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Clinical trials are becoming increasingly difficult to carry out in the face of a changing ... nurse in the areas of public education, informed consent, direct care, and.
Facilitating Clinical Trials The Expanding Role of the Nurse Constance Engelking, RN, MS, OCN Clinical trials are becoming increasingly difficult to carry out in the face of a changing health care delivery system. The reluctance of third party payers to reimburse for experimental therapy and the growing practice of providers to limit resources allocated for the care of cancer patients undergoing such therapies seriously curtail the ability of investigators to test new cancer treatments clinically. In addition, certain beliefs, attitudes, and perceptions held by the public may in terfere with patient case accrual. Nurses can help facilitate both accrual to and conduct of clinical research. This article addresses selected consumer- and provider-centered factors that inhibit clinical research. The expanding role of the nurse in the areas of public education, informed consent, direct care, and collaborative research is also described. Cancer 67:1793- 1797, 1991.

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1990 more than 1,000,000 people were diagnosed with cancer and approximately 5 10,000 were estimated to have died of their disease. I Although curative therapies exist for certain tumors, effective treatment is yet to be identified for others. To evaluate the safety and efficacy of new cancer therapies, properly designed clinical trials with adequate patient accrual must be conducted in appropriate clinical facilities. Such facilities must have sufficient re ources to support the trial. Today there is an ever-widening gap between what can be achieved scientificall y and what is actually feasible clinically. In his newe t edition of Megatrends, John Naisbitt states" . . . we are poised on the threshold of a great era in biotechnologic advancement that cannot be ignored.,,2 Media messages and observations in daily practice confirm that a high level of technologic sophistication has been reached in the treatment of cancer. Such progress allows caregivers to feel hopeful about what may be on the horizon for cancer control and to extend that sense of hopefulnes to tho e faced with cancer. Interest in cancer research appears to be on the ri e among both con umers N

Presented at the American ancer ciety ational onference on ancer and the hanging Healthcare ystem, an Francisco. alifornia. May 3- 5. 1990. From the Westchester ounty Medicnl enter Valhalla. New York and the American ancer ociety, Westchester Division . The au thor thanks the patients who contributed their thoughts and Dr. Tauscef Ahmed. Dr. Zalmen Arlin, and Ann Fulgum for their support in the preparation of the manuscript. Addrcs.~ for reprints: onstance Engelking. R ,MS, N. Westchester ounty Medicnl enter, alhalla. Y 10595. Accepted for publicntion September 14, 1990.

and providers ofheaIth care. This i sugge ted by frequent news reports that cover the research front in response to consumer demand. Indicators also exist in the print media. For example, U.S. News and World Reports recently reported that 86% of physicians surveyed felt the availability of clinical trials to be an either "important" or "very important" parameter of quality in a hospital's cancer program. 3 Although the feasibility has been establi hed and th climate appears right to support clinical research, patient accrual to clinical trials remains low. 1- upported cooperative groups accrued less than 3% of all patients with cancer and only I % of adult cancer patients entered Phase III randomized clinical trials.4 In practice, many challenges to the conduct of clinical trials exist. Our health care delivery system has been altered dramatically in response to a rapidly changing 0cioeconomic and political environment. Many of these changes have had a negative impact on cancer re earch. Technologic advances have resulted in skyrocketing costs of care. Third party payers have changed their reimbursement philosophies and are becoming increasingly reluctant to consider experimental therapie a reimbursable medical care.5 oncerned about the inabilit to reco er costs and the existing shortage of caregi ers, acute care facilities are hesitant to make commi tments to research. Some hospital have even designated special multidisciplinary committees to review proposed trials for projected impact to in litutional re ource . In addition, th selfcare consumer movement ha spurred an alternativ therapy renaissance. This article addresses consumer- and

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provider-centered factors that may hamper clinical research and the collaborative role nurses can play in facilitating clinical trials.

