6

Evidence on Nutrition Care in Outpatient Oncology: Closing Discussion

OVERVIEW

In the final session of the workshop, led by Steven Clinton, Kim Robien, and Suzanne Dixon, speakers from all sessions participated in a facilitated discussion and were presented with five questions:

1. What is new and creative in oncology nutrition care that will move the field forward?
2. How can we make the registered dietitian (RD)/registered dietitian nutritionist (RDN) part of the health care system?
3. How can nutrition care become part of routine oncology care in the outpatient setting?
4. How will nutrition care in outpatient centers be paid for?
5. What is the evidence to justify the need for nutrition care in outpatient oncology?

Rather than directly answering these questions in turn, the speakers and other workshop participants used them more as backdrop for the discussion.

Three major overarching themes emerged during the course of this discussion. Each is discussed in detail below. First, prompted by a question from Dixon and given the range of topics addressed during the workshop, from minute clinical details to community-based interventions for survivors, there was some discussion around the need to engage dietitians across the continuum of cancer care. Second, Clinton highlighted a statement that Joan McClure had made during her presentation about the fact that for

every one nutrition study in oncology, there are probably about 3,000 drug studies. This raised a question for Clinton about how to build the evidence base for nutrition interventions among oncology patients and survivors, which led to some discussion, first, around the value of observational nutrition evidence and, second, around ways to include nutrition studies in clinical drug trials. Third, there was some discussion around the value of nutrition services and ways to measure this value. This discussion was prompted by Dixon’s reminder to the workshop audience that the idea for this workshop originated before the 2010 Affordable Care Act, back when a pressing question for dietitians working in oncology was, “How do we get reimbursement?” She suggested that this question is no longer relevant, given that reimbursement for cancer care is no longer being provided in the traditional “fee-for-service” sense, and urged the nutrition community to determine other ways to demonstrate value.

Finally, this chapter concludes with a summary of the workshop chair’s closing comments.

TACKLING THE CONTINUUM OF CARE

For Dixon, one of the big tasks and challenges of moving the field of nutrition oncology forward is tackling the continuum of care. She asked, “How are we going to bring dietitians into this continuum of care?” Back when she served on that first National Comprehensive Cancer Network (NCCN) guideline panel 15 years ago, with respect to nutritional intervention during treatment, she said, “I would often hear, ‘You don’t really have any evidence that what you are doing matters.’” She would reply, “But we have plenty of evidence that what we do matters over the continuum of care for this patient’s life. Wouldn’t you feel horrible if you cured them of cancer and, five years later, they died of a preventable heart attack?”¹

In Dixon’s opinion, to capture all opportunities for dietitians to become involved in the treatment continuum, oncology nutrition needs to be considered from a “very big picture, chronic disease” perspective. She agreed with McClure’s suggestion to measure nutrition status as part of cancer drug clinical trials to help determine whether people with better nutrition status are more likely to stay on their treatments. But even doing that is looking through a very short window of time—10 or 12 or 16 weeks for most cancer survivors. What about the next 5, 10, or 30 years of cancer survivors’ lives? How should that care be addressed?

Rock wondered how the American Institute for Cancer Research (AICR) communicates new information across the continuum of care.

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¹ See Chapter 5 for summaries of Joan McClure’s overview of the history of attempts to develop NCCN nutrition guidelines and Dixon’s comments afterward.

Deidre McGinley-Gieser explained that, as with the American Cancer Society (ACS) and other organizations, what the AICR used to be called “education” has morphed into “communication.” AICR is constantly evaluating how they are communicating scientific messages to ensure that the messages they send have broad appeal. They communicate both through print (e.g., brochures and leaflets) and electronically. In their print messaging, they choose language that makes sense and is “real” and “something that people can hold onto.” In their electronic messaging, because it is a more cost-effective way to communicate, they are able to target their messages a little more narrowly and change the tone of voice depending on who they are targeting. Because AICR is a small organization, while they are able to promote their services and encourage people to join, they are not able to do the type of larger-scale community interventions that the ACS, for example, does. But they provide usable tools and information for the health professional community to use in its intervention work. Additionally, AICR holds an annual scientific conference that McGinley-Gieser described as a very important component of their whole program because it fosters discussion among multiple groups about what can be done differently, better, and more effectively. It is one of the few meetings where professionals from these different communities (i.e., oncology, dietetics) come together and discuss common issues.

