The Cancer Disparities Research Partnership Program Experience in Southern Mississippi

1. The Cancer Disparities Research Partnership Program Experience in Southern Mississippi Singing River Hospital System Pascagoula, Mississippi

3. CDRP Program Elements • Partnership among community hospital and academic institutions • TeleSynergy • Patient Navigation • Community Outreach

4. CDRP Grant in Southern Mississippi to Singing River Hospital System • Large minority African American Population • Semi-rural locale • The grant was awarded in Sept. 2003

5. Major Events of 2005 • Prior P.I. left. • Proposal for restructured Grant submitted to NIH, and NIH accepted. • New P.I. • Hurricane Katrina. • Restructuring implemented and operations were begun.

6. Grant Restructuring Plan • Day-to-day operations of Grant to be handled by Project Director rather than P.I. • Full time research nurse/case finder, rather than carving out a percentage of time of an otherwise-occupied clinic nurse. • Full time clinical associate/data manager. • Full time community outreach nurse. • P.I. @ 10% time rather than 25%.

7. Radiation Oncology Research Partnership W. Sam Dennis, PhD, MD P.I., Singing River Hospital System Sharon Spencer, MD P.I., University of Alabama Comp. CA Center – Birmingham Vince Herron, MD P.I., University of Mississippi Medical center -- Jackson

8. Patient Navigation • Our model is to use lay persons. • Providing transportation is an essential element as there is no public transportation in our community. • We continued the Navigator program largely as it existed, with two full-time Navigators. Established more documentation.

9. Katrina Effects • Direct Effects • Immediate down-time of facility • Prolonged down-time of TeleSynergy • Staff overwhelmed • Indirect Effects • Community priorities reordered • Patients ignoring cancers, presenting late

11. Singing River Hosp./Katrina • Provided shelter and services for the elderly infirm who were not evacuated. • Provided emergency services in aftermath. • Provided shelter to families of essential staff. • Served as a distribution center for water, food, and clothing for surrounding population after storm.

12. Singing River Hosp./Katrina • Came within 2 feet of flooding. • Came within 4 hours of running out of diesel fuel. • Utilized pond water from the front of the Hospital to run the air conditioning chillers.

13. Post Katrina - Community • All utilities were down. • 95% houses destroyed or flooded • ½ Medical Staff Lost everything • No power or water for several months in some areas … • …But most areas which could accept power had power back in 10 days. • Radiation Oncology resumed treating in 2 wks.

14. CDRP: Immediately Post-Katrina • Keesler AFB Clinic in Biloxi was destroyed. • We were able to ensure that NIH research protocol patients from Keesler AFB Clinic were not lost to follow-up. This involved contacting and following 15 patients and opening six protocols through our IRB.

15. CDRP: Rebuilding • With the destruction of Keesler, the research nurse employed there became available for employment and was hired by our CDRP Program. • Changes in Patient Navigator Program • Loss of one Navigator • Decision to continue with a single navigator plus a half-time van driver

16. Rebuilding : Intermediate Term: Unseen Problems • Community Physicians • Many have left (2 of 6 of surgical group). • Many living in trailers or commuting from Mobile, Alabama, 35 miles away. • Those taking trauma call are taking call for the entire Mississippi Coast. • Hospital Staff (RTT’s, Nurses, Physicist, dosimitrist, etc.) • Many working during day and rebuilding their homes at night.

17. Rebuilding: Intermediate Term: Unseen Problems • Community Leaders: many left. • Community Structure: governing structure in process of being reorganized and records transferred to temporary structures. • Katrina refugee influx: a number required treatment. Few records are obtainable. • Patients in Community: other priorities.

18. Rebuilding: Community Outreach • Full time community outreach nurse hired to present programs in various community forums regarding screening and general cancer awareness. • The Community Medical Advisory Group which met quarterly and consisted of prominent community physicians had essentially disbanded post-Katrina. Physicians who had left were replaced. The Group was restarted.

