- Email: [email protected]
Creating a Novel Structure for Nursing Research in a Cooperative Clinical Trials Group: The Children’s Oncology Group Experience
Seminars in Oncology Nursing, Vol 21, No 2, Suppl 2 (May), 2005: pp 79-88
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OBJECTIVE: To describe a novel structure designed to integrate nursing research into the Children’s Oncology Group (COG).
DATA SOURCES: Review articles, reports, and newsletters.
CONCLUSION: A new structure using nurse researcher-advanced practice nurse dyads has successfully integrated nurse researchers into COG scientific activity, as evidenced by the development of concept proposals, companion protocols, nursing objectives in therapeutic trials, and nurse-led publications.
IMPLICATIONS PRACTICE:
FOR
NURSING
This provides a promising method for integrating nurse researchers and increasing multidisciplinary research collaboration in cooperative oncology group.
Kathleen S. Ruccione, MPH, RN, CPON, FAAN: Associate Professor of Clinical Pediatrics, Division of Hematology-Oncology, Department of Pediatrics, USC Keck School of Medicine and Childrens Hospital Los Angeles, Los Angeles, CA; Pamela S. Hinds, PhD, RN: Director of Nursing Research, St Jude Children’s Research Hospital, Memphis, TN; Joetta DeSwarte Wallace, MSN, RN, CPON: Clinical Nurse Specialist, Pediatric Hematology/Oncology, Miller Children’s Hospital, Long Beach, CA; Katherine Patterson Kelly, MN, RN: Clinical Nurse Specialist, Pediatric Hematology Oncology, Children’s Hospital, University of Missouri Health Care, Columbia, MO. Supported in part by the National Institutes of Health grant nos. 5-U01-CA13539-28 (K.S.R.) and 5-U10-CA-30969-19 (K.P.K.), and by the COG grant no. NIH U10-CA98543-01 from the National Cancer Institute (Nursing Discipline portion of the COG Chair’s grant) and by an R13 grant (CA86138; awarded to P.S.H.). Address correspondence to Kathleen S. Ruccione, MPH, RN, CPON, FAAN, Childrens Hospital Los Angeles, 4650 Sunset Blvd, MS#54, Los Angeles, CA 90027; email: [email protected]
© 2005 Elsevier Inc. All rights reserved. 0749-2081/05/2102-$30.00/0 doi:10.1016/j.soncn.2004.12.002
CREATING A NOVEL STRUCTURE FOR NURSING RESEARCH IN A COOPERATIVE CLINICAL TRIALS GROUP: THE CHILDREN’S ONCOLOGY GROUP EXPERIENCE KATHLEEN S. RUCCIONE, PAMELA S. HINDS, JOETTA DESWARTE WALLACE, AND KATHERINE PATTERSON KELLY FOR THE CHILDREN’S ONCOLOGY GROUP NURSING DISCIPLINE “There’s a way to do it better. . .find it.” - Thomas Edison
F
ew would disagree that pediatric oncology has been the most successful force of modern oncology in treatment outcomes, lives saved, and clinical research productivity.1 Cure rates, as measured in 5-year survival, now exceed 75%.2,3 In addition to improvements in survival, important contributions from pediatric
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oncology include showing the value of a multidisciplinary team approach, multimodality treatment, supportive care enabling more aggressive therapy, the role of genetics in cancer etiology, family-centered care, open communication about diagnosis and prognosis, and the need for survivorship care.4,5 In fact, the population of childhood cancer survivors has increased so dramatically that their needs prompted the recent publication of an Institute of Medicine report with recommendations for survivorship care.6 Among the reasons cited for these unprecedented achievements are the good fortune of responsiveness to current therapy by the types of cancers that occur in children, and a long history of treating a majority of children with cancer according to therapeutic clinical trials.1 Since 1955, the National Cancer Institute (NCI) has supported cooperative groups organized to conduct clinical trials in childhood cancer. Four pediatric cooperative clinical trials groups merged to become the Children’s Oncology Group (COG) at the turn of the 21st century. The COG is the largest pediatric cancer clinical research organization in the world, comprised of every major pediatric cancer program in North America as well as programs in Australia, Europe, and New Zealand. The purpose of this article is to briefly describe the development and implementation of a new structure for nursing research in the COG, which was designed to enable more direct contributions of the Nursing Discipline to the scientific mission of the cooperative group. Because many of the challenges inherent in bridging the gap between nurse researchers and cooperative clinical trials groups are not unique to pediatric oncology, it is anticipated that this novel structure may be of interest to others and may provide a useful method for increasing multidisciplinary collaboration for the benefit of patients and families who need oncology care.
BACKGROUND
P
ediatric cancer clinical trials cooperative groups have ascertained and provided access to state-of-the-art treatment protocols for nearly 95% of the children with cancer under 15 years of age in the United States,7 and more than half have been entered into at least one clinical trial.8,9 This is in sharp contrast to the adult cancer experience. Children with cancer constitute 15% to 20%
of all patients entered on clinical trials by the NCI cooperative groups despite the rarity of childhood cancer, which represents less than 1% of all individuals diagnosed with cancer in the United States annually.5 In the legacy of pediatric oncology cooperative groups, Nursing Committees provided the nursing expertise needed to successfully implement and evaluate medical clinical trials. The Nursing Committees in the Children’s Cancer Group (CCG) and the Pediatric Oncology Group (POG) created working networks among their nurse members to facilitate nursing contributions to disease and discipline committees. These networks were composed primarily of advanced practice nurses who participated as members of protocol, disease and scientific committees, contributing to concept design, trial outcomes analysis and publication, and patient, family, and nursing education about treatment protocols and clinical trials.10 Responsibilities assumed by nurse members included monitoring toxic effects, writing chemotherapy guidelines, assisting with the development of protocol roadmaps, and serving as direct resources to other nurses about the content of the various treatment protocols. In addition, nurse members responded to opportunities to collaboratively address the efficacy of the medical therapies and their impact on patients.11-14 With consultation from nurse researchers, the CCG and POG Nursing Committees also examined how families were affected by participation in clinical trials. The CCG Nursing Committee investigated parents’ understanding of informed consent and parental reasons for accepting or declining random assignment in clinical trials.15,16 The POG Nursing Committee explored ways to measure parental caregiving demands inherent in selected treatment protocols.17,18 Yet despite these notable efforts spanning a 15-year period, most advances in pediatric oncology nursing research occurred outside of the oncology cooperative groups. Recently, nurse leaders have called for adult and pediatric nurse researchers and advanced practice nurses to work together in multidisciplinary research teams, and to recognize opportunities and potential advantages of integrating nursing research into cooperative groups.10,19,20 However, nurse researchers are unlikely to commit themselves to conducting their program of research in oncology cooperative groups without a clear linkage to the scientific mission of the group, and an infrastructure that supports it.
