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ONLINE EXCLUSIVE
A Demonstration Project to Increase
the Awareness of Cancer Clinical Trials
Among Community-Dwelling Seniors
Heidi E. Ehrenberger, PhD, RN, AOCN, Jamie R. Breeden, RN, MSN, CCRC, OCN,
and Mary E. Donovan, RN, MSN, FNP, CS
Key Points . . .
Purpose/Objectives: To describe the planning, implementation, and
evaluation of an educational program to increase the awareness of can-
cer clinical trials among community-dwelling seniors in a southeastern
Older adults are underrepresented significantly in cancer clini-
metropolitan community.
Data Sources: Published articles, research findings, conference pro-
cal trials.
ceedings, government-issued educational materials, and clinical expe-
The need to integrate aging and cancer research creates new
riences with patient recruitment and enrollment.
challenges and opportunities for multidisciplinary, multi-insti-
Data Synthesis: The elderly are underrepresented significantly in
tutional collaboration.
cancer clinical trials. Often, patients and the lay public are not aware
A national-level partnership can result in a successful grass-
of clinical trials or have misconceptions about research. Community
outreach efforts represent one viable strategy to close this knowledge
roots effort to promote awareness of clinical trials among
gap.
community-dwelling seniors.
Conclusions: Local communities can build partnerships to identify
creative methods for disseminating materials about clinical trials.
Implications for Nursing: Oncology nurses can create and partici-
1994, and the participation of minorities and women in clini-
pate in partnerships that communicate information about cancer clini-
cal trials within their local communities.
cal cancer research continues to be addressed systematically
(Ehrenberger, Alligood, Thomas, Wallace, & Licavoli, 2002;
Underwood & Alexander, 2000). However, researchers must
examine the issues surrounding the participation of the elderly
lthough progress is being made in the treatment and
A
in clinical trials. As patient advocates, nurses are in a unique
prevention of cancer, it remains a significant disease
position to give the public accurate information about these
of the elderly. Cancer control in seniors necessitates
studies (Joshi & Ehrenberger, 2001). This article describes the
chemoprevention, early diagnosis, and timely, effective treat-
planning, implementation, and evaluation of an educational
ment (Balducci & Extermann, 2000). Patient enrollment in
program used to increase the awareness of cancer clinical tri-
clinical trials is necessary for optimal cancer prevention and
als among community-dwelling seniors in a southeastern met-
treatment modalities. Although a high percentage of children
ropolitan community.
with cancer enroll in clinical trials, less than 3% of adults with
cancer enroll in treatment trials sponsored by the National
Cancer Institute (NCI). Recent studies have documented the
Heidi E. Ehrenberger, PhD, RN, AOCN  , is a nurse consultant and
substantial underrepresentation of older patients in studies of
adjunct assistant professor in the College of Nursing at the Univer-
treatment for cancer (Hutchins, Unger, Crowley, Coltman, &
sity of Tennessee in Knoxville; Jamie R. Breeden, RN, MSN, CCRC,
Albain, 1999; Sateren et al., 2002). This is troubling particu-
OCN  , is a clinical research nurse coordinator, formerly affiliated
larly because of the high incidence of cancer in the elderly and
with the Thompson Cancer Survival Center at Covenant Health in
Knoxville; and Mary E. Donovan, RN, MSN, FNP, CS, is a clinical
the resulting anticipation of increased cases as the U.S. popu-
research nurse coordinator in the Cancer Center at the University
lation ages (Edwards et al., 2002).
of Tennessee Medical Center in Knoxville. (Submitted April 2002.
Guidelines for the inclusion of women and minorities in
Accepted for publication January 25, 2003.)
clinical research were published by the Federal Register,
National Archives and Records Administration in March
Digital Object Identifier: 10.1188/03.ONF.E80-E83
ONCOLOGY NURSING FORUM VOL 30, NO 4, 2003
E80
Background
healthcare professionals and the Cancer Information Service
(CIS) (Dean-Clower et al., 2000). CCTEP provided healthcare
Clinical Trials and the Elderly
professionals with the knowledge and tools to educate the lay
public, patients, and patients' families about clinical trials. The
Clinical trials participation remains low, hindering research
training program's intended audience was healthcare profes-
progress and patient access to potentially beneficial therapy
sionals and social workers. The training curriculum was a
(Lara et al., 2001). Hutchins et al. (1999) examined enrollment
four-module notebook with interactive exercises, self-assess-
data in 164 Southwest Oncology Group therapeutic trials from
ment tools, and slide presentations. The slide and script pre-
1993 1996 and found that people aged 65 and older were
sentations in modules I, II, and III were aimed at the lay public
underrepresented significantly. Sateren et al. (2002) examined
with some college education and cancer knowledge and
participation in NCI-sponsored cancer treatment trials from
healthcare professionals who were not familiar with cancer
April 1998 to April 1999 and found that, among adult patients
clinical trials. Module IV, a stand-alone program that also
with cancer, those aged 80 and older were least likely to be en-
used the slide and script format, was designed specifically to
rolled. Also, less than 1% of the estimated number of adults aged
educate the lay public about cancer clinical trials.
