Need for Standardized Models of Care

Much of what is known about how long patients with cancer should be observed, and by whom, comes from pediatric cancer studies.^5,6 Even among adult pediatric cancer survivors, many are lost to follow-up as they discontinue services with their pediatric oncology providers.^7,8 Less is known about the care of survivors of adult-onset cancers who most frequently receive their care in the community, in contrast to survivors of pediatric cancers. Much of the literature is based on secondary database analyses or surveys.^9–14 What is clear is that as time from an initial cancer diagnosis elapses, survivors are more likely to receive care from their PCPs,¹⁴ and survivors with several comorbidities receive care from multiple providers.^14,15 This underscores the need to coordinate care among providers. Because no uniform standards for the care of survivors exist, significant efforts are required to understand the needs of survivors and to develop models of comprehensive, coordinated care that meet those needs.

Lack of Clinical Guidance

A major clinical barrier to standardizing survivorship care is the lack of guidance on the management of survivors with diverse cancer types treated across an age spectrum with heterogeneous approaches and modalities that continue to evolve over time. To address this barrier, an exposure-based approach has been used to coordinate pediatric survivor care that includes health screening and counseling based on the specific chemotherapeutic agents, radiation doses and volumes, and surgical procedures.¹⁶ Alternative approaches include a disease-based approach that focuses on the therapeutic modalities and health concerns related to a specific malignancy (eg, breast or prostate cancer), an organ-system approach that focuses on specific organs or organ systems affected by the cancer or cancer therapy (eg, cardiovascular or pulmonary outcomes), and a symptom-based approach (eg, fatigue or sleep disturbances). Regardless of the approach that is taken, guidance on the clinical management of cancer survivors is sorely needed to address the needs of this growing population.

Access to High-Quality Survivorship Care

As in cancer treatment, racial/ethnic and socioeconomic disparities also exist in cancer survivorship care. Lack of access to survivor care services is a major barrier to the health and well-being of cancer survivors who lack health insurance or who experience exclusions or restrictions on their policies. Although the recently passed health reform bill—the Patient Protection and Affordability Act (PPACA)—addresses many of these issues, a comprehensive, coordinated approach to cancer care is still needed to ensure access to high-quality cancer care.

From a care delivery standpoint, survivorship care has been identified as an important but non–revenue-generating service because of the limited or lack of reimbursement for significant components of the care.¹⁷ This phenomenon has resulted in a misalignment of care, whereby revenue-generating services (eg, surveillance testing) may be overused, and important but non–revenue-generating services (eg, aspects that might improve coordination of care) are underused. Developing evidence-based guidelines for survivorship care will provide the quality-based underpinnings to define the right care, making the case for increased reimbursement of these services stronger. These issues must also be considered in the context of care that is typically delivered in a variety of clinical settings, which may involve oncology, primary care, and subspecialty practitioners.

Research Needs

Increased research is greatly needed to expand the evidence base required to define optimal care delivery, including the type or components of care delivered, the manner in which that care is delivered and by whom, and the efficacy of the various models of care. Economic constraints continue to pose barriers to federal and other research investment in studies designed to explore care models and improve our understanding of the late effects among cancer survivors.

Guidance on the Clinical Management of Cancer Survivors

The 2005 IOM report recommended that “health care providers should use systematically developed evidence-based clinical practice guidelines, assessment tools, and screening instruments to identify and manage late effects of cancer and its treatment.”^4(p5) In pediatric cancer, survivorship care has been a consistent part of care for more than two decades because of the high rates of survival in pediatric cancers and the likelihood of treatment and post-treatment follow-up in multidisciplinary centers. Long-term follow-up of pediatric cancer survivors has led to an extensive evidence base linking specific therapeutic exposures with adverse outcomes as well as data to identify at-risk groups. This evidence base has been used by pediatric cooperative groups to develop guidelines for survivorship care that include systematic plans for screening, surveillance, and prevention.¹⁶

In contrast, survivorship care after treatment of adult-onset cancers more often focuses on surveillance for cancer recurrence and does not consistently address health promotion, primary or secondary cancer prevention, or symptom management of common long-term and late effects. Because of insufficient high-quality evidence to inform recommendations for follow-up care, previous efforts to develop guidelines have been unsuccessful.¹⁸ Presently, there are no standardized practice guidelines for post-therapy management of survivors with respect to early detection of long-term complications and health promotion. Clinicians need a codified set of best practices to guide them in the follow-up care of cancer survivors, individualized by disease, stage, and treatment.

