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Factors Associated With Participation in Breast Cancer Treatment Clinical Trials

Nancy E. Avis, Kevin W. Smith, Carol L. Link, Gabriel N. Hortobagyi, Edgardo Rivera

From the Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC; RTI International, Waltham; New England Research Institutes, Watertown, MA; and The University of Texas M.D. Anderson Cancer Center, Houston, TX.

Address reprint requests to Nancy E. Avis, PhD, Department of Public Health Sciences, Section on Social Sciences and Health Policy, Wake Forest University School of Medicine, Piedmont Plaza II, Winston-Salem, NC 27157-1063; e-mail: navis{at}wfubmc.edu

PURPOSE: It is well established that recruitment to clinical trials (CTs) is difficult and time consuming. This article reports on factors related to CT participation among women who were invited to participate in a CT for breast cancer.

PATIENTS AND METHODS: Breast cancer patients who were eligible for a CT were identified by 16 different cancer centers. After their invitation to participate in a trial, patients who were undecided about participation in a CT were recruited into the present study at that time. After a patient made a decision about trial participation, a telephone interview was conducted to assess knowledge of CTs, perceived benefits and drawbacks of CTs, and personal factors affecting the women's decision regarding participation.

RESULTS: A total of 208 patients participated in the study. Fifty-eight percent of the patients decided to participate in a trial. Logistic regression analyses showed that the factors best explaining participation were trial phase, perceived drawbacks, time and travel considerations, therapeutic benefit of trial, and physician recommendation. Participation rates were similar for both phase I and phase III trials. However, a higher percentage of women recruited to phase II trials accepted.

CONCLUSION: This study suggests that reducing drawbacks of CT participation, particularly travel time, and improving physician communication of trials are needed to increase trial participation.

Supported by Grant No. R44 CA62793 from the National Cancer Institute.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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