70 79 with cancer were represented in these trials. Data from
For several years, a successful national partnership facili-
both of these studies are consistent with an earlier study by
tated the promotion, dissemination, and implementation of
Trimble et al. (1994), which also found that older patients were
CCTEP at regional and local levels. The Oncology Nursing
underrepresented in NCI-sponsored cancer treatment trials.
Society (ONS), the Association of Oncology Social Work-
Barriers to enrollment in clinical trials include physician
ers, NCI, and Novartis Oncology joined forces to deliver
and patient determinants, organizational issues, and healthcare
educational programs across the country to increase aware-
system factors (Lara et al., 2001; Lengacher et al., 2001).
ness of cancer clinical trials among numerous targeted audi-
Some physicians may believe that elderly patients with can-
ences. Although this national partnership no longer exists, it
cer will not tolerate some therapies and decide against enter-
represented an innovative approach for delivering timely
ing them into clinical trials (Giovanazzi-Bannon, Rademaker,
content and can be adapted by other healthcare profession-
Lai, & Benson, 1994). Yet limited data support the idea that
als and organizations. Also, CCTEP has been re-engineered
older patients cannot tolerate or benefit from treatment in
with the release of a new Clinical Trials Education Series.
clinical trials, particularly studies that test standard drugs for
This new series contains basic and advanced educational
common solid tumors (Hutchins et al., 1999). As a partial re-
materials, workbooks, brochures, slide shows, and videos
sponse to this lack of information, clinical trials are examin-
about clinical trials for a variety of audiences (Michaels,
ing cancer therapy in older patients, including the effects of
Denicoff, Bright, Abrams, & Robinson, 2002), and many of
aging and coexisting conditions on patients' responses and
the materials now are available on the Internet. A partial list-
side effects to surgery, chemotherapy, and radiation therapy.
ing is given in Figure 1.
These studies will help determine how to improve treatment
in this segment of the population. In addition, NCI Cancer
The Educational Program
Centers recently were given the opportunity to use the infor-
mation and research priorities created in a multidisciplinary
At the local level, several individuals attended the CCTEP
workshop titled "Exploring the Role of Cancer Centers for In-
workshops at either regional or national meetings. A member of
tegrating Aging and Cancer Research" (NCI, 2002; National
ONS, in partnership with NCI's regional cancer information
Institute on Aging & NCI, 2001). Although this opportunity
specialist, local clinical research nurses, and a representative
addressed relevant issues for patients with cancer aged 65 and
from Novartis Oncology, initiated planning efforts. Their goal
older, a significant barrier identified at the workshop was that
"recruiting older patients into clinical trials and studying them
is difficult, costly, [and] time-consuming" (National Institute
on Aging & NCI, p. 79).
Cancer Clinical Trials: Basic Workbook
The public's misconceptions and unawareness of clinical tri-
Self-modulated workbook designed for individuals developing a basic
als compound the issue of recruitment. Focus groups conducted
understanding of clinical trials
by NCI found that the public often did not understand the term
Cancer Clinical Trials: In-Depth Program
"clinical trial" (NCI, Office of Cancer Communications, 1996).
Textbook designed for healthcare professionals and others that expands on
subjects outlined in the Basic Workbook
According to a Harris Interactive, Inc., survey (2000) of almost
Cancer Clinical Trials: A Resource Guide for Outreach, Education, and
6,000 patients with cancer, 85% of patients reported that they
Advocacy
were unaware of possibly enrolling in a clinical trial for their
Guide provides direction and guidance for developing clinical trial outreach
treatment. Efforts to increase the understanding of clinical re-
and education activities.
search must continue, and healthcare professionals are posi-
Trainer's Guide for Cancer Education
tioned to promote awareness of this practice. Through proactive
Manual designed for planning and conducting educational sessions on
education of the lay public, patients, and patients' families, on-
cancer-related topics
cology nurses can play an integral part in increasing under-
standing of cancer clinical trials among older adults and possi-
Figure 1. National Cancer Institute's Clinical Trials
bly increase patient participation in future clinical trials.
