5
Afternoon Breakout Sessions with Invited Speakers

DEVELOPING AND TESTING MODELS OF SURVIVORSHIP CARE

Moderator: Patricia Ganz, University of California, Los Angeles

We have four individuals with us who will be discussing and representing different types of models for delivering survivorship care. There may certainly be other models that are available. Our first speaker is Steve Woolf, a member of our committee who is a primary care physician in Virginia.

Steven Woolf, Virginia Commonwealth University

I am a family physician in the Department of Family Medicine at Virginia Commonwealth University. Let me begin by introducing the three models of survivorship care that were discussed in the report: shared care, nurse-led care, and survivorship follow-up clinics. I am going to focus mainly on the first one, but I want to set the stage for the discussions that will follow. The following figure from data reported in the IOM report shows the number of cancer-related physician office visits, by specialty, estimated from the National Ambulatory Medical Care Survey (NAMCS) (Figure 5-1). One of the points that it makes is of the 36.6 million physician office visits made for cancer care, nearly one-third (32 percent; 11.7 million visits) are made to primary care providers. That is the perspective I am trying to represent.

From the perspective of the primary care physician, however, these 11.7 million cancer-related visits made by adults are a very small fraction of



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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium 5 Afternoon Breakout Sessions with Invited Speakers DEVELOPING AND TESTING MODELS OF SURVIVORSHIP CARE Moderator: Patricia Ganz, University of California, Los Angeles We have four individuals with us who will be discussing and representing different types of models for delivering survivorship care. There may certainly be other models that are available. Our first speaker is Steve Woolf, a member of our committee who is a primary care physician in Virginia. Steven Woolf, Virginia Commonwealth University I am a family physician in the Department of Family Medicine at Virginia Commonwealth University. Let me begin by introducing the three models of survivorship care that were discussed in the report: shared care, nurse-led care, and survivorship follow-up clinics. I am going to focus mainly on the first one, but I want to set the stage for the discussions that will follow. The following figure from data reported in the IOM report shows the number of cancer-related physician office visits, by specialty, estimated from the National Ambulatory Medical Care Survey (NAMCS) (Figure 5-1). One of the points that it makes is of the 36.6 million physician office visits made for cancer care, nearly one-third (32 percent; 11.7 million visits) are made to primary care providers. That is the perspective I am trying to represent. From the perspective of the primary care physician, however, these 11.7 million cancer-related visits made by adults are a very small fraction of

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium FIGURE 5-1 Cancer-related physician office visits made by adults (ages 25 and older), by specialty, United States, 2001-2002 (average annual, in millions). their practices. There were 558.4 million visits made to primary care physician offices in 2002 (all ages), so again, the relative proportion of visits that are designated in NAMCS as cancer-related visits is small. The point of showing this contrast is to say that there is a larger holistic perspective that occurs in primary care. This notion of shared care is very prevalent across the spectrum of health conditions that primary care providers care for, not just cancer. Primary care providers report that other physicians share care for the patient’s problem in nearly one-in-five visits (18 percent) (Woodwell and Cherry, 2004). We talk about shared care in the report and at this meeting as a new, evolving idea. How exactly would it work? Are the delivery systems available to do it? Whose role would it be to handle which aspects of care? Is the primary care provider capable of dealing with it? These issues are well traveled territory in the primary care world, because it is already done for a wide variety of conditions. There is a regular relationship of shared care between primary care providers and specialists that often works very well and has been in place for many years. In the management of coronary artery disease, primary care physicians and cardiologists work together regularly in well-coordinated systems. There are lots of exceptions, and I

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium am not saying that we never have problems in those areas, but this is not uncharted territory. The management of diabetes is very complicated and involves multiple different care providers and different areas of expertise. Epilepsy, neurologic disorders, Alzheimer’s disease, bipolar disorder, and end stage renal insufficiency—these are all conditions that primary care providers regularly care for in shared care relationships with specialists. These conditions obviously differ in important ways from cancer care and from survivorship care, but nonetheless involve very serious diseases that are chronic, recurring, potentially life threatening, and complicated. What is the ideal arrangement under shared care that we aspire to, whether it is for cancer care or for these other conditions? Looking at it from the perspective of primary care, the first goal is to address all physical and emotional needs. The primary care provider’s responsibility is to deal not just with the specific condition, but the totality of conditions, both physical and emotional that the patient is facing. In the context of cancer survivorship it is not just taking care of their cancer needs, and the late effects, and other consequences of their cancer treatment. It is taking care of their renal insufficiency, chronic obstructive pulmonary disease, depression, family violence issues, and all the other things that occur in primary care. Primary care providers also assume responsibility for chronic care needs that are feasible. Primary care physicians can only do so much, both in terms of their knowledge base and in terms of what is possible in their busy office visits. The role of the primary care physician is to do what is possible and then coordinate with other providers to handle the aspects that are not. Primary care physicians should also be referring patients to specialists for periodic evaluations and to address issues that require focused expertise. They also consult with specialists to get advice on how to deal with particular problems that are outside their knowledge. Ideally, that is the way it ought to work on the primary care side. The way it ought to work on the side of the cancer team is to provide guidance. Based on what is going on with the patient, they should see the patient and provide specialized treatment as needed. They need to keep the primary care clinician informed of the treatment plan. That is where the whole notion behind the survivorship care plan comes in. The cancer team also needs to return the patient to primary care for implementation of the plan and for care of other health needs. This is something that people disagree with as being part of the ideal, but my bias is that it is ideal to return patients to primary care. The challenges to achieving this ideal are front and center in our IOM report. One is that both the primary care folks and the cancer team have to have a common understanding of the expected components of care. Roles need to be clear, and everyone needs to be on the same page about who is responsible for what. There needs to be a common play book. The absence

