5

Dissemination and Implementation: Reaching the Ideal

OVERVIEW

An overarching theme of the workshop presentations and discussions, opined Session 4 moderator Marian Neuhouser, was, “What do we next? Where do we go?” The goal of Session 4 was to discuss the dissemination and implementation of nutritional care among outpatient oncology patients and survivors. This chapter summarizes the Session 4 presentations and discussion.

First, Barbara Grant described the registered dietitian nutritionist (RDN), registered dietitian (RD), and specialist in oncology nutrition (CSO) credentials and emphasized the importance of fostering relationships between the nutrition community and organizations like the Commission on Cancer (CoC) that provide accreditation and program guidance for cancer centers.

Next, Colleen Doyle discussed the opportunities and challenges of community-based nutrition support for cancer survivors. She emphasized the need to increase awareness of and access to nutrition services and issued a call to action to everyone in attendance to “use your voice” and described the effort reflected in this workshop as the beginning of a national movement to bring dietitians not just into cancer centers and hospitals to help cancer patients, but also into community-based settings to help support survivors.

Lastly, Joan McClure discussed the National Comprehensive Cancer Network (NCCN) clinical practice guidelines and their relevance to nutritional care among cancer patients and survivors. She encouraged dietitians

who work at NCCN member institutions to seek out people who are on the guideline review panels and participate in the institutional reviews. “That is the way to get [nutrition] data into the deliberations of the panels,” she said. She also suggested integrating nutrition studies into large treatment clinical trials. With those data, she said, “you would have a much better sell to the medical community.” The opportunities for and challenges to including nutrition data in treatment clinical trials was a major topic of discussion in the panel discussion following McClure’s talk, as well as in the final session of the workshop (see Chapter 6).

DISSEMINATION AND IMPLEMENTATION OF NUTRITIONAL CARE IN ACUTE CARE AND SPECIALIZED CENTERS¹

Who Are the Oncology Nutrition Practitioners in Today’s Outpatient Cancer Centers?

Barbara Grant began by describing “who we are.” The Academy of Nutrition and Dietetics’ (AND’s) Commission on Dietetic Registration (CDR) awards and administers both RD and RDN credentials, which can be used interchangeably. The credentials are maintained through continuing education. As of February 2016, there were 94,838 RDs/RDNs.

The CDR now also awards and administers a practice-based specialist RDN/RD credential in oncology nutrition (CSO). CDR’s definition of oncology nutrition is:

The Oncology Nutrition Dietetic Practice Group (ONDPG), a practice group of the Academy, was established in 1992 with 300 members. As of February 2016, it had 2,301 members, according to Grant. But it was not until 2006 that ONDPG brought forth what Grant described as a “crazy idea,” which was that the CDR ought to credential RDs/RDNs working in oncology nutrition, given the “certified world” of cancer centers, with oncology nurses, therapists, and doctors all being board-certified. In addition to feeling it was important to have that credential, Grant and her colleagues also wanted to establish minimum competency for taking care of

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¹ This section summarizes information and opinions presented by Barbara Grant, M.S., RDN, CSO, FAND, Saint Alphonsus Cancer Care Center, Boise and Caldwell, Idaho.

individuals diagnosed with cancer. In response to their “crazy idea,” in fact, Grant said, of all the specialist RD/RDN credentials, theirs took off on the most rapid trajectory. CDR implemented the CSO credential in 2008, with the first exam conducted in 2010. Eligibility criteria include current RDN status with the CDR and 2,000 hours of oncology nutrition practice experience. The credential is maintained through examination every 5 years. As of March 2016, there were 693 practitioners holding the CSO credential, with CSOs in every U.S. state, in Canada, and overseas.

Noting that dietetics was the first health care profession in the United States to have validated practice competencies, Grant listed several foundational documents and resources:

• CDR’s Essential Practice Competencies for Credentialed Nutrition and Dietetics Practitioners (Worsfold et al., 2015);
• AND’s Standards of Practice and Standards of Professional Performance for Registered Dietitians (Generalist, Specialty, and Advance) in Oncology Nutrition, which were established in 2006, updated in 2010, and slated for further update in 2016, according to Grant (Robien et al., 2010);
• AND’s Evidence Analysis Library: Oncology Nutrition Evidence-Based Nutrition Practice Guidelines, 2007 and 2013 (www.andeal.org); and the Academy’s Evidence-Based Oncology Toolkit, 2010 (www.eatright.org/Shop).