Education Series
Note. This series is available from the National Cancer Institute Office of Edu-
The National Cancer Institute's Cancer Clinical
cation and Special Initiatives at http://oesi.nci.nih.gov/series/cted/index.html.
Trials Education Program
Cancer Clinical Trials: In-Depth Program is approved as an independent study
During the 1990s, NCI developed the Cancer Clinical Tri-
program by the Oncology Nursing Society's Approver Unit for 2.4 contact
als Education Program (CCTEP) with the assistance of
hours at no charge (www.oesweb.com/newce).
ONCOLOGY NURSING FORUM VOL 30, NO 4, 2003
E81
Program Evaluation
was to provide educational programming about cancer clinical
trials in their local community. The southeastern metropolitan
A brief program evaluation questionnaire consisted of 11
community was approximately 90% Caucasian, with more than
items. Six items used a Likert-format response set ranging
20% aged 55 or older. The community-dwelling seniors were
from one (strongly agree) to five (strongly disagree.) These
the target audience, a lay public with an increased risk for can-
items addressed the literature and clinical experiences with
cer because of their age. An ONS member contacted a nonprofit
patient recruitment and enrollment. The remaining five items
healthcare organization in the community that had a well-estab-
established demographic information (gender, age, and edu-
lished and highly publicized network of senior health centers.
cational level), previous awareness of clinical trials, and inter-
These centers provided primary health care, social services,
est in further programming about clinical trials. The anony-
health screenings, insurance assistance, and health and wellness
mous evaluation was distributed at the completion of each
education in seven neighborhoods. Each center provided the
educational seminar.
services of a primary care physician for patients aged 55 and
older. The institution's administration approved the delivery of
Results
educational programming about cancer clinical trials.
Concurrently, several clinical research nurses within the
Demographics
community were contacted to gauge interest in an outreach ef-
Data were collected from 60 seniors; however, four ques-
fort. Most research nurses were affiliated with inpatient or out-
tionnaires were incomplete and not evaluated. The adjusted
patient clinical research programs and had little time or oppor-
total sample was 56 for the analyses and composed of 43
tunity for community outreach. A select few were involved in
(77%) women and 13 (23%) men. The mean age of the re-
coordinating prevention trials and already were engaged in
spondents was 73 years (range = 5584, SD = 7.3). Thirty-
various community outreach activities. Because of workload
four percent (n = 19) of the respondents indicated their high-
issues, each research nurse was asked to commit to delivering
est level of education as completion of high school, and 57%
only one program. The time commitment was viewed as fea-
(n = 32) had attended some college. Nine percent (n = 5) had
sible, and six nurses agreed to participate in the project.
some high school or grade school education.
Modules I and IV were adapted slightly to follow the format
of a "lunch and learn" seminar, where a 90-minute program
Awareness and Attitudes Toward Clinical Trials
included a light lunch, speaker presentation, short videotape,
Of the respondents, 95% (n = 53) agreed or strongly agreed
and question-and-answer session. Objectives for the "Lunch
that clinical trials provide high-quality and up-to-date care for
and Learn About Clinical Trials" program were obtained from
patients with cancer, and 84% (n = 47) thought that they would
module IV ("Educating the Public About Cancer Clinical Tri-
be able to provide family members or friends with general in-
als") and are listed in Figure 2. Each clinical research nurse was
formation about clinical trials. Eleven percent (n = 6) were
paired with a CIS specialist and assigned to at least one senior
undecided, and 5% (n = 3) did not think they could provide this
center. The program series and scheduled dates were advertised
information. Eighty-eight percent (n = 49) believed that they
by hospital marketing personnel who regularly published an-
would be comfortable asking their doctors about clinical trials,
nouncements about their senior center programs and activities
but 12% (n = 7) were undecided; 96% (n = 54) agreed that the
via various media channels (e.g., local newspaper, newsletters,
option of participating in a clinical trial should be discussed
television). Seating was limited at each center, and those inter-
with most patients with cancer. Finally, 88% (n = 49) indicated
ested in attending the program were required to make a reser-
they would like to have more programs about clinical trials and
vation. During three months, six clinical research nurses and a
medical research, 11% (n = 6) were undecided, and one respon-
CIS specialist presented programs at seven senior centers. A fi-
dent did not want more programming on the topic.
nal program was held at the parent institution.