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium of clear, consistent guidelines that was discussed this morning is problematic in this regard. Without them, the primary care clinician and the specialist may not necessarily agree on what ought to be done. There needs to be clear communication between the cancer specialist and the primary care clinician. I hear oncologists say that they regularly communicate with the primary care clinician and vice versa. There are cases where that actually happens, but unfortunately not often enough, and not where I practice. There needs to be confidence in what the primary care clinician can do. In some settings, there is undue skepticism about the capability of primary care clinicians to handle certain things, when in fact they regularly deal with very complicated diseases on a daily basis. There also has to be clarity about what primary care clinicians cannot do. What are the limits of their knowledge? What are the limits of their capabilities? The primary care clinician needs to know what is realistic, what is feasible, and what one’s limits are. There also must be an understanding among specialists of what they can count on the primary care provider to do. Finally, there has to be a supportive infrastructure within the healthcare system that facilitates the transfer of information. This is where we need electronic health records and other changes in our system of care to overcome some of the gaps. Dr. Linda Jacobs, University of Pennsylvania: I just wanted to ask one question. How is this actually implemented at your institution, or are you speaking more generically? How successful is it? Dr. Woolf: First of all, this idea is not for academic medical centers or similar institutions. The world that I am representing is the community practice physician, not somebody working in a large infrastructure like an academic medical center. The way it is implemented varies, and the integrity with which it is implemented varies from setting to setting. For lots of other conditions, although perhaps not as much for cancer care as there should be, there is a clear understanding of what the roles are. It is understood what the cardiologist does, and what the endocrinologist does, and what the primary care clinician does in the management of these conditions. The details of how primary care physicians partner with specialists to manage other conditions are probably too elaborate to go into in just a few minutes. Infrastructure and good models do exist for other conditions, though. Dr. Archie Bleyer, American Society of Clinical Oncology: I am waiting for this to happen, and the sooner, the better. I would like cancer to be at the lead, and have all of those other diseases, such as diabetes and renal failure, learning from us. You mentioned six challenges. Another challenge I would

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium raise is reimbursement. I have been in the private sector now for half a year and watched the practice of oncology. If reimbursement rates for those sharing the responsibility of care are unequal, the person who is reimbursed more will get the burden. Having seen that firsthand on a daily basis, I wonder how that affects implementing this model. Dr. Woolf: That point was also made this morning. The misalignment of reimbursement and the priorities of health care is a systemic problem that is not limited to cancer. It is something we addressed in the report. It is a larger issue than cancer care. The things that will do the most good to improve the health of the population are not reimbursed accordingly. I will be paid hundreds of dollars to take off a sebaceous cyst, which has absolutely no benefit to a patient. However, I am paid a paltry amount for smoking cessation and cancer prevention. The reimbursement system in the country is askew. Dr. Noreen Aziz, National Cancer Institute, Office of Cancer Survivorship: Thank you for an excellent presentation. When you talk about the partnership between the cancer specialist and the primary care clinician, I think we do need to acknowledge that an integral part of the partnership is the patient or the survivor. Clear communication to the survivor about who is going to do what is going to be really critical as well. I know we all acknowledge that, but it needs to be said. Dr. Woolf: Patient-centered care is something we all espouse and emphasize, but it has to be operationalized. Dr. Aziz: That is a big challenge. Dr. Woolf: Yes, it is, I agree. Dr. Ganz: You say that specialists and primary care doctors both know what is going on in the care of patients with diabetes or heart disease. Is that because there are written documents, or is it just that over time enough family practitioners have taken care of patients with diabetes that they know when it is out of their league and they should refer to the endocrinologist? Dr. Woolf: It is both. Those conditions differ in some respects. There are much clearer guidelines about what needs to get done: How often should diabetic retinopathy screening occur? Therefore, how often do I need to send my diabetic patients to an ophthalmologist? There are clear guidelines, and it is very well known, chapter and verse, among all family physicians. Also, roles are pretty clear. When faced with a patient with acute myocar-

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium dial infarction (MI), or an exacerbation of their congestive heart failure (CHF), or exertional chest pain from their angina, most primary care physicians are pretty clear when it is time to engage the cardiologist, and when it is time to pick up the phone and make a call. In the case of cancer survivorship, there is a lack of guidelines. There is a lack of an evidence base to support clear guidelines, as we noted in the report. Roles are still unclear. Specialists may be a bit uncomfortable with the primary care provider playing an active role in the management of the condition. The primary care provider is not exactly sure of the limits of the specialist’s role. Those need to be more clearly defined and articulated. Dr. Ganz: One last question. Do you think there is a role for collaboration between professional societies? I am thinking about the fact that hormone replacement therapy (HRT) is no longer being given to the general population of women. Primary care physicians have had to learn how to use alternative approaches to HRT. Treating breast cancer survivors for menopause and osteoporosis should be very similar since they generally should not receive HRT. I can imagine that there are probably a lot of areas where the domains of survivorship care are probably already guidelined in a way in primary care. Collaborations could share that between primary care and specialties. Dr. Woolf: John Ayanian highlighted the need to get the cancer organizations and the primary care organizations working together at the end of the last session. We have a moment of opportunity here. The release of this report is a leverage point where momentum has been created that can be carried forward at the organizational level to try to expedite that. Dr. Ganz: Thanks very much, and thanks for your contribution. Linda Jacobs from the University of Pennsylvania is going to talk to us about the model at her institution. Linda Jacobs, University of Pennsylvania I am going to present a concrete example of what we are doing at the Abramson Cancer Center at the University of Pennsylvania with our Lance Armstrong Foundation Living Well After Cancer Program. I just have a few slides, so that I can then open it up to some discussion. Our initial and ongoing funding is from the Lance Armstrong Foundation. The funding was initiated in 2001 to set up an infrastructure to develop an adult survivorship program. In designing this program, we hoped it could be a model for the development of other programs across the country. Since we began the program we have acquired some additional

