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Introduction

An estimated 90 percent of oncology patients in the United States receive treatment in outpatient cancer centers and clinics (Halpern and Yabroff, 2008). This change from the older model of inpatient care has important implications for overall quality of care for oncology patients and nutritional care in particular. Amidst growing concern about access to oncology nutrition services, combined with growing recognition of the importance of providing nutritional care to optimize oncology treatment outcomes and maximize quality of life among both patients and survivors of cancer, an ad hoc planning committee of the National Academies of Sciences, Engineering, and Medicine’s Food and Nutrition Board¹ convened a 1-day public workshop in Washington, DC, on March 14, 2016, titled “Examining Access to Nutrition Care in Outpatient Cancer Centers,” to explore evolving interactions between nutritional care, cancer, and health outcomes.

Specifically, as per the statement of task (see Box 1-1), participants explored how health outcomes and survival of cancer patients in outpatient cancer centers are affected by current standards for nutritional services, nutritional interventions, and benefits associated with oncology patient access to medical nutrition therapy. Workshop speakers and discussants also

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¹ The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop has been prepared by the rapporteurs as a factual account of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They should not be construed as reflecting any group consensus.

explored the cost of outpatient nutritional care and assessed cost–benefit relationships between oncology nutrition services and health outcomes and survival. The specific workshop objectives are outlined in Box 1-2.

Importantly, this Proceedings of a Workshop summarizes information presented and discussed at the workshop and is not intended to serve as a comprehensive overview of the topic. Nor are the references cited throughout this summary intended to serve as comprehensive sets of references for any

topics; only references cited on speaker slides or in the workshop briefing notebook are cited in the text. Additional references used by the planning committee to help develop the workshop agenda are included in Appendix C. Also of note, while the material presented and discussed over the course of the workshop touched on all of the components outlined in the statement of task (see Box 1-1) and met all of the workshop objectives (see Box 1-2), some issues drew more attention than others. For example, compared to other bullet points listed in Box 1-2, there was more extensive discussion of barriers to access to nutritional care (i.e., the last bullet point). Finally, the information and suggestions for future action included here reflect the knowledge and opinions of individual workshop participants and should not be construed as consensus.

ORGANIZATION OF THIS PROCEEDINGS OF A WORKSHOP

The organization of this Proceedings of a Workshop parallels the organization of the workshop (see Appendix A for an outline of the workshop agenda), with summaries of the keynote presentation and sponsor panel (i.e., panel of representatives from all sponsors who donated at least $10,000) included in this first chapter.

Chapter 2 “Current Knowledge and Status of Nutrition Practices in Oncology Outpatient Care” summarizes Session 1 presentations and discussion, with a focus on current evidence on the role of nutrition in cancer prevention, treatment, and survivorship and the current status of nutrition practices in oncology outpatient care. Chapter 3 “Models of Care: National and International Perspectives” summarizes Session 2 presentations and discussion. Session 2 speakers described several models of nutrition care in outpatient oncology from around the world, including here in the United States, as well as in Australia, Europe, and Canada. Chapter 4 “Benefits and Costs of Care” summarizes presentations and discussion from Session 3, which focused on the economic benefits and costs of nutrition care in outpatient oncology. Chapter 5 “Dissemination and Implementation: Reaching the Ideal” summarizes the Session 4 presentations and discussion on the dissemination and implementation of nutritional care evidence. Finally, Chapter 6 “Evidence on Nutrition Care in Outpatient Oncology: Closing Discussion” summarizes the closing facilitated discussion.

KEYNOTE PRESENTATION²

Pulling together different interests relating to nutrition care access in outpatient cancer centers was “a long time coming,” Steven Clinton began.

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² This section summarizes information and opinions presented by Steven K. Clinton, M.D., Ph.D., The Ohio State University, Columbus, Ohio.

He recalled that the “war on cancer” began when President Richard Nixon signed into law the National Cancer Act of 1971. Since then, according to Clinton, the emergence of more than 40 comprehensive cancer centers and the development of cooperative groups to conduct phase III randomized trials has led to the more efficient translation of basic science into clinical care for the benefit of millions of people with cancer. These comprehensive cancer centers also serve as a framework for training and for bringing expert care into communities. “Although those of us working in the field may never feel it’s enough,” Clinton said, “we see that the cancer incidence rates, after decades of increase, have plateaued and are beginning to maybe decline.” Additionally, cancer mortality rates among both women and men have changed significantly and are clearly declining.

