The impact of sharing results of a randomized breast cancer clinical trial with study participants

Dana-Farber Cancer Institute, Boston, MA 02115, USA.
Breast Cancer Research and Treatment (Impact Factor: 3.94). 06/2008; 115(1):123-9. DOI: 10.1007/s10549-008-0057-7
Source: PubMed


There has been growing interest in providing clinical trial participants with study results yet only limited information exists regarding the process and impact of sharing results. We sought to evaluate patient perceptions of how results had been shared from a large randomized cooperative group trial, and the impact of learning results.
A subset of women who participated in NCCTG 9831 (A Phase III Trial of Adjuvant Chemotherapy with or without Trastuzumab for Women with HER2-positive Breast Cancer) were mailed surveys after the preliminary study results were released to the public and mailed to participants.
One hundred and 67 of 228 surveys sent (73%) were returned; 61% reported receiving trastuzumab on study; 4% reported recurrent disease. Ninety-five percent of participants were glad they received results; 81% were satisfied with how results were shared; 23% were more anxious after learning the results. Sixty-nine percent correctly interpreted the results. Logistic regression revealed that satisfaction with the process of receiving results was associated with satisfaction with treatment (P = 0.04), and increased anxiety was associated with dissatisfaction with treatment (0.02), incorrect interpretation of results (0.04), and not having received trastuzumab (P < 0.0001).
Sharing results directly with study participants is met with overwhelmingly favorable responses from patients, although some may not initially understand the findings. The potential for increased anxiety should be considered, and psychosocial support may be required by some. A plan to share results should be routinely and prospectively considered in the design of cancer clinical trials.

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Available from: Deborah Collyar, Oct 03, 2015
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    • "However, aggregate reports may dilute the value of results because participants will be unsure of the findings' individual significance (Dixon-Woods et al., 2006). Disclosure of summary research results, even those of a serious nature or negative results, has generally not been found to result in adverse psychological impacts in research participants although a subset of participants has experienced negative effects such as feelings of fear, guilt, and anxiety (Bunin et al., 1996; Snowdon et al., 1998; Schulz et al., 2003; Partridge et al., 2005, 2009). Those who support providing participants with the option to learn of their results, either individual or aggregate, argue that it shows respect for participants and re-positions them as active contributors to research studies as opposed to being only a means of accomplishing research (Shalowitz and Miller, 2005; MacNeil and Fernandez, 2006). "
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