The ABCs of Achieving High Quality Survivorship Care Melissa M. Hudson, MD Cancer Survivorship Division

Overview Epidemiology of survivorship Health risks affecting survivorship Risk-based survivor care Strategies and tools to achieve quality survivorship care Clinical practice guidelines Survivorship care plans Models of survivorship care

Epidemiology of Cancer Survivorship 68% with 5-year survival in U.S. 83% in childhood cancers (0-14 years) 13 million survivors 18 million by 2022! Lifetime probability of cancer in U.S. Men: One in 2 Women: One in 3 Majority diagnosed > 60 years of age Surveillance Epidemiology, and End Results, 2002-2008

Fertility & Reproduction Recurrent primary cancer Health Concerns Growth & Development Organ Function Psycho- social Fertility & Reproduction Subsequent Cancers Linear growth Skeletal maturation Intellectual function Emotional/social maturation Sexual development Sexual functioning Fertility Health of offspring Cardiac Pulmonary Endocrine GI/Hepatic Genitourinary Musculoskeletal Neurologic Recurrent primary cancer New primary neoplasms Mental health Education Social interactions Physical & body image Chronic symptoms Employment Insurance Cancer After Cancer

Cumulative Prevalence Prevalence of health conditions in childhood cancer survivors in St. Jude Lifetime Cohort 0.0 0.2 0.4 0.6 0.8 1.0 Cumulative Prevalence 10 20 30 40 50 60 Age in Years Any chronic condition Serious/life-threatening chronic condition Clinical ascertainment of late effects in 1713 adult survivors Median age at Dx: 6 yrs (range, 0-24) Median age at study: 32 yrs (range 18-60) Median time from Dx: 25 yrs (range 10-47) By age 45 years it is estimated that…… 95.5% will have > 1 chronic health condition 80.5% will have a serious/disabling or life-threatening chronic health condition Hudson et al, JAMA, 2013

Survival function estimate Late Mortality in 5+ Year Survivors All Cause Mortality in the CCSS Cohort 1.00 US Female US Male 0.95 Population Controls 0.90 Survival function estimate Cancer Survivors 0.85 Second cancer 15.2 13.9 – 16.6 Cardiac 7.0 5.9 – 8.2 Pulmonary 8.8 6.8 – 11.2 SMR 95% CI 0.80 CCSS Female 0.75 CCSS Male 0.70 5 10 15 20 25 30 35 Years since diagnosis Mertens, et al, JNCI 2008

Improving Survivorship Outcomes Health-related and QOL Outcomes CANCER SURVIVORS High-risk Groups Development of Intervention Strategies Evidence-based Clinical Care Guidelines Clinical Trials of Efficacy Implementation . “Secondary “ Prevention “Primary” Prevention Cancer Diagnosis and Treatment

Issues Impacting Cancer Treatment Associated Morbidity Provider Patient Cancer Health Care System Cancer Treatment Morbidity

Issues Impacting Cancer Treatment Associated Morbidity Provider Patient Cancer Health Care System Histology/involved sites Biology/response Treatment Surgery Chemotherapy Radiation Transplant Transfusion Treatment events Cancer Treatment Morbidity

Issues Impacting Cancer Treatment Associated Morbidity Provider Patient Cancer Health Care System Age at treatment & attained age Sex, race & ethnicity Familial & genetic factors Pre & co-morbid conditions Health behaviors Cognitive & developmental status Health knowledge Health risk perceptions Self efficacy Insurance & healthcare access Cancer Treatment Morbidity

Issues Impacting Cancer Treatment Associated Morbidity Provider Patient Cancer Health Care System Survivorship education & training Survivorship experience Practice style Perceptions regarding preventive care Access to survivorship resources Knowledge & access to individual survivor health history Cancer Treatment Morbidity

Issues Impacting Cancer Treatment Associated Morbidity Financing & payment policies Organization & affiliation of providers Data systems & information sharing Models of survivorship care Insurance coverage and benefits supporting survivorship care (especially preventive, psychosocial services) Community resources Survivorship advocacy activity Provider Patient Cancer Health Care System Cancer Treatment Morbidity

Achieving High Quality Survivorship Care Provider Patient Cancer Health Care System Cancer Treatment Morbidity

Risk-Based Survivor Care Surveillance for primary/subsequent cancers Screening and management of late effects Assessment and support of psychosocial functioning Education about cancer-related health risks and behaviors/conditions modifying risk Assistance with identifying and meeting medical and psychosocial challenges

Institute of Medicine, 2005 “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.”

