Appendix D
Commissioned Background Papers



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Implementing Cancer Survivorship Care Planning: Workshop Summary Appendix D Commissioned Background Papers

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Implementing Cancer Survivorship Care Planning: Workshop Summary Appendix D.1 The Cancer Treatment Plan and Summary: Re-Engineering the Culture of Documentation to Facilitate High Quality Cancer Care Deborah Schrag, MD, MPH* Molla Donaldson, DrPH** Abstract: Cancer chemotherapy is typically administered over many days, sometimes in the hospital and sometimes in office settings. It is notoriously difficult, and often impossible, to recreate cancer treatment histories from medical records. This impedes communication between and among health care systems, physicians, and patients as they traverse the spectrum of cancer care. Medical record keeping does not include preparation of synoptic overviews when patients transition from one therapy to another. For these reasons, it can be difficult for patients and physicians to assemble an accurate understanding of individual chemotherapy treatments as well as the overall trajectory of a patient’s cancer care. The availability of new and better drugs for treating cancer means that patients are living longer, receiving more treatment, and managing the consequences of these therapies. In turn, living longer means that cancer patients’ medical records become thicker and it becomes even more challenging and time-consuming to create a history from those written records. In addition, like society as a whole, cancer patients are increasingly mobile, seeking care at multiple settings and interacting with a variety of health care and allied professionals. In conjunction with the * Health Outcomes Research Group, Memorial Sloan-Kettering Cancer Center ** American Society of Clinical Oncology

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Implementing Cancer Survivorship Care Planning: Workshop Summary National Coalition for Cancer Survivorship(NCCS) and other patient advocacy groups, the American Society of Clinical Oncology (ASCO), the major professional organization representing medical oncologists, is developing strategies to encourage medical oncologists to prepare synoptic documents that provide an overview of care at key transition points. The goal is two-pronged: to create a synoptic document which can not only be used by other providers to quickly recreate patient medical histories, but also to serve as a springboard for discussion with patients at key transition points. This background paper first outlines the rationale for developing cancer treatment plans and summaries as a strategy to improve the quality of cancer care and then describes progress to date towards achieving this goal. I. Overview Cancer care in the 21st century is exceedingly complex. As cancer patients live longer and the range of chemotherapy treatment options expands, patients are ever more likely to receive care from multiple physicians, across diverse delivery systems, over periods of many years. Both the longer periods of survival and the multiplicity of providers make it especially challenging for oncologists to assemble all the information that is necessary to understand a patient’s cancer treatment history. It is not just that obtaining the actual physical records is problematic—although it can be—rather, the more common challenge is obtaining a coherent summation of myriad relevant events from a series of chronologically organized records. Without a summary available to them, patients who have experienced a series of complex treatments have great difficulty becoming partners in their own care after completion of curative treatment. Cancer survivors typically receive care from both oncology and non-oncology providers and eventually transition back to the “regular” health care system, where their care is usually provided by clinicians with no special oncology training. Cancer survivors report that their providers are sometimes uncertain about what, if any, special care might be required given their cancer history. To understand the cancer history, patients and their noncancer physicians face a choice between requesting entire oncology records (on the one hand) or a few key documents (on the other). The drawback of obtaining entire records from multiple settings is that they are time-consuming to review and inefficient to transmit and store. Furthermore, only a small fraction of the contents of those records is likely to be relevant for ongoing care. However, the drawback of asking for select key documents is that detail may be missing. Medical oncology treatment can be viewed as a story which begins with a detailed chapter (the new visit note) and unfolds over

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Implementing Cancer Survivorship Care Planning: Workshop Summary time in a series of follow-up chapters in office notes, chemotherapy flow sheets, surgical, radiation, imaging and laboratory reports, referrals, and possibly hospital discharge summaries. What both patients and providers often need, however, is a brief summary of this story. At present, there is no standard for preparing a “treatment summary,” and it is not part of the culture of routine oncology practice. Cancer quality-of-care research has highlighted the importance of care coordination for cancer patients. One strategy for improving coordination is to change the culture of medical records documentation so that preparation of synoptic treatment summaries becomes routine. The goal of this background paper is to: (1) describe the current practice of medical records documentation with a special focus on oncology; (2) discuss the rationale for a treatment summary; (3) address challenges for implementation and; (4) identify key components of these summaries with illustrations from sample templates developed in conjunction with the American Society of Clinical Oncology (ASCO). This background paper focuses on the overall goal of changing the culture of medical records documentation to include treatment summaries for all patients, but highlights aspects of care that have special relevance for survivors. The “transition to survivorship” care plan is simply a special type of chemotherapy treatment summary that requires special attention to issues of long-term follow-up such as fertility, management of late- and long-term effects of cancer, and screening recommendations. The objective of ASCO and the National Coalition for Cancer Survivorship’s (NCCS) treatment plan/treatment summary initiative is to ensure that synopses of care are provided for all cancer patients, including long-term survivors. Successful implementation of this initiative will require the collaboration of multiple stakeholders. Medical oncologists are usually the providers who coordinate care for cancer patients receiving multimodality treatment. For this reason, this background paper emphasizes preparation of treatment plans and summaries by medical oncologists. Moreover, medical oncology treatments are especially challenging to track in medical records because, in contrast to surgery and radiation, they unfold over lengthy time intervals. However, it is important to emphasize that the preparation of treatment summaries is relevant for other cancer providers and indeed, for all health care providers who deliver care to persons with complex chronic conditions. II. Background and Rationale: Why Cancer Treatment Summaries Are Necessary The development of a treatment summary can help achieve three objectives related to improving the quality of cancer care:1 (1) to improve coor-

