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Randomized Clinical Trials in Oncology: Understanding and Attitudes Predict Willingness to Participate

From the Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada, and Medical Psychology Unit, University of Sydney, Departments of Cancer Medicine and Psychological Medicine, Sydney University, and Sydney Square Breast Clinic, Sydney, New South Wales, Australia.

Address reprint requests to Peter M. Ellis, MBBS, PhD, Hamilton Regional Cancer Centre, 699 Concession St, Hamilton, Ontario, Canada L8V 5C2; email: peter.ellis{at}hrcc.on.ca

PURPOSE: To explore the association at different time points in the trajectory of breast cancer care, between anxiety, knowledge, and attitudes, on women’s willingness to participate in randomized clinical trials.

MATERIALS AND METHODS: A cross-sectional survey was undertaken among women attending a breast clinic for screening mammography or diagnostic assessment plus women with newly diagnosed breast cancer to assess attitudes toward and willingness to participate in randomized clinical trials of breast cancer treatment.

RESULTS: Five hundred forty-five women completed questionnaires assessing knowledge of and attitudes toward randomized clinical trials. The mean age of respondents was 48.9 years (SD, 11.3 years). Thirty-three percent of women would consider participating in a clinical trial if they had breast cancer. Women with breast cancer (31%) were significantly more likely to decline to participate than women attending for screening mammography (15%) or diagnostic assessment (15%, P = .0002). Women who might consider participating in a randomized clinical trial were more knowledgeable about randomized trials (mean difference, 0.7; 95% confidence interval [CI], 0.2 to 1.2; P = .003). In a multivariate analysis, women who would consider participating in a randomized trial were younger (odds ratio [OR], 0.96; 95% CI, 0.93 to 0.99), more likely to want an active role in decision-making (OR, 3.2; 95% CI, 1.3 to 7.6), and reported a greater impact from the positive aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.8) and less impact from the negative aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.2).

CONCLUSION: These findings suggest that women who have a better understanding of issues about clinical trials have more favorable attitudes toward randomized trials and are more willing to consider participation in a clinical trial.

Women attending for breast screening or diagnostic assessment were recruited through the Medical Benefits Fund, Sydney Square Breast Clinic.

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