CREATING A NOVEL STRUCTURE FOR NURSING RESEARCH
METHODS Nursing Research in Pediatric Cooperative Group History. (1980-2000)
I
n the past two decades, nursing research efforts in pediatric oncology cooperative groups were hampered by several factors. There was a comparatively small cadre of nurse researchers, most of whom were not affiliated with institutions participating in the pediatric cooperative groups. Although several nurse researchers had made significant and valued contributions to nursing research efforts over the years, they identified a lack of a peer group in the cooperative groups as problematic, with cooperative groups typically having only one or two nurse researchers as members. Of necessity, nurses had to collaborate across two cooperative group systems (CCG and POG), requiring added time, effort, and more complicated logistics. Additional obstacles included differences between the language and cultures of nursing science and cooperative groups, as well as different areas of research emphasis by cooperative groups (“curative therapy”) and by nurse researchers (“human experience”). Other barriers included lack of formal preparation in nursing doctoral programs about science in oncology cooperative groups, and unsatisfying experiences by some nurse researchers who left after initial involvement.10,21,22 Nurse researchers who did participate had limited and typically brief roles in the oncology cooperative groups. They reported finding it difficult to understand cooperative group processes, the conduct of science in the groups, the appropriate interactions with the committee and leadership structures of the groups, and avenues of ongoing participation in the cooperative group. The nurse researchers also reported difficulty because of the multiple and diverse requests for assistance with research ideas from nurse members of the groups. Such requests diluted the contributions that the researchers could have made if they had been able to focus on importing their own program of research into the group. Although much effort was invested in the development of nursing research ideas, few evolved into a concept or protocol approved by the cooperative groups.10 Most commonly, the nurse researchers abandoned their efforts to participate in the cooperative groups after 2 to 3 years. Within a 5-year period, five doctorally prepared nurses made an initial foray into the cooperative groups, but in the
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end conducted their research outside of the pediatric cooperative group structure. State of the Science Summit In the transition period leading to the formation of the COG, pediatric cooperative group nurse leaders had a unique opportunity to review the nursing research record in the legacy groups and consider how to identify and promote nursing research priorities effectively in the new endeavor.19,23 A nursing transition team was formed with representation from CCG and POG Nursing Committees. A critical and candid review by this team permitted enumeration of the past barriers to nursing research in the pediatric oncology cooperative groups. To address the identified obstacles, nurse leaders convened a State of the Science (SOS) Summit for Pediatric Oncology Nursing Research at the National Institutes of Health early in the year 2000.19 The conference was held to target new research ideas, forge collaborative relationships with nurse researchers not previously linked with cooperative group trials, and develop a blueprint for nursing research in the next decade. Three objectives were defined: (1) to highlight new and promising nursing research programs and emerging hypotheses that could ultimately contribute to the scientific mission of the COG; (2) to strengthen the working relationships among nurse researchers, staff nurses, and advanced practice nurses in pediatric oncology by sharing the responsibility for shaping the nursing scientific agenda and contributing to the COG scientific agenda; and (3) to foster collaboration with other disciplines relevant to the nursing and COG scientific agendas. The Summit was sponsored through a scientific workshop grant from the NCI and by matching funding from the transition leadership team representing the pediatric legacy cooperative groups. Four nurse researchers were invited to present their programs of research in the areas of neurocognitive effects of treatment, fatigue and related symptoms, coping efforts of patients and families, and self-care strategies. These areas of research were carefully selected because they aligned well with COG research priorities. Each presentation was followed by two critiques: one by a researcher who was not a nurse and the other by a nurse researcher. Working groups composed of the nurse researcher, advanced practice nurses, and critiquers then developed consensus statements
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FIGURE 1. Children’s Oncology Group Nursing Discipline.
regarding the research questions that needed to be addressed next in each research program and potential application to the cooperative group. Summit proceedings were published within the year in Seminars in Oncology Nursing and distributed to key stakeholders in the research community. Development of a New Research Structure The State of the Science consensus statements became the starting point of a strategic plan for each research program. The four SOS research foci formed the nexus of nursing research as the COG was launched in 2000. To move this plan into action, the COG Nursing Discipline needed to: (1) build an effective overall Nursing Discipline governance organization that had a research structure embedded within it, and (2) organize a cadre of nurses who would be committed to actively participating in the scientific research of the COG. The COG Nursing Discipline governance structure, shown in Fig 1, includes a leadership body (the chair, vice chair, subcommittee chairs,
and two at-large members) and four subcommittees (Clinical Practice, Clinical Trials, Education, and Research). The Research Subcommittee is co-led by Pamela Hinds and Joetta DeSwarte Wallace, modeling the purposeful partnership of a nurse researcher and an advanced practice nurse. This research structure is mirrored in the four research dyads. Table 1 identifies the terminology of the COG nursing research structure.19,24 We chose this researcher/practitioner interface approach for two reasons. First, it fosters nurse researchers’ ability to fully focus on importing and extending their program of research into the cooperative group, and builds on the earlier observation that nurse researchers needed improved education about the processes, values, and research methods of an oncology cooperative group to be able to function knowledgeably in the organization. Second, advanced practice nurses are fully integrated into the committee structure of the group, well versed in the processes of the group, respected for their clinical and educationbased group contributions, and familiar with the
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TABLE 1. COG Nursing Research Structure Terminology Term
Definition
Oncology advanced practice nurse (APN)
A registered nurse, prepared with a minimum of a master’s degree in nursing, who has acquired advanced, in-depth knowledge and preceptored clinical experience in oncology that enable him or her to exhibit a high degree of independent and collaborative judgment and clinical skill in providing nursing care to patients with cancer and their families. The APN in oncology is usually a clinical nurse specialist or nurse practitioner who is involved in direct patient care and who also has education, leadership, and research responsibilities. Traditionally, research-related responsibilities involve using research findings and assisting researchers in generating new knowledge. A doctorally prepared nurse is responsible for initiating formal investigations into health promotion, health restoration, health maintenance, prevention-related health education, early detection, and treatment of cancer. Traditionally, the nurse researcher seeks funding for research to improve the outcome of care for oncology patients. A team comprised of an oncology nurse researcher and an oncology advanced practice nurse who share an area of expertise in oncology.