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Implementing Cancer Survivorship Care Planning: Workshop Summary BOX D.1-1 Objectives of Adoption of Oncology Treatment Summaries Adoption of a treatment summary could improve three interrelated aspects of cancer care delivery: Care Coordination: between providers. Communication: between patients and providers. Efficiency: document tracking, recordkeeping for patients, providers, systems, and research. Care Coordination is especially important because: Cancer survival has improved. Cancer treatment is increasingly complex. Society is increasingly mobile and patients transition across practice sites. Unexpected events—hurricanes and other disasters—happen. More fragmentation occurs as care teams include many subspecialized members. Communication is especially important because: It is a prerequisite for shared decision making. More complex treatments and preference-sensitive options now exist. Patients desire it. Efficiency is especially important because: It limits time spent reviewing/obtaining/providing medical records. It facilitates tracking of processes and outcomes of care for quality improvement initiatives. It facilitates document storage, retrieval, copying, and transmission. It facilitates tracking of care for public health and research data collection– e.g., cancer registries. dination of care as patients transition among various health care providers; (2) to improve communication between patients and physicians; and (3) to improve the efficiency of cancer care delivery by streamlining documentation for clinicians and clinical support staff. Box D.1-1 describes three components of care—care coordination, communication, and efficiency—that could be improved by changing the culture of oncology practice to include treatment summaries. The Need for Treatment Summaries—Insights from Quality of Care Research A series of influential reports by the Institute of Medicine (IOM) called attention to systemic problems in the general health care delivery system and

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Implementing Cancer Survivorship Care Planning: Workshop Summary recommended several strategies to improve the quality of health care.2-4 With the release in 1999 of the IOM report Ensuring Quality Cancer Care and subsequent work of the National Cancer Policy Board, it has become clear that in the United States, many cancer patients, even those with adequate health insurance, do not receive the most effective available treatments in a timely fashion.2-4 Since these reports’ publication, the quality of cancer care has remained in the national spotlight. Major efforts to measure, understand, and improve the quality of cancer care have also been undertaken. In particular, the NCI and ASCO have conducted large-scale studies to characterize the state of cancer treatment and more recently to develop “Navigator” programs to prevent patients from becoming lost in the web of a complex system.5,6 Starting in 1998, ASCO and the Susan G. Komen Foundation sponsored the National Initiative on Cancer Care Quality (NICCQ). Researchers from Harvard University and the RAND Corporation reviewed medical records and interviewed patients diagnosed with breast and colorectal cancer in five U.S. cities in order to characterize the quality of their care. 6 This study underscored how difficult and time-consuming it was for highly trained researchers to locate patient data and accurately determine the treatments patients had received in order to assess whether those patients had received appropriate adjuvant chemotherapy. Even after Institutional Review Board (IRB) approval to review these records was received, many barriers to ascertaining chemotherapy use from medical record review remained. First, patients were seen by many physicians and sometimes by more than one medical oncologist. Second, most oncologists practice alone or in small-group settings and usually have paper records. Third, even when researchers were able to access oncology records, information about chemotherapy use was not easy to abstract because of highly variable patterns of documentation. Although many oncologists use flow sheets to record their use of chemotherapy, the organization and style of these documents varies considerably. Although these records may be relatively easy for oncologists to understand, they are less comprehensible to other clinicians because they include many oncology abbreviations and details of concern only to the treating oncologist, such as the white blood cell count after each dose of therapy. Information about treatment in medical oncology charts is usually recorded in an event-by-event chronological format; as a result, researchers often had to sift through many pages of notes to obtain key information about a patient’s treatment. It was even more difficult to glean from medical records whether patients had completed prescribed courses of treatment, the reasons for treatment discontinuation, and the planned next steps. Fourth, even determining diagnosis was challenging. Although initial consultation notes usually record an initial diagnosis, records often contain incomplete information because the diagnosis may evolve as more information is obtained.