Dissemination of Oncology Nutrition RDNs and CSOs in Cancer Centers Across America

Grant attributed the dissemination of oncology nutrition RDNs and CSOs in cancer centers across the United States to four key factors:

1. Relationships that she and her colleagues have forged and fostered with organizations that provide accreditation and program guidance for cancer centers;
2. Collaboration with national cancer information, survivorship, and advocacy organizations and efforts;
3. The vision of ONDPG members and support from the Academy; and
4. The networking of ONDPG members and allied oncology health care professionals. Grant said, “As you have heard today, we are a passionate and very committed group of individuals.”

The first group that ONDPG “set their sights on,” according to Grant, back in 1992, was the American College of Surgeons’ CoC. The

CoC, Grant quoted, is “a consortium of professional organizations dedicated to improving survival and quality of life for cancer patients through setting standards, which promotes cancer prevention, research, education, and monitoring of comprehensive quality care.” More than 70 percent of all newly diagnosed patients are treated in the more than 1,500 CoC-accredited cancer programs nationwide. Grant’s own cancer center, Saint Alphonsus Cancer Care Center, in Boise, Idaho, is one of these. She and her practice group decided they wanted to be a member organization of CoC within 3 years, and by 1995, they were, with Grant serving as the first liaison representative. At the time, there were only about 20 CoC member organizations. Now there are around 50. Today, Kathryn Hamilton, a CSO RDN, represents AND on the nine-member steering committee for the CoC’s 50 member organizations and the CoC advocacy committee that examines state and federal legislation. “We now have a seat at the table,” Grant stated.

Hamilton also sits on the CoC accreditation committee, Grant continued. CoC visits its accredited programs every 3 years for site evaluations. Programs must meet eligibility criteria relating to seven services: (1) diagnostic imagining services, (2) radiation oncology services, (3) systemic therapy services, (4) clinical research information, (5) psychosocial support services, (6) rehabilitation services, and (7) nutrition services. The last, nutrition services, were the more recent criterion added, in 2012. When Kathryn called to tell her, Grant said, “this actually brought tears to my Hamilton.” Effective in January 2016, all CoC-accredited cancer programs must have policies and procedures in place to ensure that patients have access to an RDN and that nutrition services are available either on-site or by referral. Additionally, rather than stating simply that “nutrition services” must be available, the eligibility requirements spells out the spectrum of services that must be available (screening and referral for nutrition-related problems, comprehensive nutrition assessment, nutrition counseling, and education). “This is huge,” Grant said. Based on her experience, she said what start as eligibility requirements often eventually become standards. She expressed hope that, in her lifetime as a clinician, these new eligibility requirements will become a standard for nutrition services. She described the process as being like “dribbling water on a stone.”

In addition to these nutrition-specific achievements, one of the CoC standards (standard 1.2) is that all cancer programs must have cancer committees. In the past, Grant said, dietitians would come and “kind of sit in the back row.” But as of 2012, while not required to be members of the cancer committees, it is strongly recommended that dietitians be members. Again, she said, “We are making our presence known.”

In addition to the CoC, another organization with whom Grant and her ONDPG colleagues thought it would be important to be involved was the

Association of Community Cancer Centers (ACCC). The ACCC has more than 700 members and more than 40 years of service. Their core purpose is to be a leading education and advocacy organization for multidisciplinary cancer teams. While they do not have accreditation standards or eligibility criteria, they do put together program guidelines that reflect optimal components for a cancer program. In 2012, after the ACCC reached out, a group of four nurses and 12 dietitians, including CSOs, put together some nutrition service guidelines. As a result of these efforts, rather than the ACCC guidelines simply stating that patients should have access to nutrition, there are four detailed nutrition services guidelines relating to the nutrition care process, medical nutrition therapy, cancer risk and cancer recurrence risk reduction, and survivorship. These are available on the ACCC website.²

In Grant’s opinion, probably the greatest opportunity for fostering a relationship to help disseminate and implement oncology nutrition services is via the NCCN, given that most of the NCCN Guidelines for Treatment of Cancer by Site do not even mention nutrition. The only ones that do are for esophageal and gastric cancers and head and neck cancers. While it may not be possible to achieve a whole nutrition guideline on its own, she suggested starting “by dribbling that water on a stone” and getting nutrition into the guidelines that already exists. The NCCN Guideline for Survivorship, however, does include a nutrition and weight management section and encourages referrals to RDNs and especially CSOs.