Nurse researcher in oncology
Nurse dyad
group protocols. These nurses are positioned to identify researchable topics related to clinical trials. They understand how cooperative group clinical trials work, but they need the expertise of doctorally prepared nurse scholars and researchers to conduct nursing research. Pairing a nurse researcher who has a defined area of scientific expertise with an advanced practice nurse who has the skills, knowledge, and familiarity of cooperative group processes provides powerful research leadership to develop research objectives or protocols that best represent the Nursing Discipline’s clinical and research priorities. Based on the areas of emphasis in the SOS, four teams of nurse scholars led by a nurse researcher and an advanced practice nurse were created. Nursing Research co-chairs worked with the Nursing Discipline chair and COG senior leadership to appoint the four dyads to COG committees that could best facilitate the research interests and talents of the dyads: (1) the neurocognitive consequences of treatment team (Ida Moore, DNS, FAAN and Patsy McGuire Cullen, MAEd, RN, CPNP) was appointed to the CNS Tumors Committee; (2) the fatigue and related symptoms team (Marilyn Hockenberry, PhD, RN and Casey Hooke, MSN) was appointed to the Acute Lymphocytic Leukemia Committee; (3) the coping efforts of
Source Lester et al, 1997
24
Lester et al, 199724
Hinds and DeSwarte Wallace, 200019
patients/families team (Joan Haase, PhD, RN and Lona Roll, MN) was appointed to the Adolescent and Young Adult Committee; and (4) the self-care team (Marylin Dodd, PhD, RN, FAAN and Tina Rasco Baggott, MN) was appointed to the Supportive Care Committee. The new nursing research structure, the dyads, and their COG committee linkages were presented at the fall 2001 COG meeting. This was the first Group meeting attended by the nurse scholars and the first opportunity for the research dyads to participate in the meetings of their assigned committees. The dyads were charged with developing research objectives that could be placed in developing or open Group protocols, or to develop companion nursing research protocols or free-standing nursing studies. Concepts for pilot, limited institution, or groupwide studies were encouraged. Through a contractual agreement, the Oncology Nursing Society provided travel support for the four nurse researchers to attend the COG meetings for the first 2 years. Subsequent travel funding was budgeted into the COG Nursing Discipline grant. Enabling and Supporting Actions To facilitate the efforts of the research dyads, the co-chairs of the Nursing Research Sub-Com-
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mittee requested that a COG statistician be appointed to work with the subcommittee. This request was approved and the designated statistician has been involved in the concepts, protocols, and grant submissions generated to date. We requested that an internationally recognized nurse researcher be appointed to the COG Scientific Advisory Board, and Dr Ruth McCorkle accepted this appointment. One of the Nursing Research co-chairs was appointed to the Steering Committee of the COG Cancer Control Committee, the first level of scientific review for most of the protocols that are generated from the Nursing Discipline. Of particular benefit to the efforts of those involved in the nursing research structure is the recently constituted COG Scientific Review Council, which processes submitted concepts within a committed timeframe and with substantive feedback. Internal efforts to facilitate the dyads’ work include quarterly conference calls with the individual dyads and the Nursing Research co-chairs, ongoing electronic communications, interactive grant reviews, and collaborative manuscript development. Dyad members meet with COG Nursing leadership during the twice-yearly COG meetings. Those meetings also have been regularly attended by representatives from the National Institute for Nursing Research and the NCI of the National Institutes of Health. Milestones and Challenges The placement of the dyads on COG committees has had varying outcomes. For example, one particularly welcoming committee assigned responsibilities to its nurse dyad that exceeded the originally agreed upon research-related commitments; the original commitments then needed to be reviewed and re-emphasized. A second dyad was originally involved in one therapeutic protocol being developed by its committee, but was advised to move to a second protocol by the committee chairperson because of slowed progress with the first assignment. This has been a positive change, enabling the dyad to develop a research objective related to a different but equally appropriate disease protocol. The third dyad, also assigned to a disease committee, has experienced a positive concurrent effort with the assigned committee developing a companion protocol to a new therapeutic protocol. The fourth dyad is assigned to a committee that is in the process of redefining its function. This has slowed dyad progress and
may well result in a new committee assignment for this dyad. Meanwhile, an additional advanced practice nurse has been added to this dyad to assist in moving it forward, making this the first team composed of a triad. Example outcomes of the new structure are listed in Table 2.
PLANNED FURTHER DEVELOPMENT NURSING RESEARCH
T
OF
COG
he first State of the Science Summit for Pediatric Oncology Nursing Research was critical for creating a new investment from the Nursing Discipline into the scientific mission of the COG. The successful integration of nursing research teams into COG provided the basis for planning the second State of the Science Summit in 2004. SOS II had the same overall goal of the first summit, but expanded that goal by developing scientific questions or hypotheses from three additional foci that will be incorporated into the nursing research structure. Three developing nursing research programs were selected for inclusion because the topics are of high interest and relevance to pediatric oncology nursing and they have clear potential for making a direct contribution to the scientific agenda of the COG. In addition, these programs were selected because the nurse researchers of each program agreed to make a commitment to COG by: (1) assisting to identify research questions or hypotheses from their respective programs that could be incorporated into future pediatric oncology clinical trials and (2) assuming leadership roles in planning the incorporation of these research questions. The three programs of research and the nurse researchers are: (1) treatment decision making (Janet Stewart, PhD, RN, Kathy Kelley, MN, and Kim PykeGrimm, MN), (2) complementary and alternative medicine (Janice Post-White, PhD, RN, FAAN and Ria Hawkes, RN, MS), and (3) end-of-life care (Pam Hinds, PhD, RN, Suzanne Nuss, MSN, and Debra LaFond, MSN). The program for the second State of the Science summit followed the same general plan as the first, with research presentations, nurse and non-nurse critiquers, working groups, and publication of the proceedings in this dedicated issue of Seminars in Oncology Nursing. Modifications in the plan for SOS II included naming of the research dyads and identification of their appropriate COG committee linkages in advance. In addition, SOS II incorporated minority,
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TABLE 2. Selected Examples of Outcomes from the New Nursing Research Structure (2001-2003) Category of Outcome
Example Outcome
1. Research objective in a developing COG protocol 2. Companion nursing research protocol to a COG therapeutic protocol 3. Nurse-initiated protocol
Change in quality of life and function in patients with medulloblastoma across treatment ACCLO1P3: Differences in parental caregiving demands in childhood ALL by length of infusion therapy ACCLO3P1: Prevention of mucositis in children with AES-0014, a glutamine-based oral care regimen for patients diagnosed with a solid tumor: A randomized placebo controlled clinical pilot Music therapy and coping in adolescents undergoing bone marrow transplantation
4. Free-standing nursing research protocol
Abbreviation: ALL, acute lymphoblastic leukemia.
international, and survivorship perspectives through invited participants. The SOS II nurse researcher-advanced practice nurse teams are being placed on COG committees, beginning their assignments at the spring 2004 COG meeting. Nurse Researcher Fellowship Program A long-standing and productive program in the cooperative group structure is the young investi-
gator fellowship program. Young investigators or investigators who are changing research focus are eligible to apply for funds to support their research and their time/effort. This program has been designed for non-nurse applicants. We plan to design a program uniquely tailored to nursing research to develop the next generation of nurse researchers who are committed to the cooperative group scientific mission. We expect to have two fellows at a
TABLE 3. Mutual Advantages of Nursing Research Participation in Oncology Cooperative Group Science To the Cooperative Group Companion protocols (nursing research and therapeutic clinical trials) share patient population and design data points ¡ greater enrollment efficiency, and opportunity to interpret data from two trials in context of one another. Involving nurse researchers helps build on the scientific breadth of cooperative group membership.
Nurse researchers contribute to group integration of health outcomes and other measures in protocol activities. Protocol databases will increasingly reflect nursing care outcomes, allowing simultaneous analysis of medical and nursing care outcomes.
To Nursing Research Cooperative group structure facilitates intervention trials and provides outcome data related to interventions.
Semi-annual meetings: - provide opportunities to meet and work on collaborative projects - alleviate sense of isolation - foster interactions with multidisciplinary researchers that may spark new collaborations - can be used for site investigator training Well-organized and highly motivated group of nurse clinicians who can guide nurse researchers’ efforts in the cooperative group. Offers opportunities for feedback during planning stages of a study to improve feasibility and scientific merit. Multisite cooperation allows access to a large number of potential study participants (1 rate of recruitment, 2 study time/ cost). These databases will be used to demonstrate progress in nursing science. Offers opportunity to increase nursing research visibility.
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time (four fellows during the 6-year grant period) to be mentored by the senior nurse researcher/ advanced practice nurse teams already committed to the COG mission. Each fellowship will be 2 years in duration. Nursing Research Strategic Meetings Current cooperative group meetings have schedules that include 4 to 5 days of concurrent committee meetings. The primary focus is on completing the work of each committee. Little time is available to develop strategic plans, assign responsibilities for implementing such plans, and then evaluating the plans. We plan two strategic planning meetings to occur over the next 5 years, attended by nurse researchers, advanced practice nurses, leaders of the Nursing Discipline Committee, and other key stakeholders with a focus on strategic planning, brainstorming, and evaluation of nursing research contributions to the COG scientific mission. Expansion of Nurse Researcher Network We plan to continue to expand the network of COG nurse researchers through our associations with the research arms of oncology nursing professional organizations (the Association of Pediatric Oncology Nurses and the Oncology Nursing Society). These collaborations are expected to facilitate further development of priority research ideas.
