Improving Outcomes of Older Patients with Cancer using Geriatric Assessment

1. Improving Outcomes of Older Patients with Cancer using Geriatric Assessment Supriya Mohile, MD, MS University of Rochester

2. Agenda • Background - GA & its importance • A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Advanced Cancer: Reducing Chemotherapy Toxicity in Older Adults (NIH R01, URCC# 13059) • Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers (PCORI, URCC # 13070)

3. Investigators • University of Rochester • Gary Morrow • Karen Mustian • Ronald Epstein • David Dougherty • Katia Noyes • Charles Heckler • Collaborating Institutions • ArtiHurria (City of Hope) • William Dale (University of Chicago)

4. Research Base Team Research Team • SupriyaMohile(PI) • Coty Reisdorf (Program Manager) • Lisa Lowenstein (Program Manager) • Sandy Plumb (Program Manager) • Terri Lloyd (Clinical Coordinator) • Allison Magnuson (Geriatric Oncologist) • GO-Getters • URCC Team • Jacque Lindke • Libby Nagalski • SebastienEstaque • Steven Marshall • Tyler Steinbler • Diane Malone • Kyra Bryce • Christine Bryce • Nikki Murray • Leslie Gilles • Cathy Lesniewski • Data Dynamites

5. Increasing number of older cancer patients

6. Comparison of % Age Distributions at Diagnosis for Population & Age at Enrollment in Treatment Trials * From NCI Surveillance, Epidemiology, and End Results (SEER) Program for 2005 to 2009 ** For Phase 2 & 3 Tx Trials 2001 to 2011 - NCI/DCTD Clinical Data Update System May 2012

7. Who are our patients? • 87 yo male living at home with significant other, dancing twice per week, new bladder cancer with evidence of metastatic disease • 93 yo female with moderate to severe dementia with a rapidly growing head and neck cancer • 75 yo s/p chemo and prophylactic whole brain RT for small cell lung cancer now with new recurrence but with severe fatigue, memory difficulties, and falls 3 months after initial treatment • 85 yo healthy male living independently with metastatic colon cancer

8. What is different about an older cancer patient?

9. How can we assess the older patient with cancer? • Comprehensive geriatric assessment (GA) is an approach to the evaluation of the older patient, leading to the early identification and treatment of areas of vulnerability. • The GA evaluates the following domains: - Functional status - Objective physical performance - 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

10. Developing a Cancer-Specific Geriatric Assessment(CSGA): A Feasibility Study RESULTS PATIENT’S ABILITY TO COMPLETE UNASSISTED FEASIBILITY Time to complete Mean 27 min (SD 10) Range 8-45 min No association of age with time to complete assessment (p = 0.13) No association of age with ability to complete without assistance (p=0.16) No: 22% Yes: 78% Hurria, Gupta, et al. Cancer, 2005

11. GA Domains Predict Chemotherapy Toxicity in Older Adults

12. Toxicity Summary 60% 50% 50% 53% 42% 40% 43% Incidence 24% 30% 26% 20% 12% 8% 6% 10% 2% 2% 0% 0% All types Heme Non-heme Grade 5 Grade 4 Grade 3-5 Grade 3

13. Predictive Model Possible score range: 0-25

14. Is GA Effective? • Yes, if screening for underlying age-related conditions is followed by implementation of an appropriate care plan. • Total time out of office visit: staff time 10 minutes, MD time perhaps 5 minutes to review information and make appropriate referrals.

15. A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Advanced Cancer: Reducing Chemotherapy Toxicity in Older AdultsGAP-70+URCC# 13059

16. Study Objective/Primary Efficacy To determine if providing information regarding GA and GA-driven recommendations to oncologists reduces grade 3-5 chemotherapy toxicity in patients aged 70 and over with advanced solid tumor malignancy

17. Study Objective/Secondary Efficacy To determine whether providing oncologists with information regarding GA and GA-driven recommendations influences… • Survival in older patients • Clinical care of older patients receiving first-line chemotherapy • Functional and physical decline