Clinical Trial Inhibitors Consumer-centered factors relate primarily to perceptions, attitudes, and resources of patients that may influence their interest in pursuing investigational treatment options and their motivation to comply with the often rigorous requirements of clinical research. Certain negative perceptions associated with research make many individuals reluctant to seek out or participate in clinical trials. Consider the commonly held notion that once a person participates in a study, his or her identity as an individual is lost to numbers, in effect, a dehumanizing experience that renders the person a mere statistic. Closely related is the idea that a clinical investigator's primary focus is on the experimental strategy rather than an individual's well-being and that the success of the trial takes precedence over the individual's survival or improved health status. In this context, the highly objectionable perception that the patient is a means to an end arises. This is particularly sensitive in the setting of Phase I trials in which the primary objective is to identify optimal dosage range and associated toxicities rather than providing efficacious therapy. Another inhibiting perception is the beliefihat any suffering that will be or has been experienced is exclusively attributable to the experimental agent, device, or approach. In this belief there is no acknowledgment that, in the ab ence of treatment, the illness itself carries consequences that are likely to induce similar suffering. Patients and their family members have a difficult time accepting the reality that the consequences of treatment balance the consequences of illness. Many patients view experimental therapy as a "last resort," believing that once it is used, the door to other treatment options slams shut and if it fails, links with the health team will be severed. Patients will sometimes reject or delay participation basing their decision on the idea of "saving" investigational options until they are "really needed ." What goes unrecognized is that the window of eligibility may be relatively narrow and that changes in disease or physical status may render them ineligible or a poor candidate for a positive outcome. on sider the patient with a high-grade lymphoma and poor risk factors who, after initial therapy, has achieved remission and who feels well, looks good, and functions normally. Despite ample data that relapse is inevitable, it can be difficult for this individual to contemplate the rigors of autologous bone marrow transplantation when the data regarding treatment outcomes are still relatively limited . Still another perceptual deterrent stems from the public's inability to adequately distinguish between scientif-

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ically controlled clinical trials and the nontraditional alternative therapies. Frequently, alternative therapies are believed to be equally effective but less toxic than those being tested traditionally. Conversely, the notion of quackery may be applied equally to both . In truth, claims regarding the effectiveness of untested therapies cannot be valid, whereas therapies being evaluated within the clinical trials framework are, by definition , scientific. Because the two are categorically different, untested therapies may be another option but never a comparable alternative to controlled clinical trials. Deterrents exist even for patients who are highly motivated to pursue experimental treatment avenues. For example, patients who have not been offered clinical trials participation by their physicians may be hesitant to raise questions about investigational therapies that they have learned about through their own personal networks or seen in the media. What holds them back is the worry that they are stepping out of their bounds and may threaten or otherwise alienate their physicians. Such concerns grow from confusion as to their own role in the decision-making process and to patient-physician communication barriers. Further, access to clinical trials is not so easy for many people. Individuals require a vast array of resources and some luck to gain access. Candidates for clinical trials need contacts who can link them up with providers offering treatments appropriate to their clinical situation. They need the intellectual ability to process often complex, highly technical information. They also need an advocate who can ensure compatibility between their goals and desires and those of the provider or principal investigator. Finally, they need the human, material, and financial resources necessary to follow through in pur uing experimental avenue. These are often out of reach for ceriain subpopulations, most especially for those who are socioeconomically disadvantaged. Examining provider or agency-centered barriers to the implementation of clinical research , it should be recognized that provider agencies often operate under some of the same inhibiting perceptions and attitudes held by the lay public, particularly among those not directly involved in cancer care. The policy of third party payers not to support experimental treatment sends a message to consumers that promotes an across-the-board perception that the value of those therapie is limited or that the ri ks far outweigh its benefit and that they are, therefore, a poor treatment option. Resources, in short supply, such a nurses, blood component , or I U beds, are reluctantly allocated to cancer patient undergoing investigational therapie , and institutions are not permitting clinical investigators to initiate new re earch programs, the priority going instead to those illnesse with superior reimbursement and for which the

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perceived potential for cure or management of disease is deemed a more realistic goal. Interestingly, many of the chronic illnesses that win out over cancer often carry similar or worse morbidity and mortality rates than some cancers. So, philosophic decisions to limit reimbursement and restrict the resources allocated to support the cancer research effort grow, in large part, from persistent stereotypic attitudes among providers toward the outcomes of cancer, from faulty or biased cost-benefit analyses and from a lack of knowledge as to the possible benefits of participation in clinical trials for the individual and for society. Although the consumer and provider-centered challenges are frustrating and the impact of the health care crisis on research seems discouraging, it should be remembered that the early periods of scientific success are frequently accompanied by gaps in the development of a working knowledge base, delays in resolving the legal, moral, or ethical issues, and difficulties in discovering new resources or ways of restructu ri ng those that exist to match the new needs. Potential Nursing Contributions The potential contributions of nurses in meeting these challenges can be appreciated in several discrete areas critical to the integrity of research. Nursing involvement can be instrumental in facilitating patient access to available trials and in ensuring rational decision-making, quality of Ijfe, and patient safety. In essence, the nurse becomes a partner to both the patient and the physician, guiding the patient through the experience and complementing the physician'S interventions to achieve positive patient outcomes.