Recognizing the importance of nutrition across the continuum of cancer care, including prevention, Grant called for continued advocating and collaborating with the National Cancer Institute, American Cancer Society (ACS), American Institute for Cancer Research, CancerCare.org, and others.

Implementation of Oncology Nutrition Care

Based on a Commission on Dietetic Registration 2014 survey of about 1,000 ONDPG members and another 600 CSOs and with a 21 percent response rate (www.cdrnet.org/CSO), 51 percent of oncology dietitians are working in ambulatory/outpatient settings (specifically, 28 percent work in a hospital/inpatient setting, 17 percent in a medical center setting, 13 percent in a community hospital setting, and 7 percent in a university/ college/educational setting), with 37 percent (across all settings) seeing 76-100 patients per month, 24 percent seeing 51-75 patients per month, 21 percent seeing 26-50 patients per month, and 15 percent seeing 1-25 patients per month. With respect to geographic reach, these practices are spread across the United States, with one-third of survey respondents being

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² See http://www.accc-cancer.org/publications/cancerprogramguidelines-overview.asp (accessed August 3, 2016).

from the south and equal distributions (21-22 percent) in the northwest, Midwest/Northeast, and West. Again, Grant, said, “We are a very committed group,” with 27 percent of respondents working more than 40 hours per week providing oncology nutrition services.

Based on a 2015 national benchmarking study conducted by the Advisory Board Company’s Oncology Roundtable, 76 percent of the 140 institutions surveyed reported having a dedicated dietitian working with cancer patients. Of these, 53 percent were generalist RDNs, and 44 percent were CSOs. The annual patient load per full-time equivalent (FTE) (among outpatient staffing) was 2,485 patients per dietitian, compared to 1,898 patients per financial counselor FTE and 1,408 patients per social worker FTE. According to 2014-2015 data collected by ACCC, while 98 percent of surveyed programs offered nutrition services, these programs did not have as many oncology dietitian FTEs (1.0) as they did social worker FTEs (1.6).

Barriers and Gaps

Oncology dietitians are often in competition with staffing that generates income, such as people who work in navigation services (i.e., navigating patients through the system), financial counselors, and people who work directly in patient treatment and care. Additionally, dietitians often feel like they are so busy with daily patient demands that they do not have time to document their need or value. Other “brutal facts,” Grant continued, include inadequate RDN staffing, referrals to RDNs that occur after patients have experienced significant side effects and/or malnutrition, and lack of funding resulting from RDN services not being billed.

Opportunities for Providing Optimal Nutrition Care

In closing, Grant briefly identified opportunities for providing optimal nutrition care. First is something she said she “stumbled upon.” It is a code (CPT Code 77470) that cancer centers can use to bill for both professional and facility fees and that has as one of its justifications that a patient needs more frequent monitoring, including nutritional consultation. These are patients receiving radiation treatment who are experiencing added toxicity that occurs with concurrent chemotherapy. Since she stumbled upon it, she investigated its history and found that billing for this code had tripled over the past 2.5 years.

Finally, Grant encouraged additional benchmarking studies and taking the lead or partnering to develop outcomes research that “shows our value.” She also called for continued advocacy and forging and fostering of relationships with accreditation organizations and organizations that are developing care pathways for the treatment of cancer.

DISSEMINATION AND IMPLEMENTATION OF NUTRITIONAL CARE IN COMMUNITY SETTINGS³

“We have been hearing it all day today: Cancer patients need our help,” Colleen Doyle started. She told two stories illustrating this. First, at a books expo in 2015, the individual who runs the ACS books department was approached by a distraught gentleman who said, “You know, you medical professionals, you medical organizations—you don’t know how to help my wife. She is undergoing treatment. She can barely eat. She is losing weight. And nobody can help. Nobody knows what to tell her.” The individual in the booth gave the distraught gentleman two books and flipped through the books and showed the gentleman some pages (Besser et al., 2009; Grant et al., 2010). The gentleman cried. “He was so happy and so relieved to have some resources,” Doyle said.

The second story was one told to her by Hamilton, co-editor of the ACS’s Complete Guide to Nutrition for Cancer Survivors (Grant et al., 2010), who witnessed the joy expressed by a husband and wife when they came into a cancer center where Hamilton was working and saw a copy of the book. The copy had been used so much that its binding had been broken and its pages filled with notes and marks. The joy expressed by the husband and wife illustrated for Hamilton how valuable and helpful this type of resource is.