18. PRO-CTCAE Exploratory Aims In collaboration with the National Cancer Institute, other exploratory aims will evaluate the role of patient-reported CTCAE in the clinical care of older adults receiving chemotherapy. These aims include the following:  • To examine the association between patient-reported symptoms (as measured by PRO-CTCAE) and geriatric domains (as measured by geriatric assessment) • To compare PRO-CTCAE and physician-rated CTCAE in a sample of older patients receiving first line chemotherapy

19. Study Design • 5 Year Study • Will enroll physicians and patients • Sample size • ~ 750 patients • Two stages • Observational lead-in period (0-3 months, 2 patients) • Then Cluster Randomized study

20. Cluster Randomized Design • CCOP sites are randomized NOT physicians, patients • A CCOP site is defined as: • A CCOP site will be defined as any practice location within an overarching CCOP designation where oncology physicians and study staff work independently (e.g., do not cross over into another site). • 16 or more sites will be included

21. Study Schema Observational Period RANDOMIZE SITES • Patients • Age≥70 • Advanced solid tumor malignancy • 1st-line chemotherapy planned Chemotherapy Toxicity (NCI CTCAE v4) • Physicians • Work at CCOP site • Not planning to retire/leave CCOP within 5 years Oncology Decision-Making Chemotherapy (Drugs, Doses, Schedule)

22. Study Schema Cluster Randomized Trial • Intervention Site • Per patient physicians receive: • GA performed • GA summary • GA-driven recommendations • *prior to treatment • Outcomes • Chemotherapy Toxicity (Grade 3-5) • Survival • Functional Performance • Physical Performance • Usual Care Site • GA performed • No GA summary provided

23. Physician Eligibility • Practicing at a CCOP site • No plans to move or retire during study period • Only patients from enrolled physicians can be consented for study • Our goal is to enroll physicians at your sites first!

24. Low Physician Burden! • Complete 10-minute surveys at the beginning of the project • These can be done on-line through REDCAP system or on paper • Help to identify patients for the study • Complete 2-minute surveys at 3 time points • Provide CRA with accurate physician rated toxicity information • Intervention group – 15-20 minute phone call with a member of the research team to discuss interpretation of geriatric assessment results and educational materials

25. Patient Eligibility: Inclusion Criteria • Age ≥70 years with cancer history • Advanced solid tumor malignancy • Be chemotherapy naive • Primary oncologist recommended first line chemotherapy treatment • Able to provide written informed consent has a health car proxy • Understands the English language

26. Study Procedures-Patients • Geriatric assessment procedures • Surveys • Beginning of study (30-45 min) • 1 month, 3 months, 6 months later (15-20 min) • PRO-CTCAE • Surveys can be done at visit or at home just prior to visit • Compensation - $15 per time point

27. CRA Training CRAs are key to study success! • Geriatric assessment training • Study Procedure Manuals • CCOP Research Base Proj. Manager (PM) will walk CRAs through screening, enrollment and GA procedures for the first 2 patients. • Always available by phone/email for questions (west coast coverage also). • Refresher training available if needed. • GA results will be reviewed in real-time by PM

28. A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy SEP 2013 OCT2013 NOV2013 DEC2013 JAN 2014 FEB2014 MAR2014 APR2014 MAY2014 JUN2014 JUL2014 AUG2014 Recruit Phys IRB Submissions Site IRB Approvals Enroll Physicians Site Training 1stPt Enrolled! Patient Enrollment continues ~ 700 pts (0-3mo observation) Initial 12 Month Timeline

29. Improving Communication for Cancer Treatment: AddressingConcerns of Older Cancer Patients and CaregiversCOACHURCC# 13070

30. PCORI Stakeholders CARG Cancer and Aging Research group U13 Oversight Board Patients and Caregivers SOCARE Board Specialized Oncology Care and Research for the Elderly CCOP Physicians Community Clinical Oncology Program Research Teams CARG: Supriya Mohile, William Dale, Arti Hurria CCOP: Supriya Mohile, Gary Morrow, Karen Mustian, Chuck Heckler SOCARE Board: Coty Reisdorf, Terri Lloyd, Nancy Dukelow, Emily McGrain, Michelle Kettinger Research Team: Supriya Mohile, Ron Epstein, Katia Noyes, David Dougherty

