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ONLINE EXCLUSIVE
Functional Integration of Nursing Research
Into a Pediatric Oncology Cooperative Group:
Finding Common Ground
Pamela S. Hinds, PhD, RN, Christina Baggott, RN-CS, MN, PNP, CPON,
Joetta DeSwarte-Wallace, MSN, RN, CPON, Marylin Dodd, PhD, RN, FAAN, Joan Haase, PhD, RN,
Marilyn Hockenberry, PhD, RN, PNP, FAAN, Casey Hooke, MSN, RN, CPON, CNS,
Patsy McGuire Cullen, MS, CPNP, RN, Ida Moore, DNS, FAAN,
Lona Roll, MSN, RN, and Kathy Ruccione, MPH, RN
Key Points . . .
Purpose/Objectives: To provide a brief description of the historic
role of nursing and nursing research in the culture of previous pediat-
ric oncology cooperative groups and compare the research language
Historically, nurses routinely did not assume independent or
used in cooperative groups with the language used in nursing research.
coinvestigator roles in oncology cooperative groups.
Data Sources: Published empirical, clinical, and methodologic re-
Nurses generally have not been formally educated about on-
ports.
Data Synthesis: The culture and language of nursing research dif-
cology cooperative groups' research processes.
fer from those of medical research and the pediatric oncology coopera-
A key aspect of fostering nursing research in oncology coop-
tive group, the Children's Oncology Group (COG). Different approaches
erative groups is understanding scientific discourse regarding
exist to integrate nursing research priorities into the priorities of COG,
clinical trials.
including freestanding protocols, companion protocols, and research
objectives included in therapeutic protocols.
Conclusions: Full integration of nursing research into COG is feasible
but dependent on recognition of cultural and language differences among
Pamela S. Hinds, PhD, RN, is a director of nursing research at St.
researchers. Integration will be demonstrated by the number of concepts
Jude Children's Hospital in Memphis, TN; Christina Baggott, RN-
and protocols contributed to or developed by active nurses in COG.
CS, MN, PNP, CPON  , is a pediatric nurse practitioner of hematol-
Implications for Nursing: Significant advances exist for nurses
ogy and oncology at the Lucile Packard Children's Hospital at
conducting research in COG. These research efforts are facilitated by a fa-
Stanford University in Palo Alto, CA; Joetta DeSwarte-Wallace,
miliarity with the science language used by other disciplines in COG and
MSN, RN, CPON  , is a clinical nurse specialist at Miller Children's
an understanding of COG's research processes. Increased interdiscipli-
Hospital at the Long Beach Memorial Medical Center in California;
nary scientific collaborations involving nurses in COG particularly benefit
Marylin Dodd, PhD, RN, FAAN, is a professor in the Department of
pediatric patients with cancer.
Physiological Nursing in the School of Nursing at the University of
California, San Francisco; Joan Haase, PhD, RN, holds an Emily
Holmquist Professorship in Pediatric Oncology in the School of
s the 21st century began, the four pediatric oncology
Nursing at Indiana University in Indianapolis; Marilyn Hocken-
A
berry, PhD, RN, PNP, FAAN, is a professor in the Department of Pe-
cooperative clinical trial groups (the Children's Can-
diatrics in Baylor College of Medicine at Texas Children's Hospi-
cer Group, Pediatric Oncology Group, National Wilms
tal in Houston; Casey Hooke, MSN, RN, CPON  , CNS, is a clinical
Tumor Study Group, and Intergroup Rhabdomyosarcoma Study
nurse specialist at Children's Hospitals and Clinics in Minneapolis
Group) merged to become the unified Children's Oncology
and St. Paul, MN; Patsy McGuire Cullen, MS, CPNP, RN, is a pe-
Group (COG). During their preceding half-century of existence,
diatric nurse practitioner at the Childhood Hematology-Oncology
the two principal legacy groups (the Children's Cancer Group
Associates of Rocky Mountain Children's Cancer Center in Denver,
and the Pediatric Oncology Group) had evolved distinct orga-
CO; Ida Moore, DNS, FAAN, is a chair and professor in the Divi-
nizational cultures. In the context of this article, culture can be
sion of Nursing Practice in the College of Nursing at the University
defined in its broadest sense as the "totality of socially transmit-
of Arizona in Tucson; Lona Roll, MSN, RN, is a clinical nurse spe-
ted behavior patterns, arts, beliefs, institutions, and all other
cialist at Christus Santa Rosa Children's Hospital in San Antonio,
TX; and Kathy Ruccione, MPH, RN, is an associate professor of
products of human work and thought" and the "predominating
clinical pediatrics at the Children's Center for Cancer and Blood
attitudes and behaviors that characterize the functioning of a
Diseases at the Children's Hospital Los Angeles in California. (Sub-
group or organization" (Dictionary.com, 2003a). The cultural
mitted December 2002. Accepted for publication May 23, 2003.)
