Sharing clinical trial results strongly favored by participants

ATLANTA -- Researchers from Dana-Farber Cancer Institute in Boston say that participants in a clinical trial of breast cancer treatment were overwhelmingly glad to learn the study's outcome, although some women were initially confused, and one in four became more anxious about their disease.

Ann Partridge, M.D., M.P.H., Eric Winer, M.D., and their colleagues discovered through a survey that 33 percent of the respondents initially misunderstood the meaning of the results or were unsure of their significance. Nearly one-quarter -- 24 percent -- were more anxious about their disease after learning the results, while 39 percent responded that their anxiety decreased. The findings will be reported at the American Society of Clinical Oncology's annual meeting in Atlanta on Sunday, June 4, 9 a.m. (Building C, Level 1, Hall C1).

Sharing results met with an overwhelmingly favorable response by the women who participated in a large Phase III study comparing treatments for HER2-positive breast cancer, an aggressive form of the disease, according to Partridge. "However, some patients may not initially understand the findings," she added. "We are continuing to evaluate the best ways to share results, and make them completely clear so that patients understand them."

Most of those surveyed initially received the results by mail or from the media, and 25 percent said they might have preferred having the findings offered before they decided whether or not they wanted to see them. Yet only four percent said they would have declined the results if offered.

The Dana-Farber research has been prompted by growing interest in providing clinical trial participants with study results. Previously, they found that clinical trial investigators were willing to do so, and that women in breast cancer trials were strongly in favor of the idea.

The new study, designed to assess the impact of the practice, involved a survey sent to 228 women who had participated in the clinical trial that compared the use of adjuvant chemotherapy alone or in combination with Herceptin, a drug that specifically targets the overactive HER2 protein that drives the breast cancer. There was extensive media coverage last September when trial officials reported that Herceptin achieved impressive reductions in the risk of cancer returning in women who had early-stage HER2-positive cancer.

The 167 responses to date represented women from 26 to 76 years in age; 83 percent were white and 60 percent were college graduates. Four percent of the participants had experienced a recurrence of their cancer. As for the way they first became aware of the study's results, 29 percent learned about it through the media, 26 percent received the information in the mail, 19 percent from a health care provider, and 26 percent through other means. Ultimately, 83 percent received a mailing about the results, and 43 percent reported that their health care provider told them in person or on the phone.

Just over half (56 percent) of the women found the information easy to understand, and only 68 percent correctly interpreted the results initially. Those who said their anxiety increased after receiving the results (24 percent) were more likely to be in the group that didn't receive the intervention -- Herceptin added to standard chemotherapy -- while the women whose anxiety eased tended to be those who did receive Herceptin.

As the move toward sharing clinical trial results goes forward, the researchers said their findings underscore the need to consider the potential for increased anxiety when sharing the information and that some participants may require psychosocial support.

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The study was funded in part by an ASCO Career Development Award.

Dana-Farber Cancer Institute (www.dana-farber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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