However, these same positive trends have created new challenges, Clinton continued. The number of cancer survivors is increasing dramatically, from about 4 million in 1975 to 14 million today and potentially 24 million by 2024. Because of these improved survival rates, coupled with the aging U.S. population, the actual burden of cancer is increasing, with 1.6 million new cancer cases in 2016 alone. Added to the increasing number of cancer survivors is the rising cost of cancer care which, according to Clinton, is expanding at a rate that exceeds virtually every other area of medicine. An estimated $124 billion was spent in 2010, a figure expected to rise to $158 billion by 2020. “I’m astounded at the cost of the drugs that we use to treat patients in my clinic,” he said.

With respect to the role of diet, nutrition, and physical activity in the war on cancer, the scientific evidence has expanded tremendously over the past few decades, Clinton observed. Systematic reviews conducted by the American Institute for Cancer Research (AICR), the World Cancer Research Fund International (WCRF), and other organizations have supplied evidence-based reports that make these data not only useful for researchers but also applicable to public health policy and to governmental food, nutrition, and agricultural programs around the world. Data have emerged showing how dietary and nutritional strategies integrated into patient care plans not only enhance therapeutic efficacy and reduce complications of therapy but also promote healthy survivorship in terms of both reducing risk of recurrence and improving overall health (i.e., with regard to other chronic disease outcomes). Additionally, integrating nutrition into both prevention and clinical care could enormously impact health care expenditures for cancer. However, in Clinton’s opinion, while this growth in scientific evidence regarding diet, nutrition, and physical activity has created enormous potential to reduce the cancer burden, this potential has yet to be fully reached.

Implementation of Research Findings: Barriers in the Medical Model

Clinton’s frustration, he said, is not only with insufficient funding for nutrition and cancer research but more so with the fact that all the knowledge that has accumulated over the past several decades is not being implemented. He recognized the enormous amount of research conducted with regards to diet, nutrition, exercise, and cancer risk and etiology that has been reviewed and organized by AICR and WCRF and the public health guidelines put forth based on that review. Without elaborating, Clinton remarked that the greatest challenge to implementation is political. He focused the remainder of his talk on barriers in the medical model, that is, barriers to actually taking care of individuals.

Regarding how to integrate diet and nutrition into medical care, Clinton observed that many experts feel that the failure lies with practitioners (e.g., physicians, nurses, nurse practitioners, physician assistants) who are not adequately trained in nutrition. In recent years, however, he has taken a different view. He mentioned attending a recent meeting where someone discussed how their institution was increasing the number of lectures on nutrition and dietary guidelines and providing first-year medical students with hands-on cooking demonstrations, and so on. He suspected that the main outcome of these entertaining demonstrations is socialization with one’s peers and perhaps an impact on the diet of the student. Given what it takes to train a physician, including 4 years of medical school, and in his case, 3 years of an internal medicine internship and residency and another 3 years of medical oncology, Clinton asked, “Do you really think those two or three lectures during your first year of medical school mean anything? Absolutely not.”

He suggested increasing awareness of nutrition in subsequent clinical training, particularly during residency and fellowship. Additionally, he suggested changing the biochemistry course most first-year medical students take to “Nutrition and Metabolism.” But, most important in Clinton’s opinion, physicians need to be taught how to use the talent pool at hand in the hospital environment. That pool is and will continue to be the registered dietitians (RDs)/registered dietitian nutritionists (RDNs). “It amazes me,” he said, “that we think that the physician needs to be the nutritionist.” When medical oncologists need radiation therapy for a patient, they do not do it themselves. They get the radiation therapists to collaborate. Likewise, with physical therapists. So, he asked, why not do the same with nutrition education? Physicians are not trained to provide nutrition education to their patients. Clinton called for more people to be trained as dietitians and nutritionists. Additionally, he called for more grants to be awarded to institutions with the infrastructure to offer combined degree training programs, particularly RDs/Ph.D.s, which he predicted will be at the forefront of bringing nutrition expertise to the bedside.