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Implementing Cancer Survivorship Care Planning: Workshop Summary The Harvard-RAND researchers presented their work to an advisory group of ASCO members interested in quality of care, representatives from the Susan G. Komen Breast Cancer Foundation, and other advocacy groups such as the NCCS. In a discussion of “lessons” learned from this large scale observational study, the utility of a chemotherapy treatment summary was recognized as a logical and potentially effective quality improvement tool. The emerging idea of an oncology treatment summary coincided with national initiatives by the NCCS, ASCO, the Lance Armstrong Foundation, the National Cancer Institute (NCI), the American Cancer Society, and the IOM to improve the care of cancer survivors. The need for a treatment summary was also evident in other research initiatives, including the NCI’s Cancer Care Outcomes Research and Surveillance Consortium (CanCORS),5 in research from the Cancer Research Network, an affiliation of large HMOs,5 as well as large interview studies highlighting problems with care coordination as especially prevalent in cancer. The treatment summary was also recognized as a potentially valuable tool to address problems with communication between patients and providers. In a recent population-based study of 1,067 colorectal cancer patients from Northern California, cancer patients completed surveys modified from the Picker Institute to report on their access to care, symptom control, psychosocial support, health information, treatment-specific information, confidence in providers and coordination of care. They identified access to information, psychosocial support, and care coordination as the three most deficient aspects of their care.7 Black, Hispanic and other non-English speaking patients reported significantly more problems than white English speakers, and this was especially pronounced in the domains of communication and coordination of care. Despite health information being readily available in multiple media formats, this and other research indicates that patients are dissatisfied with communication with their physicians. This is in part because patients value having health information that is filtered by a trusted and knowledgeable source, synthesized and custom-tailored to their individual circumstances. Coordination of Care Among Oncologists and Other Health Care Professionals Coordination of care involves facilitating patients’ access to practitioners whose expertise may improve their health outcomes or experience. These providers must have key clinical information at hand to formulate recommendations and then function collaboratively as a team to deliver care. Some practices are multispecialty and multidisciplinary, though even in these settings coordination can be a challenge. In other cases, cancer care

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Implementing Cancer Survivorship Care Planning: Workshop Summary involves providers who practice in different locations, health systems, and specialties. Coordination is generally improved when one provider—typically the medical oncologist, but sometimes the surgeon or the primary care physician—assumes responsibility for orchestrating and overseeing all aspects of care. This critical coordination function helps to ensure that health care providers work together to provide care. This role may extend well beyond making referrals. The coordinating physician must be actively engaged to ensure that neither essential pieces of information, nor the patient himself or herself, gets lost within the complex system. The coordinating physician must also ensure that other practitioners’ expertise is obtained to address frequently overlooked needs, such as psychosocial distress. Not all providers involved in a patient’s care need or want the entire oncology record. A cardiologist, for example, needs to know how much doxorubicin a patient has received, and a dentist must know what precautions are needed for a patient with a MediPort in place or when there is a history of low platelets. However, synoptic treatment plans and summaries are not simply intended to make care safer and more effective for cancer patients in nononcology settings; they can also help oncologists with coordination. When communicating with other oncologists and between oncologists and their colleagues in closely related fields like surgery and radiation oncology, every oncologist has confronted the onerous task of reading through reams of office notes and flow sheets to ascertain what chemotherapy was delivered, why it was delivered, and how it was tolerated. Communication of the Treatment Plan and Summary, and the PostTreatment Plan Between Medical Oncologists and Patients Oncologists have complex communication responsibilities when talking with patients. They must explain the patient’s diagnosis, prognosis, and therapeutic options in a comprehensible way, and listen to and incorporate patient preferences while formulating a treatment plan. Documenting treatment plans can serve as a valuable springboard for discussion about current and future chemotherapy. That is, systematic review of the information with the patient may help him or her understand the purpose of treatment, and to structure conversations about treatment decisions. Providing patients with a copy of the treatment plan may also empower them to begin conversations with family members and other health care practitioners, as well as their oncologist. Creating documents that patients can review at a later time also addresses the widely recognized phenomenon that patients remember only a small proportion of the information provided during an office visit. A physical (or access to an electronic) record enables patients to review the key content in a more relaxed setting at a place and time when information may be more easily absorbed and shared with others.

