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The Use of Lay Patient Navigators to Improve
Quality of Care and Accrual to Clinical Trials for
Radiation Oncology Patients who are Minorities or
of Low Socioeconomic Status
ASTRO
Philadelphia, Pa.
November,2006
Principal Investigator
Michael L. Steinberg, MD, FACR
Co-Principal Investigators
David Huang, MD
David Khan, MD
Allen Fremont, MD, PhD
Nell Forge, PhD
Oscar Streeter, MD
Mack Roach, MD
Profound advances in medical
science have contributed to:
• Increased longevity
• Improved quality of life for
many Americans. H.Freeman
Despite these advances, some
Americans have not fully benefited
from this progress - particularly the
poor and underserved -
as evidenced by their higher cancer
incidence and lower survival.
H Freeman
Causes of Health Disparities
Poverty/
Low Economic
Status
Social Injustice Culture
Post
Early Diagnosis/ Survival and
Prevention Treatment Treatment/
Detection Incidence Mortality
Quality of Life
Freeman, Adapted from Cancer Epidemiology Biomarkers & Prevention, April 2003
Cancer Disparities Research
Partnerships Program
Telesynergy
Awardee
Partner
Pt. Navigator NCI Cancer
Patient Center Partner
Navigator
Patient
Turning the Funding Paradigm
Upside Down
Traditional CDRP
Telemedicine Linkages
Mentor Relationship
Regional Comprehensive Urban/Rural Hospitals
Cancer Centers Serving Target Populations
Local Urban/Rural Hospitals
Serving Target Populations All Comprehensive Cancer Centers
Cancer Disparities Research
Partnership Program (CDRP)
• 5-year grant
– The program components:
• Radiation oncology clinical trials
infrastructure
• Research/Mentoring Partnerships
• Telecommunication – TELESYNERGY®
U.S. Map
U.S. MAP
ULAAC
Urban Latino African American Cancer
Health Disparities Project
Centinela Freeman Regional Medical Center
ULAAC OBJECTIVES
• Established the infrastructure to conduct cancer
clinical trials
• Developed a lay patient navigator program
primary goals
• To decrease barriers to receiving cancer care
• To examine the possibility of increasing voluntary accrual to
clinical trials though the function of the lay navigator
CFHS Service Area
Centinela
Freeman
Marina
Campus
Centinela Freeman
Daniel Freeman
Campus
Centinela Freeman
Centinela Campus
Centinela Freeman
HealthSystem
Service Area
April 2005 Employee Forums
Our Patients
Service Area
Latinos African Americans
52%
34%
Radiation Oncology
Latinos African Americans
71%
13%
Our Partners
• Centinela Freeman
• USC
• UCSF
• RAND
Initial Navigator Concepts
• Cancer care is a complex and multi-factorial
series of interactions with the healthcare system
• Patient navigators (culturally appropriate
personal patient advocates) can facilitate
patients through the care process.
• The concept of a patient navigator and the
corresponding literature shows wide variance in
definitions and implementation
INITIAL CONSIDERATIONS
• Lay Navigator program best fit our needs
– Diversity of ethnicity and language in service area
– Perceived cost
• All patients are offered navigation and
continue to receive navigation whether they
qualify for or participate in clinical trials
INFRASTRUCTURE
Offices/Community Center
Staff:
– Debbie Karaman, MPH, Community Health Educator
– Erika Cobb, Administrative Assistant
– Hershel Knapp, PhD, MSW
– Magdalena Serrano, USC MSW Intern
– Nicole Harada, Clinical Trials Coordinator
– Susan Richardson, RN, Oncology Nurse
– Keith Andre, MA, Project Administrator
Community Liaison:
– MAB
– CAB
Cancer Disparities Research Partnership
(CDRP)
Patient Navigation Model
Patient Navigation
Cancer Diagnosis
Outreach Rehabilitation
Resolution
Abnormal Finding
Abnormal
Results Diagnosis Treatment
Navigation
Freeman, et.al., Cancer Practice, 1995. Conclude
LAY NAVIGATOR ROLE
• The navigator’s primary function is guiding
cancer patients through the health care
system
• Assisting with access issues
• Developing relationships with service
providers
• Tracking interventions and outcomes
RECRUITING AND SCREENING
PROSPECTIVE LAY NAVIGATORS
• Community Health Educator Networking:
– Phone
– E-mail
– Community Advisory Board
• Screening
– Phone
– Orientation Session Prior to Training
– Motivations
TRAINING COURSE
• The navigator 6 hour training course over 3 days
emphasizes:
– Investigating and implementing resources for
patients in a timely fashion