Pediatric Guideline Design Evidence linking late effects with therapeutic exposures Screening recommendations based on expert clinical experience Allows identification of high-risk categories Matches magnitude of risk with intensity of screening Evidence-Based Guidelines for Childhood Cancer Survivors: A Hybrid Model

www.survivorshipguidelines.org

Clinical Practice Guidelines Exposure-based Includes screening and counseling based on specific chemotherapy, radiation doses/volumes and surgery Disease-based Focuses on modalities and health concerns related to a specific malignancy (e.g., NCCN breast, prostate) Organ-system based Considers specific organ systems affected by cancer or cancer therapy Symptom-based Targets symptoms common to many cancer diagnoses and treatment (e.g., fatigue, sleep, cognition)

Guidance for Long-Term/Late Effects Depression & anxiety Fatigue Neuropathy Weight change Sexual dysfunction Cardiac dysfunction Chronic pain Lymphedema Osteoporosis Cognitive dysfunction Impaired fertility Second cancers Menopausal symptoms

Institute of Medicine, 2005 “Patients completing primary treatment should be provided with a comprehensive care summary and follow-up plan that is clearly and effectively explained.”

Care Across Survivorship Spectrum Primary Interventions Risk-adapted therapy considering cancer- and host-related factors Cancer Diagnosis Secondary Interventions Health education Health screening/surveillance Risk-reducing interventions Long-Term Survival Oncology Care Survivor Health & QoL Thus we arrive at a model using primary prevention measures starting from cancer diagnosis in a pediatric healthcare setting that shifts to secondary prevention measures when long-term survival is achieved that requires transition from a pediatric to adult health care setting. Primary Care Hudson M, Cancer 2005

Challenges with Care Transitions Survivors/Families Are uninformed about details of cancer history Have strong bond with treating clinicians Fear transition Oncology providers Want to see long-term survivors May not prepare survivor/GP for care transition May not be informed about survivorship issues May not consistent address preventive care

Challenges with Care Transitions Primary care providers Unfamiliar with survivor health issues Subtypes are numerous/diverse Treatments are diverse/constantly evolving Have limited incentive to develop expertise Many subtypes are rare May be uncomfortable with caring for survivors, especially those who are medically complex

Oncology & Primary Care Providers Awareness of Late Effects Survey of PCPs (n = 981) and Oncologists (n = 1,125) from AMA Masterfile Absolute response: 57.6% (PCPs, 57.9%; oncologists, 58.3%) Late Effect (Therapy) Oncologist Aware PCP Aware Cardiac dysfunction (doxorubicin) 95% 55% Neuropathy (oxaliplatin) 97% 22% Premature menopause (cyclophosphamide) 71% 15% Nekhlyudov, JOP, 2013

Survivorship Care Plan Personalized document from oncology clinician: Summary of cancer history/treatment Primary cancer surveillance plan Cancer/cancer treatment health risks Subsequent cancer/late effects screening Lifestyle impact on cancer-related risks Screening for/management of comorbid conditions Definition of roles of involved providers Resources to address medical/psychosocial needs

Survivorship Care Plans (SCPs) in Research and Practice Do SCPs address known deficiencies in care? Do they promote comprehensive care? Can they be developed in busy clinics? Are they being used once provided? When is the optimal time to provide them? Have SCPs been implemented widely? Do SCPs include info recommended by the IOM? The Institute of Medicine (IOM) recommends the use of survivorship care plans (SCPs) for all cancer survivors. Developing useful SCPs requires understanding what survivors and their providers need and how SCPs can be implemented in practice. Published studies investigating the perspectives of stakeholders (survivors, primary care providers, and oncology providers) were reviewed regarding the content and use of SCPs. All National Cancer Institute (NCI)-designated cancer centers were surveyed concerning the extent to which SCPs for survivors of breast and colorectal cancers are in use, their concordance with the IOM’s recommendation, and details about SCP delivery. Survivors and primary care providers typically lack the information the IOM suggested should be included in SCPs. Oncology providers view SCPs favorably but express concerns about the feasibility of their implementation. Fewer than one-half (43%) of NCI-designated cancer centers deliver SCPs to their breast or colorectal cancer survivors. Of those that do, none deliver SCPs that include all components recommended by the IOM. Survivors’ and providers’ opinions about the use of SCPs are favorable, but there are barriers to implementation. SCPs are not widely used in NCI-designated cancer centers. Variation in practice is substantial, and many components recommended by the IOM framework are rarely included. CA Cancer J Clin 2012;62:101-117. VC 2012 American Cancer Society. Salz, CA Cancer J Clin, 2012