McGinley-Gieser’s description of AICR’s work prompted Dixon to ask about inroads that other groups have made and whether there are lessons to be learned. For example, she mentioned the Lance Armstrong Foundation (now known as the Livestrong Foundation) and the YMCA and the work they do with physical activity. She suggested looking at work that these and other organizations have done to raise awareness and improve access to people who have relevant knowledge. These organizations could serve as models for moving forward and addressing the continuum of care.

INCORPORATING NUTRITION STUDIES INTO DRUG CLINICAL TRIALS

During her presentation on the NCCN guidelines, McClure had stated that, while the best nutrition evidence may be among breast cancer patients and survivors, for every one of those nutrition studies, there are probably some 3,000 drug studies. Clinton agreed with McClure that “the database is so profoundly different.” Moreover, he observed, in nutrition research, much of the work is lab based. Much of the data are coming from cells in culture and from lab animals and, as such, are insufficient to define clinical standards. There is what he described as a “big barrier” in the translation of that work into the clinic. He called for “a stronger collection of good solid clinical studies.” He suspected, however, that very few RDs have

research grants. In his opinion, to compete with the drug treatment evidence base, “We need more RD/Ph.D. folks that have a foot in the clinic and have another foot in the laboratory.” This will require getting the National Institutes of Health (NIH) to recognize that nutritional oncology warrants a “bigger slice of the pie.” Meanwhile, the most important step to take now, as a group, in his opinion, is to identify which area of the evidence base is most substantial, significant, and compelling. He suggested targeting disease-specific NCCN guidelines where the evidence is the most compelling. He said, by “picking our battles, we win.” Those wins will foster additional research, he predicted. “I see light at the end of the tunnel,” he said, “as dim and flickering as it may be.”

Rock found it interesting that nutrition guidelines for survivorship have been accepted,² given that there have been only two dietary intervention studies in survivors and that neither yielded very compelling evidence regarding the effectiveness of the dietary interventions. The NCCN survivorship guidelines are based mostly on observational data. McClure replied that the nutrition portion of the survivorship guideline falls within the healthy lifestyle section, alongside physical activity, immunizations, supplements (i.e., not taking them), smoking (i.e., not smoking), sleep, and hygiene, that is, things associated not only with lower likelihood of recurrence, but also lower risk of heart attack and stroke. Rock interpreted this to mean that the guideline is based more on the effects of comorbidities than on cancer-specific survival. McClure replied, “It is the big picture of healthy living.” McClure mentioned the chair of the panel, Crystal Denlinger, a medical oncologist, and the “fabulous” job she did with the guideline.

Robien commented that several other (non-NCCN) recommendations are similarly based on observational studies. She named AICR, World Cancer Research Fund, and the ACS. When those guidelines are operationalized and applied to data from prospective cohort studies, Robien said, “They are being confirmed.” So while a randomized controlled trial provides a stronger level of evidence, there is so much observational data and so much consistency that when the guidelines are evaluated this data should count as well, in her opinion.

With respect to which cancer and which area of the continuum of care has the strongest set of observational data, Clinton identified breast cancer survivors as having a very strong set of observational data in addition to a small amount of intervention data and lots of laboratory/mechanistic data. Colorectal cancer survivors who have had partial colectomies may be another “low-hanging fruit,” in Clinton’s opinion, not so much with

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² See Chapter 5 for a summary of McClure’s overview of the history of attempts to develop NCCN nutrition guideline.

recurrence, where observational data are limited, rather with respect to preventing second primaries.