Perhaps the greatest barrier to implementation, one that Clinton highlighted, is lack of reimbursement for RD/RDN services, given that hospitals and other institutions will not invest in a service unless they can see a tangible return on investment. But the financial challenges, he said, are “really deep.” In spite of the positive effects the 2010 Affordable Care Act, which has greatly improved access to medical services for many who were previously uninsured, the cost of healthcare in the United States is increasingly being shifted to the patient, with insurance costs, co-pays, and annual deductibles rising every year. Clinton mentioned treating a patient with terminal cancer whose monthly co-pay for pain medications jumped from $15 in December to $500 on January 1. In this kind of health care system with patients paying that much for critical items such as pain medications, Clinton asked, “How are we going to achieve payment for nutritional services?” Compounding the challenge are growing social and economic disparities that make it even more difficult to meet the rising cost of healthcare. So the financial challenges are an “enormous obstacle,” Clinton summarized.

Another major barrier to implementation is the need for standards of care regarding evidence-based nutritional support. Recognizing that many organizations have worked on developing standards of cancer care in various ways, Clinton suggested that these same organizations work together to develop peer-reviewed standards of care for nutrition support services in cancer centers. He pointed to the National Comprehensive Cancer Network (NCCN) guidelines for cancer therapy as an outstanding example that profoundly impacts the quality of cancer care in the United States. Perhaps it is time to revisit the integration of nutritional services into specific components of the NCCN guidelines. With both head and neck and oral cancers, where surgical procedures coupled with chemotherapy and radiation make it difficult for patients to consume an adequate diet, there is very clear and strong evidence that nutritional support can greatly improve the ability to receive a full complement of effective therapy on time and at the most impactful dose. Based on this evidence, the NCCN guidelines include suggestions for nutrition interventions that help to promote optimal outcomes for patients with head and neck and oral cancer. But all cancer types need to undergo this type of review, Clinton opined, and the information needs to be made readily available to all practitioners.

In addition to education and training translational investigators, we also need a greater number of RDs/RDNs in the cancer center to meet demands. For Clinton, who is privileged to work at one of the National Cancer Institute’s (NCI’s) comprehensive cancer centers, when he calls a dietitian to consult on an outpatient, he often finds the RD to be covering five different buildings that have 4,000 outpatient patient clinic visits a day. Most cancer centers are similarly understaffed in outpatient settings, which increasingly account for the vast majority of cancer care.

Another barrier to implementation, in Clinton’s opinion, is the lack of infrastructure. For Clinton, when he calls an RD who is covering five different buildings and 4,000 patients per day, the question is not only when can the RD get to the clinic, but also where is the space? Dietitians need dedicated space. Additionally, Clinton observed, all data relevant to nutrition care need to be integrated into the electronic medical records system so the data are readily available to everyone on the health care team.

In Clinton’s opinion, the supplement industry set up a barrier to the integration of evidence-based nutritional support into cancer care. He called for enhancing the U.S. Food and Drug Administration (FDA) oversight and empowering the Office of Dietary Supplements to do more to provide education for cancer patients. Many patients, when they complete active care, whether that has been chemotherapy, surgery, or radiation, reach a point in time when their clinician says, “Well, congratulations. We’ll see you in 3 months.” Suddenly, all that intense care and interaction with caregivers is severed. That is when many patients step back and realize they want to step up and do something for themselves. Unfortunately, in Clinton’s opinion, that is when a high school student working at one’s local health food store becomes the provider of advice and guidance for cancer survivorship. He added, “There’s much worse than that.” The supplement industry, in Clinton’s opinion, is one of the biggest challenges for cancer survivors.

To close, Clinton emphasized that the time is now to take greater action in this arena. In his opinion, all professional organizations related to nutrition need to be made aware of the potential for this field to contribute significantly in the war on cancer. There is no doubt, he said, “We can have a very dramatic and significant impact. So learn today, speak up, and act.”

SPONSOR PANEL

Representatives from the six sponsors who contributed more than $10,000 to support this workshop described their institutions’ interests in the workshop topic.

First, Deirdre McGinley-Gieser, Senior Vice President for Programs at AICR, described AICR as a national nonprofit organization based in Washington, DC, with a focus on the link between nutrition, physical activity, and weight management to the risk of cancer. The workshop agenda “goes to the heart” of AICR’s mission, she said. AICR’s evidence has shown for many years that diet and nutrition play a crucial role in not only cancer prevention, but also treatment and survivorship. Moreover, patients and families recognize this and are receptive to making healthy changes. The challenge is lack of access to the experts, the oncology dietitians. Oncology dietitians help patients to manage side effects and other difficulties during treatment and to adopt lifelong healthy eating habits after treatment. AICR

wants to see improved access to nutrition services. “It’s part of who we are and what we do,” McGinley-Gieser said. The organization will continue to support the work that emerges from this workshop.