To address this need, ASCO aims to optimize the long-term follow-up of cancer survivors by developing guidance for their clinical management. This guidance will be consensus based and informed by the evidence in the extant literature regarding the associations between therapeutic exposures and the specific outcomes (recognizing that many of the data do not distinguish between specific cancer diagnoses and/or age of exposure). The guidance also will be informed by the moderating influences of comorbidities, lifestyle, and exposures, again drawing on evidence from the general population or extant literature in other diseases.

As a first step, the Cancer Survivorship Committee is partnering with the ASCO Clinical Practice Guidelines Committee to develop clinical guidance for oncologists on the management of late and long-term effects. This guidance will use the newly established modified Delphi approach of ASCO for obtaining expert consensus after systematic review of the literature.¹⁹ In developing this guidance, ASCO will rely on the expertise of clinicians well versed in the care of cancer survivors when developing suggested recommendations for screening of late effects, in terms of who should be screened (at-risk population), what modalities should be used (screening tests), and the frequency (intensity) and duration of screening (period at risk). These recommendations will be evaluated periodically and updated when needed to reflect any new evidence in the literature. As these recommendations are used in clinical practice, they will be refined to reflect the clinical experience gained from their usage—both in terms of the yield of the screening tests, the extent to which effective treatments are available, and the cost effectiveness of using these recommendations. This will be accomplished through ASCO quality improvement mechanisms, as described later in this article.

Applicability to Nononcology Settings

It also is important that evidence-based recommendations be accessible to nononcologists and serve as a foundation to codify best practices for all survivorship care settings.⁴ For this reason, the ASCO guidance will be designed to be applicable to all medical settings, not just the academic setting, as well as disseminated broadly for implementation on a large scale to oncologists, patients, and other providers, including nurse practitioners, physician assistants, and primary care physicians.

Use of Existing Nononcology-Based Guidelines

Importantly, ASCO acknowledges that other general health guidelines and guidance exist outside of the oncology spheres that are relevant when treating cancer survivors. Oncologists might not be up to date on this guidance specifically (eg, bone health monitoring, osteoporosis prevention, exercise and diet recommendations, smoking cessation and tobacco control, and sexual and reproductive health). For this reason, encouraging adherence to relevant general population guidelines is vital.

Academic Models

Most academic cancer centers and programs in the United States, Europe, Australia, and Canada have developed, or are in the process of developing and evaluating, various models of care. Some clinics are embedded within a specific disease (eg, breast cancer) management team; others serve survivors of different cancers. Most groups have adopted either a consultative or a longitudinal model. In the former, survivors are seen for a one-time consultation, during which a cancer treatment summary/survivorship care plan is developed, and the survivor is provided with tailored information and, if needed, referral to specialized services are made. After this visit, the survivor returns for long-term care with his or her oncologist or PCP. Clinics adopting the longitudinal model receive survivors transitioned from their oncologist, generally 1 to 5 years after completion of therapy, and then provide ongoing survivorship care.

Community Practice Models

In the community setting, many oncology practices have similarly implemented survivorship clinics or expanded the services they provide. The National Cancer Institute (NCI) provides funding to 30 community cancer centers in 22 states through the NCI Community Cancer Center Program (NCCCP).²¹ A key aim of this program is to enhance cancer survivorship care services available at community hospitals. Resources developed through the NCCCP network are made available to other community cancer programs through publications, presentations at national meetings, and through the NCCCP Web site.²¹

Integration With Primary Care

Regardless of the survivorship care model, the PCP must be better integrated into the system. Numerous surveys have described the general lack of knowledge and discordance in management preferences among oncologists, PCPs, and cancer survivors.^13,22–26 Several studies have found that cancer- and non–cancer-related preventive services are more likely to be up to date for cancer survivors observed by both an oncologist and a PCP, in comparison with care by a single provider.^9–11,27,28 However, there is consensus that both types of health care providers (ie, cancer specialists and PCP) are important to the long-term health of the cancer survivor and that nurses and nurse practitioners are integral to this care, both within the oncologist's practice as well as in the PCP's office.^4,20