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Implementing Cancer Survivorship Care Planning: Workshop Summary After a course of chemotherapy is complete, the summary and plan for follow-up, including surveillance for recurrence and late effects may serve as a valuable foundation for discussion. Providing patients with a document empowers them to communicate effectively with other providers. whether or not they understand every sentence in the document. This may be especially important for non-English speaking patients Practice Efficiency: Minimize the Administrative Burden for Administrators and Staff Information about medical oncology treatment is not recorded in a single place or in a standardized format in health care records. As a result, when multiple oncologists are involved in a patient’s care, they typically request a patient’s entire record and thus create a workload that burdens office staff and physicians. A chemotherapy treatment plan outlining the planned regimen and a subsequent treatment summary describing how treatment was tolerated and the outcomes of care could streamline communication among oncologists and between oncologists and other key cancer-care providers, such as surgeons and radiation oncologists. Facilitate Quality of Care Monitoring and Improvement In order to evaluate the quality of cancer care, it is not necessary to know the number of milligrams of every treatment dose. Neither is it necessary to know the specifics of every dose delay or reduction. The inclusion of chemotherapy treatment summaries in medical charts would have greatly simplified the work of the NICCQ investigators by reducing the need to sift through pages of records that were not relevant to assessing quality. More generally, quality of care monitoring also involves ensuring patients’ safety, both individually and as a member of a group receiving similar chemotherapeutic agents. For example, it is critical to identify harmful effects of chemotherapy drugs that emerge after these drugs have received FDA approval (sometimes called, “after market” monitoring). Treatment summaries that track and aggregate the toxicities that patients experience could greatly facilitate monitoring such unexpected effects, especially if the treatment summary is developed in electronic form with flexible reporting capability. III. The Culture of Medical Records Keeping by Physicians Physicians are required to keep medical records that describe health care delivery. These records serve multiple purposes. They enable the individual physician to recall his or her thoughts and plans from one visit to the

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Implementing Cancer Survivorship Care Planning: Workshop Summary next. Documentation also provides key information to other health care providers working with the oncologist as well as clinicians at other sites. Documentation fulfills a legal function by creating a permanent record of health care. Although some new electronic systems are changing the status quo, medical records are almost always organized chronologically by events, such as visits. The abstraction necessary to create a synopsis is challenging, time-consuming and requires physician input. However, electronic systems can be structured to facilitate this activity by populating specific fields of key relevance such as diagnostic information; for example, site, histology and stage. When care evolves over time, these records become progressively denser and more difficult to review. It is common practice to focus on the most recent history, and for this reason key information may become buried in a thick stack of documents. Consider the challenge for an emergency room (ER) physician evaluating a dehydrated patient with longstanding metastatic breast cancer. The ER physician can easily determine what operations have been performed by searching the record for operative and pathology reports. Episodes of radiation are summarized. Hospitalizations are described with a discharge summary. However, recreating the trajectory of the cancer care history requires review of medical oncology notes to determine the drugs given and the context of treatment. Although this information is available, it is often spread across multiple visit notes, flow sheets, and treatment administration records. It can be sufficiently difficult to reconstruct a cancer history from a medical record that a physician in the ER may avoid the chart altogether and instead try to obtain this history directly from the patient. When patients are careful historians and attentive to important detail, this strategy works reasonably well. However, when patients are too ill to provide history, lack informed caregivers, or have language barriers, they may not be able to provide important information. In addition, records include detail that may not be helpful, even to treating oncologists. A key example is documentation for the purpose of billing. In the mid-1990s, the Health Care Financing Administration (HCFA, now the Centers for Medicare and Medicaid Services or CMS) developed a detailed set of rules delineating documentation standards for billing Medicare. These rules specified the number of items in the physical exam (for example three aspects of the respiratory system) and the number of body systems that need to be included in a systems review in order to bill for complex “evaluation and management” visits. These requirements led to burgeoning detail in medical records and widespread use of templates with detailed physical exams and reviews of systems to support reimbursement. However, this information often has minimal value for either patients or providers. Physicians developed standardized templates

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Implementing Cancer Survivorship Care Planning: Workshop Summary patients are aware of this and are able to take responsibility for obtaining at least some of their necessary care. Others can be empowered if made aware of what the plan should be. There will always be a proportion of patients, however, who lack the knowledge or personality to advocate for themselves. As a result, one of the most valuable features of holding cancer providers responsible for a survivorship care plan may actually be in defining explicitly which providers will take responsibility for different aspects of a patient’s care. Assessing whether the survivor and involved providers are aware of and agree on who will take on the various roles of cancer surveillance, screening for other cancers where appropriate, and noncancer and preventive care is an important end point to consider studying. Acceptability and Satisfaction As different methods of implementing survivorship care plans are developed and tested, the satisfaction with and acceptability of the format of care planning needs to be assessed. For example, will patients accept an off-treatment consult with a nurse practitioner in a survivorship clinic, and are they as satisfied with this as if their oncologist had done it? Will they interact with web-based applications or do they prefer written documents? There are several instruments designed to measure satisfaction that could be adapted to be relevant to questions related to survivorship care planning. Survival Quantity and quality of life are generally considered to be the primary outcomes of biomedical research. Survivorship care plans could affect overall survival by improving adherence to important surveillance recommendations, ensuring optimal noncancer care, and/or by causing positive lifestyle changes. It may be worthwhile to look for this in some studies, but as described above, it may be difficult to detect what would likely be relatively small survival differences in most cases, and follow-up would have to be very long. Quality of Life Quality of life may be affected more directly than survival by survivorship care planning. Having specific recommendations about what to do for follow-up may decrease patient anxiety and ameliorate depressive symptoms. Early identification of late effects with appropriate intervention may decrease physical symptoms and improve functional status. On the other hand, highlighting all of the long-term or late effects that are possible may actually increase distress. Perceived health and self-esteem may be improved