Next, Elaine Trujillo of the Nutrition Science Research Group at the National Institutes of Health’s (NIH’s) NCI echoed Clinton’s opening remarks about how this workshop was “a long time coming.” According to Trujillo, there are 69 NCI-designated cancer centers across the United States providing diagnosis and treatment to more than one-quarter of a million people. Because these centers provide the best quality of care, they attract people from around the world, she noted. But there is only 1 dietitian for every 2,600 of these patients. She asked, “How is it possible, with this wonderful treatment, that nutrition, which is so basic, so fundamental, so essential for life—how is it that a patient can go from diagnosis to survivorship and not receive routine nutrition care?” In Trujillo’s opinion, this workshop represented an opportunity to begin talking about next steps so every cancer facility that offers treatment is equipped with nutritional services.

Evidence indicates, Trujillo continued, that scientific data continue to be inadequately applied to clinical practice and that this is certainly the case for nutritional science. She wondered whether, without access to nutritional services, advances in nutritional science research are even “trickling down” to patients. Historically, when thinking about the nutritional status of patients with cancer, the focus was on cachexia and anorexia. But today, obesity is a growing problem in the cancer population, among both patients and survivors. There is good evidence, according to Trujillo, showing that cancer survivors respond well to weight loss treatments. Yet there are very few weight loss treatment opportunities available for cancer patients and survivors, although she noted a 2014 report issued by the American Society of Clinical Oncology emphasizing the oncology community’s commitment to look for ways to implement nutrition weight loss programs for cancer survivors. A group at particularly high nutritional risk and one often missed as being at high risk is patients with sarcopenic obesity. Sarcopenia in cancer patients is associated with poor functional status, shorter survival, and a higher incidence of dose-limiting toxicity. As would several speakers throughout the day, Trujillo emphasized the need for standards of nutritional care for cancer patients and survivors and remarked that implementation of such standards would help to identify these and other nutritionally high-risk patients.

Also as did several other speakers, Trujillo highlighted the need to address reimbursement of nutritional services and called for more data to make the case for such reimbursement. Although poor nutritional status has been associated with increased hospital cost, very few studies have examined the cost-effectiveness of nutritional interventions. “We

need to think about what type of data is best to capture the cost savings,” she said.

Trujillo also mentioned dietary supplements and noted that the NIH Office of Dietary Supplements is interested in understanding the current use of dietary supplements in cancer patients, which is a lot higher than use of dietary supplements in the general American population and often under-reported. Although some supplements may be beneficial, Trujillo continued, others may cause serious side effects and interfere with cancer treatment. She noted that the NCI’s Division of Cancer Prevention has sponsored large clinical trials of dietary supplements and, according to Trujillo, has found them to be harmful. She suggested that RDs who can talk with patients about the safety and efficacy of supplements need to be part of multidisciplinary cancer care teams.

Next, Russell Clayton, chief medical officer of Alcresta, Inc., explained that in November 2015 FDA approved an Alcresta product for use in adults to hydrolyze fats in enteral formula. This product is a device designed to be used with enteral nutrition (“feed tubing”) for a particular subgroup of patients, that is, patients who cannot hydrolyze fats. This includes patients with pancreatic cancer. Clayton expressed surprise at some of the responses he received when talking with dietitians and oncologists about potential use of the products. While some folks were enthusiastic, others were not. They told Clayton they do not use enteral nutrition in patients with pancreatic cancer. Given that, according to Clayton, 65 to 85 percent of these patients have malnutrition, he was puzzled as to why this is the case. One answer he received was that enteral nutrition is not reimbursed by health care insurers or that reimbursement requires that certain criteria be met. Another was lack of resources, that is, that there were not enough staff to help manage patients on enteral nutrition. Yet another answer, which Clayton found the most troubling, was that many patients with pancreatic cancer are incurable and that placing a feeding tube confuses end-of-life issues. In his opinion, whether fighting for survivorship or fighting to make the last days of life as dignified and comfortable as possible, malnutrition during the last days of life should not be part of the problem. His goal at this workshop was to better understand what Alcresta can do to help remove some of these barriers so patients who need enteral nutrition can get it.