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium funding from the NCI and the Department of Defense for a few specific research studies looking at particular issues in survivorship. This program bridges the Children’s Hospital of Philadelphia (CHOP) Survivorship Program, which has been in existence for over 20 years, with the Abramson Cancer Center. My co-director is Anna Meadows, who is sitting here in the audience. The CHOP program is staffed by a multidisciplinary team. One of the strong aspects of our program is consistent team leadership. It helps to have one person who is 100 percent involved in the program as the director. I am a nurse practitioner in oncology, as well as primary care, and I am also a researcher and an educator. We also have very strong institutional support from the University of Pennsylvania, both financially and philosophically. We are a patient-focused program that integrates clinical care, research, and education. Believe me, it has not been easy to get this program up and running. It has really been a trial and error experience. We piloted lots of different approaches until we came upon something that actually worked for us. What we are trying to do in our program is build upon established surveillance guidelines. We have heard a lot about the lack of evidence-based guidelines, and it is true that there are very few. There are no existing tools or guidelines for the care of adult cancer survivors, other than a few focused on treatment-related issues. However, there are some data-based and consensus guidelines for the care of children. We actually reference the Children’s Oncology Group guidelines quite a bit when we are making decisions such as whether or not someone should have a particular test based upon the treatment that they received. Our program has several other goals. We hope to establish a standard evaluation approach for our patients. We are developing a database that includes information from a number of research protocols. We aim to disseminate our findings by collaborating with our Penn network of hospitals, which consists of hospitals within a couple hundred mile radius. We also disseminate our work through presentations and publications. In addition, we hope to collaborate with other survivorship centers down the road. Finally, we plan to serve as a model for other survivorship programs in the country. Our program is an adult cancer survivorship program, with a focus on clinical care, research, and education. However, a relatively new component of our program includes young adult survivors of childhood cancer. We have recently developed a transition program with CHOP to refer the care of young adult survivors to us. We have patients anywhere from 21 years of age to 40 who are still being seen there. They will be seen one last time at CHOP, and then it is recommended that they move their care to us. When they come to us, they are accompanied by a summary of their care, and what treatment they received. It is usually two pages, and it is very

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium comprehensive. It guides us as we determine what we need to do for the patient. We, in turn, write the same type of report to send to primary care providers and the patient if they want it. We try to involve families as well as providers in the care. In many cases families do come with these patients. Our team is multidisciplinary. We have a number of medical oncologists and advance practice nurses, as well as psychiatrists, cardiologists, and rehabilitation medicine specialists. Our advance practice nurses are all nurse practitioners, so they can bill. We also have a number of primary care providers who have an interest in survivorship working with us. Our research is also multidisciplinary. For example, some of the primary care providers are doing research in complementary and alternative medicine. Our rehabilitation specialist does research in lymphedema. We also have an exercise physiologist working with us who is very interested in lymphedema. We have a medical geneticist working with our team looking at the genetics of testicular cancer. We also have an entire service of nutrition and psychosocial counselors. It is actually funded by a grant from another source. We refer almost all of our patients to counseling. Whether or not they go is up to them, but we recommend it. It can include families. We also recommend nutrition counseling for a number of people who have issues related to weight gain, weight loss, lipid profiles, and other problems. What we have discovered over the last five years is that one model of care does not necessarily work. There are lots of reasons why one model will not work. I think it is institution-dependent, regionally-dependent, and patient population-dependent. We found that we have two different models. We have what we call the practice model, and then what we call the consultative model. I will just briefly go over these. The practice model is one where we actually see the patients. We tell them that the focus of their care is disease surveillance, health promotion, and disease prevention. A number of protocols and ongoing studies are made available for patient enrollment on an optional basis. If they choose not to enroll, they are still cared for in our program. Our focus in the area of health promotion and disease prevention is on developing an individualized risk profile largely based on the treatment that they received. It is more treatment-focused than disease-focused—mantle radiation, certain drugs, et cetera. Family history is, of course, a big component of this risk assessment. We recommend screening according to this risk profile. We are using this model with testicular cancer survivors and survivors of childhood cancers. With such a large population of cancer survivors at our institution, we discovered that we cannot see everyone in the clinic. For example, we have a very large breast service at Penn with 10 different breast oncologists. We could not manage to see all those survivors. It was also a territorial issue, with oncologists not wanting to give up patients, and patients not wanting

