1. U13 Discussion Topics Cancer and Aging Research Group (CARG) National Institute on Aging (NIA) National Cancer Institute (NCI)

2. Session 1: Geriatric Assessment and Geriatric Assessment Guided Interventions

3. Discussion Leader: William Tew What are the outcomes we should study in older patients? List all. Focus on what is imp to patients—cognition, etc function, qol, Qol –maintenance, improvement not letting decline Individualized outcomes, goals change as pts go thru experience, evolve Hetrogeniety, evolving of goals Therapies - alternative treatments Qol—independence, Symptom management, toxicity, side effects, e.g sleep, fatigue, nutritional deficits, tolerating treatments Divide into geriatric outcomes and cancer outcomes. Patient centered outcome: how and when are these the same and how and when are these different? Notes: Distinguish between geriatric and patient centered outcome. Notes:

4. Measuring toxicities, Well-being subjective Whole life context of pt frame

6. Discussion Leader: Grant Williams Can we come to a consensus about what we mean by geriatric oncology interventions (geriatric vs. oncologic/therapeutic)? Care processes model – Standardizing, calibration? Goal directed approach e.g. cardio problem—individualize the approach, apply pertinent approach Pragmatically thinking about implementing Cluster interventions –geri, med, social, functional, i.e. types of interventions Teach how to do –onc—can it fundamentally change? Pt—PCP, Onc, old person—look from all standpoints, connect dots for a pt treatment Pt—should include palliative care, tolerance for pt, communic values for pt-economic, med Encompass all things of pt in a individualized mannner. 1) care model provider needs to think of Interventions need to be complex, challenge of science (rigorous design) Process needs to be replicated across sites, possible Depression prevalent, shld be accommodated Geri-onc research—look at share models Pall care; geri principles encompass pall care, second nature, geritricians already do this If there is data in the geriatric world, do we need studies in an oncology specific population and if so how should they be designed differently? Notes:

7. If there is data in the geriatric world, do we need studies in an oncology specific population and if so how should they be designed differently?

8. Discussion Leader: Andy Chapman What is the minimum requirement for assessing comorbidity in a cooperative group trial? 1. multi—bunch of disease no one dominating 2. one dominating Assessing how comor impacts; identify ind comor, then think abt hwo they impact Shld collect it in trials Comor crowd out stuff that matters when included, take time, shld prioritize, they’re not most imp Need to measure, overlap bet comorob and toxicities (over time) differnce bet comorob and toxicity, List of many comorob not going to work Cant ignore comorob, can be extrac from pt records, measure relev to geri pop, esp severity. Eg. Diabetes Onc hat—pt pop similar to present pt –knowledge of comorb will help Multiple comorob pts probably not on clinical trial Not seeing much association Have accurate know of meds list Everything else aside from cancer list as comorob—little clue abt how to direct intervention; comorb assess critically imp; need trials in real context of pt –else eliminating our knowledge abt the real pt.

9. Charac of study pop need to match pt being treated

10. What eligibility criteria should we eliminate? How shld we get pharma to

11. How do we capture/quantify multi-morbidity and how does this differ based on study design and outcomes? Med counts are inferior to standard measures of comorob List Comorbod—how many; meds—how many, which collect Not just improve survival, but also quality long term Shld do study w performance status, functional status

12. How do we capture/quantify multi- morbidity and how does this differ based on study design and outcomes? Notes: What eligibility criteria should we eliminate?

13. Discussion Leader: Allison Magnuson How should Geriatric Assessment recommendations/interventions be delivered and can we optimize mechanisms for uptake? Improve communic between groups involved in pt care, e.g phone Recognize local resources, be flexible, need team doing work to be part of implementation team Exploit resources around us, e.g leash program -- nurse program—deal w care improvement processes; residential, make connec w this resource Context imp—cost effective, efficacy, Philosophy—engaging clinician administrator Interventions—shld have discrete goals, thus follow recommendations When implementing complex intervention—shld have understandable outcomes, geri oitcomes Incorporate implementation strategy –interpersonal, organizational Trials – teaching oncs requires a lot of training has to be built in, Implementation strategies—1. onc use geriatricians on spot, then could study this (create model then study it). Replicate that, if works Implementation—education big part –geri oncs--; Adoptability –to their own area; Leadership shld be involved in it, to cell it. Impr feature—include pt advocates to enhance communic features, e.g. some of it is language, bond, learning from pts.