The program's primary financial consideration was the cost
Discussion
of the luncheon. The educational materials were obtained es-
sentially at no charge from CIS. In addition, the senior centers
The national partnership served as a model for this grass-
provided the meeting space at no charge, and speakers volun-
roots effort to promote the awareness of clinical trials among
teered their time and effort. The marketing and program pro-
community-dwelling seniors. The implemented "Lunch and
motion were included as part of a larger, existing hospital-
Learn About Clinical Trials" program was received well by
based program and were less costly. An educational grant
the seniors. Identifying an established network of senior
from Novartis Oncology helped underwrite the expenditures
health centers clearly facilitated program planning. In addi-
and was essential to the implementation of the program.
tion, the institution's promotion of the series was key in en-
suring program visibility. When developing a marketing plan
Learn what cancer clinical trials are and their key role in producing better
for an individual clinical trial, the study's parameters and
care.
marketing strategies should define the targeted population
Understand the importance of consumer knowledge about cancer clinical
(Adams, Silverman, Musa, & Peele, 1997; Meadows, 2000).
trials and the two types of information they may need.
The small-group format at each senior center allowed inter-
Become familiar with some of the prevention and treatment approaches that
action between the speakers and the audiences. Studies have re-
current clinical trials are evaluating.
ported that recruitment efforts are more successful if presenta-
Appreciate the negative public health effects of low public and patient
tions are made directly to older adult audiences; this allows
participation in cancer clinical trials.
potential participants to identify the study with an individual,
Figure 2. "Lunch and Learn About Clinical Trials" Program
voice concerns, and receive answers in a personalized format
Objectives
(Adams et al., 1997). Most participants were eager to learn about
ONCOLOGY NURSING FORUM VOL 30, NO 4, 2003
E82
Conclusion
clinical research and wanted more opportunities to learn about
research. Perhaps the most encouraging feedback was that the
Public education in cancer clinical trials continues to be
majority of respondents (88%) believed that they could ask their
paramount, particularly among the elderly population. NCI's
doctors about clinical trials, and 84% indicated that they would
Cancer Clinical Trial Education Series provides oncology
feel comfortable sharing information about clinical trials with
nurses and other healthcare professionals with tangible tools
family members or friends. Anecdotal reports indicate that a few
to disseminate this important information. A professional part-
respondents later spoke to research nurses about participation in
nership can serve as a vehicle for program planning and
a chemoprevention trial. Although this feedback is encouraging,
implementation locally, regionally, and nationally. As Sateren
only long-term evaluation can determine the relationship be-
et al. (2002) stated, ongoing partnerships with professional so-
tween educational programming and clinical trials participation.
cieties may be an effective approach to increase enrollment in
In addition, the clinical research nurses, who were employed
clinical trials. The current study's authors recommend that lo-
at local institutions or physician practices that participate in clini-
cal communities create partnerships and identify senior cen-
cal trials, reported valuing the opportunity to present informa-
ters or other established networks to use the readily available
tion related to their daily practice. The ability to use a prepack-
NCI materials to disseminate information about clinical trials.
aged program with slides and a script enhanced program
As the need for integrating clinical research in aging and can-
delivery. Clinical research nurses could bring their own institu-
cer heightens, increasing the awareness and knowledge of
tional perspective to a "Lunch and Learn About Clinical Trials"
clinical trials among seniors is an important initial step.
program, but the overall presentation remained standardized.
Limitations of the demonstration project included the lack of
The authors acknowledge the following research nurses for their assistance
a formalized baseline assessment. Although the program evalu-
and support of this program: Kim Kincaid, RN, Becky Libby, RN, Lisa
ation ascertained the participants' previous awareness of clini-
Livingston, RN, and Josie Stanga, RN. In addition, they acknowledge Lynne
cal trials, it did not account for exposure to promotional mate-
Busby (now deceased) and Susan Long of the Baptist Health System of East
rials prior to the program. A small percentage of the seniors
Tennessee, Edward Matthews of Novartis Oncology, and especially Phyllis
Heath, formerly with the Mid-South Cancer Information Service.
may have learned about clinical trials through the promotional
materials about the upcoming program series. Because the dem-
onstration project was deemed logistically feasible with over-
Author Contact: Heidi E. Ehrenberger, PhD, RN, AOCN, can be
all encouraging results, more rigorous evaluation strategies are
reached at ehrenber@utk.edu, with copy to editor at rose_mary
recommended. In addition, ethnically diverse populations
@earthlink.net.
should be targeted.
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