CONCLUSION “The innovation point is the pivotal moment when talented and motivated people seek the opportunity to act on their ideas and dreams.” - W. Arthur Porter.
T
he new nursing research structure adopted by the COG was suggested by two basic aspects of the experience of nurses in oncology cooperative groups. First, past efforts by the nursing discipline to generate research in the cooperative groups relied heavily on a single nurse researcher who was expected to facilitate the research efforts of other nurses. In many cases, the content or the methods of these studies was outside the expertise of the nurse researcher; thus, the efforts of the nurse researcher were less productive than they would have been if focused within the researcher’s area of expertise. Also, the nurse researcher was not expert at group systems and processes. Sec-
ond, advanced practice nurses were well integrated into the committee structure of the cooperative groups, well versed in the processes of the cooperative groups, highly respected for their clinical and education-based contributions to the groups, and intimately familiar with the therapeutic protocols generated by the groups. However, they did not have expertise in research design and data analysis. They rarely had time to conduct research independently given their demanding practice roles. Based on these attributes, the COG Nursing Discipline implemented a research structure using nurse researcher/APN dyads. The dyads have been strategically deployed to link with key COG scientific and disease-focused committees, and have made progress in contributing objectives to protocol studies as well as in designing companion studies. The new research structure has been successful in integrating nurse researchers into COG scientific activity, as evidenced by the development of concept proposals, companion protocols, and placement of nursing objectives into therapeutic trials. The research structure has been fully supported by the COG leadership, as evidenced by its willingness to support a second State of the Science Summit aimed at enlarging the structure to include three additional research teams. Clinical trials, cooperative groups, and nursing research each face challenges and opportunities arising from a changing health care environment. Today, nurse researchers have numerous opportunities for studying important questions and issues in promoting health, ameliorating the side effects of illness and the consequences of treatments, while optimizing the health outcomes of people and their families.25 These opportunities present new challenges. Baldwin and Nail26 have made the following recommendations to clinical nurse researchers: create a research program that has maximum adaptability, gain a thorough understanding of organizational administration and priorities, increase the visibility of nursing research, market the necessity for nursing research, increase database management skills, engage in multidisciplinary research, and maintain flexibility in study design. At the same time, clinical trials cooperative groups are challenged to enhance international cooperation in clinical trials, encourage greater involvement of third-party payers in clinical trials, build on the scientific breadth of the members, identify the most ap-
CREATING A NOVEL STRUCTURE FOR NURSING RESEARCH
propriate therapies to consider for reimbursement, establish a framework which builds on the strengths of each of the members, and to integrate health outcomes and economic measures into protocol activities.27 Integration of nursing research into the cooperative group setting offers a promising avenue for meeting these opportunities and overcoming these challenges. There are significant advantages for nurses conducting research in pediatric cooperative groups, and reciprocally significant advantages for a cooperative group when nursing research is conducted as part of the scientific mission.21 Some of these advantages are summarized in Table 3.
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Dr Joseph V. Simone noted in a recent commentary about the COG that “Pediatric oncology has been the innovator for many facets of oncology. Its institutional and cooperative group leaders have an opportunity to reconsider and debate its direction and structure to assure its leadership role in the future.”1 The COG Nursing Discipline has been engaged in a vibrant and thoughtful process of defining nursing research structure and strategy. The new COG structure for nursing research offers a promising means of integrating nursing research into a cooperative group in alignment with the group’s scientific mission. This structure may be applicable in other clinical trial cooperative groups.
REFERENCES 1. Simone JV. Pediatric oncology – quo vadis? Oncology Times 2003;25:13-14. 2. Ries LAG, Smith MA, Gurney JG, et al(eds): Cancer Incidence and Survival Among Children and Adolescents: United States SEER Program 1975-1995. Bethesda, MD, National Cancer Institute, SEER Program, NIH Publication No. 99-4649, 1999. 3. Jemal A, Tiwari RC, Murray T, et al. Cancer statistics, 2004. CA Cancer J Clin 2004:54:8-29. 4. Bleyer WA: The impact of childhood cancer on the United States and the World. CA Cancer J Clin 1990;40:355-367. 5. Donaldson SS: Lessons from our children. J Radiat Oncol Biol Phys 1993;26:739-749. 6. Hewitt M, Weiner SL, Simone JV (eds): Childhood Cancer Survivorship: Improving Care and Quality of Life. Washington, DC, Institute of Medicine, National Research Council. The National Academies Press, 2003. 7. Ross JA, Severson RK, Pollock BH, et al. Childhood cancer in the United States: A geographical analysis of cases from the pediatric cooperative clinical trials groups. Cancer 1996;77:201-207. 8. Bleyer WA: The U.S. pediatric cancer clinical trials programmes: International implications and the way forward. Eur J Cancer 1997;33:1439-1447. 9. Murphy SB: POG, CCG, IRSG, NWTSG unanimously agree to form single group: Pediatric Intergroup Summit, July 1998. Pediatric Oncology Group Quarterly Newsletter, Summer: 1-3, 1998. 10. Ruccione K, Kelly K. Pediatric oncology nursing in cooperative group clinical trials comes of age. Semin Oncol Nurs 2000;16:253-260. 11. van Hoff J, Hockenberry-Eaton MJ, Patterson K, et al. A survey of antiemetic use in children with cancer. Am J Dis Child 1991;145:773-778. 12. Tubergen DG, Gilchrist GS, O’Brien RT, et al. Improved outcome with delayed intensification for children with acute lymphoblastic leukemia and intermediate presenting features: A Childrens Cancer Group phase III trial. J Clin Oncol 1993;11:527-537.
13. Bradlyn AS, Ritchey AK, Harris CV, et al. Quality of life research in pediatric oncology. Research methods and barriers. Cancer 1996;78:1333-1339. 14. Kurre HA, Ettinger AG, Veenstra DL, et al. A pharmacoeconomic analysis of pegaspargase versus native Escherichia coli L-asparaginase for the treatment of children with standard-risk, acute lymphoblastic leukemia: the Children’s Cancer Group study (CCG-1962). J Pediatr Hematol Oncol 2002;24:175-181. 15. Ruccione K, Kramer RF, Moore IK, et al. Informed consent for treatment of childhood cancer: Factors affecting parents’ decision-making. J Pediatr Oncol Nurs 1991;8:112-121. 16. Wiley F, Ruccione K, Moore I, et al. Parents’ perceptions of randomization in pediatric cancer clinical trials: A report from the Children’s Cancer Group. Cancer Pract 1999;7: 248-256. 17. James K, Keegan-Wells D, Hinds PS, et al. The care of my child with cancer: Parents’ perceptions of caregiving demands. J Pediatr Oncol Nurs 2002;19:218-228. 18. Keegan-Wells D, James K, Moore K. A pilot study to test the instrument: The care of my child with cancer. J Pediatr Oncol Nurs 1998;15:136-137. 19. Hinds P, DeSwarte-Wallace J. Positioning nursing research to contribute to the scientific mission of the pediatric oncology cooperative group. Semin Oncol Nurs 2000;16: 251-252. 20. Given B. Into the millennium: Open the door and let the future in for cancer nursing research. Oncol Nurs Forum 2001;28:647-654. 21. Hinds PS, Baggott, C, DeSwarte-Wallace J, et al. Functional integration of nursing research into a pediatric oncology cooperative group: Finding common ground. Oncol Nurs Forum 2003;30: E121-E126. 22. Haberman M. Advancing cancer nursing through nursing research. In: Yarbro CH, Frogge MH, Goodman M, Groenwald SL (eds): Cancer Nursing Principles and Practice (5th ed). Boston, MA: Jones and Bartlett, 2000:1728 – 1740.