14. Moving research to reality: Dissemination and implementation of recommendations in a community setting.

15. Session 2: Functional, Physical Performance, and Nutrition Interventions

16. Proximal/ surrogate endpoints Clinical relevance of endpoint to patients Translational endpoints Cost-effectiveness Barriers to exercise/nutrition becoming part of standard supportive care Cultural acceptability Dose/ Schedule of Intervention Adapting existing geriatric interventions Fidelity Complexity of older adults with cancer – its impact on study participation and effectiveness of intervention Generalizability vs Study Population Homogeneity Selecting Population Intervention Outcomes D&I/Cost/ Payer

17. Discussion Leader: Tanya Wildes Selecting patients for intervention studies: Embracing the complexity of the older patient Encourage conversations about physical activity with patients before designing interventions. Understand patient limitations to activity, to be able to design realistic programs that are integrated to pt lifestyle Lifestyle interventions, if designed appropriately, start with the patient and aim to make incremental changes to get to target outcome measures. Important to be patient centered Rules and guidelines protect the patient, but may limit interventions Need trials in the most frail patients. Creatively design trials that can be done safely, risk- stratifications, close monitoring. Broaden trials to patients who are not historically on trials There are also risks of physical inactivity Dissemination of discussion to patients in community Heterogeneity of population vs narrow focus of clinical question, but runs into problems of recruitment Selection for supportive care/intervention/lifestyle trial needs to be as specific as for a traditional oncology therapeutic trial

18. Discussion Leaders: Wendy Demark- Wahnefried & Karen Mustian Intervention: Understanding dosing and scheduling of interventions, tailoring interventions for the cancer patient Obesity epidemic and how it affects survivors, older cancer pts – interventions needed. Weight management programs need to consider sarcopenia and associated risks Is there adequate training for oncologists to prescribe an exercise/diet intervention? –Physician training very limited. We need to incorporate allied professionals who are experts to work as part of the team. –ASCO tool –Role of oncologist to reinforce program vs leading How do we put this into practice? Easy, accessible to be able deliver in community Access is available to exercise physiologists, but not with specific oncology training Nutrition: supplements, power foods are being marketed to patients

19. Discussion Leader: Aminah Jatoi Outcomes: Selecting outcomes that are clinically meaningful (proximal/surrogate outcomes, translational endpoints) Functional outcomes: running versus driveway walk –Focusing on individualized change from baseline Exercise impact on the cancer –Measure disease-focused outcome ie biochemical markers Practical outcomes relating to function: Hand grip, get up and go –Neuropathy and gait –Impact on depression and other mood changes Patient-center outcomes: completion of treatment –Patient-involvement is critical Patient compliance, feasibility, sustainability Pre-treatment and post-treatment framework Deprescribing that occurs: improvement of polypharmacy Multiple targets that exercise improves  multiple endpoints Placebo as part of the intervention:  need attention controls

20. Goal attainment scaling Need for measures that delineate clear differences between cancer and non-cancer participants Placebo is ok if it benefits the patients Impacts on the tumor Alternative therapies

21. Discussion Leader: Enrique Soto Dissemination and Implementation: Changing culture to make interventions part of standard supportive care Exercise as good supportive care  power to show changes in OS, PFS –Challenge trial adapted for older patients Design for implementation  need stakeholder input –Academic leadership, payers, patients, research team, community resources, IT –Have a mechanism in mind from the beginning for dissemination and implementation –Social impact on lifestyle changes Show cost-effectiveness Notes

22. Gathering data on cost effectiveness so payers will support interventions Develop the outcome specific to exercise that is as attractive as pain and nausea Pick cancer specific outcomes  dose exercise to target the cancer-specific outcome –Patient input mandatory: ie: do you want to impact your neuropathy, fatigue, or infection? Payment based on cost-saving interventions Which older adults benefit most from exercise/nutrition interventions? –Ultra-frail vs. active adult vs. sedentary –Age group specific? Step-specific: 7,000 versus 10000 –Least amount of muscle mass (sarcopenic) Responders are not the “frailest of frail” –Average of 2 comorbidities –Obesity versus overweight Subacute rehab setting as an existing infrastructure –Incentives for patients and providers to want to exercise  continue cancer treatment Payers second after have buy-in from patients and providers Patient involvement is critical Training patients

