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Identification of accrual barriers onto breast cancer prevention clinical trials: a case-control study
Preventive and Behavioral Medicine Publications and Presentations
  • Robert H. Houlihan, Virginia Commonwealth University
  • Michael H. Kennedy, East Carolina University
  • Robert R. Kulesher, East Carolina University
  • Stephenie C. Lemon, University of Massachusetts Medical School
  • D. Lawrence Wickerham, National Adjuvant Breast and Bowel Project
  • Chung-Cheng Hsieh, University of Massachusetts Medical School
  • Dario C. Altieri, University of Massachusetts Medical School
UMMS Affiliation
Department of Cancer Biology; Department of Medicine, Division of Preventive and Behavioral Medicine
Publication Date
Document Type
Adult; Breast Neoplasms; Case-Control Studies; *Clinical Trials as Topic; Female; Humans; Middle Aged; *Patient Selection; Physician-Patient Relations; Questionnaires
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.
DOI of Published Version
Cancer. 2010 Aug 1;116(15):3569-76. Link to article on publisher's site
Related Resources
Link to Article in PubMed
PubMed ID
Citation Information
Robert H. Houlihan, Michael H. Kennedy, Robert R. Kulesher, Stephenie C. Lemon, et al.. "Identification of accrual barriers onto breast cancer prevention clinical trials: a case-control study" Vol. 116 Iss. 15 (2010) ISSN: 0008-543X (Linking)
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