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium to leave their oncologist. For these reasons we have developed the consultative model for our breast cancer patients, which is our largest and growing endeavor. We have a breast cancer survivor protocol which incorporates a questionnaire that elicits information about symptoms and quality of life. We have pilot tested the questionnaire with the patients and after about six months we stepped back to revise and revamp it. We are about to re-submit the protocol revision to move forward. Because of issues related to IRB approval and HIPAA, we cannot put patient information into a database at Penn, even if it is protected and coded, unless the patient has given us permission to do so. Everything that we do is consent-driven. Our research program is evolving. Our ultimate goal is to adopt this model with each of the disease types. We hope to have a lymphoma survivor protocol, a lung cancer survivor protocol, et cetera. Personnel-wise this can be very expensive, and we do not have designated oncologists who are going to practice exclusively with cancer survivors. Instead we have collaborative practices at Penn that are oncology and nurse practitioner partnerships. We have solid tumor, breast, and bone marrow transplant teams. Each team has a group of physicians and nurses that coordinates their schedules. If we are going to open, for example, a lung cancer survivor protocol, we meet with that group of oncologists and advance practice nurses, and talk to them about our program. The infrastructure will be there, meaning the database for entering the data. We will develop the tools. Then we will say to them, “Who would like to take the lead on this?” It does not really matter whether it is a nurse practitioner or an oncologist who takes the lead as being the PI (principal investigator) on that particular protocol. Their responsibilities will be to make sure that the questionnaires and the tools are distributed or mailed to the patients in their practice. We will have research coordinators who track their return and ensure that the data get entered into the database. This very large database includes different patient populations, but allows analyses of similar variables among the groups. Different populations of cancer survivors can be compared for research purposes. Even though we call this aspect of our program a research protocol, the activity is not driven by hypotheses or specific questions. It is really an effort to gather descriptive data to provide a baseline of information on our survivor population. We re-mail the questionnaires annually, so that we can see if there are changes in the symptoms that people are reporting. Many of the late effects we might expect will not appear for four or five years. Just because they are not having a particular symptom today, does not mean they are not going to be having it a year from now. I close with a little note of special thanks to the Lance Armstrong Foundation, because we could not be doing this and could not have started doing it without their help. Thank you.

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium Dr. Ganz: Is there a specific question for Linda? Susan Leigh: Linda, thank you so much for describing a clinic that many adult survivors have wanted for years. We have always looked at pediatrics and said, “Why can’t we have something like that for adults?” There have been any number of excuses, but now it is happening. Now that we have a number of models of adult clinics around the country, it will be interesting to see the difference in the needs for the adult clinic versus the pediatric clinic. When you were the only one around, there were a number of survivors to whom we have said, “Go to the University of Pennsylvania and see if you can get in and have a consultative session yourself.” Can you give me an idea of how much it would cost for somebody coming from around the country? Is there any kind of a ballpark figure for the cost associated with coming to your clinic for your general consultation? Dr. Jacobs: We went through trying to develop a billing number when we first started the program, but were not successful. We see survivors in our program as part of their routine follow-up. For example, we will tell people if you are going to come to our program, this replaces your yearly follow-up with your oncologist. The patient has to make the decision whether or not they choose to do that. We do follow-up surveillance, and this is considered a routine medical visit. We have had patients come to us, for example some testicular cancer survivors, who say that their oncologists discharged them from care. They have not seen an oncologist in two years. They want to know what they should be doing now. They can come to us and it is billed as a routine visit, or as a new patient visit if it is their first time coming to us. We do not have an issue with that because patients generally come as part of routine care. If they are having an acute medical issue, the visit can be usually justified through an ICD-9 code. Dr. Ganz: Linda, can you say your fee for a new patient consultation is such and such or your fee for a follow-up visit is such and such? Do you have a number on that? Dr. Jacobs: We do, but I generally refer them to the billing office. I do not deal with the numbers. Dr. Mary Vargo, Case Western Reserve University: I work within a physical medicine and rehabilitation program, and I am interested in the subspecialist component of your program. Specifically, from a rehabilitation perspective, it can be relatively easy to figure out who has lymphedema and needs a referral to our service. However, there are other issues, such as debility, musculoskeletal pain issues, and fatigue. Do you have specific

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium screening tools that you find useful for capturing patients that have those sorts of needs, or is it a more global kind of assessment? Dr. Jacobs: As part of the screening we have a list of simple, patient-focused questions. The patient checks off whether or not they are having any of those symptoms. We then get computer-generated feedback for the patient and the patient will get a letter listing the symptoms that they complained about, the issues that they had, and the recommendations that we make for follow-up. Generally, if we have patients who present with those types of symptoms and complain of fatigue and certain musculoskeletal things, we will refer them to our rehabilitation collaborator, Andrea Cheville. They make an appointment with her for an evaluation. Andrea does use the Disabilities of the Arm, Shoulder, and Hand (DASH) measure and a few other assessment tools. We also have physical therapy right there. We do not incorporate specific tools other than very simple things into our protocols because everything has to get approved by the IRB. If you are going to send a screening instrument to one patient, you would have to send it to the entire group. We would be collecting more and more data. Our general line is that we are collecting this as baseline data. You can query the database, see if there is an issue that you would like to study, and then write a research protocol for it. Then you can collect the data yourself in a research protocol, for example, to test one particular tool. The database is available for people to access patients for further study. Mary McCabe, Memorial Sloan-Kettering: I would like to thank Linda and her group for being very generous to us when we first started our survivorship efforts. They were enormously helpful in preventing us from making some initial big mistakes. I have a question about your consultative model and its potential for expansion. In the future, how do you see the communication with the oncologists who are continuing to see these patients, but also with the primary care physicians? How might that work? Dr. Jacobs: As part of our program, a summary letter is dictated for every patient. The initial evaluation is summarized to include treatment information, risk information, side effects the patient has experienced, family history, and medical problems experienced since treatment. Everything is in that initial letter. We also compose subsequent letters for follow-up appointments saying what has or has not been done. Recommendations are also listed under health promotion and disease prevention, such as a recommendation for a baseline echocardiogram. The recommendations are made, and they are sent to the primary care providers or whoever the patient tells us to send them to. The patient has to provide us with that list. The patient also receives a copy of the letter.