23. Evaluating interventions for cultural sensitivity Concept of current pain for future gain and “selling exercise and nutrition” for long term improvement Evaluate the cultural sensitivities  inform interventions Determine cultural barriers to long term benefits of exercise/nutrition Physical disability, access, literacy Understand the barriers that are not only cultural Nutritional and behavioral interventions must be tailored in a culturally sensitive way in clinical trial development

24. Session 3: Funding: Working with the NIH, ACS, and PCORI

25. Discussion Leaders: Supriya Mohile & William Dale Research Priorities Basic Science Interface of aging, biomarkers of cancer, how they contribute to our knowledge A mouse model of aging phenotype, Extending to translational, core phenomenon, q about having cancer treatment accelerate aging, telemores, measure …. Hallmark paper—hallmarks of cancer, hallmarks of aging—papers overlap in two papers evidence that can be drawn from –1) exercise trials, 2) aging related biomarker, function related biomarker, chemo impacts on increasing…..P16 levels, look at hallmarks of aging -- good to look at Tissue useful in looking at hallmarks Add tissue to survey studies? Find unique markers in cancer… Biomarkers – how responsive they are? Inflammatory markers—hallmark of aging, think about interventions, harvest these markers..

26. Clinical Research Sarcopenia, not enough health services research Imaging data –phenotypes Challenges to doing intervention trials in older people, funding for it, what are strategies, support for such studies? Safety and accountability needed for such studies Success in approving trials of elderly –drugs, dose, don’t know—these are imp q 1. Review committes going thru process definiing priorities—contact them now, will help 2. Priorities—translational science, tissue, blood samples —toxicities, etc (very expensive trials)

27. Survivorship Pt stakeholder—pts don’t think about survivor, we think about quality of life, relationships, social conditions, insurance, economics, beyond 1 year—don’t have that data, challenge Disconnect between survivor and research on survivorship….geriatrics and survivorship not put together,,,,survivors are older people No forum for directors of survivorship programs to talk, e,g ASCO, NIH might want to look into this Issues—why we don’t have data, not willing to fund; take a long time, eat money to collect data over time, cant afford it, worse from peoples perspective; think about how to use databases to e.g. combine SEER, Medicare databases to study survivorship. That way can collect data longitudinally, combine data from EMRs, tap into those databases. Not intrinsic in most EMRs to have functional data—this is where we can get additional data. Be creative about using existing databases. Can you design …studies….. EMRs don’t like to talk to each other. Pts, Pt advocates care about their health, lets help them find us….

28. Discussion Leaders: Erica Breslau Improving enrollment to and submission of studies for older adults with cancer: Pt perspective in trial— Track pts broadly, no money to follow up rigorously, got only 6 percent in a recent trial (what happened to 94%) Barriers—toxicity; couple succesful studies– ovarian cancer study—succesful, pt-phy component in trial must have contributed Shared DM may be a factor that contributed to success Caregiver burden Technology, home-based assessments, telemedicine Educational aspect of this—need to do more—disseminate info to pts Q in lung cancer—……platform funding………….. SCOREBOARD—older pts remember horror studies from “clinical trials” therefore that dictates their responses to these clinical trials – enrollment suffers Pts –role in clinical trials—phys had told them about the trials; physicians said “I don’t think they could do this….studies need to be important to them—when that is clear, they would enroll

29. Discussion Leader: Sandy Mitchell Cooperative group mechanism- clinical trials: Cancer care Delivery Research (CCDR)

30. Discussion Leaders: Supriya Mohile, William Dale & Arti Hurria U13: Next steps and identifying partners for future meetings: Notes

