A study among African American patients with cancer who had declined to participate in a therapeutic clinical trial found that few patients reported receiving a positive recommendation from their physician to participate in the trial. “Patients gave multiple refusal reasons,” researchers led by Richard F. Brown, PhD, of the Virginia Commonwealth University School of Medicine, Richmond, reported in the Journal of Oncology Practice. “Most participants refused as a result of fears of additional burdens and adverse effects.” In addition, family members often recommended against trial participation.
The investigators noted that less than 5% of all adult patients with cancer participate in clinical trials and even lower rates have been reported among racial/ethnic minority populations. The study builds on a previous one that explored reasons for refusing to participate in a clinical trial among a sample of 1,995 patients with cancer evaluated for a therapeutic clinical trial over a 4-year period.
“In that study, African American patients were 1.8 times more likely to refuse trial participation than white patients,” the researchers wrote. “When we assessed 11 specific refusal reasons, we found that, compared with white patients, [African American] patients were more likely to cite no interest in trials, pressures from family members, and feeling overwhelmed by the decision-making process, or to provide no reason for refusal. These results suggest that [African American] patients may value interventions that promote information exchange and decision support.”
The current study included 22 consecutively recruited African American patients who had declined to participate in a therapeutic clinical trial at a National Cancer Institute-designated cancer center. The average age was 57; 68% were female; and 46% had been diagnosed with breast cancer.
“Slightly more than half of participants (n = 12; 55%) rated their health status as poor or fair, and almost a third (n = 7; 32%) reported that the cost of care prohibited them from seeking health services,” the investigators stated.
Responding to psychosocial questionnaires, 91% said that they had high needs for information and 68% that they wanted to share decisions. Patients indicated high levels of social support, as well as self-efficacy to understand and participate in care, maintain a positive attitude, and seek/obtain information.
“All participants discussed a clinical trial with either a physician alone or a physician and nurse in combination,” the investigators noted. Nearly one-third of patients (n = 7; 32%) “reported receiving written information that they could take home to review,” the authors added. Three patients (14%) “remembered receiving a positive recommendation from their physician to participate in the trial.”
Among the concerns cited by those declining participation in a clinical trial were increased treatment related burden (cited by 55%), potential adverse effects of the treatment received in the clinical trial (50%), and computerized randomization to a treatment arm (36%). Some also cited pressures from family members not to participate because the trial “was too risky and they didn’t want their family member to be a research ‘guinea pig.’” Other patients just felt overwhelmed.
Comparing patients’ concerns with the information they were given, the investigators “found that patients misunderstood critical information such as the existence of a placebo control or identified extremely rare adverse effects as their primary concern. These findings are consistent with research that has identified significant patient misunderstanding of trial information,” the authors noted.
Patients were asked to consider the potential utility of four decision support tools. Having the opportunity to use a decision aid to discuss the advantages and disadvantages of participation with a physician was supported by 73% of the patients. Being provided with a question prompt list before their discussion about the clinical trial was viewed favorably by 66%, receiving an informative DVD by 55%, and having access to a patient navigator by 45%. In addition, 45% rated all four options as potentially beneficial.
“Our results suggest that clinician researchers consider several actionable items,” the researchers concluded. They listed these items as: “(1) that clinicians provide a clear recommendation about joining a clinical trial, (2) that the role of the person discussing the trial be clearly identified, (3) that lay language handouts be provided to accompany trial information and consent forms, and (4) that patients’ family member or other support person be encouraged to attend the consultation.” ■