Community-Based Settings for Supporting Cancer Survivors in Healthy Behavior Change

Through her work with the ACS, Doyle has been fortunate to visit many different hospitals, cancer centers, and other entities that have survivorship wellness programs. It has been a “real delight,” she said, seeing the social support provided by community groups. She emphasized the many other opportunities that exist in the community for nutrition intervention, for example, retail-based clinics and recreation facilities. She mentioned having recently heard that one retailer was about to begin pilot testing having dietitians in their clinics. She pointed to diabetes prevention programs being implemented in the YMCA as an example of what can be done in recreation facilities. This is a “hot topic” right now, Doyle said. When she searched the Internet for community-based nutrition programs for cancer survivors, more than 3.5 million entries came up. She added, “With our survivorship numbers increasing, this issue is only going to be growing and presents us with a lot of need and opportunity.”

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³ This section summarizes information and opinions presented by Colleen Doyle, M.S., RD, American Cancer Society, Atlanta, Georgia.

Doyle mentioned two research projects on community-based nutrition support for cancer survivors that she thought had innovative components that speak to “a lot of what happens if we are really going to . . . grow our initiatives for cancer survivors.” The first project, Growing HOPE, is a garden-based nutrition and physical activity education program for cancer survivors. For Doyle, both the results of the project (increased physical activity, decreased weight, improved dietary patterns, and improved biomarkers of health) and “the legs” that the initiative has in the community are “really exciting.” As opposed to “just being one gardening program,” the project has opened doors with relationships to Federally Qualified Health Centers and other collaborators in the community.

The second project, Moving Forward, a weight loss intervention trial for African-American breast cancer survivors, showed positive results after an Illinois pilot test (i.e., significant decreases in weight, daily calories, and dietary fat; significant increases in daily vegetables, fiber, daily vigorous activity; and a trend toward increased moderate activity). At the time of this workshop, the project was being tested as part of a randomized controlled trial. The innovative component of this project, Doyle said, is its partnership with the Chicago Park District. The park district is training their own staff so there is some potential for sustainability when funding runs out, according to Doyle. She said, “There are many different types of partners that we need to be tapping into to help advance this issue for cancer survivors. This to me was just another really great example of a nontraditional partner really stepping up to help advance initiatives for cancer survivors.”

Doyle referred workshop participants to a 2015 meta-analysis published in the Journal of Cancer Survivorship that covered a variety of effective telephone, print, and Web-based interventions (Goode et al., 2015). She encouraged all dietitians to be aware of these different types of interventions and to be thinking about how to promote and work them into their systems.

Challenges for Communities

Many articles on community-based nutrition intervention in cancer survivors conclude, “We need more research.” While she agreed, Doyle said, “But there is a lot of really good work going on out there that is ready for implementation.” The question for Doyle is, what works for whom? What works with African-American breast cancer survivors in Chicago, for example, might not work with Caucasian breast cancer survivors in San Francisco. That different interventions work for different groups of survivors has implications for what to do within any given survivorship community.

Upon figuring out what works for whom, the next question for Doyle is, “How do we take [that] to scale?” How can something that yields such

positive results be expanded across the country? Or, how can obesity interventions that work in Mississippi, for example, be taken to scale in other Southern states where obesity problems exist?

Another critical challenge, one that Doyle said the ACS thinks about all the time, is how to help navigate survivors to effective programs in their communities. The ACS has what they call their “community resource connection,” and people can find their local ACS community resource connections online. Doyle noted that a 2017 Food and Nutrition Board workshop, Incorporating Weight Management and Physical Activity into Cancer Treatment: Overcoming Barriers in the Delivery of Care, was being planned and that some of the questions likely to be addressed include: What are the criteria for effective programs? What programs are out there? How can survivors be navigated to these programs?

A final challenge, in Doyle’s opinion, is that there are not enough RDs to go around. She mentioned two nutrition-related interventions tested by the ACS that were partially created and tested by dietitians, but delivered by lay health workers. Both programs, despite not being delivered by dietitians, nonetheless yielded positive results. The first was Body & Soul, a telephone-based intervention that led to a significant increase in fruit and vegetable consumption (NCI, 2014). The second was Choose to Change, a dedicated counselor program that led to significant weight loss among overweight and obese participants and a significant increase in fruit and vegetable consumption among all participants.

