Do patients participating in clinical trials want to know study results?

Patients with cancer are not routinely provided with results of trials in which they have participated unless the information would influence their future care. In recent years, there has been increasing interest on the part of patient advocates and clinical researchers in offering trial results to all study participants (1, 2). The Summit Series on Clinical Trials stated that results of trials, both positive and negative, should be made available to participants and that providing results should be considered the ethical norm (3). We developed and administered a questionnaire to consecutive patients enrolled in a multicenter phase II study for first-line treatment of advanced breast cancer (4) during the outpatient visit on week 2 of treatment, after participating institution local institutional review board approval. Sixteen sites enrolled patients on the treatment trial, and patients from 15 sites returned surveys. Fifty-one (93%) of 55 patients enrolled on the trial completed the survey. Median age of survey respondents was 54 years (range 29– 82 years) and 84% were white. Ninetyfour percent of respondents graduated from high school, and 61% had a college degree (Table 1). The vast majority (96%, 49 patients) of the 51 patients surveyed indicated that they wanted to be informed of the results of the trial. Ninety-six percent (49 patients) of the 51 patients agreed or strongly agreed with the statement “As a participant in this trial, I believe that I have a ‘right’ to be informed of the results when available.” Forty-seven percent (24 patients) of the 51 patients indicated that their interest in the results would be affected by how they personally fared with the treatment. College graduates were less likely to indicate that their interest would be affected by their response to the treatment (26% versus 80%, P<.001). Although 47% (24 patients) of the 51 patients indicated that their interest in receiving results might vary, 96% (23 patients) of these 24 patients would still want to receive results, even if they did not benefit from the study treatment. Ninety percent (46 patients) of the 51 patients would want their family or loved ones informed of the results if they were unable to learn them. The women indicated that study results could be provided by their physicians (86%), nurses (37%), a member of the research team (45%), or a special person (4%). Thirty-seven percent wanted to be contacted only by their physician. They said results could be shared in various ways including in person (69%), over the telephone (22%), and by mail (69%). Twenty-five percent only wanted to be told the results in person. There are two important observations from this study. First, most patients surveyed wanted to know the results of their treatment study. Second, many women felt that it should be their doctors who share study results with them. In much the same way that doctors are responsible for obtaining informed consent when entering a patient on study, patients expect their doctors to communicate research results. These findings warrant confirmation and further evaluation among patients in other settings. Although this study was multicenter and included a relatively broad patient population, the small sample size, administration of a single survey per patient, and use of an unvalidated survey limit the generalizability. Despite these limitations, the findings are of interest as efforts are implemented to provide feedback to participants about trial results (1,2,5). Future research should focus on providing trial results to interested participants with follow-up assessments to determine the impact of this information. Such research may ultimately improve patient–provider communication and patient satisfaction with care and could potentially lead to greater clinical trial participation.