attributes of the groups were reflected in a variety of ways, in-
cluding meeting format, voluntary participation, communication
Digital Object Identifier: 10.1188/03.ONF.E121-E126
ONCOLOGY NURSING FORUM VOL 30, NO 6, 2003
E121
styles, decision making, group policies and procedures, infor-
Formally prepared to function as independent or collabora-
mation flow, work pace, and power structures. In these two
tive researchers, nurses with doctoral degrees primarily fo-
group cultures, efforts to initiate nursing research programs had
cused on patient survival and the "human experience" of pa-
limited success. However, nurses in these groups viewed the
tients, families, and healthcare providers during cancer
merger as an opportunity to critically evaluate past nursing re-
treatment (Haberman, 2000). This research focus differed
search efforts and develop plans for a new approach that
from the predominant "curative therapy approach" of coop-
would facilitate nursing contributions to the new cooperative
erative groups' clinical trials. Although complementary to the
group. One factor identified as a contributor to past failures of
curative approach, the human experience focus was consid-
nursing research efforts in cooperative groups was the differ-
ered by non-nurses to be of secondary importance and too
ence between the language used in nursing research and co-
complex to study in oncology cooperative clinical trials.
operative groups. The purpose of this article is to provide a
Nursing research and knowledge only recently have
brief description of the historic role of nursing and nursing
reached a point where conducting clinical trials on variables
research within the culture of pediatric oncology cooperative
considered important to nursing care is possible. Many nurse
groups and help translate the research language used in coop-
researchers completed their doctoral programs with minimal
erative groups into the language used by nursing researchers.
to no exposure to the dominant designs of clinical trials that
The historic perspective and translation of language are antici-
are sponsored by oncology cooperative groups and other as-
pated to increase interdisciplinary collaboration by allowing
pects and processes of cooperative groups. Instead, nurse re-
scientists from different disciplines to speak, or at least under-
searchers were prepared formally in the language of social
stand, the same research language.
sciences and, to a lesser extent, basic sciences.
With this difference in research language and values, few
Background
nurse researchers committed themselves to establishing a re-
search career in oncology cooperative group activities. Sev-
Nurses' Role in Cooperative Groups
eral nurse researchers found establishing relationships with a
Beginning in 1955, the National Cancer Institute has spon-
cooperative group difficult and left after a brief period (Ruc-
sored oncology clinical trials cooperative groups as a part of
cione & Kelly, 2000). Recently, oncology nurse leaders have
its efforts to generate and foster clinical trials. These groups
urged adult and pediatric nurse researchers and advanced
commonly design and implement multisite clinical trials of
practice oncology nurses to work together in interdisciplinary
new drug treatments, surgical or radiation interventions, or
research teams and use the research language used by other
symptom management interventions (Works, 2000). Histori-
disciplines (Given, 2001). In addition, nurses in COG have
cally, nurses have contributed significantly to the successful
planned to initiate greater efforts to contribute to cooperative
implementation of adult and pediatric oncology cooperative
groups and identify and facilitate the research priorities of the
group clinical trials. They have participated in protocol or dis-
nursing discipline within cooperative groups (Fochtman &
ease committees in varying roles that include concept design,
Hinds, 2000; Hinds & DeSwarte-Wallace, 2000; Ruccione &
trial outcomes analysis and publication, and patient, family,
Kelly). These factors suggest that this is an opportune time to
and nurse education about treatment protocols and clinical
review the causes of the previously limited nursing contribu-
trials (Klimaszewski et al., 2000). Nurses were responsible for
tion to pediatric oncology cooperative groups.
