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Patient and physician attitudes toward breast cancer clinical trials: developing interventions based on understanding
Michelle E Melisko1, Fern Hassin, Lauren Metzroth
1University of California, San Francisco, USA.
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.
Insights
Low enrollment in breast cancer clinical trials stems from patient and physician barriers like randomization reluctance. Addressing these concerns and improving trial awareness can enhance participation in cancer research.
Area of Science:
- Oncology
- Clinical Research
- Patient Advocacy
Background:
- Clinical trials are crucial for advancing cancer therapies but face low enrollment rates, particularly in breast cancer (2-3%).
- Understanding patient and physician barriers is key to improving trial participation.
- Growing interest in complementary and alternative medicine (CAM) necessitates exploring its role in clinical trials.
Purpose of the Study:
- To identify patient and physician barriers to breast cancer clinical trial participation.
- To implement interventions aimed at increasing awareness and interest in clinical trials.
- To assess attitudes towards complementary and alternative medicine (CAM) clinical trials.
Main Methods:
- Surveys administered to breast cancer patients and physicians between 1997-2000.
- Initiation of regional programs to promote breast cancer clinical trials.
- Analysis of demographic correlations with perceived barriers and attitudes towards trials.
Main Results:
- Key patient barriers included reluctance to be randomized, time constraints, and fear of adverse effects.
- Physician barriers involved randomization, staff time, and enrollment costs.
- Both patients and physicians showed openness to CAM clinical trials, with attitudes varying by demographics. Favorable views on clinical trials improved over the study period.
Conclusions:
- Attitudes toward clinical trials are evolving, influenced by patient age and disease stage.
- Addressing patient-specific concerns and randomization uneasiness is vital for future enrollment strategies.
- Interventions may positively impact trial perceptions, though direct causality requires further investigation.
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