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23. Fochtman D, Hinds PS. Identifying nursing research priorities in a pediatric clinical trials cooperative group: the Pediatric Oncology Group experience. J Pediatr Oncol Nurs 2000;17:83-87. 24. Lester J, Glass E, Owen E. Statement on the Scope and Standards of Advanced Practice in Oncology Nursing. Pittsburgh, PA: Oncology Nursing Press, 1997.
25. Hinshaw AS. Nursing knowledge for the 21st century: Opportunities and challenges. J Nurs Scholarsh 2000;32: 117-123. 26. Baldwin KM, Nail LM. Opportunities and challenges in clinical nursing research. J Nurs Scholarsh 2000;32:163-166. 27. Comis RL. The cooperative groups: Past and future. Cancer Chemother Pharmacol 1998;42:S85-S87.
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OBJECTIVE: To describe a novel structure designed to integrate nursing research into the Children’s Oncology Group (COG).
DATA SOURCES: Review articles, reports, and newsletters.
CONCLUSION: A new structure using nurse researcher-advanced practice nurse dyads has successfully integrated nurse researchers into COG scientific activity, as evidenced by the development of concept proposals, companion protocols, nursing objectives in therapeutic trials, and nurse-led publications.
IMPLICATIONS PRACTICE:
FOR
NURSING
This provides a promising method for integrating nurse researchers and increasing multidisciplinary research collaboration in cooperative oncology group.
Kathleen S. Ruccione, MPH, RN, CPON, FAAN: Associate Professor of Clinical Pediatrics, Division of Hematology-Oncology, Department of Pediatrics, USC Keck School of Medicine and Childrens Hospital Los Angeles, Los Angeles, CA; Pamela S. Hinds, PhD, RN: Director of Nursing Research, St Jude Children’s Research Hospital, Memphis, TN; Joetta DeSwarte Wallace, MSN, RN, CPON: Clinical Nurse Specialist, Pediatric Hematology/Oncology, Miller Children’s Hospital, Long Beach, CA; Katherine Patterson Kelly, MN, RN: Clinical Nurse Specialist, Pediatric Hematology Oncology, Children’s Hospital, University of Missouri Health Care, Columbia, MO. Supported in part by the National Institutes of Health grant nos. 5-U01-CA13539-28 (K.S.R.) and 5-U10-CA-30969-19 (K.P.K.), and by the COG grant no. NIH U10-CA98543-01 from the National Cancer Institute (Nursing Discipline portion of the COG Chair’s grant) and by an R13 grant (CA86138; awarded to P.S.H.). Address correspondence to Kathleen S. Ruccione, MPH, RN, CPON, FAAN, Childrens Hospital Los Angeles, 4650 Sunset Blvd, MS#54, Los Angeles, CA 90027; email: [email protected]
© 2005 Elsevier Inc. All rights reserved. 0749-2081/05/2102-$30.00/0 doi:10.1016/j.soncn.2004.12.002
CREATING A NOVEL STRUCTURE FOR NURSING RESEARCH IN A COOPERATIVE CLINICAL TRIALS GROUP: THE CHILDREN’S ONCOLOGY GROUP EXPERIENCE KATHLEEN S. RUCCIONE, PAMELA S. HINDS, JOETTA DESWARTE WALLACE, AND KATHERINE PATTERSON KELLY FOR THE CHILDREN’S ONCOLOGY GROUP NURSING DISCIPLINE “There’s a way to do it better. . .find it.” - Thomas Edison
F
ew would disagree that pediatric oncology has been the most successful force of modern oncology in treatment outcomes, lives saved, and clinical research productivity.1 Cure rates, as measured in 5-year survival, now exceed 75%.2,3 In addition to improvements in survival, important contributions from pediatric
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oncology include showing the value of a multidisciplinary team approach, multimodality treatment, supportive care enabling more aggressive therapy, the role of genetics in cancer etiology, family-centered care, open communication about diagnosis and prognosis, and the need for survivorship care.4,5 In fact, the population of childhood cancer survivors has increased so dramatically that their needs prompted the recent publication of an Institute of Medicine report with recommendations for survivorship care.6 Among the reasons cited for these unprecedented achievements are the good fortune of responsiveness to current therapy by the types of cancers that occur in children, and a long history of treating a majority of children with cancer according to therapeutic clinical trials.1 Since 1955, the National Cancer Institute (NCI) has supported cooperative groups organized to conduct clinical trials in childhood cancer. Four pediatric cooperative clinical trials groups merged to become the Children’s Oncology Group (COG) at the turn of the 21st century. The COG is the largest pediatric cancer clinical research organization in the world, comprised of every major pediatric cancer program in North America as well as programs in Australia, Europe, and New Zealand. The purpose of this article is to briefly describe the development and implementation of a new structure for nursing research in the COG, which was designed to enable more direct contributions of the Nursing Discipline to the scientific mission of the cooperative group. Because many of the challenges inherent in bridging the gap between nurse researchers and cooperative clinical trials groups are not unique to pediatric oncology, it is anticipated that this novel structure may be of interest to others and may provide a useful method for increasing multidisciplinary collaboration for the benefit of patients and families who need oncology care.
BACKGROUND
P
ediatric cancer clinical trials cooperative groups have ascertained and provided access to state-of-the-art treatment protocols for nearly 95% of the children with cancer under 15 years of age in the United States,7 and more than half have been entered into at least one clinical trial.8,9 This is in sharp contrast to the adult cancer experience. Children with cancer constitute 15% to 20%
of all patients entered on clinical trials by the NCI cooperative groups despite the rarity of childhood cancer, which represents less than 1% of all individuals diagnosed with cancer in the United States annually.5 In the legacy of pediatric oncology cooperative groups, Nursing Committees provided the nursing expertise needed to successfully implement and evaluate medical clinical trials. The Nursing Committees in the Children’s Cancer Group (CCG) and the Pediatric Oncology Group (POG) created working networks among their nurse members to facilitate nursing contributions to disease and discipline committees. These networks were composed primarily of advanced practice nurses who participated as members of protocol, disease and scientific committees, contributing to concept design, trial outcomes analysis and publication, and patient, family, and nursing education about treatment protocols and clinical trials.10 Responsibilities assumed by nurse members included monitoring toxic effects, writing chemotherapy guidelines, assisting with the development of protocol roadmaps, and serving as direct resources to other nurses about the content of the various treatment protocols. In addition, nurse members responded to opportunities to collaboratively address the efficacy of the medical therapies and their impact on patients.11-14 With consultation from nurse researchers, the CCG and POG Nursing Committees also examined how families were affected by participation in clinical trials. The CCG Nursing Committee investigated parents’ understanding of informed consent and parental reasons for accepting or declining random assignment in clinical trials.15,16 The POG Nursing Committee explored ways to measure parental caregiving demands inherent in selected treatment protocols.17,18 Yet despite these notable efforts spanning a 15-year period, most advances in pediatric oncology nursing research occurred outside of the oncology cooperative groups. Recently, nurse leaders have called for adult and pediatric nurse researchers and advanced practice nurses to work together in multidisciplinary research teams, and to recognize opportunities and potential advantages of integrating nursing research into cooperative groups.10,19,20 However, nurse researchers are unlikely to commit themselves to conducting their program of research in oncology cooperative groups without a clear linkage to the scientific mission of the group, and an infrastructure that supports it.
