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

Abstract：

BACKGROUND: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. PATIENTS AND METHODS: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. RESULTS: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). CONCLUSION: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.

journal_name

Breast Cancer Res Treat

journal_title

Breast cancer research and treatment

authors

Partridge AH,Wolff AC,Marcom PK,Kaufman PA,Zhang L,Gelman R,Moore C,Lake D,Fleming GF,Rugo HS,Atkins J,Sampson E,Collyar D,Winer EP

doi

10.1007/s10549-008-0057-7

subject

Has Abstract

pub_date

2009-05-01 00:00:00

pages

123-9

issue

eissn

0167-6806

issn

1573-7217

journal_volume

115

pub_type

杂志文章,随机对照试验

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