A great example of incorporating a nutrition study into a phase III clinical trial, Clinton continued is the colorectal cancer studies conducted by Charles Fuchs, a physician at the Dana-Farber Cancer Institute (Harvard Medical School). In a phase III trial, the Harvard food frequency questionnaire was used to survey participants. Clinton said, “It amazes me that we would even do a phase III chemotherapy trial and not spend the extra few hundred thousand dollars to collect that kind of data,” for example, by conducting nutritional assessments or sampling blood for biomarkers of nutritional status. He wondered whether there was a way to push in this direction with the NIH with respect to phase III therapeutic trials.

Liz Isenring suggested that, rather than “reinventing the wheel,” perhaps a first step toward developing site-specific guidelines would be to see whether those or other available guidelines are appropriate. She viewed updating or endorsing already existing guidelines as another type of “low-hanging fruit” and suggested looking at head and neck cancer in particular, given existing Wiki guidelines³ that have been endorsed by multiple countries.

With respect to levels of evidence in nutrition compared to what is expected with the medical model, Isenring commented that she and colleagues are in the final stages of a large national psycho-oncology and nutrition collaborative research study in Australia and that some of the interventions in psycho-oncology are based on no evidence. “We have got to really put this [level of evidence] into context,” she urged. For certain interventions, for example in the area of artificial nutrition support and tube feeding, while there might not be a meta-analysis of level I randomized controlled trials, there might be some “pretty good” evidence from level II or III studies.

Rhone Levin noted that the Clinical Oncology Society of Australia (COSA) guidelines for head and neck cancer were approved during the 2013 EAL update process as being appropriate for use in the United States and therefore were added to the library. The Oncology Nursing Society Putting Evidence into Practice guidelines were added as well.

In addition to building the evidence base for nutrition interventions among oncology outpatients, for Robien, another reason the nutrition community should become involved with clinical trials is to support standardization with respect to how body surface area is assessed and height and weight data are collected. There is a lot of what she described as

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³ Guidelines developed by the Clinical Oncology Society of Australia (COSA) for the nutritional management of adult patients with head and neck cancer; available online at http://wiki.cancer.org.au/australia/COSA:Head_and_neck_cancer_nutrition_guidelines (accessed August 3, 2016).

“ambiguity” with respect to measuring even those “simple things.” She agreed with Clinton that adding nutritional studies to phase III trials would be a “very small add-on.” In fact, according to Robien, nutritional status data are already being collected for many outcomes of interest, such as ability to complete treatment regimens and the NCI’s common toxicity criteria.

Part of the challenge for dietitians to become involved in clinical trials, Dixon remarked, is that many RDs do not feel confident putting themselves at the table that early in the continuum of care. She viewed it as an issue of education and training and the reality, based on her experience, that many RDs working in comprehensive cancer centers would not even know how to approach an investigator working on a phase II or phase III clinical trial and ask, “Have you ever thought of measuring the impact of nutritional status on whether or not your patients get their full course of treatment?” She encouraged more thought around how to change the culture of dietetics and empower dietitians to put themselves forward and say, “I really want to be part of this study and give you my expertise.” Robien agreed with Dixon, but asked where “people who are in the trenches” are going to find the time.

Clinton cautioned against selecting NCCN guideline committee members based purely on experience as practitioners. A professional who has been trained to be what he called an “academic thinker” can still be a great practitioner who provides good care. That said, in Clinton’s opinion, the field of dietetics needs a greater subset of professionals who are trained, perhaps with Ph.D.s, to also be the scientists who sit at the table to help design, execute, and analyze data. He was unsure how many of the approximately 94,000 RDs in the United States have additional training as scientists. Whatever the number, he said, “It is clearly not enough.” He called for an expansion of research opportunities for RDs, perhaps through directed requests for training proposals from the NIH. Dixon replied that often, when RDs earn Ph.D.s, they are no longer clinically focused and no longer have that access. She agreed that efforts need to be directed toward fostering dietitians who have feet in both worlds. Robien added that, perhaps instead of specializing in nutrition, RDs who decide to work toward Ph.D.s should specialize in epidemiology, where there is more focus on study design and data analysis skills. “You can always go back to your clinical roots,” she said. “I think that we need more methodologists.”