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METHODS Nursing Research in Pediatric Cooperative Group History. (1980-2000)
I
n the past two decades, nursing research efforts in pediatric oncology cooperative groups were hampered by several factors. There was a comparatively small cadre of nurse researchers, most of whom were not affiliated with institutions participating in the pediatric cooperative groups. Although several nurse researchers had made significant and valued contributions to nursing research efforts over the years, they identified a lack of a peer group in the cooperative groups as problematic, with cooperative groups typically having only one or two nurse researchers as members. Of necessity, nurses had to collaborate across two cooperative group systems (CCG and POG), requiring added time, effort, and more complicated logistics. Additional obstacles included differences between the language and cultures of nursing science and cooperative groups, as well as different areas of research emphasis by cooperative groups (“curative therapy”) and by nurse researchers (“human experience”). Other barriers included lack of formal preparation in nursing doctoral programs about science in oncology cooperative groups, and unsatisfying experiences by some nurse researchers who left after initial involvement.10,21,22 Nurse researchers who did participate had limited and typically brief roles in the oncology cooperative groups. They reported finding it difficult to understand cooperative group processes, the conduct of science in the groups, the appropriate interactions with the committee and leadership structures of the groups, and avenues of ongoing participation in the cooperative group. The nurse researchers also reported difficulty because of the multiple and diverse requests for assistance with research ideas from nurse members of the groups. Such requests diluted the contributions that the researchers could have made if they had been able to focus on importing their own program of research into the group. Although much effort was invested in the development of nursing research ideas, few evolved into a concept or protocol approved by the cooperative groups.10 Most commonly, the nurse researchers abandoned their efforts to participate in the cooperative groups after 2 to 3 years. Within a 5-year period, five doctorally prepared nurses made an initial foray into the cooperative groups, but in the
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end conducted their research outside of the pediatric cooperative group structure. State of the Science Summit In the transition period leading to the formation of the COG, pediatric cooperative group nurse leaders had a unique opportunity to review the nursing research record in the legacy groups and consider how to identify and promote nursing research priorities effectively in the new endeavor.19,23 A nursing transition team was formed with representation from CCG and POG Nursing Committees. A critical and candid review by this team permitted enumeration of the past barriers to nursing research in the pediatric oncology cooperative groups. To address the identified obstacles, nurse leaders convened a State of the Science (SOS) Summit for Pediatric Oncology Nursing Research at the National Institutes of Health early in the year 2000.19 The conference was held to target new research ideas, forge collaborative relationships with nurse researchers not previously linked with cooperative group trials, and develop a blueprint for nursing research in the next decade. Three objectives were defined: (1) to highlight new and promising nursing research programs and emerging hypotheses that could ultimately contribute to the scientific mission of the COG; (2) to strengthen the working relationships among nurse researchers, staff nurses, and advanced practice nurses in pediatric oncology by sharing the responsibility for shaping the nursing scientific agenda and contributing to the COG scientific agenda; and (3) to foster collaboration with other disciplines relevant to the nursing and COG scientific agendas. The Summit was sponsored through a scientific workshop grant from the NCI and by matching funding from the transition leadership team representing the pediatric legacy cooperative groups. Four nurse researchers were invited to present their programs of research in the areas of neurocognitive effects of treatment, fatigue and related symptoms, coping efforts of patients and families, and self-care strategies. These areas of research were carefully selected because they aligned well with COG research priorities. Each presentation was followed by two critiques: one by a researcher who was not a nurse and the other by a nurse researcher. Working groups composed of the nurse researcher, advanced practice nurses, and critiquers then developed consensus statements
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FIGURE 1. Children’s Oncology Group Nursing Discipline.
regarding the research questions that needed to be addressed next in each research program and potential application to the cooperative group. Summit proceedings were published within the year in Seminars in Oncology Nursing and distributed to key stakeholders in the research community. Development of a New Research Structure The State of the Science consensus statements became the starting point of a strategic plan for each research program. The four SOS research foci formed the nexus of nursing research as the COG was launched in 2000. To move this plan into action, the COG Nursing Discipline needed to: (1) build an effective overall Nursing Discipline governance organization that had a research structure embedded within it, and (2) organize a cadre of nurses who would be committed to actively participating in the scientific research of the COG. The COG Nursing Discipline governance structure, shown in Fig 1, includes a leadership body (the chair, vice chair, subcommittee chairs,
and two at-large members) and four subcommittees (Clinical Practice, Clinical Trials, Education, and Research). The Research Subcommittee is co-led by Pamela Hinds and Joetta DeSwarte Wallace, modeling the purposeful partnership of a nurse researcher and an advanced practice nurse. This research structure is mirrored in the four research dyads. Table 1 identifies the terminology of the COG nursing research structure.19,24 We chose this researcher/practitioner interface approach for two reasons. First, it fosters nurse researchers’ ability to fully focus on importing and extending their program of research into the cooperative group, and builds on the earlier observation that nurse researchers needed improved education about the processes, values, and research methods of an oncology cooperative group to be able to function knowledgeably in the organization. Second, advanced practice nurses are fully integrated into the committee structure of the group, well versed in the processes of the group, respected for their clinical and educationbased group contributions, and familiar with the
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TABLE 1. COG Nursing Research Structure Terminology Term
Definition
Oncology advanced practice nurse (APN)
A registered nurse, prepared with a minimum of a master’s degree in nursing, who has acquired advanced, in-depth knowledge and preceptored clinical experience in oncology that enable him or her to exhibit a high degree of independent and collaborative judgment and clinical skill in providing nursing care to patients with cancer and their families. The APN in oncology is usually a clinical nurse specialist or nurse practitioner who is involved in direct patient care and who also has education, leadership, and research responsibilities. Traditionally, research-related responsibilities involve using research findings and assisting researchers in generating new knowledge. A doctorally prepared nurse is responsible for initiating formal investigations into health promotion, health restoration, health maintenance, prevention-related health education, early detection, and treatment of cancer. Traditionally, the nurse researcher seeks funding for research to improve the outcome of care for oncology patients. A team comprised of an oncology nurse researcher and an oncology advanced practice nurse who share an area of expertise in oncology.