Post-Treatment and Survivorship: Awareness of National Guidelines

The ACS’s national survivorship guidelines have been available only since 2012 (ACS, 2012) because, according to Doyle, the evidence up until then was not strong enough to make certain recommendations for some groups of cancer survivors. Unfortunately, she opined, as already mentioned earlier during the workshop, obesity rates are high among cancer survivors (28 percent), with 32 percent reporting no leisure time activity and with many survivors (15 percent) reporting they still smoke (Underwood et al., 2012). Even though evidence of the importance of eating well and being active continues to grow, results of a survey conducted in 2008 indicate that survivors are no more likely than the general population to meet ACS health behavior recommendations (Blanchard et al., 2008). Yet, cancer survivors who follow the guidelines not only are at lower risk of recurrence and second cancers, but they are also at lower risk for other health problems (e.g., cardiovascular disease) and generally have a better quality of life (McCullough et al., 2011; Kabat et al., 2015).

To determine whether people understand connections between health and various factors, such as where they live, Doyle and colleagues con-

ducted a series of video focus groups with survivors and non-survivors both, people with a healthy body mass index (BMI) versus an unhealthy BMI, and among different racial and ethnic groups. Across the board, Doyle said, while respondents were aware of other diseases and chronic conditions related to overweight and obesity, lack of activity, and poor nutrition, most respondents did not mention cancer. Likewise, when participants talked about healthy living, many talked about longevity and, when pushed, talked about heart disease or diabetes, but again, most respondents did not talk about cancer. Some respondents, Doyle said, almost seemed to be experiencing some kind of fatigue around messages, that is, that the messages were just “more and more stuff about how bad it is to not be at a healthy weight.” Interestingly, Doyle noted, survivors were only slightly more aware of the link between cancer and obesity than non-survivors were.

“We have got a big awareness problem,” Doyle said. She did not know of any national study on the awareness among cancer survivors of the effect of nutrition and physical activity on cancer. Learning how to communicate with cancer survivors about this issue “is really important,” Doyle said. “We don’t want them to feel like we are putting the blame on them.” She emphasized the importance of learning how to send messages not only to individuals, but also health care providers.

She also highlighted the important role that the community plays in making it easier for people to eat better and be more active and shared with the workshop audience a story about being on vacation many years ago and calling her office when she and her husband arrived at their vacation beach house. She left the beach house phone number with her office and instructed them not to call her unless there was an emergency. She hung up the phone, turned around, and her husband was looking at her like she had lost her mind. He said, “Do you mind telling me what nutrition-physical activity emergency there could possibly be?” Doyle said she thinks about that a lot because, in her opinion, “We are in an emergency right now in this country.” Interventions have been tested and shown to be effective in survivors. She said, “We then turn them back loose into these communities” where people do not have access to healthy, affordable fruits and vegetables or where they may not be able to safely play. “We have got a lot of work to do,” she said. She referred workshop participants to the ACS’s 2012 recommendation for community action. Without community involvement, Doyle said, “we can’t sustain lifelong healthy eating [and] active living.” She noted from an Institute of Medicine report (IOM, 2003), that it is unreasonable to expect that people will change their behavior easily when so many forces in the social, cultural, and physical environment conspire against such change. The true determinants of health, she said, are “where we live, work, eat, play, and pray.”

Engaging Cancer Survivors as Advocates

There are more than 14 million cancer survivors in the United States. Doyle said, “We have a lot of opportunity to engage them in new and different ways . . . to support healthy eating.” Imagine passionate breast cancer survivors up on Capital Hall advocating for nutrition intervention work or a cancer survivor approaching a school district and asking, “Why are you cutting recess?” In her experience, one of the first things people who are diagnosed say to her is, “Tell me what to do to not get this again.” Then they ask what they should be telling their family to do to avoid getting cancer. In Doyle’s opinion, cancer survivors are very powerful advocates for change in their communities.

Engaging Others as Well

But it is not just cancer survivors, but everyone “in this room,” Doyle said, who is a champion for this issue of nutrition and nutrition support for cancer survivors. She said, “We need to use our voice and grow that field of champions out there.” In addition to using their voice, she urged workshop participants to leverage relationships, stay committed, collaborate, think outside the box, implement and evaluate, and then figure out how to get tested interventions to where they need to be and how to sustain them so they really make a difference for people. Doyle viewed the effort reflected in this workshop as the beginning of a national movement to bring dietitians into cancer centers and hospitals and into community-based settings where they can help support survivors. She said, “I hope that when you leave here today, you will be able to think of at least two or three things you could do in addition to what you are doing now to really help support cancer patients.”