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Implementing Cancer Survivorship Care Planning: Workshop Summary for some patients while others may become overly focused on their previous cancer experience, have increased fear of recurrence, and have trouble moving on with their lives. Consequently, preferences for the health state resulting from implementation of survivorship care plans may be reflected in measurable differences in utility. Processes and Quality of Care While not enough is known about the efficacy of treatment summaries and survivorship care plans to establish the simple fact of their creation as indicators of quality cancer care, some of the processes embedded in the care plans do have sufficient evidence base to be evaluated as measures of quality. In this way, quality of care becomes an outcome by which different models of care can be evaluated. For example, it is widely accepted that colorectal cancer survivors should undergo regular endoscopic surveillance to detect recurrence, new primaries, and/or to remove premalignant polyps. Therefore, studies comparing different “best practice models” could be evaluated to see which one produced the most adherence to this recommendation. Health Care Resource Utilization On the systems level, efficiency is a very important outcome. Any form of care plan implementation is going to consume resources, especially provider time. On a larger scale, health care costs may be affected in uncertain ways. For example, formal plans could decrease patient anxiety and result in fewer interval visits to physicians. Clear information about the likely course of disease and surveillance plan may avert inappropriate workup of probably unrelated symptoms by providers who are less familiar with specific cancer situations. Alternatively, survivors may seek investigation for potential problems they have been made aware of by the survivorship care planning process and would not otherwise have pursued. Also, if successful, survivorship care plans may cause patients who currently are not receiving appropriate surveillance measures to receive them, thereby resulting in increased appropriate health care utilization and costs. Hopefully these latter interventions would also improve health outcomes, however, allowing evaluation of the cost-effectiveness of survivorship care plans. A consideration when studying the economics of this is that the analytic methodology of discounting generally makes interventions like survivorship care plans that have up-front costs but benefits that often do not accrue until many years in the future appear relatively unattractive.

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Implementing Cancer Survivorship Care Planning: Workshop Summary Population The next consideration when designing research is to define the population to be studied. The notion of survivorship care planning applies to all cancer survivors. However, certain elements are more important for some than for others. Patients with very early-stage cancers may not need a specific surveillance plan, as the risk of relapse is vanishingly small. Lifestyle recommendations are more important for a survivor of head and neck cancer, for example, smoking cessation, than they are for a lymphoma survivor. Psychological distress may be more likely in a patient who has undergone disfiguring surgery (mastectomy or colostomy) than one who has had little long-term effect from cancer treatment. The concerns of an adolescent or young adult cancer survivor may have little in common with those of a geriatric oncology patient. The emphasis of the survivorship care plan will have to be tailored to the situation of each survivor, and as such, studies focused on the specific concerns relevant to relatively homogeneous populations of survivors will usually be most informative. Even a study focused on a narrowly defined clinical situation will have to consider the diversity of the survivor population, however. Investigators will need to decide whether they want to study a representative sample of all patients or to focus on the priority areas of a subgroup. For example, how does the information needs of Spanish-speaking Latino survivors differ from those of white English-speaking patients? Should surveillance recommendations be modified in the presence of significant comorbidity? Is a web-based application as helpful to elderly survivors as younger ones? How does socioeconomic status affect the importance of employment and insurance assistance? Are survivorship resources accessible to survivors in different geographic locations across the country and across the continuum of urban and rural settings? Should children and adolescents be included? The tradeoffs necessary when studying defined populations involve balancing the efficacy of a care planning intervention against effectiveness and generalizability, while also considering practical matters of ease of subject recruitment and statistical power. Caregiver Burden Cancer survivorship affects more than just the cancer patient. There is a growing literature on the burden of cancer treatment on caregivers, and the challenges cancer survivors face can similarly affect the health and quality of life of their loved ones. As a result, it is appropriate for investigators to design studies that inquire whether survivorship care planning could affect satisfaction and health-related quality of life outcomes for caregivers as well.