– Offering compassionate and non-judgmental
communication…active listening skills
– Completing appropriate records of all interactions
on behalf of patient
– Empowering patients to self-advocate in the
healthcare realm
Training Program
18 17
16
14
14
12
10 9
8
8
6
4
2
0
Group 1 Group 2 Group 3 Group 4
Active Navigators
12
10
10
8
8
6 5
4
4
2
0
Group 1 Group 2 Group 3 Group 4
Ethnicity of Active
Navigators
25
21
20
15
10
5 4
1 1
0
African Americans Latinos Native American Pacific Islander
Navigators Who Are Cancer
Survivors
14
12
12
10
8
6
4
2
2 1 1 1
0
Breast Prostate Esophageal Colon Lung
Patient Navigation Data
300
261
250
200 172
150
89
100
50
0
Approached Accepted Declined
67% accepted navigation
Ethnicity of Patients
Approached
200 185
180
160
140
120
100
80
60
34 29
40
20 10
3
0
African Latinos Caucasians Asians Others
Americans
Percentage Breakdown:
71% African Americans, 13% Latinos, 11% Caucasians, 4% Asians, 1% Other
Ethnicity of Patients
Accepting Navigation
80% 71% 70% 67%
70%
60% 55%
50%
40% 33%
30%
20%
10%
0%
Latinos Asians African Caucasians Others
Americans
24/34 7/10 124/185 16/29 1/3
Reasons for Declining
Navigation
60 57
50
40
30
20 14
10
10 5
2 1
0
Not interested Self sufficient Strong family Unable to Previous Medical
support contact cancer background
ASSESSMENT OF EFFECTIVENESS
AND QUALITY ASSURANCE
• Navigators and patients queried multiple
times and in various ways during the
navigation process
• Assessments used to modify training and
navigation process
• Assess effectiveness of various
components of the program
ASSESSMENT OF EFFECTIVENESS
ADDRESSING BARRIERS
• Identification of patient specific barriers to care
• Chart and navigation records are audited to
determine time to solution of barrier
• The deficiencies receive follow up by staff and
are identified and tracked in a database
Barriers to Care: Chart Audit
PT Dx Barriers Navigator Date of Date Days Resources Did ULAAC
ID# Assigned Review closed open Identified staff assist
Navigator?
009 Colon 1. Transportation 132 04/29/05 04/30/05 2 Taxi No
voucher
program
2. Financial 131 04/29/05 04/30/05 2 Beckstrand No
Cancer
Foundation
6 Most Common Barriers
70 65
60
50
40
33
30
19
20
11
8 7
10
0
Transportation Psychosocial Financial Fear of Cancer Caregiver Language
Results of Clinical Trials Accrual
• 7 Trials Open
– 5 NCI/RTOG Sponsored Trials
– 1 NCIC Sponsored Trial
– 1 Multi-institution device Trial
0
1
2
3
4
5
6
7
8
9
P4
8
R
TO
G
03
15
6
R
TO
G
03
21
M
4
am
m
oS
ite
D
C
IS
3
R
TO
G
04
13
1
R
TO
G
98
04
Trial Enrollment
1
R
TO
G
02
32
1
Accrual to Trial by Ethnicity
18
16
16
14
12
10
8
6
4 3 3
2 1
0
African Americans Latinos Caucasians Asians
Clinical Trials Participation
(14 month time period)
30
24
25
20 17 16
15
10
5
0
Eligible Screened Enrolled
Reasons for Non Accrual to Clinical
Trial
3.5
3
3
2.5
2
2
1.5
1 1 1
1
0.5
0
Preferred Traditional Screened/Ineligible Did not feel it was Felt overwhelmed Lack of Support
Tx necessary
Clinical Trial Accrual/Navigation
23 Patients
(24 Enrollments)
16 7
Accepted Navigation Declined Navigation
Cancer Post-Treatment Survey
1. Are there quantitative differences
between patients who received
navigation versus those who did not in
various QOL domains?
2. Are there patient perceived quality of
care differences in the two groups?
Cancer Post-Treatment Survey
Source:
RTOG A-5 Demographic Survey
FACIT and Model Questions
Domains Evaluated
Spiritual
Social/Family
Physical
Emotional
Functional
Patient Centered Questions
Relationship Based Questions
CONCLUSION
• Ongoing Evaluation Will Provide Practical
Information Regarding
– Elimination of barriers to care
– Quality assessment of lay navigation
– Effects of navigation on accrual to clinical
trials
“Still Too Separate, Not Yet
Equal” … A. Epstein
• Most Existing Information On Disparity Focuses
On
– Ability To Afford Care
– Knowledge, Beliefs, Preferences
– Doctor/Patient Relationship
• Bach Suggests That Structural Features Of The
Delivery System Contribute To Disparity in
Quality
“Still Too Separate, Not Yet
Equal” … A. Epstein
• Describing And Explaining Disparities Is
Much Easier Than Devising Strategies To
Reduce Disparities
• Researchers Should Shift Focus To
Developing Infrastructure and Improving
Policies That Will Reduce Disparities
ill Reduce Disparities
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