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


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).


CONCLUSIONS
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.
Partridge
Ann H
AH
Dana-Farber Cancer Institute, Boston, MA 02115, USA. ahpartridge@partners.org
Wolff
A C
AC
Marcom
P K
PK
Kaufman
P A
PA
Zhang
L
L
Gelman
R
R
Moore
C
C
Lake
D
D
Fleming
G F
GF
Rugo
H S
HS
Atkins
J
J
Sampson
E
E
Collyar
D
D
Winer
E P
EP
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D001007:Anxiety; D017024:Chemotherapy, Adjuvant; D017326:Clinical Trials, Phase III as Topic; D003142:Communication; D003625:Data Collection; D006801:Humans; D008875:Middle Aged; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D010465:Perception; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012044:Regression Analysis; D012107:Research Design; D000068878:Trastuzumab
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068878:Trastuzumab