While there were several calls for adding nutritional components to phase III trials and the comparatively minimal cost of doing so, a couple of workshop participants cautioned that the current structure of the NCI funding and the “hoops to jump through” pose a challenge. Rock remarked that the NCI now requires all phase III trials to operate as part of its community-based oncology group system, rather than be investigator initiated as in the past, and that many older study designs would not even begin to

be evaluated by the NCI today. A workshop participant added, “It sounds easy to say, ‘Oh, just collect dietary assessment on all the patients going through X, Y, Z trials.’ . . . I think it is going to be more difficult.” Collection of those data requires approval from multiple parties even before any funding decisions are made, the participant stated.

Revisiting earlier comments about the need to empower dietitians, there was some additional discussion about the importance of dietitians developing relationships with advocates and other oncology professionals as a way to “get the word out” and build momentum for conducting nutrition studies. Fonfa encouraged dietitians to attend as many conferences as possible and submit abstracts to “get the word out.” Another workshop participant emphasized grassroots efforts within dietitians’ workplaces and the importance of developing relationships with not only physicians, but also physical therapists, speech therapists, and nurses, so these other professionals begin seeking out dietitians’ expert opinions, much like physicians send their patients to physical therapists because they recognize the value of physical therapy. Strengthening those relationships, the participant opined, would strengthen the case for incorporating nutrition into clinical trials.

In Clinton’s opinion, dietitians “hold their own very nicely” when given the opportunity to work with professionals in other disciplines. The challenge, as he saw it, is that there are 6,000 new cancer diagnoses for every consult a dietitian is able to do. There is a “disconnect,” he said, “between what we think we need right at the moment and what we actually have on the ground.” Robien saw the same challenge. She asked where “people who are in the trenches” are going to find the time to participate in clinical trials.

DETERMINING THE VALUE OF NUTRITION SERVICES

Dixon reminded the workshop audience that discussion about this workshop originated before the 2010 Affordable Care Act. Back then, the question for dietitians who worked in oncology was, “How do we get reimbursement?” Now, without reimbursement being provided in the traditional fee-for-service sense, she said, “We really have to start thinking creatively about this.” In her opinion, asking how dietitians will get reimbursement is no longer the relevant question. The nutrition community needs to define ways to determine value.

Mention of value spawned a brief discussion around coding, with an unidentified workshop participant suggesting that one way to justify employing full-time dietitians in oncology centers is to use codes that indicate cases where dietitians are needed. Clinton replied, “I have a strong opinion about this.” Recognizing that coding is key to current billing, he did not think that health care providers should be the coders. “We have got better things to do,” he said. Good physicians do their best to document what

their patients’ problems are in their notes, he said, but it is impossible to memorize the many constantly changing codes. Another workshop participant wondered if there were even some basic codes, for example a malnutrition code, which could be used. Dixon suggested that other ways to justify employing full-time dietitians include sharing information from this meeting (e.g., this workshop summary) and using the Academy of Nutrition and Dietetics’ (AND’s) Evidence Analysis Library (EAL) to make the case that, for example, a one-day-a-week dietitian is not enough to provide a given type of grade A level evidence-based care. Additionally, she suggested that perhaps the AND’s Oncology Nutrition Dietetic Practice Group (ONDPG) could create an article for their newsletter that could serve as a resource for ways to code that may improve the recognition of malnutrition in the clinical setting.