19. Community Status: Present • Population: Former county population – 150K. Current – unknown. • Housing, County: 8700 trailers/new-temp-housing remain at end of Aug. ’06. Peak was 10,700 in May ’06. • Government: housed in temporary structures and functioning. • Some community members are now willing to think about cancer and research.

20. Post Katrina: Community Outreach • Developed program materials. • From Jan. ’06 thru Oct. ’07 presented 37 programs, at businesses, Senior Center, Civic Organizations, Post Office, and Hospital. Included lectures and screenings • 1452 patients reached.

21. Post Katrina: Patient Navigator Program • Assessment/monitoring tools developed • Documentation in electronic medical record • Support for internal monitoring and analysis • Patient Navigator Brochure • Redesigned for patient focus • Satisfaction Survey developed

23. Pt. Navigator Program: Categories of Services Provided • Medication Procurement Assistance – 49 • Transportation – 28 • Social Services – 11 • Counseling Referrals – 3 • Financial - 23

24. Post Katrina: TeleSynergy • Was inoperative post-Katrina due to destruction of the high-bandwidth lines required. Restarted Feb. 2006. • Monthly meetings with Research Partners. • Weekly meetings of staff associated with grant program.

25. NIH Research Protocol Accrual and Follow-up • Prior to grant reorganization: no accruals. • Since grant reorganization and up to present: 8 new accruals. • Follow-up: 15 Keesler patients. • Follow-up: 17 patients previously entered from Singing River Hospital when it functioned under the auspices of Tulane University.

26. Post Katrina: Research Tools Developed • Casefinding Logs • All new referrals to Cancer Center are screened & tracked for final treatment plan • Casefinding Forms/packet (for M.D.) • Communication form for consult visit with Fast Fact Sheet attached for any potential study • Patient Fast Fact Sheets (for Pt.) • Study-specific brief intro handout given to patients during treatment planning process (IRB approved) • Study Patient Identification/Info Cards (Re: hurricane) • For use with study patients in the event of evacuation, contains study sponsor contact info and study-specific patient ID number • Used in collaboration with study calendar for individual patient

27. CLINICAL RESEARCH TRIAL – PATIENT FAST FACT SHEET CALGB 49907 – Breast Cancer Study We would like to provide some very basic information about a clinical trial that your physician has begun to discuss with you. Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer. The goal of this research is to find better ways to treat cancer and help cancer patients. As one of your treatment choices, you are being asked to consider participating in this clinical trial because you are a woman 65 years of age or older with early stagebreastcancer that has been removed by surgery. We believe that you may meet the eligibility requirements for this study. This trial is being conducted in many locations by the National Cancer Institute through a research group called CALGB. The Singing River Hospital System Regional Cancer Center is conducting the study locally. It is expected that about 600-1,800 people will join this study. WHY IS THIS RESEARCH STUDY BEING DONE? The purpose of this study is to compare the safety and effectiveness of adjuvant combination chemotherapy using either cyclophosphamide + methotrexate + 5-flurouracil (CMF), or doxorubicin (also called Adriamycin) + cyclophosphamide (AC), with the chemotherapy drug capecitabine, in women 65 years of age and older. The study will also help gain more information about the effects of each of the treatments on physical and emotional well-being and how well the participants assigned to receive capecitabine follow the treatment plan. WHAT ARE THE TREATMENT POSSIBILITIES? You will be “randomized” into one of the treatment groups described below. Randomization means that you are assigned to a group by chance. The treatment group you are assigned to is chosen by a computer. Neither you nor your doctor will choose which group you will be in. You will have an equal chance of being assigned to either group. Treatment A If you are assigned to this treatment group, you and your doctor will decide whether you will receive the CMF or the AC standard combination chemotherapy. These treatments are given as outpatient treatment in the clinic.  If you choose CMF, you will be given a prescription for cyclophosphamide tablets, which you will take by mouth, daily for 14 days. You will be given methotrexate and 5-fluorouracil, through a vein, on days 1 and 8. This treatment will be repeated every 28 days. This 28 day period is called a treatment cycle. You will receive 6 cycles of this treatment.  If you choose AC, you will be given doxorubicin and cyclophosphamide through a vein on day 1, every 21 days. This 21 day period is called a treatment cycle. You will receive 4 cycles of this treatment. Treatment B If you are assigned to this treatment group you will be given a supply of capecitabine tablets, which you will take at home, by mouth, twice daily for 14 days. This treatment will be repeated every 21 days. This 21 day period is called a treatment cycle. You will receive 6 cycles of this treatment. The study staff will give you additional instructions on how to take the capecitabine. (con’td – next page)