Some cancer survivors, perhaps 20%, had low-intensity cancer treatment and have a low risk of recurrence. They may have few physical problems after their cancer, experience no lasting toxicity of therapy, and have minimal risk for late-occurring health problems related to the cancer therapy. At the other extreme, some survivors have either a high risk of recurrence, severe organ dysfunction persisting well beyond the cessation of cancer therapy, or a substantially high risk of serious late effects. In the middle of this continuum are most cancer survivors, who have varying risks that are modified by their comorbid health conditions, lifestyle health behaviors and practices, and genetic predispositions. Heretofore, most cancer specialists have treated all of the above in the same fashion, an approach that results in an inappropriate allocation of finite resources. With spiraling health care costs globally, a more parsimonious approach must be taken regarding the care of cancer survivors. The notion of an oncologist observing all cancer survivors for the rest of their lives may not be the best use of resources for every patient with cancer. Models of risk are needed to stratify cancer survivors into different levels of intensity and settings for follow-up care. Components needed in such models include risk of recurrence, persistence of moderate to severe toxicity of therapy, risk of serious physical late effects, and psychosocial status.

Shared-Care Model

Ideally, a shared-care model, using a risk-stratified approach, can take advantage of the expertise of the cancer team and the PCP in coordinating survivor follow-up.²⁰ The United Kingdom National Cancer Survivorship Initiative is integrating a risk-stratified approach in the upcoming national plans for care of cancer survivors. Using this approach, when a patient is diagnosed with cancer, he or she is referred from the PCP to the cancer specialist. The cancer specialist then communicates with the PCP, providing a written cancer treatment summary. The cancer specialist is the cancer care provider for the patient throughout the period of cancer therapy and during the time post treatment when the patient is at highest risk recurrence, while the PCP continues to deliver non–cancer-related care. On completion of therapy, the cancer specialist provides a written treatment summary and survivorship care plan to both the patient and PCP.

Use of Treatment Summaries and Care Plans

To ensure care coordination among oncologists, PCPs, and other providers, ASCO promotes the use of written treatment summaries and care plans, which communicate the survivor's health status, provide a care roadmap to ensure survivor-appropriate services, and clearly delineate which provider is responsible for which aspect of care.^4,12,29 Adherence to this practice is a core measure of the ASCO Quality Oncology Practice Initiative (QOPI) and is also an American College of Surgeons Commission on Cancer Program Standard for 2012.³⁰ ASCO recommends providers take into consideration several components of care when developing survivorship care plans (Table 1).

Quality improvement data from QOPI consistently show low use of treatment summaries and care plans. An important issue is the significant time and resource barriers to developing the summaries and care plans in the community setting.³³ Ultimately, the patient can be transitioned (based on a risk assessment) to the PCP, who can then integrate his or her survivorship care into a comprehensive health care and wellness program. Grunfeld et al^34–36 have performed a series of studies showing that this approach is effective and cost efficient in the care of patients with breast cancer who have a low risk of recurrence and are without major cancer-related problems. The Cancer Survivorship Committee is partnering with the ASCO Quality of Care Committee to assess how to increase the utility and uptake of treatment plans and summaries and what changes are needed for this to occur. One important issue to address is better integration of treatment plans and summaries into electronic health records. In this respect, development of an automated, programmable application to expedite the process of treatment planning and care plan summaries is an important goal.

ASCO recognizes there is no established framework of optimal care and transitions across the survivorship spectrum; it is committed to working with other stakeholders in the oncology community to identify and promote survivorship care models that are coordinated and interdisciplinary and fit a variety of community and care settings. To this end, ASCO has begun development of a compendium of survivorship tools and resources for oncology providers. An important component of this compendium will be capturing the different models that are being used today by oncologists, including insight from providers on the resources needed, the pros and cons of the model being practiced, and lessons learned.

Ultimately, the testing of various models through demonstration projects is needed to identify optimal methods of care, and dissemination of information and education on these models to both providers and patients will be necessary. ASCO is committed to partnering with others in the oncology community to move the field in this direction.