31. Goals of Research • To improve communication about age-related concerns of older patients with cancer and their caregivers • Studies evaluating patient-reported HRQoL have shown that providing summaries to oncologists improves communication about HRQoL • Providing a summary of geriatric assessment results has potential to improve communication about age-related concerns of older patients with cancer and their caregivers

32. Age-Related Concerns

33. Intervention is the GA Summary!

34. Study Objective/Primary Efficacy Primary Aim: To determine if providing GA information to patients, their caregivers, and oncologists improves communication regarding age-related concerns. Secondary Aims: Quality of Life and Satisfaction

35. Study Design • 3 Year Study • CCOP physicians, patients, and caregivers • Sample Size ~578 patients and a corresponding caregiver for each (1156 total) • Two stages • A short observational lead-in period (0-3 months, 2 patients per site) • Then Cluster Randomized Trial

36. Study Schema Observational Period • Patients • Age≥70 • Advanced solid tumor malignancy • Decision to undergo cancer treatment RANDOMIZE SITES Caregivers Age ≥ 21 years • Physicians • Work at CCOP site • Not planning to retire/leave CCOP within 2 years

37. Study Schema Cluster Randomized Trial AUDIOTAPED VISIT • Outcomes • Physician-patient communication • Patient & Caregiver • Quality of life • Satisfaction with decision • Intervention Site • Patient, Caregiver, & Physician receive: • GA Summary • *prior to treatment Usual Care Site no GA summary given

38. Patient Eligibility: Inclusion Criteria • Age ≥70 with a diagnosis of cancer. • Diagnosis of an advanced solid tumor malignancy. • Treatment naiive for advanced cancer • Deciding on first line treatment for cancer • Does not ultimately need to receive cancer treatment • Able to provide informed consent orhas a health care proxy • Understands English language

39. Caregiver Definition “A caregiver is someone you rely on for help and support. A caregiver could be a family member, friend or someone else. This person may do one or more of the following: go with you to doctor’s appointments, help you understand your treatment options, help you make decisions about your medical treatment, help with routine day-to-day activities (e.g., transportation, handling finances or other paperwork). If you have more than one caregiver, list the one who is most likely to accompany you on visits to the doctor.” Patients will be asked to choose a caregiver that could participate, but caregiver participation is NOT REQUIREDfor patient participation.

40. Study Procedures - Patients • Compensation - $15 per time point • Geriatric assessment procedures • Audio-taping one oncology visit • Surveys • Beginning of study (50 min) • 1 month, 3 months, 6 months later (30 min) • Surveys can be done at visit or at home just prior to visit

41. Study Procedures - Caregivers • Compensation - $15 per time point • Agree to audio-taping if present at oncology visit • Surveys • Beginning of study (30 min) • 1 month, 3 months, and 6 months after visit (20 min) • Can be done at visit or at home before visit

42. Audiorecordings • There is no way you can actually know what is said without doing audio-recordings. • Thousands of oncology visits have been audio-recorded and have contributed to important findings about how to improve communication about difficult and sensitive topics in oncology

43. Audiorecordings Confidentiality • Confidentiality is paramount. All transcripts that are used for analysis are de-identified. Those doing the analyses will not know the name or location of the physician or patient. • There have never been any breaches of confidentiality in the thousands of physician office visits audio-recorded locally • There have never been legal ramifications of audio-recording.

44. Improving Communication for Chemotherapy CCOP Site 12 mo. Startup Timeline SEP 2013 OCT2013 NOV2013 DEC2013 JAN 2014 FEB2014 MAR2014 APR2014 MAY2014 JUN2014 JUL2014 AUG2014 Recruit Phys IRB Submissions Site IRB Approvals Enroll Physicians Site Training 1stPt Enrolled! (0-3 mo observational period) Patient & Caregiver Enrollment - up to 578 Pt and 578 Caregivers

45. ?