A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: trial design and baseline findings.
OBJECTIVE
This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment (GERA) on colorectal cancer (CRC) screening.


METHODS
The trial includes asymptomatic patients who are 50-79years and are not up-to-date with CRC screening guidelines. Patients who responded to a baseline telephone survey are randomized to a GERA or Control group. GERA group participants meet with a nurse, decide whether to have a GERA blood test (a combination of genetic polymorphism and folate), and, if tested, receive GERA feedback. Follow-up telephone surveys are conducted at 1 and 6months. A chart audit is performed at 6months.


RESULTS
Of 2,223 eligible patients, 562 (25%) have enrolled. Patients who enrolled in the study were significantly younger than those who did not (p<0.001). Participants tended to be 50-59years (64%), female (58%), white (52%), married (51%), and have more than a high school education (67%). At baseline, most participants had some knowledge of CRC screening and GERA, viewed CRC screening favorably, and reported that they had decided to do screening. Almost half had worries and concerns about CRC.


CONCLUSIONS
One in four eligible primary care patients enrolled in the study. Age was negatively associated with enrollment. Prospective analyses using data for all participants will provide more definitive information on GERA uptake and the impact of GERA feedback.
Myers
Ronald E
RE
Division of Population Science, Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA 19107, USA. ronald.myers@jefferson.edu
Manne
Sharon L
SL
Wilfond
Benjamin
B
Sifri
Randa
R
Ziring
Barry
B
Wolf
Thomas A
TA
Cocroft
James
J
Ueland
Amy
A
Petrich
Anett
A
Swan
Heidi
H
DiCarlo
Melissa
M
Weinberg
David S
DS
D000367:Age Factors; D000368:Aged; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000235:genetics; D055088:Early Detection of Cancer / Q000706:statistics & numerical data*; D004781:Environmental Exposure; D005260:Female; D005492:Folic Acid / Q000097:blood; D005817:Genetic Counseling; D005820:Genetic Testing / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D010358:Patient Participation; D011110:Polymorphism, Genetic; D011320:Primary Health Care; D018570:Risk Assessment / Q000379:methods*
D005492:Folic Acid