1. Developing and Implementing Intervention Studies Using Geriatric Assessment Supriya Gupta Mohile, M.D., M.S. Assistant Professor of Medicine James Wilmot Cancer Center University of Rochester

2. What We Know Life expectancy of community dwelling older adults is heterogeneous Health status conditions, outside of cancer, are common in patients with cancer –Comorbidity, disability, geriatric syndromes Geriatric Assessment (GA) can categorize patients into risk of further morbidity and mortality Cancer and cancer treatment worsen other health status conditions

3. IADL Deficit is Associated with Survival in Older Cancer Patients Charlson score was not associated with prognosis Maione et al. JCO 2005 Overall Survival QoLIADL A.B.

4. Cancer Increases Likelihood of Having Vulnerability and Frailty Outcomes evaluated: –Vulnerability Vulnerable Elders Survey score > 3 –Functional limitations –Geriatric Syndromes –Frailty Age > 85 or > 3 comorbidities or any GS –Poor Health Status Mohile, et al. JNCI, 2009.

5. U13 Summary: Gaps in Knowledge Gap 1: Clinical Measures Most Relevant to Older Adults are Rarely Incorporated Into Oncology Clinical Trials or Clinical Care Gap 2: Biological & Physiological Markers of Aging are Inconsistently Incorporated in Oncology Research Gap 3: Too Few Studies Focus on Frail Older Adults or Those Aged > 75 years Gap 4: Clinical Trial Infrastructure Incompatibility With Geriatric Needs (Dale, Mohile, et al. JNCI, 2012)

6. Filling Gap 1 GA is an approach to the evaluation of the older patient Includes an evaluation of the following domains: – Functional status – Comorbid medical conditions – Cognition – Nutritional status – Psychological status – Social support – Geriatric syndromes Each domain is an independent predictor of morbidity and mortality in the older patient

7. Filling Gap 1: Incorporating GA into Oncology Research We know that GA can help: –Identify patients at most risk for toxicity (Hurria et al. JCO, 2011; Extermann et al. Cancer, 2012) –Predict survival Now, we need to try to improve outcomes –Incorporate GA into clinical trials for older adults –Educate providers for cancer patients on how use information to select treatment options for older patients –Develop interventions

8. Gap-What do we Mean by GA Interventions? Interventions to improve “geriatric” outcomes –Derived from geriatrics literature –Multicomponent –Targets a geriatric domain –Who should implement? Interventions to improve “cancer” outcomes –Providing GA information to physicians, patients, caregivers during treatment decision-making

9. GA-Guided Care Processes Care processes use GA in two distinct, but related, ways. –They use GA to identify specific evidence-based geriatric interventions to be implemented Physical therapy for a patient with mobility deficits. –They use a GA to guide cancer treatment decisions Selection or dosing of chemotherapy.

10. Examples Cancer Treatment –Change in type or schedule of chemotherapy In the Hamaker review, the initial treatment plan was modified in 39% of patients after GA evaluation. Considering all studies, two thirds resulted in less intensive treatment. Functional status –PT/OT/fall risk assessment/safety eval/PERS Comorbidity –Tailoring (reducing) meds, eliminate dangerous meds Cognition –Decision-making capacity, delirium prevention Social support –Living situation (safety), health care proxy, planning (Magnuson et al. Curr Ger Reports, 2014; Hamaker et al. Acta Oncol, 2014)

11. Using GA to Guide Interventions

12. Delphi Participants Identified US-based experts in geriatric oncology: –Cancer and Aging Research Group –Participants at previous conferences held through the U13, “Geriatric Oncology Research to Improve Clinical Care.” –Leads or directs a clinical geriatric oncology program Expert panel –32 completed Round 1 –30 completed Rounds 2 and 3

13. Physical Performance: Interventions and Treatment Decisions Interventions: -Round 2: Ratings -Round 3: Consensus (93%) Treatment Decisions: -Round 2: Ratings -Round 3: Consensus (93%) Intervention Average Rating IQR Physical Therapy9.102 Exercise8.391.75 Occupational Therapy 8.362 Home Safety Evaluation 8.172 Δ To TX Plan Average Rating IQR Address safety during treatment 8.442 Modify treatment choice 7.962.75 Modify dosage 7.353

14. Filling the Gaps: Design and Implementation of Studies to Evaluate GA Interventions Establish a gold standard for GA interventions –Identify highest priority interventions to be disseminated in oncology (“biggest bang for the buck”) –Tailor interventions to outcome –Decide who should implement interventions Build a network to implement studies –“Gold standard” studies in geriatric oncology clinics –Disseminate in community (e.g., NCORP) Work together –Need multidisciplinary expertise –Develop a consistent approach to geriatric oncology studies –Learn from phase III intervention studies from geriatrics

15. Mechanisms

16. Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients (PCORI)

17. Multidisciplinary Geriatric Oncology Clinic: Gold Standard? Name: Specialized Oncology Care and Research for the Elderly (SOCARE) –Partners with a similar clinic at the University of Chicago Purpose: To provide resource where oncologists, surgeons, radiation oncologists, primary care physicians, and geriatricians can seek a comprehensive evaluation and opinion regarding cancer care for an older person

18. Can We Get There Faster? Funding mechanisms –Who should we send our applications to? –Need to ensure geriatric oncology expertise during the review Identify best ways to accrue patients to geriatric oncology trials –Enlist practitioners in the community Infrastructure mechanisms –Adopt practices from geriatric trials (e.g. phone call assessments, home based laboratory draws/evaluations)? Do we need a consortium for cancer and aging research which focuses on establishing evidence for vulnerable and frail elders with cancer?