the daily coordination of activities associated with clinical
The Importance of Science
trials and administering the protocol-directed therapy through
patient care (Aikin, 2000). As essential as these nursing func-
and Research Language
tions were, they did not include principal responsibilities for
generating research objectives or designing studies to address
Clinical, basic, and translational research are the core activi-
specific research questions or hypotheses.
ties of cooperative groups. Research scientists share the cul-
In part, nurses did not assume routinely independent or col-
ture of modern science. Because culture and language are in-
laborative research roles in oncology cooperative groups be-
extricably linked, basic and clinical research scientists share
cause curricula in nursing academic graduate programs gave
a common language that has facilitated their communication
insufficient attention to science in these cooperative groups. Re-
in the new COG organizational culture. In the context of this
search terminology, roles of studies' principal investigators and
article, language is defined in the inclusive sense of the "com-
coinvestigators, and examples of group research were not stud-
munication of thoughts and feelings through a system of ar-
ied routinely. Thus, nurses were not prepared formally to as-
bitrary signals, such as voice sounds, gestures, or written sym-
sume leadership roles in cooperative groups. Although gradu-
bols" through a system used by a nation, people, or other
ate-level academic programs for nurses studying advanced
distinct community (Dictionary.com, 2003b). The nursing re-
practice oncology or research began to proliferate in the 1980s
search culture and language (derived from social sciences)
(Brown & Hinds, 1997; McGee, 1988), these programs were
differ from that of medical research. A key aspect in fostering
limited in number and did not contain content on oncology
nursing research in COG is full integration of nurse scientists
cooperative groups and clinical trials consistently (e.g., termi-
into the cooperative group, but differences in language and
nology and purposes of different clinical trials, strategies and
culture may influence the quality of collaboration between
ethics of monitoring clinical trial activities). In addition, some
scientific disciplines.
nurses entered nononcology graduate programs and were not
Basic differences between nursing research and cooperative
exposed to curricular content on cooperative group clinical tri-
groups' language and values are listed in Table 1. Notable
als. Once employed, these nurses experienced serious difficul-
differences include nursing's emphasis on health, symptom
ties finding time and mentorship to conduct independent or
management, and quality of care compared to the cooperative
collaborative clinical research.
groups' emphasis on disease and treatment outcomes. An
ONCOLOGY NURSING FORUM VOL 30, NO 6, 2003
E122
Table 1. Examples of Language and Value Differences Between the Pediatric Oncology Cooperative Group
and Nursing Research
Elements of Culture:
Pediatric Oncology Cooperative Group
Language and Values
Nursing Research
Domains of interest
Foci
Foci
Cure and survival
Health promotion
Novel drug testing
Disease prevention
Supportive care
Health education
Chemoprotectant
Health restoration
Health maintenance
Outcomes
Outcomes
Therapeutic efficacy
Biophysical
Complete response
Temperature
Partial response
Sleep
Stable disease
Wound healing
Progressive disease
Fatigue
Recurrence of disease
Psychosocial
Secondary disease
Mood
Toxicity
Social support
Grades 14
Coping
Morbidity
Hope
Disability
Behaviors and safety
Complications
Adherence to treatment
Quality of life
Health beliefs
Survival
Self-care skills
Event free
Quality of life
Time to disease progression
Delivery of care
Disease free
Patient and family satisfaction with care
Models of care
Staffing patterns
Types of designs
Phase IIV
Historical
Qualitative
Descriptive
Correlational
Ex post facto
Quasi-experimental
Experimental
Methodologic
Primary funding sources
National Institute of Nursing Research, Na-
Investigational drug branch
tional Institutes of Health (NIH)
Community clinical oncology program
National Cancer Institute, NIH
Cancer control
American Cancer Society
Cooperative group outreach program
Oncology Nursing Society
Cancer therapy and evaluation program
Sigma Theta Tau International
Pharmaceutical companies
Note. Based on information from Friedman et al., 1995; Gullatte & Otto, 2001; Haberman, 2000; Lester et al., 1997; McFadden, 1998; Mooney & Haberman,
1996.