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Implementing Cancer Survivorship Care Planning: Workshop Summary Setting There is no single organizational model that must be adopted in order to deliver high-quality care to cancer survivors. Although the National Coalition for Cancer Survivorship (NCCS) articulated the proposal that “long-term survivors should have access to specialized follow-up clinics that focus on health promotion, disease prevention, rehabilitation, and identification of physiologic and psychological problems,” in reality, whether follow-up is provided by oncologists, PCPs, or specialized survivor clinics is not the important issue. Rather, it is by ensuring that a named provider is responsible for each aspect of follow-up that the chances of quality care occurring will be maximized. In fact, the IOM’s Committee on Health Care Quality in America affirmed that “care based on continuous healing relationships” is important. In other words, patients shouldn’t necessarily be removed from the care of their treating PCPs and oncologists in order to receive specialized survivor care. In addition, other specialists may be involved, and/or a “shared care” model of cooperation between specialists and primary care physicians in the follow-up of the cancer survivors could be attempted. The logistics of implementing formal survivorship care planning would be quite different if it was envisioned to occur in an oncologist’s office, primary care practice, or specialized survivorship clinic. Therefore, in most cases, possibly with the exception of patient-driven care planning formats discussed below, investigators will have to decide and clearly specify which model they will study. Even within a setting there are questions to be addressed about the efficiency, acceptability, and quality of survivorship care planning when it is carried out by treating physicians, allied providers such as nurses or nurse practitioners familiar with the patient, or by providers specialized in survivorship care planning but not familiar with the individual patient, as would be encountered in a specialized survivorship clinic. Few dedicated survivorship clinics currently exist, and they are all quite different. Some only take over the mechanics of surveillance, while others focus on providing primary care, especially to disadvantaged populations. Still others take on a consultative role, looking for signs and symptoms of long-term and late effects and then making appropriate referrals, as well as assisting with the transition consultation and creating a survivorship care plan. In this way, specialized clinics could help with the workload barrier; however, patients and physicians may fear losing contact with each other and so the feasibility of such a model is a question requiring study. Consequently, the fifth recommendation of the IOM report calls for funding organizations to “support demonstration programs to test models of coordinated, interdisciplinary survivorship care in diverse communities and across systems of care.”

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Implementing Cancer Survivorship Care Planning: Workshop Summary Care Plan Format If survivorship care planning is currently carried out at all, it is usually in the sense of informal discussions with patients near the end of treatment about what the plan will be going forward. The IOM report suggests that that should change and provides examples but does not give a specific prescription about what form the survivorship care plan should take. Simply having a consultation in which all the elements of the plan are discussed, leaving the patient responsible to write down or remember the salient points, would probably still be a large improvement over current transition practices. However, it is expected that some form of documentation of the process that can be shared with the patient and other providers would be even more successful. A written consultation note or letter will achieve some of the aims of the IOM, but because of a lack of standardization it is quite likely to miss some of the suggested elements. Standardization of the survivorship care plan to some extent is probably desirable. Some clinics use a combination of general and tailored information to develop a plan for patients. For example, templates can have spaces for a provider to fill in the elements of a treatment summary and surveillance plan on forms preprinted with standard lifestyle recommendations and lists of available resources. There are several examples of this sort of program in individual pediatric oncology clinics, a larger province-wide program in the Canadian province of Ontario, and the patient-centered materials developed by the Lance Armstrong Foundation. Electronic and/or handwritten versions of the templates can be available as necessary and each evaluated scientifically. Creating even a standardized survivorship care plan is time-consuming and difficult, however. Providers could attempt to create a document as they go along during the course of care, but realistically, busy oncologists are usually stretched to their limit dealing with the acute toxicities of treatment and are unable to also work consistently on posttreatment care planning. Templates could increase feasibility if nonphysician staff such as nurses or nurse practitioners could assemble much of the data. Automated systems can be envisioned in which drugs, cumulative doses of chemotherapy, and radiation sites and fractions could be pulled from pharmacy and other administrative records and fed into the evolving treatment summary. Even with standardization and automation, however, creation of a survivorship care plan will still require significant time and resources. Advocacy organizations like the American Cancer Society and Lance Armstrong Foundation have tried to support patient-directed models by providing information on survivorship issues for common cancer types and helping survivors summarize for themselves their medical treatment and plan for follow-up care. It may be that such an approach is more realistic than a physician-based model.

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Implementing Cancer Survivorship Care Planning: Workshop Summary Another big challenge of survivor care is the mobile patient population. A wonderful care plan can be developed, but if the patient subsequently moves to a new area, changes insurers, or even just changes doctors, the information can become practically inaccessible to his/her new providers. Because of this, an important area in need of research is the evaluation of technologies that could create care plans that are truly portable and accessible from almost anywhere. Options include “smart cards” or other media that a patient could physically carry with a large amount of electronic data in a more portable form than a paper record. Another exciting possibility is web-based applications. Patients could control access to a web-based record through standard Internet security measures (e.g., passwords, USB keys). Physicians with limited electronic resources in their practices but with Internet access could contribute to and edit information for the treatment summary and care plan over the web. In this way, a patient’s plan could have input from all relevant providers. If a provider did not have Internet access, it could still provide the information for the patient or another provider to input. If the patient does not have Internet access, the final product could be printed in a hard copy version, thereby getting around the problem of disparities in electronic resources among patients that currently exist. Such formats have been implemented in some controlled settings, but their utility as population-based interventions remains to be established. Study Design Qualitative Research The evaluation of survivorship care plans can involve most types of health services research study designs. Because this is a new intervention, not actually in widespread use, there is a lot of qualitative work to be done to understand the current problems in, for example, coordination of follow-up, or what the most important barriers are to implementing survivorship care planning in practice. Focus groups or key informant interviews could be undertaken with different stakeholders (e.g., survivors, oncologists, PCPs) to explore these issues and inform the design of larger quantitative studies. Case reports can increase awareness of uncommon late effects or describe anecdotal situations in which survivors may find themselves related to work or insurance. Observational Research If the important questions are known, observational studies can be designed to attempt to quantify and prioritize the areas of need. Cross-sectional surveys can address current practices in the various aspects of