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium The final challenge to investment is the competition for funds. I have said earlier that we compete for much of the dollars and resources coming to the NCI, monies that are rarely distributed evenly across the cancer control continuum. We always have to be cognizant of that, and reflect on what the best mix of those dollars is, and what is the most equitable. Despite these challenges to survivorship research, I am very excited, and feel it is wonderful to be here at this point in time. I think as Patti said we are at a critical juncture. We have tremendous momentum that is building. We have cancer survivors in leadership positions (e.g., NCI, ASCO), which is incredibly empowering. We have this new report on the street that we can build on with an evidence base. And, we have now invested, particularly at the Cancer Institute, in a variety of platforms to pursue survivorship research. These data resources include our clinical trials groups to our cohort and epidemiologic studies that are looking at big populations to see who gets cancer. Within these latter studies, we now have growing numbers of cancer cases that can be used to ask questions such as “What were they like before they developed cancer?” “What can we tell about them on the other side in terms of their survivorship?” “Is there information buried in those studies that we can leverage?” Various administrative, linked data sources are all well described in the IOM report: SEER-Medicare linkages; the Cancer Research Network; the CanCORs database; and the practice-based research networks we heard about. There are also descriptive population-based data sets from the National Center for Health Statistics, including the National Health Interview Survey and the Behavioral Risk Factor Surveillance System, which you heard John Ayanian talk about earlier. Again, all of these resources allow us to compare our cancer survivors with non-cancer populations, and examine the relative burden of having a diagnosis of cancer. We can use this information to, over time, monitor these burdens, and determine whether we are making progress in reducing cancers’ cost. The ongoing samples of survivors that the American Cancer Society is supporting and various registries abroad that we have heard about represent additional outside sources of information. In summary, we have a rich and broad array of data resources that we are poised to extend and operationalize to address survivorship issues, and to me that represents an incredible opportunity. I want to end with what I think are several key targets for investment, and I speak on behalf of our office. We talk regularly about these issues, and this list reflects our collective experience (Box 5-5). I want to emphasize two issues in the area of essentially fundamental research. Understanding the role of, and impact of, survivorship on caregivers is a fundamental research area in need of pursuit. For the most part, these individuals are family members. As more care is being pushed out into the

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium BOX 5-5 Future Targets for Investment Two key research areas: Exploration of the basic and biomedical aspects of survivorship Understanding the role of and impact on caregivers Partnerships (NCI-wide; NIH-wide; other cancer agencies and foundations) Delivery systems for survivorship research (e.g., Cancer Information Service, internet, personal digital assistants (PDAs), Community Clinical Oncology Programs (CCOPS), Cancer Centers) and care (e.g., evidence-based, cost-effective, efficient, and equitable models) Communication (researchers, healthcare providers, survivors/families, payers, policymakers) Identification of evaluation metrics to assess our “success” in improving the health and care of cancer survivors and their families community, and as more people experience cancer as a chronic illness, caregivers and family members are going to be a key element in sustaining, supporting, providing interventions to, and altering outcomes for survivors. As a consequence they need to be a population that is targeted for research. Surprisingly, when we look at our nationwide topical portfolio analysis, what is fundamentally lacking in survivorship-focused research are basic science studies. We do not see gene-environment studies that address survivorship questions. We do not see mechanistic studies of what it is about specific drugs and treatment exposures that, whether due to their biological, biochemical, or molecular effects cause toxicities long-term. We do not have an established base of bench science in survivorship research. It is simply not someplace that our scientific community has gone. I think hidden in this neglected arena may be some provocative and rewarding frontiers to explore. Clearly, nobody is going to achieve the many mandates outlined alone. Fortunately, the IOM and ASCO have brought all the partners together at this meeting. This effort has to be all about partnerships. By way of illustration, we at the NCI need to find a way to integrate what we do not just across the NCI, but also across the other institutes: Aging, Mental Health, Nursing, Neuromuscular Diseases, and Heart, Lung, and Blood. We need to draw upon that collective scientific expertise and bring it into the cancer arena. We also need to interface with our advocacy partners, our voice out there, and our champions if you like, in promoting what we do. We need to

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium partner with diverse entities so that we can coordinate our efforts, not be duplicative, and use precious resources in the best way possible. A third target for future investment is exploring delivery systems with the potential to bolster the larger research agenda. Can we use the Cancer Information Service, personal digital assistants, the Internet, and the other new technologies that are available to deliver interventions? Can we use the Community Clinical Oncology Programs to get interventions out there? Are cancer centers using them as delivery platforms for promoting cancer survivorship research or care? Does the research say how survivorship care should be delivered? What is the best way to do it? What are the costs and what are the associated benefits? What are the various models that are going to be most effective, efficient, and equitable that we can use to deliver care that will improve survivors’ outcomes? A fourth area for investment is in communication. It will do us no good at all if we do not communicate what we know or have learned. Fundamentally, what the survivorship care plan is all about is communicating what science has taught us. We have to be able to talk to one another, not just the researchers, but also the clinician, patient, consumer, and payer communities. Communication is going to be very key, and we live in a big communication world. There is more and more information being pushed out there. Helping people access it and understand it is increasingly important. It will be vital to know what they need, when they need it, and how they need it. Finally, as mentioned earlier, while we are at this very momentous point, we need to think about what our benchmarks for success are going to be. Is it to have 15 million survivors? I do not think so, because knowing that we have 15 million survivors is really not very helpful. We need to know what it is that we are trying to improve. We need to know about the quality of life of those survivors and the quality of their care. We need to know whether we are reducing the cancer burden, or whether this cost is simply escalating. We need to know if we can prevent some of the long-term effects. Importantly, we need benchmarks now before we go too far down the road. I know that even if we set them up, we will later think, “Gee, why didn’t I ask that?” as all of us in research have done. However, we have to be thoughtful now, because we have an obligation to mark our progress, and not just programmatically. When you go back down to Congress, or to the cancer institute director for that matter, you need to say where you expect to go and what you expect to achieve with the public’s investment. We need to be able to say that we are going in the right direction, and that we are doing what it is that we set out to do. I think that is going to require us to have a thoughtful dialogue, and to look at the many levels of metrics that we may need in place to be able to do that. Thank you.