Integrating Survivorship Into Graduate Medical Education

Post-treatment survivorship care, as a distinct phase of the cancer care trajectory, is a relatively new concept, and current health professional academic curricula generally do not reflect this change. Several areas have been identified as essential for survivorship care training, listed in Table 2. According to an IOM review of the curricula for medical oncology in graduate medical education programs, only some of the required content areas are currently represented.⁴ One content area of particular importance is planning follow-up care and coordination of care in a shared-care model. Oncologists remain uncertain about whether survivors receive survivor-appropriate care once in the primary care setting¹³; likewise, PCPs may be anxious about caring for survivors because of their lack of involvement in and communication about their patients' care during active cancer treatment.^15,26,34,36 This anxiety is exacerbated when a survivor's care is transferred back to the PCP, who may be unfamiliar with follow-up and long-term care guidance.³⁹ Furthermore, patients often expect oncologists to be the only providers of their cancer care and express concerns about PCPs' perceived lack of knowledge in providing survivorship care. Along with its efforts to increase provider confidence in providing survivorship care via the promotion of evidence-based educational opportunities, ASCO should develop an ongoing relationship with nononcology specialty boards to collaborate in determining the specific knowledge for which these boards require proof of proficiency for certification.

Identifying Knowledge Gaps

Critical to the process of research planning and prioritization is the identification of knowledge gaps. Key areas of interest include the differential and/or cumulative impact of organ dysfunction and other morbidities that develop and become clinically detectable long after the active treatment of cancer. Improved understanding of correlations between comorbidities, genetics, treatment-related exposures, and quality of survivorship is essential. The development of a research agenda requires some degree of consensus on prioritizing efforts regarding specific outcomes of interest: second cancers, organ-system toxicities, and functional status in multiple domains, including psychosocial health, premature death, and testing of therapies to ameliorate long-term and late effects. Another broad area of likely research interest and importance relates to survivorship care delivery; thus, models of care specific to patient populations and practitioner and institutional resources, preferences, and limitations require defining best practices in the context of health services research.^13,42

Inventory of Existing Research Activity

Essential to the process of strategic research planning is the development of an inventory of existing research initiatives and activities. Given the current environment, needless duplication should always be avoided. A recent literature review and summary of survivorship research activities at NCI-designated cancer centers provide a framework and justification for assessing ongoing or recently completed, peer-reviewed, and externally funded research projects outside of the cancer centers program.⁴³ A more holistic assessment of federally funded, state-funded, and private research portfolios could prove useful in determining the scope and breadth of research in this area. As a first step in capturing a broader representation of projects, ASCO is surveying its membership with a goal of ascertaining members' perception of the importance and their personal level of interest and engagement in survivorship research. A second aim is to generate data on study questions, patient populations examined, primary and secondary end points, participating sites, sample sizes and study designs, and funding sources. Analysis of these data will help to address knowledge gaps and prioritize research efforts moving forward.

Leveraging NCI Reorganization to Better Integrate Survivorship Research

The current redesign and reorganization of the NCI clinical trial enterprise represent an opportunity to advance a cancer survivorship research agenda within NCI-sponsored clinical trials. This could be achieved through expansion of existing special funding mechanisms such as the Biomarker, Imaging and Quality of Life Studies Funding Program from the Divisions of Cancer Treatment and Diagnosis and Cancer Prevention. ASCO can advocate for appropriate survivorship expertise representation on each of the NCI disease-specific steering committees directed by the NCI Coordinating Center for Clinical Trials. Similarly, the Quality of Life/Symptom Management Steering Committee can be tasked with assuring that survivorship research interests are adequately represented in trials supported by the Cancer Therapy Evaluation Program and the NCI Divisions of Cancer Therapy and Diagnosis and Cancer Prevention. Embedding survivorship objectives into specific front-line treatment trials may facilitate evaluation of the effects of multiple factors including sex, age, and pretreatment functional status on long-term health. This could in turn inform the design of subsequent intervention studies within similarly treated patient populations. Evaluating similar end points across a spectrum of trials for different diseases may prove helpful in uncovering exposure relationships between other clinical variables. The cooperative group/cancer center enterprise-wide implementation of a standardized clinical data management system will simplify the data submission and management requirements, as will the development of a limited, pertinent set of data elements. When validated and standardized, these would prove useful in the setting of cross-study comparisons of treatment effects on survivorship measures of interest.