DEVELOPING GUIDELINES FOR NUTRITION IN CANCER PATIENTS⁴

NCCN is an alliance of leading U.S. cancer centers devoted to patient care, research, and education, Joan McClure began. Its mission is to improve the quality, effectiveness, and efficiency of cancer care so patients can live better lives. One of its major initiatives over the past 20 years has been the development of clinical practice guidelines.⁵ The purpose of the guidelines is to minimize variation in care, to set a standard of care for quality

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⁴ This section summarizes information and opinions presented by Joan McClure, M.S., National Comprehensive Cancer Network, Fort Washington, Pennsylvania.

⁵ See https://www.nccn.org/patients/guidelines/cancers.aspx (accessed August 3, 2016).

evaluation, to use as an assessment tool for payers to determine appropriate care, and to use as an educational instrument.

A high-quality guideline development process has several characteristics, McClure continued. First, it should be an explicit process. McClure noted that NCCN’s process is published on their website, NCCN.org. Second, it should be evidence based when possible. With cancer, only about eight percent of recommendations across all treatment algorithms are based on what NCCN considers high-level evidence, according to McClure. “That is a problem,” she said, and it highlights the need for more clinical trials. “It is not that the evidence is out there, and we choose to ignore it,” she said. “It is that it doesn’t exist.” Much of oncology care is based on phase II studies or on historic practices. In many cases, clinical trials of current standards of care would probably be unethical (e.g., colectomies for colon cancer). A third characteristic of a high-quality guideline development process it that a level of evidence is identified for each recommendation. Fourth, the process should involve a multidisciplinary panel, especially in oncology, McClure said, because the care is shared across a number of different types of professionals. The core oncology group typically comprises a surgeon, pathologist, medical oncologist, and radiation oncologist. The NCCN guideline panels draw from about 40 different specialties, from nutrition to psychiatry. Fifth, panelists should be experts who understand the data. Sixth, conflicts of interest need to be managed and identified for users so they are aware of biases. Seventh, the guidelines should be updated frequently. NCCN guidelines are updated at least once per year, according to McClure, and some as often as five or six times per year as the standard of care changes. Eighth, the guidelines should be logical and follow the thought processes of users. It is much easier for providers to integrate new standards into their practices when the standards align with the way providers are accustomed to thinking about a problem. Lastly, guidelines should provide supporting documentation and extensive bibliographies.

The NCCN Guidelines

The NCCN guidelines have become the standard of clinical care and policy in the United States and increasingly around the world, according to McClure. In the 15 years she has been at NCCN, McClure has noticed a tremendous difference in the amount of acceptance the guidelines have received. They are downloaded about 6.5 million times yearly, with almost half of the downloads coming from outside the United States. She explained that they are continuum of care guidelines, which means that they follow the progression of disease from screening and diagnosis all the way through palliation and survivorship. There are a total of 62 different clinical practice guidelines in oncology, with 176 continuously updated algorithms, or

decision pathways. The guidelines are widely available free of charge on the internet. They form the basis for insurance coverage policy and quality evaluation, with the Centers for Medicare & Medicaid Services (CMS) and all major payers in the United States using them for at least some portion of their coverage and reimbursement policies.

The guidelines are supported by 49 multidisciplinary panels, with 25-30 experts per panel. The panelists are nominated by NCCN member institutions. Together, these panelists volunteer more than 26,000 hours yearly. Most panels have patient advocates on them, and some panels actually solicit input from patient advocacy organizations. They also receive submissions from both the pharmaceutical industry and payer community, and also from community oncologists and oncology societies. In 2016, the American Society for Radiation Oncology (ASTRO) started conducting their own reviews of the NCCN guidelines and providing input to the NCCN panels. The panels also receive individual recommendations from patients or family members who ask for consideration of particular items.

McClure encouraged dietitians who work at NCCN member institutions to seek out people who are on the review panels. “Tell them that you want to participate in the institutional review,” she said. “That is the way to get [nutrition] data into the deliberations of the panels. This is really important.”