important shared focus is quality of life for pediatric patients
erative group setting, the intervention usually involves testing
and their families. A significant difference in research designs
the effectiveness of a new therapy, such as a drug, surgical, or
is the presence of an intervention in all types of cooperative
radiation intervention. With the exception of phase I trials,
group studies compared to the descriptive, noninterventional
primary interests include overall patient survival, disease-free
studies that currently dominate in nursing. This difference is
survival, and intervention toxicity.
likely to decrease in the next few years because of the previ-
Clinical trial terminology is not used commonly in nursing
ously completed exploratory and descriptive research that will
research, and nursing studies lack parallel models for phase I
increase the amount of interventional research performed by
IV studies. Key characteristics of clinical trial phases are de-
nurses.
scribed in the following paragraphs (Ungerleider, Ellenberg,
& Berg, 2001; Works, 2000), and parallels to clinical nursing
Research Language in Cooperative Groups
studies are listed in Table 2.
A clinical trial is a prospective research study of human
A phase I clinical trial tests a new intervention for the first
participants that is designed to answer specific questions about
time in a small sample of individuals (e.g., 2080 partici-
biomedical or behavioral interventions. In the oncology coop-
pants). No form of randomization is involved. In the language
ONCOLOGY NURSING FORUM VOL 30, NO 6, 2003
E123
Table 2. Translation of Cooperative Group Design Language Into Nursing Research Language
Clinical Trial
Characteristics
Parallel Nursing Study
Characteristics
Phase I
New intervention testing
Intervention pilot test
New intervention testing
One-group design
One group, pre-experimental design
Small sample
Small sample, determining effect size
Dose escalation
Dose-limiting toxicity
Phase II
Study intervention in larger groups deter-
Intervention study
Determining safe intervention delivery,
mining new drug or treatment combin-
timing, and dose
ation's effectiveness with a particular
Determining effect of intervention on
type of cancer
dependent variables of interest
Larger sample
Quasi-experimental design
Determined efficacy (survival)
Randomizing intervention or standard
Evaluated safety
care
Basing sample size on intervention ef-
fect size
Phase III
Comparison of new intervention to stan-
Multisite intervention study
Replicating study in larger sample
dard treatment (disease-free survival)
Quasi-experimental design
Large sample
Randomization
Monitor adverse effects (toxicity)
Phase IV
Extension and application to
Determining intervention effects in dif-
Determine efficacy in different population
different populations
ferent but relevant populations
Randomization
Quasi-experimental design
Randomization
Comparing intervention to standard care
be classified as phase III clinical trials because of sample size
of nursing research, a phase I clinical trial could involve pi-
limitations and the inability to compare more than one experi-
lot testing of an intervention in a small group of subjects. A
mental intervention. However, nurses can take advantage of
one-group pre-experimental design could be used in which
COG to conduct phase III trials.
subjects serve as their own controls. The study may evaluate
Phase IV clinical trials evaluate treatment effectiveness and
a dose range (e.g., identifying the most effective frequency or
safety in different populations. In nursing, this can involve
intensity of an exercise intervention for individuals with
testing an intervention that is effective for one sample popu-
chronic illness) or determine treatment effectiveness (e.g., the
lation (e.g., children with ALL) in a different but appropriate
dose or amount of intervention needed to achieve a small,
population (e.g., children with brain tumors). Because control
medium, or large change in the dependent variables).
of all potentially confounding variables is difficult to achieve,
A phase II clinical trial determines efficacy and further
study designs in phase IV nursing studies most likely are
evaluates the safety of the intervention. The study involves a
quasi-experimental.
larger group of subjects and does not require, but may include,
randomization. Many nursing intervention studies could be
Advantages of Nurse Participation
classified as phase II clinical trials. The effect of the interven-
in Oncology Cooperative Group
tion is determined by the magnitude of change in the trials'
dependent variables. The efficacy of the intervention usually
Scientific Processes
is tested in a homogenous sample (e.g., children with acute
lymphocytic leukemia [ALL]), and the sample size is based
Because cooperative groups serve as models for clinical tri-
on a power analysis using the magnitude of the effect estab-
als throughout the world (Comis, 1998), significant advantages
lished in the phase I trial. The study design typically would be
exist for nurses conducting research in pediatric cooperative
quasi-experimental. Although randomization is not a require-
groups. Likewise, significant advantages exist for cooperative
ment in phase II studies, most nursing studies involve ran-
groups when nursing research is conducted as a part of their
domization in the new intervention or standard care group.