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium Dr. Ganz: Next we will hear from Frank Johnson, a surgeon who was a member of our IOM panel from St. Louis University. Frank Johnson, St. Louis University Thank you. Our committee has endorsed a previous recommendation of the Institute of Medicine dealing with health insurance. A rational national universal-access medical system that is affordable, accessible, and acceptable to meet society’s needs would benefit cancer survivors probably more than anything else that has been discussed today, but I do not want to dwell on this. Quite a bit can be accomplished with the current system that we have, and also could be accomplished within a rational national healthcare system that I just mentioned. I am a surgical oncologist, and cancer patient follow-up has been one of my academic interests over the last several years. I am particularly interested in the follow-up of patients that have been treated with primary curative intent surgery, plus or minus chemotherapy and radiation therapy. Research from this work has shown that existing guidelines, whether published in books or journals, from prestigious societies and institutions, are largely based on the opinions of experts. They vary widely. My colleagues and I have estimated that the cost difference among the recommendations of highly acclaimed institutions and organizations varies, usually by a factor of five, sometimes up to 100 fold. We have also discovered wide variability among experienced, highly credentialed clinicians who are caring for patients with particular cancers in terms of the intensity of follow-up that they provide. Such patient groups include survivors of colon cancer, lung cancer, prostate cancer, melanoma, sarcoma, and rectal cancer. In all of these instances we have found a great deal of variation, which we think is probably unwarranted. This conclusion relates to recommendation 10 of the report: “Answers to the following basic questions about survivorship care are needed: How frequently should patients be evaluated following their primary cancer therapy? What tests should be included in the follow-up regimen?” How do we get rid of the apparently unwarranted variability in the clinical practice guidelines that have been put forward in the literature? How do we settle on guidelines? How can we get evidence-based guidelines? Low-quality evidence such as expert opinion, retrospective data, and evidence from registries has not proved very persuasive, because we do have variability in recommendations from the leaders of this discipline. We know that randomized clinical trials are feasible. They do change practice, and as evidence for this I cite the two Italian trials of breast cancer patient follow-up that were published over a decade ago (GIVIO, 1994). Over 1 million randomized clinical trials have been published in the literature since the

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium first one in the late 1940s. Nonetheless, the Institute of Medicine has estimated that only about 4 percent of the medical decisions we make as clinicians are based on high-quality evidence (IOM, 1992). Therefore, we have to select the targets for randomized clinical trials very carefully. We know that prevalent clinical problems can be effectively studied with randomized clinical trials. Things like treatment of hypertension, whether patients with coronary artery disease should be treated with surgery or angioplasty, and tight or routine glycemic control of diabetics have been addressed in clinical trials. I think we all would agree that proper cancer patient follow-up should be subject to randomized clinical trials of the same sort that has proved very effective in defining the standards of care in our country and, for that matter, around the world. Using reasonable assumptions, I estimate that about 1 million people enter cancer patient follow-up each year in the United States after primary curative intent treatment. Almost all of the trials that have been conducted so far dealing with cancer patient follow-up after initial treatment have been underpowered. Many trials have been based on very few patients and purport to define a standard of care, but they are not persuasive. Large randomized trials, however, are difficult to carry out, as they take a lot of cooperation and institutional support, several years to accrue enough patients to meet the target goals, and several more years to get results. Other speakers have addressed the potential drawbacks of these trials, namely the moving target, different strategies, and improvement in treatment. The goals of follow-up include, first, detection of the recurrence of the index cancer. This is what patients come to your office or my office and ask about. Has my cancer come back? I think this is job number one. Detection of second cancers is, in my opinion, a very important goal as well, because often these are relatively easy to treat and they tend not to be as advanced as the earlier primary. Quality-of-life issues have been discussed at some length today. Detection of long-term effects of therapy is another very laudable goal. These can be, and have been, inserted into randomized controlled trials. As I said, there have been a few adequately powered randomized clinical trials of cancer patient follow-up. The two breast cancer trials were done by Italian researchers. The Italians have also almost reached the target for completion of a colorectal cancer patient follow-up trial, comparing intensive versus minimalist follow-up strategies. There is a British trial in the works on sarcoma patient follow-up, comparing minimalist versus aggressive follow-up. There is another British trial of colorectal cancer patient follow-up, which amazingly includes a no follow-up arm. But where are the American trials? There are no American trials of adequate power that I am aware of in any of the solid organ tumors dealing with the best way to follow such patients. The committee feels that the United States should

