Participation in Clinical Treatment Trials: Factors Affecting Participation for Women with Breast Cancer

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Abstract
A retrospective descriptive study was conducted to investigate reasons for participation or nonparticipation in clinical treatment trials among women with breast cancer. Eighty-two breast cancer patients from a university-based medical center (n = 40) and a rural community hospital (n = 42) were selected from hospital tumor registry records. Thirty-minute face-to-face interviews were conducted to identify reasons for participation or nonparticipation in clinical treatment trials. Those who were not asked initially to participate in a trial (either because of trial unavailability or ineligibility or because they simply were not asked) were also asked if they would have participated had they been invited. Thirty-four (41%) were eligible for participation in one or more of the currently ongoing clinical trials. Only 20 (59%) of these women were invited to participate in a treatment trial by their physician. Of those asked, 14 (70%) agreed to participate. The majority of women who were not invited or not eligible stated that they would have participated if invited (50% of those not invited and 70% of those not eligible). Reasons for participation included personal benefit, altruism, doctor's recommendation, desire to foster the progress of medical research, and previous experience with cancer or medical research. Reasons women gave for not wanting to participate included negative beliefs about clinical trial research, lack of knowledge about clinical trial research, personal issues, and requirements of the protocol. Among eligible women, those who were not offered trial participation were older than those offered participation (average age 63 years vs. 54 years; p = 0.025). Logistic regression analysis identified two areas that predicted participation: knowledge about research studies (OR = 3.98; p = 0.05) and attitudes about research studies (OR = 3.6; p = 0.03). Working status, cancer detected by a physician, and knowledge of signs and symptoms of cancer were modestly associated with participation. Three areas of intervention were identified that would foster clinical trial participation for breast cancer: (1) protocols need to be designed with broader eligibility criteria or more protocols need to be written, (2) physicians should be encouraged to invite all eligible patients to participate, and (3) knowledge and attitudes of patients regarding clinical trials need to be improved.