efforts. A benefit for nurse researchers, as they increasingly
A phase III clinical trial is designed to compare a new in-
become focused on developing and testing nursing interven-
tervention with other standard or experimental interventions
tions aimed at improving patient outcomes, is that oncology
and obtain data on adverse events and intervention safety.
cooperative groups are structured uniquely to facilitate inter-
Phase III clinical trials involve large groups of participants
vention trials and provide outcome data related to interventions.
(several hundred to several thousand). Historically, the need
The semiannual meetings of cooperative groups' scientists pro-
for large sample sizes and the lack of appropriate infrastruc-
vide opportunities for nurses to meet regularly and work on
tures to effectively coordinate large multisite studies have
collaborative projects. These meetings alleviate the sense of
caused difficulties for nurses conducting phase III clinical tri-
isolation that some nurse researchers experience in their own
als. Only a limited number of nursing intervention studies can
institutions where colleagues may not be interested in similar
ONCOLOGY NURSING FORUM VOL 30, NO 6, 2003
E124
Nursing's Contribution to the Science
populations, concepts, designs, or measurement issues. The
meetings also foster interactions with multidisciplinary re-
of Cooperative Groups
searchers and often produce new scientific collaborations.
COG includes a well-organized and highly motivated group
Nursing research in COG may take the form of freestand-
of nurse clinicians. These nurses are knowledgeable about
ing or companion protocols, the latter focusing on nursing
research protocols, have a good sense of clinical trial design,
care research objectives and linked to a disease-specific pro-
and often are eager to be involved in nursing research at a
tocol or trial. Alternatively, the objectives may be sponsored
variety of levels. Of particular importance, they are well
by nursing but incorporated into a therapeutic protocol. In any
versed in pediatric oncology cooperative groups' values and
of these approaches, the study protocols may be open for par-
language and have established collegial relationships with
ticipant enrollment in a limited number or to all COG institu-
group members from other disciplines. Nurse clinicians can
tions. Studies that are limited in the number of institutions
guide nurse researchers' efforts skillfully, and both groups can
involved have the advantage of recruiting nurses who can
become highly accomplished research collaborators.
dedicate some of their time to the studies and actively enroll
COG offers opportunities for receiving feedback during the
patients. Small studies with manageable numbers of research-
planning stages of a study, which allows feasibility and scien-
ers make dispensing information about study logistics easier.
tific merit. In COG, this feedback first may come from nurses
Groupwide approaches allow study findings to be generalized
attending the nursing research committee meetings or the dis-
across geographic and patient diversities.
ease committees (most often comprised of physician clinical
Freestanding nursing protocols are highly visible and pro-
investigators who develop therapeutic clinical trials meetings).
vide recognition of nurse productivity in cooperative groups.
In the early phases of study development, the nursing research
Nurse researchers also may secure extramural funding more
committee can offer thoughtful critiques of research concepts
easily for independent protocols rather than for research ob-
in a supportive atmosphere and language familiar to nurses.
jectives integrated in treatment-related protocols. Finally,
This committee also is a place where possible design, method-
freestanding protocols can provide a forum for pilot testing
ology, and statistical questions can be addressed. In addition,
nursing research studies that may be integrated into treatment-
the concepts' significance and adherence to COG research pri-
related, groupwide studies at later dates.
orities can be discussed. Critique by other disciplines can be
An advantage of companion protocol approaches is that the
anticipated so that language and design issues can be ad-
patient population and design data points are shared between
dressed prior to presentations at the disease committees. COG
two clinical trials, thus giving greater enrollment efficiency
has the resources (e.g., trial sites, personnel, participants, re-
and opportunity to interpret the data from the trials in the
cruitment, data analysis, management capabilities) that sup-
context of one another. An example of the harmony of a
port the implementation and evaluation of approved studies.
companion protocol approach is in a current nursing proto-
As studies progress, COG meetings can be used to bring par-
col that is examining the differences in sleep efficiency, du-
ticipants together to receive training in intervention, evalua-
ration, fatigue, dexamethasone pharmacokinetics, and phar-
tion, or quality control.