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium explicitly set out to design such trials and carry them out. I am glad to know that some of the decision-makers that can authorize such trials are present in the audience. As Floyd Bloom said in his presidential address to the American Association for the Advancement of Science, there are a huge number of potential variables: a large number of described medical conditions, a large number of drugs and dosages, many guidelines, and millions of rules. We already know that there are hundreds of different kinds of cancers, and many hundreds of potential follow-up tests to be used. We can only focus on the most important problems to deal with in randomized clinical trials. We know that the anecdotal and other low-quality evidence has not been persuasive. We know that the actual practice of expert clinicians varies widely. The variation in actual practice does not seem to be influenced greatly by the age of the doctor, the initial stage of the tumor, the geographic location of the doctor, or by the managed care organization penetration rate in the area where he or she practices. These are the conclusions of some of the research that we have done, and I do not have time to show you the data on which those conclusions are based. We have concluded that the major reason for the variability in actual practice and promulgated in guidelines is the lack of high-quality evidence on which doctors, patients, and insurance companies can base their decisions. This is not news to this audience. This variability, however, results undoubtedly in overuse, underuse, and misuse of medical care resources, and probably costs some patients their lives. A research finding from Phelps and Parente (1990) indicated that there is some potential that the investment of money in trials to determine the best form of follow-up for patients after potentially curative treatment may actually save money in the long run. It could be by one or two orders of magnitude. Such research has been felt to be beneficial. What I hope to do today is to help the decision-makers allow us to do what I think everybody in this room would like to do. That is to base the care of patients that have had curative treatment for various sorts of cancers on high-quality evidence. Making these investments in research is working towards a highly attainable and very obvious goal. It involves billions of dollars, because cancer patient follow-up testing, counseling, and administration of corrective actions is very expensive. The benefits of figuring out how best to carry out post-treatment follow-up include better outcomes for our patients, and possibly some cost savings. Thank you very much for your attention. Dr. Ganz: I think we have about five or ten minutes for questions. Dr. Eva Grunfeld, CancerCare Nova Scotia: I wanted to thank everybody for their presentations. Julia, you were so exciting, you made me want to

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium rush out and write that protocol right away. I am on the Research Advisory Committee for the Canadian Breast Cancer Research Alliance, and we have just launched our first ever RFA on cancer survivorship. It has been an up-hill battle keeping it on the table as we vied for funds with the basic scientists. Frank, I would like to comment on your issue about the payback on clinical trials, on the cost of doing the clinical trials, and whether we actually see a cost savings from the results of those clinical trials. We did a modeling study in which we modeled the cost of doing a randomized controlled trial on intensive versus minimalist follow-up for colorectal cancer, and assessed how long it would be before we would get the payback on that clinical trial. We estimated it would be about four years if the results are implemented. As a slight outsider, I do want to raise one point, because I was a little perplexed about the report, and I wonder if you can give me some insight on it. The report I think is excellent. I was struck, however, that in the models of follow-up care which you identify worthy of further investigation you identified the shared care model, a nurse-led model, and the survivorship clinic models. I am struck by the fact that the primary care model, which has the strongest, largest evidentiary base to it, was not one that was recommended for further testing. I think there is a slight disconnect between the evidence you are presenting in the report and the conclusions that you are coming to. I would be interested in your views on that. Dr. Ganz: I am not sure if others want to respond to this, but I think your work was in fact cited in the report. One of our concerns is that in the United States many people do not have primary care or they do not turn to their primary care physician as the first source of care in the way they do in the U.K. or in Canada. The shared care model seemed to be more appropriate in our setting. Dr. Grunfeld: I appreciate that there is a different system. What strikes me is that you are suggesting three models for testing. You are not suggesting three models for implementation. Given that this report recommends a research agenda, it would be consistent with the evidence to include researching a primary care model. One point, indeed, the two countries in which I tested both of those models have the same response. It is inappropriate. The family care physician cannot do it. They came to it equally cynical. That is an outsider’s view on the report that you might be interested in hearing. Dr. Ganz: I think part of the situation is we have people in this country who never go to see their primary care physician. I have patients who are in

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium health maintenance organizations who have a primary care physician that they have never seen. They are assigned only in name to that physician. That is often the norm here, rather than a relationship that has been established. We would not even have a primary care physician (PCP) to test the model with. You at least had PCPs that people had identified as caregivers. Dr. Rowland: Hopefully, we are going to have some data from the SEER registry soon looking at where people are getting their follow-up care for the major cancers in this country. At present, we do not even know where the bulk of our older survivors actually are getting their care. We suspect it is largely with primary care providers. While survivors may come in for specialty care when diagnosed, they go back out into the community after treatment ends. You raise an interesting empirical question for which I hope we can get answers. Also, I cannot wait to see your research. The hook is to get the basic sciences interested in survivorship, and then we will get the money. Dr. Jerome Yates, American Cancer Society: Julia, I would take the opposite tack. Unless you get funding with RFAs in very targeted, well-defined subsets of populations, I think it will be extremely difficult to get this kind of research funded and to compete with the basic sciences. All you have to do is watch what is going on at the NCI now. At the ACS, 70 to 80 percent of the money goes to basic bench laboratory research. I am hoping to twist that around a little bit in the future, but this is a problem. One of the biggest problems with research in this area is you are dealing with low event rates. We see only the serious complications in relatively early follow-up. We also have large populations that are really heterogeneous. We need to think about being able to shift some of the administrative data sets from CMS and some of the large insurers to collect the information that will tell us about exposures. Maybe old people who have had a fair amount of platinum lose enough nephrons that they get into renal trouble when they are 75, when they would not have if they had not been exposed to these drugs. We do not have that kind of information, and I think that that is a real problem. It is something that we could try to address and see if we could use these large administrative data sets to help us sort out some of these problems. Lastly, I think we do know some of the things that cause problems. Clearly adriamycin affects heart disease in combination with atherosclerosis and some of the neurotoxic agent’s effects in older people may be worse than they are in younger people. We ought to take some of those things that we actually know can cause problems, subset those populations, and study them in terms of the follow-up, rather than studying the whole general