Mention of the EAL prompted Clinton to wonder whether there might be a way to create a joint effort between the U.S. Department of Agriculture’s Nutrition Evidence Library (NEL), which Clinton described as being “amazingly skilled” at conducting literature searches and evaluating data, and the AND. In his opinion, messages based on a joint effort and the level of objectivity associated with the NEL process might have greater value than messages coming from a professional organization by itself. Robien noted that the framework and process of the NEL are the same as those of the EAL. Clinton then wondered whether there might be a way to work with NIH, for example, to conduct these evaluations such that the AND does not have to bear the entire cost of what is a laborious process.

There was some brief discussion about insurers, with one participant wondering whether it might be possible to get them involved, for example, by engaging employers, and another agreeing that it would be a “great idea” and that Aetna and UnitedHealth Group (through Optum) both already have “fantastic” cancer advocacy programs. Dixon noted that a dietitian in ONDPG provides lectures and classes for Aetna. She viewed the challenge as, “How do you capitalize on that to reach beyond just the occasional once-a-quarter type of class?”

Another workshop participant suggested that Vice President Joe Biden’s cancer “moonshot” campaign and his apparent openness to engage multiple stakeholders from different fields creates a unique opportunity to engage a broader national dialogue about nutrition in cancer. Robien agreed. Clinton, however, expressed uncertainty. He stated that, while Biden’s “heart is in the right place,” he questioned Biden’s appreciation for the key role of prevention in the “war on cancer.” At a recent Washington, DC, roundtable discussion on the topic, Clinton did not recognize any nutritional scientists at the table. The focus of the conversation, he said, was on molecular markers and sequencing, “big data,” and ways for pharma to use those data to develop personalized targeted drugs. Acknowledging his

own cynicism, Clinton said, “But right now, this is the line of thinking.” In his opinion, it is “such a strong wave in the scientific community” that it obscures the fact that 15-20 percent of the population is still smoking despite 50 years of scientific evidence on the effects of smoking. One of the biggest challenges “in this current paradigm,” he said, is just getting a seat at the table. He suggested that if some of the organizations represented at this workshop were to lobby at Biden’s door on behalf of food, nutrition, and cancer prevention, “maybe we can at least get a foot in the door.” Rock agreed with Clinton that, right now, there is no room at the table. Even “the physical exercise” people are not at the table. She said, “There is no mention of behavior at all.” More generally, Rock emphasized the behavioral challenge that dietitians are up against. It is one thing to exercise every now and then. It’s “quite another thing” to give up cheesecake and chocolate chip cookies. She said, “People eat food, not nutrients.”

CHAIR’S SUMMARY

To conclude the workshop, Rock summarized some of the major overarching themes of the workshop presentations and discussions. First, the objective of the first session of the workshop was to describe the current status of nutritional care for oncology outpatients. “We concluded,” Rock said, “that there was a fair amount of evidence.” While there is still not “enough” evidence, as Joan McClure discussed during her presentation on the NCCN guidelines, Rock said, “We are on the road.”

The second workshop objective was to describe the ideal care setting for nutritional care for oncology outpatients. Rock highlighted the international models of care, especially early care, described by Liz Isenring.

The third workshop objective relating to the potential benefits of outpatient nutritional care was met, Rock observed, over the course of several sessions.

With respect to the fourth workshop objective, that is, describe issues relating to cost–benefit assessments for both recent diagnosis and post-treatment care, Rock highlighted Jim Lee’s discussion about ways to conduct cost–benefit assessments without collecting too much detail. Much of that detail, Rock said, can be daunting for people who are not health economists.

Lastly, with respect to the fifth workshop objective, there was plentiful discussion around barriers to achieving an ideal care setting and ways to overcome these barriers. Rock referred to some of the Session 4 discussion around using community-based organizations, like the ACS, to overcome barriers across the continuum of care (see Chapter 5 for a summary of this discussion). A target group that this workshop only briefly touched, Rock observed, was childhood cancer survivors. Another important point is that

the bulk of medical care for all long-term cancer survivors is provided by primary care providers. We often criticize oncologists for neglecting nutritional issues Rock said, “but after the oncologists are done with initial care of cancer patients, there is a much larger group of health care providers that are really the first-line caretakers of these patients.”