macogenetics in children and adolescents being treated for
The cooperative group structure, through multisite coopera-
ALL before and during dexamethasone pulses (grant RO1
tion, allows global access to a large number of patients for
NR07610). This protocol is linked to three frontline thera-
recruitment into clinical trials. Often, this can increase rates of
peutic protocols whose overall objectives are to improve the
patient recruitment and has the potential to decrease the time
cure rate of children with non-B cell ALL. The same patient
and costs of conducting trials. Multicenter cooperation is very
population would participate in the therapeutic and compan-
important to trial centers with small patient populations where
ion protocols. Data collection times for nursing protocols
only a limited number of trials may be open to accrual. Also,
match those for the therapeutic protocols so that patients do
larger centers host multiple trials, and the same patients are
not need to return to the care setting for additional nursing
eligible to consider enrolling in more than one therapeutic and
data collection, and the outcomes from the nursing and medi-
nontherapeutic trial at the same time.
cal protocols can be used to help interpret the other protocols'
As nurses begin to consistently conduct their research in
findings.
cooperative groups, protocol databases can become more re-
Nursing objectives, inserted in disease-specific research
flective of nursing care outcomes. These databases then can
protocols, provide a systematic approach to examining sup-
be used to demonstrate progress in nursing science. In addi-
portive care, symptom management, quality of life, self-care
tion, the databases will allow simultaneous analysis of nurs-
skills, and other patient or family responses to cancer and its
ing and medical care outcomes.
treatment while allowing data to be compared with treatment
Finally, cooperative groups offer opportunities to increase
outcomes. All patients enrolled in disease-specific protocols
nursing research endeavors' visibility. Nursing research
also will participate in nursing objectives. Mechanisms avail-
must be visible to have a role in establishing research priori-
able in cooperative groups to facilitate patient enrollment and
ties (Rieger, 2002). In the COG disease committees or sci-
monitoring then become available for nursing objectives.
entific committees (i.e., those that focus on cancer control,
Efforts to incorporate nursing objectives in disease-specific
supportive care, or end-of-life care), opportunities exist for
protocols are enhanced greatly if they occur during the proto-
nurses to discuss, collaborate, and improve their science in in-
cols' development stages and not after protocols are open for
teraction with other scientists from a variety of backgrounds. In
recruitment. Nurses who are active members on disease com-
doing so, these nurses can assist others in refining their re-
mittees of cooperative groups are in a key position to know
search questions and methods and contribute more directly
when new protocols are being developed and the primary de-
to the scientific mission of pediatric oncology cooperative
sign features of new protocols. Furthermore, at times, treat-
groups.
ment-related protocols are amended or temporarily closed.
ONCOLOGY NURSING FORUM VOL 30, NO 6, 2003
E125
Freestanding nursing research protocols associated with such
Enhance international cooperation in clinical trials.
protocols could remain open for recruitment, whereas nursing
These goals are remarkably similar to the vision of COG,
which is to incorporate the talents of all members to facilitate
objectives nested within an existing non-nursing protocol
would depend on recruitment to the primary study.
its scientific aims. One factor that will assist nurses' ability to
integrate and contribute to cooperative groups is being able to
Conclusion
speak the same research language that dominates COG. In ad-
dition, non-nurse members of the cooperative groups must be
The nature of cooperative group science is changing, which
familiar with these language differences to assist in translat-
makes this an ideal time for nurses to become more actively
ing nurses' research ideas that are highly relevant to coopera-
involved. Comis (1998) identified several general goals of co-
tive groups.
operative groups that are not yet fully realized.
Build on the scientific breadth of members.
The authors gratefully acknowledge the editorial review of this work by
Integrate health outcomes and economic measures in pro-
Donald Samulack, PhD, director of scientific editing at St. Jude Children's
tocol activities.
Research Hospital in Memphis, TN.
Identify the most appropriate therapies to consider for reim-
bursement.
Author Contact: Pamela S. Hinds, PhD, RN, can be reached at
Establish a framework that builds on the strengths of each
pam.hinds@stjude.org, with copy to editor at rose_mary@earthlink
member.
.net.
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