31. Session 4: Cognition: Understanding Cognition in Older Patients with Cancer

32. Discussion Leader: Melisa Wong Older cancer patients face additional risk factors for delirium. How do we apply the results of general geriatric delirium studies to our cancer patients? What cancer-specific studies on delirium prevention and treatment are needed? Not screening for delirium in routine care, incidence undetermined Challenges in identifying delirium in secondary analysis, chart extraction (hospital elder life program, chart based delirium method-sensitivity 70%) Increased uptake of CAM to screen for delirium, highest sensitivity (mostly validated in the inpatient setting/ER, not outpatient, never cancer center) Oncologists don’t get screening, under-recognition Programs with geriatric oncology nurses, resources for delirium identification and education (nursing program…) Important to engage nurses in delirium screening, incorporate CAM into vital signs -> need to have nurses on board What to do with positive CAM? How often to report (at least daily)? Burden for physicians CAM used in different frequencies in different settings Prevention is better, minimal treatment available

33. Screening for delirium is time-consuming and expensive but knowing the prevalence can assist in prevention, hospitals care about falls which are linked to delirium Using CAM as the secondary outcome in clinical trials? Check at least daily if possible and at-risk times, depending on the aims of the study (home-based version) No outpatient delirium screening, oncologists don’t know how to follow-up. FAM-CAM (family version) for warning signs, detect early signs of delirium 80-90% sensitivity

34. Discussion Leaders: Gretchen Kimmick & Stuart Lichtman As we institute screening in the clinic for cognition using geriatric assessment, what should oncologists do with the results? Patients’ choices to decline screening, would ask patients how they want to proceed but would provide education and explanation to guide next step in treatment (may ne unsafe) Need to treat patients same level of respect Higher threshold of thinking ethical issues if patients disagree with recommendations, but we don’t if patients agree. We offer options Patients may have ability to decide treatment but may have MCI, incorporate into physical exam Patients decline screening because they are afraid they won’t get treatment, harder to withdraw treatment than to offer Use it to determine side-effects of treatment rather than initiation of treatment Not a lot of data to use cognitive screen test to decide on treatment, no correlation with outcome We are obligated to protect patients, raise level of awareness among oncologists e.g. Beers list Not a lot studies look at how physicians make decisions, comparison between oncologists with geriatrics training vs. not Cognitive issues rare in general geriatric population, unclear about cancer population

35. If referral out to geriatrics is not feasible or patient declines, what is the obligation for the oncologist? How do we study this? Notes:

36. Discussion Leader: Tina Hsu How do we standardize procedures related to including older patients with cognitive impairment into research studies? Standard set of neurocognitive assessment, neuro-onc community currently using it (ASCO plenary session) 45% with dementia informed of diagnosis, usually appears on the problem list but being ignored, under-recognized but significant impact on patients Issues with terms – memory, alzheimer’s, dementia. Patient only admits to memory problem even though on meds PCP knows about diagnosis but somewhat ignored What is our ethical obligation in informing patients, caregivers, and physicians Patients on research studies, cognitive issues identified but not in the position to inform patients (IRB – don’t screen for cognition since no ways to follow-up) Older breast cancer survivors – cognition along the cancer trajectory – struggle the most with borderline cognitive issues Bilingual and cultural differences

37. Obligated for researchers to let the primary team knows about incidental findings Build into consent process “what do you want us to do with the incidental info”, decision made prior to study rather than later NCI – if threshold score is this then contact PCP – geriatric assessment study. How about healthy controls -> ask the patients NIA supports reporting abnormal results to patients SCOREBOARD experience – engage with stakeholders, ask if make sense to them

38. Session 5: Interdisciplinary Team Building

39. Discussion Leader: Keith Bellizi Survivorship plans for older adults What are the key elements of unique outcomes for older adults? Patient function? Quality of life? Mortality? Geri onc community approach shld be how can we help Philosophical approach—shld we weigh into this issue, need more robust evidence on this, the goal is different R21, ro1 to address this at NCI. Look at appropriate comments on this, cancer not treated in PC settings, 4 elements--….. Assessing as finishing treatment, 3) prevention of future problems Supportive care shld not be forgotten, nutritionist, PT, OT etc not just look at it in terms of Survivorship, Care plans: informed consent—process occurs over time; care plans: occur over long haul, not just handing documents to people, care plans include interaction, communic, over time Not a plan—it’s the planning—PCP and oncologist, idea is to optimize care of pt, loss of spirit behind document