Representing the American Cancer Society (ACS), Colleen Doyle, managing director of nutrition and physical activity, mentioned having attended an Institute of Medicine meeting a few years ago and talking about the concept of this workshop. She echoed other speakers’ excitement and gratitude that this workshop was finally happening. Providing nutrition and physical activity support to cancer patients and survivors is critical to the ACS’s mission to help save more lives from cancer. On behalf of the ACS, Doyle said “we are thrilled” to be part of this meeting and “excited” to help expand

nutrition services for cancer patients and create healthy environments for cancer patients where barriers to eating well and being active are reduced. Additionally, she echoed Clinton’s sentiment about the critical importance of reimbursement.

Next, representing the Academy of Nutrition and Dietetics (AND) and the AND Foundation, Alison Steiber, chief science officer, remarked that while the Academy’s more than 100,000 credentialed practitioners clearly do not meet the need for practitioners described earlier by Clinton, nonetheless it is a very large workforce. Founded in Cleveland, Ohio, in 1917, the AND serves many purposes, including advocacy, the provision of professional resources, education, and research. One of the biggest member benefits with respect to research, Steiber observed, is the Academy’s Evidence Analysis Library (EAL), which is focused on creating evidence-based systematic reviews that pull together nutrition information from studies in humans and that can be used to develop practice guidelines. In 2013, the EAL released an updated Oncology Evidence-Based Nutrition Practice Guideline (AND, 2013), which Steiber described as a “huge undertaking.” It includes five nutrition screening recommendations, six nutrition assessment recommendations, one nutrition diagnosis recommendation, eight nutrition intervention recommendations, two monitoring and evaluation recommendations, and one outcomes management recommendation.

But creating guidelines, Steiber said, is not enough. To help fine-tune and improve the guidelines, she emphasized the importance of not just collecting outcome data from practitioners, but of generating new outcome data as well. To help with this effort, the AND recently created a Web-based program, the Academy of Nutrition and Dietetics Health Informatics Infrastructure (ANDHII), that allows clinicians to enter outcome data. Based on the data already collected, Steiber and colleagues submitted an abstract to the 2016 Food and Nutrition Conference Expo (FNCE).³

Finally, Katrina Claghorn, an outpatient oncology dietitian at the University of Pennsylvania, spoke on behalf of the Oncology Nutrition Dietetic Practice Group (ONDPG) of the AND. She echoed other remarks about the lead-up to this workshop, calling it a “historic day.” Outpatient oncology nutrition has evolved into its own field of practice over the past 20 years, especially with the shift to outpatient care, with 90 percent of cancer care now being provided in the outpatient clinic (see Box 1-3). Yet, Claghorn said, while witnessing the growth of outpatient cancer centers, she has been troubled by not seeing a corresponding increase in dietitians in these facilities. She remarked that she frequently receives calls from dietitians who are new to outpatient oncology seeking advice on guidelines for care and

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³ The 2016 FNCE will be held in Boston, Massachusetts, in October 2016.

how to screen and triage patients. She finds it frustrating that she cannot provide concrete answers.

Claghorn’s hope was that this workshop would help to validate the integral role that nutrition therapy plays in cancer care. “There is perhaps no other area of medicine where the risk of malnutrition is greater,” she said. The diseases most affected by malnutrition, in order of risk, are pancreatic cancer, lung cancer, head and neck cancer, and gastrointestinal cancer, followed by stroke and chronic obstructive pulmonary disease. So the top four diseases are cancers. Claghorn remarked that many workshop attendees had likely witnessed how, among cancer patients, medical nutrition therapy delivered by dietitians can help to prevent delays in treatment, prevent unplanned hospitalizations, avoid reactionary nutrition support, improve outcomes in patient satisfaction, and reduce the cost of care. Additionally, registered dietitians serve an important role in helping cancer survivors with the long-term side effects of treatment, one of the most challenging being obesity. Registered dietitians also serve as intermediaries between conventional and complementary medical practitioners. In closing, she reiterated the need for practice guidelines and standards of care to move the field forward. In her opinion, this workshop could not have been more timely in galvanizing action and providing future direction to ensure that dietitians “will have a seat at the table.”

To end the sponsor panel, moderator Cheryl Rock recognized additional sponsors of the workshop who were in attendance: Susan Bratton from Savor Health, Ann Fonfa from The Annie Appleseed Project, and Noreen Luszcz from OptionCare.

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