Progress Report, Jan. 2006: CDRP Grant Programs

1. Progress Report, Jan. 2006:CDRP Grant Programs Singing River Hospital System Pascagoula, Mississippi

3. Background • 600 bed community (county) hospital system located on eastern part of Mississippi coast • Prior research affiliation with Tulane U. and ACOSOG and participation in Z10 (sentinel node in breast CA study) and B32, among others • Received CDRP Grant beginning in FY 2003 • Received Patient Navigator Grant

4. MS/AL 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 Maggie Clarkson, RN, MS Grants Program Director, Singing River Hospital System

5. Major Events of 2005 • Prior P.I. left to accept position at an academic institution, June 2005. • Dr. W. Sam Dennis, new P.I., July, 2005. • Proposal for restructured Grant submitted to NIH, and NIH accepted, August, 2005. • Hurricane Katrina, August 29, 2005. • Restructuring implemented and operations were begun.

6. Grant Restructuring Plan • Day-to-day operations of Grant to be handled by Project Director: Maggie Clarkson, R.N., M.S. • Grants Administrator to be 60% time. • P.I. % time reduced from 25% to 10%, and several Co-investigators brought in from prominent community physicians. • Full time research nurse/case finder. • Full time clinical associate/data manager.

7. MS/AL RADIATION THERAPY RESEARCH PROGRAM STAFFING PLAN SRHCC UABCCC P.I. – Dennis (10%)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ----------- P.I. - Spencer CO – P.I. Grants Administrator(0.6 FTE) -------PROGRAM DIRECTOR (1 FTE) Clarkson (3%) Hull (3%) Sariego (2.5%) Lyell (2.5%) RESEARCH STAFFOUTREACH STAFF (*)PATIENT NAVIGATORS Research Nurse (1 FTE) Health Educator/RN (1 FTE) Patient Advocate/Van Driver (2) FTE) Data Manager (1 FTE) CONTRACT: Biostatistician

13. Katrina Effects • Hospital continued to function on generator power. • Radiotherapy Dept. resumed treating patients within two weeks. • Keesler AFB Medical Center (Biloxi) severely damaged. Future status still uncertain. Patients on research protocols from that facility are now being followed and treated at SRH. • Cancellation of several planned community outreach programs.

14. Katrina Effects (cont) • Many people have lost homes, jobs, medical insurance, family support structure. Priorities have shifted toward providing for basic needs rather than protocol participation. • The devastation cuts across social class. Many community leaders who might otherwise be involved in volunteer projects for their communities are now involved in providing for basic needs.

15. Grant Restructuring Progress • Organizational structure complete. • All positions filled. • 1 F.T. project director (going to 50% time) • 1 P.T. grants administrator (@ 60% time) • 1 F.T. experienced research nurse • 1 F.T. clinical associate (data manager) • 1 F.T. nurse for Outreach Programs • 1 F.T. Patient Navigator (replacement) • Office space is secured and currently being occupied. • Re-budgeting completed, yrs. 3 – 5.5.

16. Grant Restructuring Progress 2 • A case mix analysis for our patient population has been done to prioritize clinical trial activation. • Operating procedures and systems have been put in place for data and outcomes measures. • A Data Safety Monitoring Plan has been developed and approved by SRHS IRB and NIH. • Facility certificates, RTOG and CTSU, have been updated.

17. Grant Restructuring Progress 3 • A local investigator/advisory group with quarterly meetings has been established and the first meeting held. • As part of the Partnership Program, a routine Telesynergy meeting schedule has been established for monthly investigator meetings, monthly research staff meetings, and CDRP-wide Patient Navigator meetings are being finalized.

18. Grant Restructuring Progress 4 • Have activated 13 Clinical Trials based on our case mix and 2 Clinical Trials for patients from Keesler AFB through our IRB. • Have contacted and accepted 15 cooperative group study patients for treatment/follow-up from Keesler post Katrina and have performed all the attendant regulatory functions. These pts. would have been lost to follow-up if our Grant had not been been in place accommodate them. • Have screened 42 patients as possible candidates for Clinical Trials. Five of the 42 were potentially eligible for an active study. After final eligibility check, two are still pending.

19. Grant Restructuring: Ongoing • Need to establish a Scientific Review Committee. • Plan to establish an annual workshop/retreat for the Partnership Program. • Need to do the physics part of the RTOG and CTSU facility certifications (“exposing phantoms”).

20. Patient Navigator Program Progress • Restructured of the Navigator roles, including job description and team assignments. • Developed documentation/data management system to monitor services provided and support analysis of patient population served. • Hired a replacement navigator and relocated office space. • Developed Navigator Program operating procedures and established documentation logs.

21. Patient Navigator Program: Ongoing Development • Re-education of Cancer Center Staff as to Navigator role. • Development of Outcomes Measurement Criteria, including patient satisfaction and communication efficacy.

22. Community Outreach Program • Outreach Nurse hired January 3, 2006. • Conducting inventory and review of existing cancer control programs. • Conducting patient population analysis to identify target populations and potential delivery sites. (Complicated by shifting populations due to Katrina.) • Developing short term and longitudinal outcome measures for outreach activities.

23. Community Outreach Program: Future Projects • Orientation and training materials development. • Prioritization of cancer control topics for emphasis in Yr. 3 of Grant. • Implementation of Focus Groups. • Development of Cancer Center teaching programs regarding Chemotherapy, Radiotherapy, and clinical trials.

24. Special Projects • Keesler AFB clinical trials patients follow-up and treatment continuation. • Mississippi Gulf Coast Community College Honors Students Special Projects. (One student helped revise and update the investigational drug policies and helped set up the monitoring program for indigent patient drug procurement.)

25. Summary • We feel that a great deal of progress has been made in restructuring the Grant in a short time and despite challenges posed by Katrina. • We look forward to the future opportunities and challenges afforded by the Grant.