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Implementing Cancer Survivorship Care Planning: Workshop Summary survivorship care planning. They can be used to identify deficiencies in patients’ knowledge of their disease and its treatment, the surveillance plan, possible late effects, and resources available to them. Surveys can also be used to document the amount of communication that has taken place between the various specialists and with PCPs. Lastly, surveys can assess satisfaction and acceptability of different models of survivorship care among diverse stakeholders. Some aspects of care relevant to survivorship planning can be observed directly rather than relying on patient or physician report in surveys. Retrospective medical record review and examination of administrative claims data are examples of noninterventional study designs that can confirm practice patterns with respect to surveillance for recurrence and management of long-term and late effects. Studies employing such methods can provide important insight into actual care delivered. Prospective Cohort Studies Different settings and formats for the creation and implementation of survivorship care plans can be piloted in prospective cohort studies. Such studies would generally start with a baseline measure of the outcome of interest, say, knowledge or anxiety. The survivorship care plan would then be implemented and follow-up determinations of the change from baseline would indicate whether the program was considered a success or failure. Other cohort studies would evaluate a nonrandom mix of patients who did and did not receive various elements of a care plan, allowing assessment of outcomes for hypothesis generation. Quasi-experimental studies, in which there are both intervention and control groups but without random allocation of subjects into these groups, can also provide evidence of the effectiveness of survivorship care plans. Such studies can take the form of before/after analyses of outcomes divided at the time of implementation of a survivorship care plan program. This type of research is susceptible to secular trends in outcome, however, which could result from increasing general awareness of cancer survivorship among patients and providers. Another quasi-experimental design could be to take advantage of a natural experiment in which some constituents of a care plan are implemented for one group of patients but not for another similar group. Comparison of outcomes between these groups could provide information about the effects of these parts of the care plan. Randomized Controlled Trials The most powerful study design is the randomized controlled trial. Randomization can be at the level of the patient, although this may lead to

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Implementing Cancer Survivorship Care Planning: Workshop Summary contamination as a provider may become generally more aware of the importance of planning for survivorship and bias the study toward the null by treating control patients more like the intervention patients than they otherwise would. The problem of contamination also precludes the use of crossover designs for most questions related to survivorship care planning. Alternative designs would be to randomize providers or practices, but then there may be an imbalance in characteristics of the providers in each group, or of the patients in these practices, that could affect the outcome of the study. Given the IOM recommendation, investigators should be aware that institutional review boards may not consider it ethical to randomize patients to having no survivorship care planning and so a “usual care” intervention, rather than a placebo, may have to be devised. This could consist of tailored information rather than a formal consultation, for example. Unfortunately, providing an intervention to the control group will bias any study toward the null and necessitate a larger sample size. Examples of Research Questions and Study Designs Question: What are the practical barriers to implementing survivorship care plans in oncology practice? Study Design: Focus groups with providers from a variety of settings (e.g., private practice versus academic centers, different specialties, managed care versus fee-for-service contractors). Questions could try to elicit ideas for ways to facilitate transition consultations and creation of survivorship care plans in real world settings. Key informant interviews with medical directors and practice managers may provide insight into the feasibility of programs that depend on additional investment in information technology. Estimating the resource burden of creating a survivorship care plan could inform policy decisions about reimbursement for survivorship transition consultations. Question: In what areas do patients currently need more information: their diagnosis, previous treatment, plan for surveillance and monitoring, possible late effects, resources available, and/or who to turn to for different problems? Study Design: Cross-sectional survey of survivors of all kinds to assess their current knowledge and desire for information in order to find which elements of the proposed survivorship care plan have the greatest gaps between desired and actual knowledge, and to identify subpopulations of patients in which certain needs are particularly prevalent.