Nurse researcher in oncology
Nurse dyad
group protocols. These nurses are positioned to identify researchable topics related to clinical trials. They understand how cooperative group clinical trials work, but they need the expertise of doctorally prepared nurse scholars and researchers to conduct nursing research. Pairing a nurse researcher who has a defined area of scientific expertise with an advanced practice nurse who has the skills, knowledge, and familiarity of cooperative group processes provides powerful research leadership to develop research objectives or protocols that best represent the Nursing Discipline’s clinical and research priorities. Based on the areas of emphasis in the SOS, four teams of nurse scholars led by a nurse researcher and an advanced practice nurse were created. Nursing Research co-chairs worked with the Nursing Discipline chair and COG senior leadership to appoint the four dyads to COG committees that could best facilitate the research interests and talents of the dyads: (1) the neurocognitive consequences of treatment team (Ida Moore, DNS, FAAN and Patsy McGuire Cullen, MAEd, RN, CPNP) was appointed to the CNS Tumors Committee; (2) the fatigue and related symptoms team (Marilyn Hockenberry, PhD, RN and Casey Hooke, MSN) was appointed to the Acute Lymphocytic Leukemia Committee; (3) the coping efforts of
Source Lester et al, 1997
24
Lester et al, 199724
Hinds and DeSwarte Wallace, 200019
patients/families team (Joan Haase, PhD, RN and Lona Roll, MN) was appointed to the Adolescent and Young Adult Committee; and (4) the self-care team (Marylin Dodd, PhD, RN, FAAN and Tina Rasco Baggott, MN) was appointed to the Supportive Care Committee. The new nursing research structure, the dyads, and their COG committee linkages were presented at the fall 2001 COG meeting. This was the first Group meeting attended by the nurse scholars and the first opportunity for the research dyads to participate in the meetings of their assigned committees. The dyads were charged with developing research objectives that could be placed in developing or open Group protocols, or to develop companion nursing research protocols or free-standing nursing studies. Concepts for pilot, limited institution, or groupwide studies were encouraged. Through a contractual agreement, the Oncology Nursing Society provided travel support for the four nurse researchers to attend the COG meetings for the first 2 years. Subsequent travel funding was budgeted into the COG Nursing Discipline grant. Enabling and Supporting Actions To facilitate the efforts of the research dyads, the co-chairs of the Nursing Research Sub-Com-
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mittee requested that a COG statistician be appointed to work with the subcommittee. This request was approved and the designated statistician has been involved in the concepts, protocols, and grant submissions generated to date. We requested that an internationally recognized nurse researcher be appointed to the COG Scientific Advisory Board, and Dr Ruth McCorkle accepted this appointment. One of the Nursing Research co-chairs was appointed to the Steering Committee of the COG Cancer Control Committee, the first level of scientific review for most of the protocols that are generated from the Nursing Discipline. Of particular benefit to the efforts of those involved in the nursing research structure is the recently constituted COG Scientific Review Council, which processes submitted concepts within a committed timeframe and with substantive feedback. Internal efforts to facilitate the dyads’ work include quarterly conference calls with the individual dyads and the Nursing Research co-chairs, ongoing electronic communications, interactive grant reviews, and collaborative manuscript development. Dyad members meet with COG Nursing leadership during the twice-yearly COG meetings. Those meetings also have been regularly attended by representatives from the National Institute for Nursing Research and the NCI of the National Institutes of Health. Milestones and Challenges The placement of the dyads on COG committees has had varying outcomes. For example, one particularly welcoming committee assigned responsibilities to its nurse dyad that exceeded the originally agreed upon research-related commitments; the original commitments then needed to be reviewed and re-emphasized. A second dyad was originally involved in one therapeutic protocol being developed by its committee, but was advised to move to a second protocol by the committee chairperson because of slowed progress with the first assignment. This has been a positive change, enabling the dyad to develop a research objective related to a different but equally appropriate disease protocol. The third dyad, also assigned to a disease committee, has experienced a positive concurrent effort with the assigned committee developing a companion protocol to a new therapeutic protocol. The fourth dyad is assigned to a committee that is in the process of redefining its function. This has slowed dyad progress and
may well result in a new committee assignment for this dyad. Meanwhile, an additional advanced practice nurse has been added to this dyad to assist in moving it forward, making this the first team composed of a triad. Example outcomes of the new structure are listed in Table 2.
PLANNED FURTHER DEVELOPMENT NURSING RESEARCH
T
OF
COG
he first State of the Science Summit for Pediatric Oncology Nursing Research was critical for creating a new investment from the Nursing Discipline into the scientific mission of the COG. The successful integration of nursing research teams into COG provided the basis for planning the second State of the Science Summit in 2004. SOS II had the same overall goal of the first summit, but expanded that goal by developing scientific questions or hypotheses from three additional foci that will be incorporated into the nursing research structure. Three developing nursing research programs were selected for inclusion because the topics are of high interest and relevance to pediatric oncology nursing and they have clear potential for making a direct contribution to the scientific agenda of the COG. In addition, these programs were selected because the nurse researchers of each program agreed to make a commitment to COG by: (1) assisting to identify research questions or hypotheses from their respective programs that could be incorporated into future pediatric oncology clinical trials and (2) assuming leadership roles in planning the incorporation of these research questions. The three programs of research and the nurse researchers are: (1) treatment decision making (Janet Stewart, PhD, RN, Kathy Kelley, MN, and Kim PykeGrimm, MN), (2) complementary and alternative medicine (Janice Post-White, PhD, RN, FAAN and Ria Hawkes, RN, MS), and (3) end-of-life care (Pam Hinds, PhD, RN, Suzanne Nuss, MSN, and Debra LaFond, MSN). The program for the second State of the Science summit followed the same general plan as the first, with research presentations, nurse and non-nurse critiquers, working groups, and publication of the proceedings in this dedicated issue of Seminars in Oncology Nursing. Modifications in the plan for SOS II included naming of the research dyads and identification of their appropriate COG committee linkages in advance. In addition, SOS II incorporated minority,
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TABLE 2. Selected Examples of Outcomes from the New Nursing Research Structure (2001-2003) Category of Outcome
Example Outcome
1. Research objective in a developing COG protocol 2. Companion nursing research protocol to a COG therapeutic protocol 3. Nurse-initiated protocol
Change in quality of life and function in patients with medulloblastoma across treatment ACCLO1P3: Differences in parental caregiving demands in childhood ALL by length of infusion therapy ACCLO3P1: Prevention of mucositis in children with AES-0014, a glutamine-based oral care regimen for patients diagnosed with a solid tumor: A randomized placebo controlled clinical pilot Music therapy and coping in adolescents undergoing bone marrow transplantation
4. Free-standing nursing research protocol
Abbreviation: ALL, acute lymphoblastic leukemia.
international, and survivorship perspectives through invited participants. The SOS II nurse researcher-advanced practice nurse teams are being placed on COG committees, beginning their assignments at the spring 2004 COG meeting. Nurse Researcher Fellowship Program A long-standing and productive program in the cooperative group structure is the young investi-
gator fellowship program. Young investigators or investigators who are changing research focus are eligible to apply for funds to support their research and their time/effort. This program has been designed for non-nurse applicants. We plan to design a program uniquely tailored to nursing research to develop the next generation of nurse researchers who are committed to the cooperative group scientific mission. We expect to have two fellows at a
TABLE 3. Mutual Advantages of Nursing Research Participation in Oncology Cooperative Group Science To the Cooperative Group Companion protocols (nursing research and therapeutic clinical trials) share patient population and design data points ¡ greater enrollment efficiency, and opportunity to interpret data from two trials in context of one another. Involving nurse researchers helps build on the scientific breadth of cooperative group membership.
Nurse researchers contribute to group integration of health outcomes and other measures in protocol activities. Protocol databases will increasingly reflect nursing care outcomes, allowing simultaneous analysis of medical and nursing care outcomes.
To Nursing Research Cooperative group structure facilitates intervention trials and provides outcome data related to interventions.
Semi-annual meetings: - provide opportunities to meet and work on collaborative projects - alleviate sense of isolation - foster interactions with multidisciplinary researchers that may spark new collaborations - can be used for site investigator training Well-organized and highly motivated group of nurse clinicians who can guide nurse researchers’ efforts in the cooperative group. Offers opportunities for feedback during planning stages of a study to improve feasibility and scientific merit. Multisite cooperation allows access to a large number of potential study participants (1 rate of recruitment, 2 study time/ cost). These databases will be used to demonstrate progress in nursing science. Offers opportunity to increase nursing research visibility.