Promoting Innovative Research Methods

Addressing real and perceived barriers to survivorship research requires innovative approaches to clinical research methods. Given the constraints on investigator and institutional resources, consideration should be given to maximally use methods of data self-reporting by study participants. As well, a uniform treatment summary, completed at the conclusion of protocol therapy, can facilitate the capture of details to evaluate possible exposure relationships and the risk of long-term and late effects.

Leveraging Opportunities in Health Reform

Survivors and their providers should look for opportunities to leverage the provisions of the PPACA designed to assist in care coordination, such as those addressing accountable care organizations (ACOs), community health teams, and medical homes, where available (Table 4). The recent federal rule defines an ACO as a group of providers or service suppliers working together as a team to coordinate care for original Medicare beneficiaries (this rule does not apply to Medicare Advantage).⁴⁵ Although controversial, the new policies governing ACOs have emphasized the need for patient-centered, coordinated care. The rule also recommends that ACOs develop care plans for high-risk individuals, a strategy that holds particular promise for cancer survivors who often must see multiple specialists and providers.⁴⁵ ACOs also emphasize evidence-based care, which, if achieved, could assure that survivors receive quality care from their medical teams. Although these provisions of the PPACA are promising, it is important that policymakers, at both the state and federal levels, adopt safeguards to help ensure that all cancer survivors have access to adequate and affordable care. In a similar vein, a PPACA provision for community health teams provides grants for health care entities to create coordinated interdisciplinary and interprofessional teams of health care providers with the goal of working with PCPs to integrate and coordinate care for patients outside of ACOs.⁴⁶ The medical homes provision allows states to use existing Medicaid care structures to encourage health professionals to provide, among other services, coordinated care for individuals with chronic diseases by paying these groups at an enhanced federal matching level.⁴⁶ For inclusion of follow-up care of cancer survivors within the medical homes framework, it is imperative that cancer be considered a chronic disease.

Safeguards for Access Through Adequate Coverage and Reimbursement

One major barrier to widespread implementation of coordinated care strategies for cancer survivors is the lack of coding and reimbursement policies that adequately reflect the delivery of survivor-specific services. With the elimination of consultations from Medicare as reimbursable services, a lack of a clear reimbursement structure exists for physicians treating survivors, leading to unfair and inadequate reimbursement for these services. The Comprehensive Cancer Care Improvement Act, reintroduced to Congress in December 2011, aims to address this issue by creating a Medicare reimbursement structure for cancer care planning while authorizing funding for educating health care professionals on the development of coordinated cancer care plans and grant funding for survivorship research.⁴⁷ ASCO supports the Comprehensive Cancer Care Improvement Act and recommends physician reimbursement for survivorship care be adequate to support robust discussion of issues with patients with cancer and cancer care planning, including medical, psychosocial, and access issues.⁴⁸ In addition to cancer care planning, ASCO supports Medicare reimbursement to cover survivorship services related to surveillance, prevention, and management of late effects. In an effort to identify which health care services are essential to providing optimal health care to survivors, ASCO will work with stakeholders to identify a set of essential health benefits for cancer survivors and advocate for coverage of these services.

Education of Policymakers

Increasing policymaker awareness of cancer survivorship issues is also important to ensuring widespread support and policy implementation of key quality survivorship care provisions. Policymakers at all levels should be educated on what cancer survivorship is, why it is important, and how survivors are affecting our health care system. Congress should encourage the National Institutes of Health, the Centers for Disease Control and Prevention, and other federally funded agencies to develop comprehensive cancer control strategies that include consideration of survivorship care. Also, Congress should promote the implementation, evaluation, and refinement of existing cancer control strategies. ASCO is committed to working with policymakers to increase awareness of the unique issues of cancer survivors and the policy changes needed to improve their care.

Research

Because the need for additional clinical evidence on survivorship care is significant, advocating for financial support of research for survivorship care is key to moving survivorship care forward. The government should fund research to strengthen the evidence supporting cancer care recommendations and guidelines. When such guidelines are supported by more robust evidence, it will become easier for patients to secure coverage for guideline-recommended treatments.⁴⁸ ASCO is committed to ensuring that the long-term implications of survivorship issues remain at the forefront of our national cancer care discussion, especially when considering the ever-growing population of cancer survivors.