40. Can we create a Care Plan Document specifically for older adults?

41. Discussion Leader: Keith Bellizi Survivorship plans for older adults: Economics issues- What is the “value proposition” (i.e. cost- effectiveness) for survivorship care plans? Consider research on the efficacy of alternative care plan models. Notes: Patients, caregivers, and advocates: what is their proper role in survivorship plans and research? Notes:

42. Discussion Leaders: Andy Artz & Erica Ramsdale Care Models: Operationalizing interdisciplinary teams to care f—or older adults with cancer. Who are the key members of such teams (Medical specialties: oncology, geriatrics, palliative care, primary care; others: nursing, pharmacy social work, nutrition, physical therapy)? Who “leads” the team? To build on our success getting some other leadership-rehab med, PT, OT etc Formation of teams based on specific diseases in cancer care, recog of content expertise based on cancer, whio shld lead team Team leader? Not relevant for pts –pt stakeholder. Shld be relevant for pt. If pt makes it thru surgery, radiation, pt needs to be set free of disease, begin taking responsibility to care for themselves, not make it a dogmatic pursuit for all pts across board, think about from pts perspective. Individualize care plans for pts. Is this different from treatment plan? Those that don’t need ….. Try to represent pts, range of perspectives,,,,, Tend to isolate cancer care from PCPs,

43. Discussion Leaders: Andy Artz & Erica Ramsdale Care Models: Operationalizing interdisciplinary teams to care for older adults with cancer. Situational issues: Acute vs chronic disease phase; academic vs community settings; specific tumor types treated differently? Don’t need a lot of change, make sure doing what needs to be done, be careful where along survivorship spectrum, not right conversation, Focus on new pts Which specialist needed over time, PCP, should they be back in another court? There are 2 areas we need to learn more abt: 1. pt advocates wise in many ways, research needs to be generalizable to pop, 2. re informed consent—papers have gotten ridiculous—advocates need to bring this up. Eg one double spaced page of informed consent

44. IOM report Minimal Dataset—how to include characteristics that are important to older patients in all cancer patients, what are the 5 things that we need to capture with patients providing data efficiently and through electronic medical record Advocate to NCI and others that research in geriatric oncology is a high priority Cover letter on the white paper to include IOM report (not just us), send to multiple directors at NCI Geriatric oncology reps on all steering committees (disease specific, symptom management, CCDR) and include geriatric oncology on research priorities that are being developed by NCI steering committees, raise it on the next Chairs call (try to get it on the agenda) Engage patients and advocates (but how?)—use nonprofit organizations e.g., Sue Koman Patent extension issue—needs to go to Congress and FDA first—very controversial Increasing representative populations on clinical trials could be addressed at the NCI level Legislative strategy—success of Alzheimers group for allocating resources, find champion in legislation, SCOREboard meet with them? If anyone knows congressmen or women and/or staffers, reach out to them and work together to deliver consensus messages We have many allies: advocacy groups like AARP and reach out to other organizations that are powerful Provide slides for allies to use

45. What are the key transitions for patients/families and for the system?

46. Session 6: Methodology and Dissemination

47. Part A: Methodology

48. Moderator: Karla Ballman Current trials and other research often do not contain either the measures or the methodology most appropriate to build the database on the typical population of older adults with cancer. Alternatives to the usual outcomes (mortality) -- such as QOL, functional independence -- and the usual methods (clinical trials) – such as pragmatic trials – exist. How do we incorporate these alternatives into the current structures to change clinical practice?

49. Slide 48 cont Not getting elderly in trials right now, e.g. pragmatic trials If trial doesn’t work in adult pts, probably doesn’t work in older people, #s may not be sufficient to…. Use a sequential design, may be an approach Lower toxicities in younger pops Don’t know if effacacious till 5 yrs out. What are burning qs ? Work on those

50. Discussion Leader: Vicki Morrison How can important geriatric measures be consistently incorporated into oncology research trials? Are pragmatic trials the best way to do this? Notes: Which endpoints are the most important? Notes: When should issues of safety be incorporated into the trial structure? Notes:

51. Discussion Leader: Ajeet Gajra What policies, infrastructure and funding mechanisms are needed to generate the highest- impact research in geriatric oncology? Do we first need policy change or methodology change? What do we change first? Policy or methodology? Needs to be funded so we can collect data Starting point: people often think abt clinical trials, where is end-point best suited. E.g delirium? Take more than one point, get grants etc, rfa’s Q9 dissemination ‘’developing new funding mechanisms, learn how system works, respond. Identify high priority items to work on, what can we get done on these items. Think about dissemination etc, concepts in each group Add ‘comorbidities’ to Jan’s list Culture change in clinical trials, e.g undertreating older adults, without that hard to go on What (non-traditional) mechanisms are available to support the needed research using non-traditional methods – PCORI? CMS? Health Services? Coop Groups? Notes:

52. Part B: Policy And Dissemination

53. Moderator: William Dale Policy makers and general public are unaware of geriatric oncology agenda at a basic level; most don’t realize that clinical trials rarely include the patients most likely to have cancer. While geriatric oncology is foreign to most healthcare policy people and to the public at large, they would be interested if they knew the details and importance. The opportunity exists for us to shape people’s ideas about what geriatric oncology is, and what it stands for through evidence-based narratives, exemplified by Atul Gawande’s latest book. Qs to H Pollack: How to do this as a community? Tremendous interest, needs to be simple if famous person got on media, that might help geri-onc story along; positive message conveyed to public thru social media etc Shld we get different skills to convey communic research to general public? People interested, find the right angle to approach public Self-promotion—way to convey our message, need spokesperson

54. Media may distort physicians message? How do we know message may have an impact? Speak as a group—rather than wait for an individual charismatic ind to communicate. Will see progress –metric of progress-people notice even in your own community—that is progress The magic is in the work—get involved when roles open up—do a lot of work behind the scenes E.g. HC: staffers talk—talk about breakthroughs—targeted therapies, people want to hear about dramatic, but talk about ordinary in that many are affected by this ……..I regard this ….older pts….. Human enterprise of taking care of older people…… AG book, good example n=200 pts E,g,: VA health systems have great problems, yet gets press about veterans etc.

55. Discussion Leader: Aaron Yao How do we communicate best with policy- makers about health reform? How do we educate the “right people” [policy elites] on key gaps? Who are the elite people we should try to get involved? How do we get in touch with these types of people? How do we best disseminate “best evidence” to influence decision-makers in policy? Notes:

56. Discussion Leader: AaronYao How do we communicate best with policy-makers about health reform? How do we inform the public on needed policy changes? What are the KEY issues we want to get across or to communicate as most important? Notes: Where do we prioritize and invest our efforts to get the biggest benefit (ASCO, IOM, AGS, AACR, others)? Notes:

57. Discussion Leader: Ryan Nipp How do we build on the success of the U13 conferences in moving forward to create infrastructure to advance geriatric oncology? Which organizations should we partner with moving forward? Candidates include CARG, ASCO, AGS, SIOG… How should we best work together? Move forward Where have we come, what do we want to accomplish here, Continue to bring in new investigators, move forward Pick up Jan’s challenge, try to put into action ideas that came up here, pick up item partner w others, move forward Other countries have different problems,,,,, Present our science, partner w SIOG etc., energy in U13 meetings unique, capture, move Partner w other similar ergs e.g exercise in older adults, internationally others, partner w those, ger-onc special interest grps collaborate w them; spend 2 wks w eminent scientists E.g. In reviewing papers –tell authors, at each role take responsibility to bring up geri-onc issues Forming own cooperative grp? May not be so fruitful

58. Target and focus—take your passion apply to that……. Personal story: WD: meeting at Rochester w Supi… apply for U13……got funding…. Accomplished first U13….. Father passed away from cancer…. Personal inspiration…. Josh passed away, Supi did everything on this U13 SM: we care about our pts, passionate abt pts, met Arti, Heidi, Stu, saw field change (geri-onc), difficult to change jobs……you be the advocate…. Keep connected w WD, AH, have kept me going…..helped each other…besides onc mission. Many different ways to approach doing a U13….. AH: who we need is in this room—human capital—to move things forward— special thanks to WD, SM, HC, funders, to junior people who inspire us, pts advocates who keep us rounded, appreciate all others,,,, HC: Owe tremendous debt to WD, SM, AH. Others should step up and next U13 should be re-applied for ….step-up……self-made alliances work better than appointed alliances…… BC: each individual volunteer to help go forward…….