28. CLINICAL RESEARCH TRIAL – PATIENT FAST FACT SHEET (CON’TD) CALGB 49907 – Breast Cancer Study All Treatment Groups After you have completed the study treatment, if your breast cancer is the type that is responsive to hormones your doctor may recommend hormonal therapy with tamoxifen, anastrozole, exemstane or lettozoloe. WHAT TESTS ARE INVOLVED? If you take part in this study, you will have the following routine tests and procedures before the study treatment begins: you will be asked to give your medical history and have a physical examination, blood tests, a chest x-ray and a mammogram. If you are going to receive the AC treatment, you will have a MUGA scan or an echocardiogram, which measure your heart’s ability to pump. During the time that you are receiving the study treatment, a physical examination and blood tests will be done on day 1 of each treatment cycle. If you are receiving the CMF treatment blood tests will also be done on day 8 of each cycle. MUGA scans or echocardiograms will be done as your doctor feels necessary. After the study treatment has been completed, the physical examinations will be done every 6 months for 2 years, then annually thereafter. The blood tests and mammograms will be done annually. HOW LONG ARE PARTICIPANTS IN THE STUDY? We think you will receive study treatment for 3 to 6 months, depending on which treatment group you are assigned to. After the treatment has been completed your doctor will follow your medical condition for up to 15 years to learn about the long-term effects of the study. WHAT’S NEXT? Your doctor will discuss your treatment options with you again, including the opportunity to participate in this study. If you are interested and you and your doctor agree that this study would be of potential benefit to you in treating your cancer, the Research Nurse will do further evaluation of your records to make sure you are fully eligible to join the study. If you qualify to join the study, you will be given as much time as needed to ask questions and make an informed decision. We have a research nurse available to help answer your questions. WHERE CAN YOU GET MORE INFORMATION? If you are interested in learning more about the opportunity to participate in this research study, please let your doctor know. You may call the Singing River Regional Cancer Center Research Nurse at 228-809-5639 or e-mail M_RECORE@srhshealth.com. You can call the Cancer Information Service at 1-800-4-CANCER or visit the National Cancer Institute’s Cancer Trials Web Site at http://www.cancer.gov/clinicaltrials for information on clinical trials or http://www.cancer.gov/cancerinformation for information on cancer.

29. Clinical Research: Our Approach • Open Protocols that fit our patient population. • Open lots of Protocols. 26 open now. • Screen lots of patients. 314 patients screened (through one week ago). • Institution is not touted to the community as a “research institution.” We feel it is important to maintain current image.

30. Results of 246 Screened Cases No Study Available: 166 cases Study Available: 80 Not Eligible (stage; co-morb.) 33 MD Preference to tx off-study 12 Patient Declined 15 Insurance would not cover 12 ACCRUED 8

32. Summary • Partly recovered from Hurricane Katrina • Staffing is in place (one exception) • Research, TeleSynergy, Navigator, and Community Outreach going forward. • 8 NIH Protocol accruals. • Providing research follow-up for 32 research patients from Keesler and from our facility. • Developed “wallet card” for disasters. • Developed “fast facts” pt. sheet, each protocol.