Survivorship Care Plans (SCPs) in Research and Practice Concerns regarding feasibility of implementation Limited data suggesting suboptimal uptake and adherence to inclusion of IOM components Limited data addressing impact on health outcomes and access to care No data evaluating cost to benefit of SCPs Consensus regarding potential benefits in education and care coordination A recent trial by Grunfeld et al is the only study to investigate the role of SCPs on health outcomes. 57 In a randomized controlled trial of 408 survivors of early stage breast cancer, all patients had their care transferred to a primary care provider for exclusive follow-up. In addition, patients in the intervention group received a comprehensive SCP that was reviewed in a 30-minute educational session with an oncology nurse. The SCP was also sent to the patient’s primary care provider. A year after the intervention was delivered, there were no differences detected between groups on self-reported health outcomes, including cancer-specific distress, generalized distress, patient satisfaction, and general health status. Self-reported continuity of care and the identification of the primary care provider as the physician primarily responsible for follow-up also did not vary between groups. These findings suggest that for survivors of early stage breast cancer, an SCP in itself may not improve health outcomes. However, actual care provided by primary care providers was not assessed; the possibility remains that health outcomes may differ if primary care providers who receive SCPs deliver care differently from providers who do not receive SCPs. Salz, CA Cancer J Clin, 2013

Need for SCP research Critical components Optimal format(s) Timing of delivery Impact on health outcomes Cost: benefit

Institute of Medicine, 2005 “…qualified organizations should support demonstration programs to test models of coordinated, interdisciplinary survivorship care in diverse communities and across systems of care.”

Models of Survivorship Care Time Treatment of Cancer Cancer Center Follow-up Long-Term Follow-Up CommunityFollow-up tertiary care centers with consultative services, free-standing cancer centers that integrate survivorship care within their disease-oriented teams using advanced practice nurses Shared Care Specialized LTFU Clinic Other Models Adapted from Singer et al, Pediatr Blood Cancer, 2013

Models of Survivorship Care Specialized LTFU Program Usually based at cancer center Cancer-related consultations General or disease-oriented Most do not provide primary care Multidisciplinary care team Medical Psychosocial Core components Survivorship care plan Delivery of risk-based care Venue for research & training health care professionals tertiary care centers with consultative services, free-standing cancer centers that integrate survivorship care within their disease-oriented teams using advanced practice nurses

Models of Survivor Care Specialized LTFU Program Community LTFU Care Backbone of care for pediatric survivors Limited number see adults Cancer-related consultations Based at hospital or cancer center Multidisciplinary care team Medical Psychosocial Core components Survivorship care plan Delivery of risk-based care Venue for research & training health care professionals Geographically and financially more accessible Integrates survivor care and primary care Focus on primary care health education Less focus on cancer-related health education Risk-based survivor-focused care dependent on provider/ survivor knowledge Supports independence of young adult survivors Poses challenges to outcomes research

Shared Survivorship Care Follow-up in cancer center with transition to community Ongoing contact with community providers Continuous availability of cancer center team Provides services to larger number of survivors Potentially more cost-effective than cancer center follow-up Maintains link to cancer center to monitor late outcomes

Gaps in Knowledge Regarding Long-term Outcomes: A Theoretical Model 1.00 Cancer Survivor Population General Population Excess Lifetime Morbidity Associated with Cancer and Therapy ? .75 .50 Cumulative Incidence Advanced Onset of Morbidity Associated with Cancer and Therapy ? .25 0 10 20 30 40 50 60 70 Age (Years) Unknown Emerging Known

Achieving Quality Survivorship Care Develop guidance for clinical management of long-term and late effects Increase collaboration between oncology and primary care providers Improve health professional education and training Enhance patient/family education and self-advocacy Support survivorship research Promoting policy change to ensure access to health care services

Achieving High Quality Survivorship Care Providing care in diverse health care settings Cancer-center Community oncologist Primary care Shared care Serving diverse survivor populations Race/ethnicity Cultural Education Maintaining flexibility “One size does not fit all”

Research to Address Knowledge Gaps Characterize outcomes after cancer Characterize high risk populations Inform optimal screening methods Define standards for survivorship care Evaluate impact of care plans Determine effective models of care Identify methods to improve care coordination Identify methods to motivate participation in health promotion

Achieving High Quality Survivorship Care Advocating for policy change Health Care Reform & Survivorship Care Focus on screening, wellness, prevention Improving reimbursement for care Coordination of care by health care providers Interventions to address psychosocial/practical concerns Increase policy maker awareness of survivorship as a public health issue Funding for cancer research

Thank you for your attention! Acknowledgements American Lebanese Syrian Associated Charities (ALSAC) NCI Cancer Center Support (CORE) grant CA 21765