Stem cell Survivorship: Searching for a solution to our success. Rich Boyajian NP Clinical Director of the LAF ad u lt su rvivorship clinic

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1 Stem cell Survivorship: Searching for a solution to our success Rich Boyajian NP Clinical Director of the LAF ad u lt su rvivorship clinic

2 Location of Centers Participating in t he CI BMTR Slide 2 SUM07_3.ppt

3 The Issue Allogeneic stem cell transplant is associated with significant early morbidity and mortality, outcomes continue to improve and there are more long term survivors. The success of Stem cell transplant programs is in part due to standards of practice (SOP) focused on the early post transplant time period (One yr or less)..

4 Causes of Death aft er Transplant ations Done in Autologous Relapse (70%) Organ toxicity (6%) IPn (1%) Infection (8%) HLA-identical Sibling Other (13%) GVHD (13%) Other (16%) Relapse (41%) Unrelated Donor GVHD (2%) GVHD (14%) Relapse (34%) Infection (17%) IPn (3%) Organ toxicity (10%) Other (16%) Organ toxicity (10%) Infection (20%) IPn (6%) Slide 17 SUM07_17.ppt

5 BMT is not over w hen D/C from Inpatient

6 Survivorship Care: Increased risk of secondary solid tumors after transplant Surveillance does for not go away and increases. Recurrence The risk and at 15 perhaps yrs is 3x secondary general Population cancer Psychosocial needs Symptom management Screening for long term effects/ GVHD Education about Resources Late effects Wellness focus Lifestyle/behavioral interventions Non-cancer care Other medical conditions

7 Since the 2006 publication of There has been a focus on the care of longer term survivors

8 Opportunities to Improve Transplant Care Cancer Diagnosis Acute Transplant care Transitional Extended Long term Follow up Primary Care

9 Phases of Survivorship Care Transitional follow up is a period when active treatment ends but there is a high risk of relapse and acute complications. Each disease, each stage may have different lengths of time in this period Extended Follow up is an arbitrary point when a survivor transitions to a lower risk of relapse and acute complications. Provider focus more on long term risks, and wellness. Long term follow up is similar to extended but care is transitioned to the PCP follow up

10 Tailoring Clinical Services Cancer Diagnosis Acute Transplant care Transitional Extended Long term Follow up Primary Care Transition Points

11 Tailoring Clinical Services Cancer Diagnosis Acute cancer care Transitional Extended Long term Follow up Primary Care Transition Points

12 Transplant Survivor Risk Analysis There are many d efinition of risk Oncology providers should consider risk to be: The chance that a long-term/late effect resulting from a therapeutic exposure impacts a survivor's health. A therapeutic exposure is: chemotherapy, biological agent, radiation field or surgical intervention utilized to treat a survivor s malignancy. These therapeutic exposures, while necessary may adversely affect the patients to whom they are administered.

13 Risk Analy sis A process consisting of 3 components: Risk assessment, Risk management and Risk communication.

14 Risk Assessment The World Health Organization defines as a scientifically based process consisting of the following steps: Hazard identification, Hazard characterization, Exposure assessment, and Risk characterization.

15 Risk Assessment H azard id entification: The identification of the therapeutic exposure capable of causing a longterm/late effect H azard characterization: evalu ation of the longterm/late affect associated with therapeutic exposure

16 Long term vs. Late effects Late -Occur after treatment has been completed Long term -Effects that persist after completion of treatm ent

17 Risk Assessment Exposure assessment: the determination of the relationship between the therapeutic exposure and the severity and/or frequency of the associated longterm/late effect. Risk characterization: the estimation of the probability of occurrence and severity of a known or p otential longterm/late effect in a particular survivorship population.

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19 Risk Management A process of weighing guidelines options in collaboration with all of the survivor s involved providers. Considers risk assessment along with other appropriate factors for the health protection of the su rvivor. is the strategy cost effective, does it do what it is designed to do (efficacy), and is it reasonable to implement (practicality) must be taken into account. These and numerous other issues must also be consider when developing a risk management strategy that is appropriate for prevention, detection and control of long-term/late effects.