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time (four fellows during the 6-year grant period) to be mentored by the senior nurse researcher/ advanced practice nurse teams already committed to the COG mission. Each fellowship will be 2 years in duration. Nursing Research Strategic Meetings Current cooperative group meetings have schedules that include 4 to 5 days of concurrent committee meetings. The primary focus is on completing the work of each committee. Little time is available to develop strategic plans, assign responsibilities for implementing such plans, and then evaluating the plans. We plan two strategic planning meetings to occur over the next 5 years, attended by nurse researchers, advanced practice nurses, leaders of the Nursing Discipline Committee, and other key stakeholders with a focus on strategic planning, brainstorming, and evaluation of nursing research contributions to the COG scientific mission. Expansion of Nurse Researcher Network We plan to continue to expand the network of COG nurse researchers through our associations with the research arms of oncology nursing professional organizations (the Association of Pediatric Oncology Nurses and the Oncology Nursing Society). These collaborations are expected to facilitate further development of priority research ideas.
CONCLUSION “The innovation point is the pivotal moment when talented and motivated people seek the opportunity to act on their ideas and dreams.” - W. Arthur Porter.
T
he new nursing research structure adopted by the COG was suggested by two basic aspects of the experience of nurses in oncology cooperative groups. First, past efforts by the nursing discipline to generate research in the cooperative groups relied heavily on a single nurse researcher who was expected to facilitate the research efforts of other nurses. In many cases, the content or the methods of these studies was outside the expertise of the nurse researcher; thus, the efforts of the nurse researcher were less productive than they would have been if focused within the researcher’s area of expertise. Also, the nurse researcher was not expert at group systems and processes. Sec-
ond, advanced practice nurses were well integrated into the committee structure of the cooperative groups, well versed in the processes of the cooperative groups, highly respected for their clinical and education-based contributions to the groups, and intimately familiar with the therapeutic protocols generated by the groups. However, they did not have expertise in research design and data analysis. They rarely had time to conduct research independently given their demanding practice roles. Based on these attributes, the COG Nursing Discipline implemented a research structure using nurse researcher/APN dyads. The dyads have been strategically deployed to link with key COG scientific and disease-focused committees, and have made progress in contributing objectives to protocol studies as well as in designing companion studies. The new research structure has been successful in integrating nurse researchers into COG scientific activity, as evidenced by the development of concept proposals, companion protocols, and placement of nursing objectives into therapeutic trials. The research structure has been fully supported by the COG leadership, as evidenced by its willingness to support a second State of the Science Summit aimed at enlarging the structure to include three additional research teams. Clinical trials, cooperative groups, and nursing research each face challenges and opportunities arising from a changing health care environment. Today, nurse researchers have numerous opportunities for studying important questions and issues in promoting health, ameliorating the side effects of illness and the consequences of treatments, while optimizing the health outcomes of people and their families.25 These opportunities present new challenges. Baldwin and Nail26 have made the following recommendations to clinical nurse researchers: create a research program that has maximum adaptability, gain a thorough understanding of organizational administration and priorities, increase the visibility of nursing research, market the necessity for nursing research, increase database management skills, engage in multidisciplinary research, and maintain flexibility in study design. At the same time, clinical trials cooperative groups are challenged to enhance international cooperation in clinical trials, encourage greater involvement of third-party payers in clinical trials, build on the scientific breadth of the members, identify the most ap-
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propriate therapies to consider for reimbursement, establish a framework which builds on the strengths of each of the members, and to integrate health outcomes and economic measures into protocol activities.27 Integration of nursing research into the cooperative group setting offers a promising avenue for meeting these opportunities and overcoming these challenges. There are significant advantages for nurses conducting research in pediatric cooperative groups, and reciprocally significant advantages for a cooperative group when nursing research is conducted as part of the scientific mission.21 Some of these advantages are summarized in Table 3.
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Dr Joseph V. Simone noted in a recent commentary about the COG that “Pediatric oncology has been the innovator for many facets of oncology. Its institutional and cooperative group leaders have an opportunity to reconsider and debate its direction and structure to assure its leadership role in the future.”1 The COG Nursing Discipline has been engaged in a vibrant and thoughtful process of defining nursing research structure and strategy. The new COG structure for nursing research offers a promising means of integrating nursing research into a cooperative group in alignment with the group’s scientific mission. This structure may be applicable in other clinical trial cooperative groups.
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13. Bradlyn AS, Ritchey AK, Harris CV, et al. Quality of life research in pediatric oncology. Research methods and barriers. Cancer 1996;78:1333-1339. 14. Kurre HA, Ettinger AG, Veenstra DL, et al. A pharmacoeconomic analysis of pegaspargase versus native Escherichia coli L-asparaginase for the treatment of children with standard-risk, acute lymphoblastic leukemia: the Children’s Cancer Group study (CCG-1962). J Pediatr Hematol Oncol 2002;24:175-181. 15. Ruccione K, Kramer RF, Moore IK, et al. Informed consent for treatment of childhood cancer: Factors affecting parents’ decision-making. J Pediatr Oncol Nurs 1991;8:112-121. 16. Wiley F, Ruccione K, Moore I, et al. Parents’ perceptions of randomization in pediatric cancer clinical trials: A report from the Children’s Cancer Group. Cancer Pract 1999;7: 248-256. 17. James K, Keegan-Wells D, Hinds PS, et al. The care of my child with cancer: Parents’ perceptions of caregiving demands. J Pediatr Oncol Nurs 2002;19:218-228. 18. Keegan-Wells D, James K, Moore K. A pilot study to test the instrument: The care of my child with cancer. J Pediatr Oncol Nurs 1998;15:136-137. 19. Hinds P, DeSwarte-Wallace J. Positioning nursing research to contribute to the scientific mission of the pediatric oncology cooperative group. Semin Oncol Nurs 2000;16: 251-252. 20. Given B. Into the millennium: Open the door and let the future in for cancer nursing research. Oncol Nurs Forum 2001;28:647-654. 21. Hinds PS, Baggott, C, DeSwarte-Wallace J, et al. Functional integration of nursing research into a pediatric oncology cooperative group: Finding common ground. Oncol Nurs Forum 2003;30: E121-E126. 22. Haberman M. Advancing cancer nursing through nursing research. In: Yarbro CH, Frogge MH, Goodman M, Groenwald SL (eds): Cancer Nursing Principles and Practice (5th ed). Boston, MA: Jones and Bartlett, 2000:1728 – 1740.
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23. Fochtman D, Hinds PS. Identifying nursing research priorities in a pediatric clinical trials cooperative group: the Pediatric Oncology Group experience. J Pediatr Oncol Nurs 2000;17:83-87. 24. Lester J, Glass E, Owen E. Statement on the Scope and Standards of Advanced Practice in Oncology Nursing. Pittsburgh, PA: Oncology Nursing Press, 1997.
25. Hinshaw AS. Nursing knowledge for the 21st century: Opportunities and challenges. J Nurs Scholarsh 2000;32: 117-123. 26. Baldwin KM, Nail LM. Opportunities and challenges in clinical nursing research. J Nurs Scholarsh 2000;32:163-166. 27. Comis RL. The cooperative groups: Past and future. Cancer Chemother Pharmacol 1998;42:S85-S87.