In addition to input from all these various sources, each year NCCN staff conducts a literature search for all phase II and III clinical trial reports and examines those that are relevant to decisions the guideline panels will be making. The panelists discuss the evidence and vote for changes in the guidelines, as needed. NCCN then updates the algorithms and references, working with the panel chair, vice-chair, and members to ensure accuracy. Even after posting newly updated guidelines on the NCCN website, NCCN continues to review new information. If there is anything that comes out that changes the standard of card, for example, if the U.S. Food and Drug Administration approves a new drug or if a clinical trial is stopped for efficacy or toxicity reasons, an interim meeting with the relevant panel is called to discuss the data and a decision is made as to whether the guideline needs to be immediately changed.

Each guideline is based on what the NCCN calls a “category of evidence” and consensus. Category 1 evidence, McClure explained, is what NCCN defines as “high-level” evidence, which means there are randomized controlled clinical trials or meta-analyses addressing that particular issue and the panel considers the evidence to be persuasive, with at least 85 percent of member institutions agreeing this is the case. Category 2A evidence is based on lower-level evidence, including phase II trials, case series, and even the clinical experience of panel members when other data are lacking. Again, at least 85 percent of NCCN member institutions must agree that

the intervention is appropriate. Category 2B is also based on the same type of lower-level evidence, but with NCCN consensus being only between 50 and 80 percent that the intervention is appropriate. Lastly, Category 3 recommendations can be based on any level of evidence, but with major disagreement among member institutions (i.e., at least three institutions on each side) that the intervention is appropriate. Category 3 discussions are very spirited discussions, where participants feel strongly, she said. All NCCN recommendations are category 2A unless otherwise noted.

There are many gaps in the evidence along the continuum of care, McClure said. Panels fill those gaps with their expert experience, sometimes extrapolating from data in other situations and other times basing their decisions on their own clinical experience. For a number of low-incidence cancers, the gaps are especially large.

Over the last 2 years, in response to people who use the guidelines wanting to know how panel members make decisions about what to include and not include, McClure and her team at NCCN have been more explicitly categorizing the evidence so that clinicians and patients can make decisions based on their own values. Using a consistent “evidence block” methodology, which takes into account efficacy, safety, quality of evidence, consistency of evidence, and affordability, McClure explained that they started with systemic therapies (i.e., started explicitly categorizing the evidence) and are going to expand into radiation therapy, surgery, diagnosis and evaluation, and surveillance over the next few years. NCCN views these evidence blocks as potential tools not only for clinicians to evaluate therapies, but also for clinicians and patients to share decision making. The evidence blocks are being published alongside the guidelines. The more filled in the blocks, “the better,” McClure said.⁶

NCCN Guidelines for Nutrition in Cancer Patients

NCCN has made three separate attempts to develop guidelines for nutrition in cancer patients. The first attempt was 15 years ago. The panel had a medical oncologist chair and was composed of equal numbers of physicians and professionals from the nutrition community (e.g., Ph.D. nutritionists, RD). McClure recalled, “The physicians and the nutritionists did not speak the same language. They didn’t think the same things were important. They didn’t think the same data were persuasive. We couldn’t get to the point of even a draft guideline.” Although that first attempt was what she described as a “disaster,” they thought the need was important enough to try again.

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⁶ For more information, see https://www.nccn.org/evidenceblocks/pdf/evidenceblocksuserguide.pdf (accessed August 3, 2016).

The second panel was composed almost exclusively of professionals from the nutrition community. The panel put together what McClure described as “a very complete draft from the perspective of the nutrition community.” But the draft was not approved by the NCCN guideline steering committee, which is composed of physicians. McClure said, “You need to get yourselves embedded with the physician community . . . learn to talk the same language and to look at data in similar ways.” While there have been a number of good studies on nutrition in breast cancer survivors, she continued, in comparison to most other cancers, that number is relatively small compared to the 3,000 or so studies on treatment for breast cancer that are published every year. She said, “The physician community regards your evidence base, in my opinion, as relatively poor.” Additionally, she said, physicians are very aware that, with nutrition, “One size does not fit all.” There are big differences in the nutritional needs and issue for patients with breast cancer versus head and neck cancer versus advanced ovarian cancer. She suggested “attacking” the issues one by one, disease site by disease site. Not only do different diseases have different nutritional issues, but each treatment intervention needs to be addressed separately. “It is going to be a long haul,” she said.