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Implementing Cancer Survivorship Care Planning: Workshop Summary Question: Is there variation in surveillance practice? Study Design: Administrative data analysis of surveillance practices for patients with stage II and III colon cancer, analyzing practice patterns and outcomes by geography, provider and patient characteristics (e.g., age, sex, race, socioeconomic status), organizational and insurance structure, and whether disparities in the quality of follow-up care exist. Question: How much does a transition consultation for survivorship care planning increase patients’ knowledge of their previous treatment and care plan? Study Design: Prospective cohort study in which there is a base-line assessment of stage I–III breast cancer survivors’ knowledge of these areas just after completion of primary therapy via an interviewer-administered survey. All subjects would then have a transition consultation and be given a written survivorship care plan. Six months later another interviewer-administered survey would assess change in knowledge from baseline. Question: What are the effects of survivorship care planning on a survivor’s family and caregivers? Study Design: Prospective cohort study in which prostate cancer caregivers’ burden is evaluated over a 2-year period and related to whether the survivor received a survivorship care plan, adjusted for other explanatory variables. Question: Does survivorship care planning decrease anxiety and depression? Study Design: Before/after study in which anxiety and depression levels are measured in a cohort of patients finishing treatment for Hodgkin’s disease in a major referral center. A transition consultation and survivorship care plan is then implemented at that institution and anxiety and depression levels are evaluated for patients completing treatment in the following year. Question: How does receipt of different parts of the survivorship care plan affect satisfaction with the transition from active cancer treatment? Study Design: Analysis of data from a natural experiment in which different practices have implemented different parts of the care plan. Patients in each practice can be surveyed to assess their levels of satisfaction and differences related to the part of the care plan they received. Question: Are transition consultations with a specialized survivorship nurse practitioner acceptable to patients? Study Design: Randomized controlled trial in which head and neck cancer patients are randomized between either having a survivorship

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Implementing Cancer Survivorship Care Planning: Workshop Summary care plan created by a specialized nurse practitioner during a consultation in a survivorship clinic or during a routine visit with their medical oncologist near the end of primary therapy, comparing measures of satisfaction between the two groups. Question: Can specific interventions targeted to lifestyle changes to decrease risk behaviors be more successful in the context of survivorship care planning. Study design: Randomized controlled trial in which breast cancer patients completing adjuvant chemotherapy all receive a transition consultation and survivorship care plan, but half are invited to take part in an intensive diet and exercise intervention immediately, while the other half receive the same intervention 6 months later. Acceptance, compliance, and measures of dietary and exercise improvement would be the outcomes. Question: Does survivorship care planning decrease unnecessary health care resource utilization? Study Design: Practices are randomized between usual care: giving patients individually-tailored treatment summaries, informal discussion of surveillance plans, and standard information about available resources; and an intervention group in which the survivorship care plan explicitly lays out the plan for surveillance and which symptoms should prompt medical evaluation. Data collected will include the costs associated with creating the care plan, and enumeration of physician visits and investigations received. This study could also inform cost-effectiveness analyses should improvement in survival and/or quality of life be found to be attributable to institution of such plans. Question: Which format of survivorship care plan is most effective at increasing communication among providers? Study Design: Practices are randomized between web-based and paper versions of the survivorship care plan (with copies sent to all involved physicians). Survivors’ PCPs are later asked to answer basic questions about the survivor’s cancer and its care, using records available in their office. Conclusion Over time, as studies evaluating the effects of survivorship care planning on relevant outcomes are carried out, they would serve as the basis for secondary data analyses such as systematic overviews and technology assessments. Surveillance practices have already been the subject of several meta-analyses and decision analyses but this is only one component of care

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Implementing Cancer Survivorship Care Planning: Workshop Summary planning. Rigorous efficacy and effectiveness data would lead to the development of evidence-based clinical practice guidelines for survivorship care planning (the IOM report’s third recommendation), thereby creating standards of care. From such standards, quality indicators related to survivorship care (promulgated in the fourth recommendation of the IOM report) could be identified and validated. This would spawn a field of inquiry related to access to care and disparities for different survivor populations. The fifth recommendation in the IOM report calls for funded demonstration programs to test models of care, and the final recommendation advocates that public as well as private agencies such as insurance plans should increase their support of survivorship research and expand mechanisms for its conduct. This last recommendation is actually the first step in all of this, however, as establishing an evidence base for the creation and implementation of survivorship care plans through the type of research outlined herein is necessary to realize the IOM’s vision in which attention to the transition from cancer survivor to cancer patient is accepted as a routine part of oncology practice. REFERENCES 1. Johnson FE: Overview, in Johnson FE, Virgo KS (eds): Cancer Patient Follow-Up. St. Louis, Mosby, 1997, p. 4. 2. Ganz PA: A teachable moment for oncologists: cancer survivors, 10 million strong and growing! J Clin Oncol 23:5458-5460, 2005. 3. Miedema B, MacDonald I, Tatemichi S: Cancer follow-up care. Patients’ perspectives. Can Fam Physician 49:890-895, 2003.