Purpose: Clinical trials are essential to develop and test novel therapies, yet only 2%-3% of women with breast cancer enroll. We sought to describe patient and physician barriers to trial participation and then implemented targeted interventions to increase awareness and interest in trial participation. Also, with increasing patient interest in complementary and alternative medicine (CAM) for cancer, we explored attitudes regarding CAM clinical trials.
Patients and methods: Between 1997 and 2000, questionnaires were offered to patients with newly diagnosed or recurrent breast cancer and to physicians specializing in breast cancer. Programs aimed at patients and physicians from our geographic region to increase their support for breast cancer clinical trials were initiated in 1997. Correlation between perceived barriers and patient and physician demographics were explored. Reluctance to be randomized, extra time, and concerns about worse side effects with the experimental arm were the most significant patient barriers. Physician barriers included randomization, extra staff time, and increased costs of enrollment. Patients and physicians approved of studying CAM in clinical trials, with different scores based on age and type of practice. Physicians and patients developed more favorable views of clinical trials between 1997 and 2000.
Results: Although many barriers still exist, this study suggests that attitudes toward clinical trials are evolving and significantly affected by patient age and stage of disease. Because different patients and some different physicians were surveyed, it is difficult to conclude that the changes occurred as a result of the interventions.
Conclusion: Future efforts to improve enrollment should focus on patients' individual concerns and the uneasiness with the randomization.