Patient participation in cancer clinical trials: A pilot test of lay navigation.
BACKGROUND
Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators.


METHODS
A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-minute CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation.


RESULTS
During this 12-month pilot project, 85% (95% CI: 72%-93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%-98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation.


CONCLUSIONS
In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC; College of Nursing, Medical University of South Carolina, Charleston, SC.
Kathleen B
KB
Cartmell
College of Health Professions, Medical University of South Carolina, Charleston, SC.
Heather S
HS
Bonilha
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC.
Terri
T
Matson
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC; College of Nursing, Medical University of South Carolina, Charleston, SC.
Debbie C
DC
Bryant
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC; College of Nursing, Medical University of South Carolina, Charleston, SC; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
Jane G
JG
Zapka
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC.
Tricia A
TA
Bentz
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
Marvella E
ME
Ford
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.
Chanita
C
Hughes-Halbert
College of Health Professions, Medical University of South Carolina, Charleston, SC.
Kit N
KN
Simpson
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
Anthony J
AJ
Alberg
barriers to care; clinical trial education; clinical trial enrollment; clinical trial understanding; health disparities; patient navigation