers to accrual for a clinical trial.;Results of the first two research questions supported the comparability and generalizability of the study findings to the general population for breast cancer prevention clinical trial subjects. Results of the first two research questions supported the comparability and generalizability of the study findings to the general population for breast cancer prevention clinical trial subjects. Results of the third research question showed that when adjusting for subject demographics, and in the presence of other questions, four factors (1) clinician expertise and qualifications (p =.012, OR: 4.903; 95% CI: 1.411 to 17.043); (2) personal desire to participate (p = .033, OR: 3.158; 95% CI: 1.100 to 9.062); (3) perceived value of the trial (p = .020, OR: 2.921; 95% CI, 1.184 to 7.209); and, (4) level of trial inconvenience (p = .002, OR: 0.095; 95% CI, 0.021 to 0.435), significantly influenced a woman's decision to enroll onto a clinical trial more than other eligible subjects.