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium group of breast cancer patients, or colon cancer patients. We need to break it down if we want to get some payoff with a relatively modest investment. Dr. Horning: In preparing for this session, and speaking with Lois Travis, I was reminded that earlier this year I got a note from our cooperative group saying that they wanted to discontinue follow-up in as many clinical trials as possible because our budgets are flat and expenses are going up. I was advised to check off the trials for which we could discontinue follow-up in five years. I do think we are missing opportunities to think about economies of scale in coordinating survivorship research with ongoing clinical trials intervention. I agree fully with that last statement that we should be selective about the clinical trials that we choose for follow-up. We should choose trials that are representative of the different questions that we want to ask, such as questions about underserved populations and questions about differences in age and exposure. We have clinical trials now that have very different interventions, and those would certainly be at the top of the list to highlight. I think that we are missing opportunities to work together in thinking across the broad clinical trials efforts, and selecting the menu that can cross horizontally and vertically to catch most of these areas that we would like to study further. Dr. Sheldon Greenfield, University of California Irvine: If we followed these notions of imaginatively focusing on a limited number of questions, it could lead to quality measures. We could pick out a half a dozen. I wonder if an NCI goal for the next two or three years might be to find data, not necessarily from trials, and come up with a half a dozen measures given the pressure that is put upon us by everybody. No institute would ordinarily take up that goal, but the pressure is mounting. If we wait for trials, we may not get there in time. Julia, maybe you could respond to that. Dr. Rowland: Thanks, Shelly, a very thoughtful comment. The large shift that has occurred at the NCI is the growing commitment to dissemination. We are looking at what the quality indicators should be, and how we push the science out. I think the answer to it used to be that we were content just to be the generator of the evidence base, and then we let everybody else worry about how it is applied. I do not think that is true any more. There are a number of ongoing projects, including collaborations with other entities, to look at some of the benchmarks. Molla Donaldson at NCI could generate a list of projects better than I can. Maybe one of the reasons that I put that point at the end of my slides is in part because I am perennially frustrated when people ask me about the

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium numbers of survivors. Well, 10 million. So what? It just tells me who is alive after a diagnosis. It tells me nothing about the health and well being of that population, or where they are in the trajectory. Just as a simple marker I would love to be able to tell you more about who is in active treatment, who is really in this post-treatment survivorship period, who has progressive disease, what their health status is, and how they are different from peers who do not have a cancer history. I think those are very real questions, and a very appropriate task to ask NCI to take a lead on, but certainly not as the only stakeholder. Dr. Winn: We really need a parsimonious set of measures moving ahead. The difficulty right now is what they should be. One of the next steps could be to think in terms of a framework of quality measures which would get at the parameters, the scope, the priorities, and the best practices out there. Eventually you can come to say, “Let’s look at these 20, and then maybe we can get down to the 5 or 6 that are the ones to go forward.” Dr. Travis: I want to thank Julia for the nice explanation of transdisciplinary science versus interdisciplinary and multidisciplinary science. It is possible to include basic scientists in our research, because we have ongoing a large international study of survivors of Hodgkin’s, breast cancer, or testicular cancer. We are looking at second cancer risk in these patients, and have the basic scientists helping us in this new field of molecular epidemiology. They are trying to figure out the markers of DNA repair and other markers that might determine who is at the highest risk of second cancers. For people who are studying gene-environment interactions, this is a wonderful forum to do this type of research because it is one of the few situations where you have humans deliberately exposed to carefully measured amounts of carcinogens such as radiation and chemotherapy. You can look at the measured doses, compare them to the outcome, look at differences in various DNA repair genes and other markers, and then determine who is at the highest risk and how you predict that. It is possible to incorporate them, and I have several bench scientists involved in our new study. Dr. Johnson: The American College of Surgeons Oncology Group represents a large group of surgeons. Surgeons, I will remind the audience, are responsible for most of the cures of cancer in this country, with or without chemotherapy and radiation therapy, to give those other disciplines their due. This group has the advantage over other groups of being able to easily obtain a piece of tumor tissue, as well as a sample of normal body tissue or fluid. Important information can be gotten from these carefully stored bits of tissue.

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From Cancer Patient to Cancer Survivor-Lost in Transition: An American Society of Clinical Oncology and Institute of Medicine Symposium The American College of Surgeons Oncology Group has proposed trials of long-term follow-up in patients treated surgically with or without chemotherapy and radiation therapy, using the repository containing the original tumor tissue and a sample of non-tumor tissue. Those trials have been rejected by the Cancer Therapy Evaluation Program (CTEP) of NCI. I speak for the American College of Surgeons Oncology Group when I say this should change. There should be an acceptance of this group’s strengths, and a willingness to fund follow-up trials using the available tissue to do the correlative studies that everybody agrees are so valuable. Dr. Ganz: I am going to let Dr. Horning have the last word. Dr. Horning: I wanted to support what Lois just said. My strong feeling is that the integration of the basic science is absolutely imperative to move this field forward. Among the biggest news in science in the last couple of weeks are the results of HapMap project.1 People are debating about what this is going to mean in terms of the prediction of disease and possibly implications for prevention. There is a feeling that this is going to impact our understanding of how individuals handle different drugs. Cancer chemotherapeutic agents are going to be lead candidates for study. The other point I want to make is that I do not think it is an either/or situation. It is not, and should not be, that we are competing for the same funding. This is a perfect time for team science. It is a perfect time for multiple principle investigators. I think we have to think about how we can work together and collaborate. What we really talked about a lot today is the fact that we wish we had more evidence-based guidelines and measures for today’s patients. We also know that there is a built in latency period for many of these side effects to play out over time. We critically need the biomarkers and surrogate markers to predict them as early as possible, so that intervention strategies can be employed. Dr. Ganz: So, I think we are about ready to have the rest of the group join us. Thank you all. 1   The International HapMap Project is a partnership of scientists and funding agencies from Canada, China, Japan, Nigeria, the U.K., and the United States to develop a public resource that will help researchers find genes associated with human disease and response to pharmaceuticals (www.hapmap.org, accessed December 28, 2005).