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22 Risk Communicat ion The interactive exchange of information and opinions throughout the risk analysis process concerning hazards & risks, risks & related factors and risk perceptions amongst risk assessors, risk managers, consumers, industry, the academic community, and other interested parties. This includes the explanation of risk assessment findings and of risk management decisions. Risk assessors- Transplant/Oncology providers Risk managers- Transplant/Oncology and Primary care Consumers- Transplant survivors Industry- The greater Oncology community and Insurance industry Academic community Other parties

23 What do your patients need? What should be in the care plan? Transplant Clinic Representatives Disease center Representatives Small Working Group- Standardized long term follow up Care

24 Transplant Survivor s have care that varies in intensity

25 Tailoring Stem Cell follow up Step one- Know your patient Summary of treatment Known complications Med ical history

26 Treatment summary (many centers/organizations are working on their own version) Diagnostic tests performed and results Tumor characteristics (e.g. site, stage, grade, markers) Dates of treatment initiation and completion Surgery, radiotherapy, chemotherapy, including agents used Treatment regimen, total dosage, clinical trials (if any), and toxicities experienced during treatment Psychosocial, nutritional, and other supportive services Contact information on treating institutions and providers Id entification of a key coord inator of continu ing care

27 Tailoring Clinical Services Step two- Based on the information gathered in Step one what are the survivors at risk for Transplant has a very good start

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38 Next steps... Follow up care should resemble the On Treatment plan Sit down with the Leaders Go over the special report with them Review the guidelines Standardize the recommendations into your practice (treatment plan)

39 The Allogeneic Stem Cell Transplant Surv iv orship Mult idisciplinary Clinic

40 Mission Statement: Stem Cell Transplant Survivorship Collaborative The mission of the Stem cell/bone marrow transplant program/ Adult Survivorship program collaboration is to promote the health and well-being of the allogeneic stem cell transplant population by providing accessible, high-quality medical care for patients who are one year from their transplant. This collaboration is committed to providing services that will address the holistic needs of the patients and that exceed their expectations. The collaborative clinic will not focus on disease follow up, or graft vs. host disease treatment, rather it will focus on the development of risks and recommendations related to prior therapy as well as patient education around developing a wellness plan specific to the unique needs of this patient population.

41 M onthly BM T multidisciplinary Survivorship clinic Objectives for the first year of operation include: Create a clinical practice that will exceed pts' expectations measured by post visit patient survey Establish SOP regarding risks and recommendations related to the transplant as well as any prior therapy Provide high-quality health care to patients who are one year post transplant. defined by the standards of practice regarding risks and recommendations related to prior therapy developed by the collaboration between the stem cell transplant group and survivorship program Establish SOP regarding patient education around developing a wellness plan specific to the unique needs of this pt population

42 ELIGIBILITY CRITERIA: Year 1: Patients who Underwent a fully ablative transplant from non cord blood donor source and are Alive and disease free 1 year post transplant. Year 2: Expanded to Patients who Underwent a fully ablative transplant from cord blood donor sources as well as Who have underwent transplant using a reduced intensity regime and are Alive and disease free 1 year post transplant.

43 STANDARDS OF CARE Non graft vs. host disease Risk Surveillance Dr. Corey Cutler is working with the Adult Survivorship program to develop standards of practice regarding long term risk screening that the clinic will utilize as the basis of their practice. non graft vs. host or disease risk surveillance standards of care that includes but is not limited to physical exams, laboratory tests, imaging additional providers need to be involved in patients care and any other special testing. Major component of the Survivorship Standards of care Reviewed annually to incorporate change as new evidence or innovative therapies become available.

44 WELLN ESS FOCUSED CARE Screening tool to assess the survivor s stage of readiness for behavior change Provide standardized patient health education materials Create a provider education manual to instruct each survivorship provider in the proper implementation of the stages of change visit model

45 Operational overview DFCI Transplant Providers Day 0 8 Months Post 1 Yr Post BMT 18 Months Post StemSoft Report Eligibility Admin Contact MD Admin arranges Testing Eligible Admin Sends Letter Clinic visit Dr Saavedra Dr Treister Dr Cutler Nancy Campbell Nutrition Amy Grose LICSW Rich Boyajian NP Ineligible Admin? about Re-contacting Eligibility Admin Re-contact MD

46 Operational overview DFCI Transplant Providers Clinic Visit 1 Month After Visit 2 Yrs Post BMT 3 Yrs Post BMT Clinic visit Provider Dr Saavedra documentation Dr Treister Additional Dr Cutler Testing Nancy Campbell Nutrition Referrals Amy Grose LICSW Rich Boyajian NP Admin schedules annual follow up Admin sends Satisfaction Survey Annual Visit To Monitor for non-gvhd risks & screenings

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