Educating the Public Education is necessary to raise awareness, dispel misperceptions, and change negative attitudes about cancer research. Nurses, by virtue of their contacts with the public and the public's regard for them as health care experts, are in a strategic position to deliver accurate public education messages about the goals, process, and potential outcomes of clinical trials participation . Because nur es are more abundant in rural areas than other health team members, they can bring that message to a population that might otherwise remain unaware of such treatment opportunities. Similarly, other untapped groups, such as the elderly and the poor, could be reached by nurses staffing neighborhood health centers and "free" clinics. Nurses are the primary health professionals to refer individuals seeking information to national information hotlines and to recommend available printed materials describing clinical trials to the public. Nurse can also contribute by participating in the development of additional instruc-

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tional materials and audiovisual aids appropriate for those at various reading levels, of differing cultural backgrounds and languages. Patient case accrual, now only a fraction of what is needed, could improve ifnurses were organized to carry out a focused public education effort. If public policymakers (i.e., insurance boards, legislative representatives, and hospital planners) were targeted, policies and laws more supportive of clinical trials could be the outcome. In addition, such an effort could potentially result in greater public dollar support for clinical research.

Ensuring Informed Consent Informed consent is often thought of as the simple signing of a legal document. In reality, it is a dynamic process that evolves over time. This process entails the noncoercive presentation of clear and honest facts that an individual can use to make a rational decision. Although it is not within the scope of nursing practice to make treatment recommendations or to initiate the consent process, the precedent and character of nursing involvement in this dimension of patient care was clearly established in the Cancer Chemotherapy Guidelines published by the Oncology Nursing Society in 1988. 6 According to that document, the nurse is responsible for engaging in behaviors that will enhance patient/family understanding of medical information; facilitate patient, family, and physician discussion of priority issues; and promote communication regarding perceptual incongruencies among and between patients, their family members, and the physician. It has been noted that oncology nurses are well suited to this role and that they serve in specific way to fulfill those expectations. As teacher, nurses reinforce. interpret, and clarify the large volume of complex information imparted by physicians at the time therapy is recommended. Frequently, patients and families have difficulty processing the information delivered either because they are overwhelmed by its complexity or because the stresses ofitlness impair their ability to sort it out, retain it, or recall it. Education is provided to both patients and the family members who will be supporting them throughout the decision-making process and the course of treatment. Information given verbally is supplemented with printed materials to further enhance understanding. As counselor, the nurse assists patients and their famjly members to formulate questions, facilitates their consideration of pros and cons associated with proposed therapies, and is available to help them articulate questions or concerns to the physician. 0 often when patients are given the opportunity to ask questions, they re pond by saying that they know they must have them but are not clear where to begin or how their questions should be phrased.

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As liaison, the nurse communicates incongruencies in patient, family, and physician perceptions of treatment goals, short- and long-term effects of treatment, and prognostic projections. This permits resolution of disparities prior to the initiation of therapy and ensures a clear understanding of what is being proposed. This strategy may minimize future conflicts arising from differing perceptions and may ultimately preserve rapport between the patient and the health team. As a supporter, nurses can reassure patients ". . . that clinical research is legitimate, carefully designed and . . . commonly used in the treatment of cancer.,,7 Nurses can also reassure patients that regardless of their treatment decisions, links with health team will remain intact, thus communicating a sense of nonabandonment. By providing information in a nonjudgmental manner, the door is opened for patients to discuss questions, express concerns, and reveal true feelings about what has been recommended and what may lie ahead for them. Effecting all of these roles promotes patient autonomy and independence and may encourage active participation in the management of their illness. Satisfying individual experiences during therapy (e.g., maintaining a degree of personal control, having open communication with health team members) may eventually alter negative societal perceptions regarding clinical trials participation.

Study Implementation Another area in which nurses play an important role is that of actual study implementation. Providing direct hands-on care is a traditional aspect of this role. During the 1980s nurses became technically proficient in the delivery of experimental agents and monitoring of patient responses. Nurses perform pretreatment assessments to validate that eligibility criteria have been met. They coordinate the details of therapy and the trial itself. They administer the agent(s) and assist with procedural aspects of the trial. They evaluate and document patient responses. Less traditional but increasingly common is involvement in describing patient acuity associated with particular trials so that staffing needs and subsequent budgetary requirements can be accurately forecast.s Nurses also serve as consultants to hospital administrators and work with physician investigators to design implementation strategies that will increase efficiency and keep patients safe during the trial. Such partnerships can result in a collaborative plan that not only meets the needs of the patient but also ensures the integrity of the study.