Thus far, the only “hard and fast” nutrition recommendations where consensus has been possible are with survivorship. The recommendations are for nutrition and weight management. They are publicly available on the NCCN website, McClure noted.

Some Strategies for Moving Forward

In closing, McClure suggested some strategies for moving forward. First and foremost, develop a more extensive evidence base. She suggested integrating correlative nutrition studies and nutrition status studies into large treatment clinical trials and seeing who responds versus who does not respond and what survivorship is for people with good nutrition status versus poor nutrition status. With those data, she said, “You would have a much better chance to convince the medical community.” Additionally, she encouraged, again, dietitians who work at NCCN member institutions to make themselves known to the guideline steering committee representatives from those institutions and to participate in the institutional reviews. She also encouraged dietitians who are not at member institutions to submit data to the panels.

PANEL DISCUSSION WITH SPEAKERS: DATA GAPS IN COMMUNICATION AND DISSEMINATION OF ONCOLOGY CARE

Following McClure’s presentation, she, Grant, and Doyle participated in a panel discussion with the audience.

Nutrition Screening

The first question was directed at Barbara Grant. An audience member asked whether nutrition screening in particular is required as part of the Commission on Cancer (CoC) eligibility criteria. Grant clarified that nutrition screening is something that is recommended, but it is not a required standard at this point.

The NCCN Guidelines: Get Involved

Suzanne Dixon was on that first NCCN nutrition panel and agreed with McClure, “It was a disaster.” But that was 15 years ago. Dixon said, “We bemoan how little we have now, but we certainly had a lot less when I went through that experience.” She learned a lot going through that experience, including that it was because she made herself visible to her institution that “somebody put me out there.” She encouraged “everyone in this room to go back to your institution and make yourself visible. People will recognize that and invite you to participate.”

In response to McClure mentioning during her presentation that ASTRO provides input to the NCCN panels, Grant remarked that there is some good nutritional intervention evidence in the Evidence Analysis Library (EAL) for certain cancers and at certain points along the continuum of care. McClure encouraged submissions from the nutrition community, particularly if a professional organization “mentored” the submission so that, to help manage time constraints, panels are receiving only single collated submissions rather than multiple separate submissions.

The Challenge of Testing Nutrition Interventions in Clinical Trials

Dixon wondered how to reconcile the need to collect and analyze nutrition intervention data with the knowledge that nutrition interventions do not fit the Western medical model of placebo-controlled, double-blinded clinical trials. In “free-living humans,” she said, the level of evidence for nutrition intervention is never going to be the same as it is with pills. In clinical trials, some people take pills with active constituents. Other people take pills with no active constituents. Testing nutritional interventions is more complicated because of contributing factors, such as “bleed-over” from the intervention group to the control group. Bleed-over occurs when people in the control group suddenly start doing something different based on, for example, some popular diet that is in the media. McClure responded that these are the same issues that come up with “big data.” She did not elaborate, but suspected that sorting through these issues will be part of the larger discussion around how to use big data.

McClure also reiterated the importance of including nutrition assessments in some of the large clinical trials of treatment interventions and conducting planned subsets of analyses based on nutritional status. If you can demonstrate in a large, well-controlled clinical trial that people with better nutritional status do better in either or both the experimental and control arms, she said, “you would be far ahead of where you are today.”

The CSO Credential

An audience member asked about ways to expand the CSO credential and whether the numbers are small because there is no demand or because demand for the credential needs to be exhibited. Grant replied that it is a new credential and that its numbers are growing. Because it is not required the way the RD/RDN credential is required, many dietitians pay for it without institutional support. That makes it tough, she said. Robien added, based on what she has observed, that the credential seems to be limited to dietitians who need it for their jobs. She sees a lot of job advertisements for RDs indicating that they want the successful applicant to become CSO-certified within a certain period of time. Levin described it as a “catch-22” situation. If there were more positions for nutritionists in oncology, then more people would be interested in training in oncology. “But there just aren’t that many positions,” she said. Those that do exist, she added, “tend to be very grueling.” An audience member suggested that recommendations be made on the employer end because those would drive payer demand which, in turn, would drive provider demand and create more job opportunities for CSOs (i.e., because they would be part of the employer–payer contract). Grant repeated that just having the RD/RDN credential in the CoC eligibility requirements is huge. She suggested that in another year or two, perhaps the CSO credential can be recommended as well.

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