Maximi=ing Research Finally, because nurses have the longest and most intimate contacts with patients and because they are mandated by Nurse Practice Acts in most states to diagnose

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and treat actual or potential responses to illness and treatment, nurses are in a prime position to make valuable contributions in the realm of symptom management. For individual patients, nurses initiate and carry through measures to prevent or minimize treatment-induced symptomatology. These interventions can help to facilitate individual patient compliance with requirements of the particular regimens being evaluated. On a broader level, collaboration between physician and nurse investigators in designing research proposals can maximize the possibilities for data collection. When patients are accrued to trials testing new therapies, an opportunity to gather data about other associated phenomena is presented. Research that describes changes in physical, psychologic, and family functioning, identifies symptoms or symptom complexes, and evaluates standard or new patient care protocols add an important quality of life dimension to medically oriented research. Nurses have already made significant contributions in building a symptom control knowledge base independently. Cotanch 9 has conducted extensive research to examine the phenomenon of nausea and vomiting. Piper et at. 10 have constructed a theoretkal framework relevant to the experience of fatigue. Nurse researchers at Yale University have identified and studied the occurrence of weight gain in women receiving adjuvant treatment for breast cancer. I I Eilers et al. 12 have completed reUability and validity testing on an instrument designed for oral assessment. These examples represent only a small percentage of the nursing research currently being conducted. A combined research effort between medicine and nursing in which the objectives of the trial are expanded and the responsibility for accrual is shared could enrich the character of the data generated and subsequently result in improved outcomes for patients.

Conclusion Conducting clinical trials in today's health care milieu is fraught with problems. Negative public attitudes and perceptions discourage patient accrual. Shrinking dollars restrain reimbursement and resource allocation needed to support the effort. rnvolving nurses in expanded roles may help to meet some to the challenges posed. Perhaps the current health care crisis is actually presenting a major opportunity to intensify collaborative nurse-physician relationships. Joining in an effort to facilitate the conduct of clinical trials can result in many positive outcomes. Gaps in public/provider knowledge and understanding of clinical trials may be bridged, and in doing so, doors previously closed to research may be opened. Pervasive misperceptions that discourage study participation may be corrected. Novel health care delivery approaches designed to maximize the use of existing resources in meeting the needs ofpatients undergoing experimental therapies may

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be developed. Opportunities to participate in research may be extended to new groups of patients such as the elderly and the poor who are motivated and who can realistically benefit. Finally, by designing research that captures information not only related to treatment efficacy but also to associated quality of life issues, symptom control strategies, and cost-benefit ratios, the quality of cancer research could be enhanced. REFER ENCES I. American Cancer Society. Ca ncer Facts and Figures. Atlanta: American Cancer Society, 1990. 2. Naisbitt J, Auberdene P. Megatrends 2000. New York: Morrow, 1990. 3. U.S. News and World Reports. Americas best hospitals. April, 1990; 83.

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4. Lawrence W. Proceedings of the American Cancer Society Workshop on Clinical Trials (introductory remarks), 1990. 5. Yates J. Rei mbursement in clinical cancer research: Current issues. Biolher Cancer 1988; 4: 1-6. 6. Cancer Chemotherapy Guidelines. Recommendations for nursing practice in the acute care setting, Pittsburgh: Oncology ursing Society, 1988. 7. Bujorian G. Clinical trial: Patient issues in the decision-making process. Oneal Nllrs Fonlm 1988; 6:779-782. 8. Garre P, Barr J. Increasing severity of illness among patients undergoing Phase I trials. Calleer Nurs 1989; 2:107-111. 9. Cotanch P. Measuring nausea and vomiting in clinical nursing research. Oneal Nllrs Fonlln 1984; 3:92-94. 10. Piper B, Lindsey A, Dodd M. Fatigue mechanisms in cancer patients: Developing nursing theory. Oneal Nurs Forum \987 ; 6:17-22. II . KnobfMK, Mullen J, Xistris D el al. Weight gain in women with breast cancer on adjuvant chemotherapy. Oneal Nurs Fonlm 1983; 10: 28-33. 12. Eilers J, Berger A, Peterson M. Development, testing and application of the oral assessment guide. Olleol Nurs Fontm 1988; :325-330.