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Walking Forward: NIH Disparity Project to Lower Cancer Mortality Rates For American Indians in Western, South Dakota R

R APID C ITY R EGIONAL H OSPITAL. John T. Vucurevich Cancer Care Institute. Walking Forward: NIH Disparity Project to Lower Cancer Mortality Rates For American Indians in Western, South Dakota RTOG January 2008 Update. Daniel G. Petereit, MD University of Wisconsin Medical School

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Walking Forward: NIH Disparity Project to Lower Cancer Mortality Rates For American Indians in Western, South Dakota R

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  1. RAPID CITY REGIONAL HOSPITAL John T. Vucurevich Cancer Care Institute Walking Forward: NIH Disparity Project to Lower Cancer Mortality Rates For American Indians in Western, South Dakota RTOG January 2008 Update Daniel G. Petereit, MD University of Wisconsin Medical School University of South Dakota Medical School Rapid City, South Dakota e-mail: dpetereit@rcrh.org

  2. Partner Institutions • Rapid City Regional Hospital and NCI • Rapid City Regional Hospital • Pine Ridge, Rosebud, Cheyenne River, Rapid City • University of Wisconsin – Madison • Partner institution • Co-PIs: • Mark Ritter, PhD, MD • Amy Moser, PhD • Mayo Clinic • Partner institution • Co-PI : Judith Kaur, MD • Consultant • Linda Burhansstipanov • Native American Cancer Research Corporation

  3. Phase II/III Clinical Trials Prostate brachytherapy Breast brachytherapy Tomotherapy Reduce overall treatment duration Phase II/III cooperative group trials Surveys Address barriers to health care General population Cancer population Patient Navigator Program Community education Assistance with service and access issues documentation and data collection ATM analysis To determine association between ATM heterozygosity and sensitivity to radiation Key Elements of Disparity Project

  4. Number of Patients with Mean and Median Number of Contactspatients received cancer tx and were navigated during tx or FU Number of patients served Mean and Median number of contacts

  5. Yearly Mileage for Walking Forward Team

  6. Impact of Patient Navigation • Reduction treatment interruptions? • Overall experience during treatment enhanced? • Any change in trust towards the health care system? • Cultural competency: • Molloy, K, et al. Developing and Implementing a Culturally Competent Patient Navigator Program in American Indian communities in Western, South Dakota. Association of Community Cancer Centers Oncology Issues, 22 (5);38-41, Sept/Oct 2007.

  7. Average Treatment InterruptionsImpact Patient Navigation Petereit, Molloy et al. Patient Navigator Program to Reduce Cancer Disparities in the American Indian Communities of Western, South Dakota. Cancer Control: Journal of the Moffitt Cancer Center. July 2008

  8. Surveys • 1. Community Survey to identify and document the barriersto timely and effective cancer screening, diagnosis and treatment for the Native American community • Opened in 06/04 – data collection completed (N=984) • 2. Cancer Patient Survey to assess barriers to timely and effective cancer care in a population with demonstrated stage disparities and to evaluate patient navigationprogram • 204 surveys completed: 80 NA’s, 124 non-NA • Interim analysis completed (see next slides); accrual ongoing • Co-PI: Ashleigh Guadagnolo, MD, MPHUniversity of Texas MD Anderson Cancer Center

  9. Cancer Survey: Mistrust and Satisfaction • Data set N=165 (52 Native Americans and 113 non-Native) • Native Americans expressed significantly higher levels of mistrust (p=0.0001) and lower levels of satisfaction with health care (p = 0.0001) • In multivariable analyses, Native American race was the only factor found to be significantly predictive of higher mistrust and lower satisfaction with healthcare, even when adjusting for income, education, and geographic remoteness. Guadagnolo A, Petereit D, et al. Racial disparities in trust and satisfaction with health care among Native Americans presenting for cancer treatment. Manuscript in review. Submitted October, 2007.

  10. Cancer Survey: Knowledge and Attitudes • • Native Americans scored lower on screening knowledge battery (p=0.0001) and exhibited more negative attitudes about cancer treatment than non-NA’s (p = 0.0001) • • In multivariable analyses, Native American race was the only factor found to be significantly predictive lower screening knowledge and more negative attitudes about cancer treatment, even when adjusting for income, education, and geographic remoteness. Guadagnolo A, Petereit D, et al. Racial disparities in knowledge, attitudes, and stage for screen-detectable cancers among Native Americans presenting for cancer treatment. Manuscript in review.

  11. Cancer Survey: Persistent Stage Disparity • Native Americans presented with more advanced-stage screen detectable cancers than non-NAs (breast, cervix, colorectal, prostate) 45% vs. 24%, p=0.04. • Of patients with screen-detectable cancer, the identifying diagnostic was a screening test for 68% of white vs. 37% of Native American patients. (p=0.006).

  12. Cancer Survey: Implications • Stage disparity shows continued barriers to timely and effective cancer care • Mistrust and less satisfaction with prior health care emphasizes need for patient navigation • Less screening knowledge and more negative attitudes toward cancer care emphasizes need for educational interventions

  13. Community Survey: Screening Rates (N=900) • Breast 61% (214/353) • Cervix 49% (275/567) • Prostate 32% (32/100) • Colorectal: • females 24% (41/172) • males14% (13/91)

  14. Community Survey: Updated Results (N=900) • AIs indicated that they were more likely to be screened if: • a screening advocate made public presentation • a screening clinic came to their community • they knew more about screening • they had help with transportation • they had help making appointments • Fifty-three percent of males and 70% of females planned on obtaining cancer screening

  15. Phase II Trial HDR Brachytherapy Stage I and II Breast Cancer: Rapid City PI Petereit • Similar criteria as previous APBI RTOG trial • 34 Gy/10 Fxs • Endpoints: • Evaluate the rate of acute, late toxicities • Efficacy, local control, cosmesis • 20 pts (4 AIs) enrolled on clinical trial out of about 100 total procedures • 10 pts interstitial technique, 10 pts Mammosite • 2 G3 toxicity: recurrent infection requiring drainage • both are with Mammosite technique

  16. Phase II Study High Dose Rate Brachytherapy Advanced Prostate Cancer • Patient eligibility: intermediate, high-risk prostate cancer • Androgen ablation: 6 to 12 months • EBRT 2.2 Gy X 16 over 15 treatment days, HDR 9 Gy X 2 • Endpoints: • Evaluate the rate acute, late toxicities • Efficacy HDR boost • 4 pts (0 AIs) enrolled on clinical trial out of about 100 total procedures • No G3 toxicities • Low accrual because of tomotherapy / IMRT trial • HDR FX schedule recently changed from 6.5 x 3, to 9 Gy x 2 to increase accrual by eliminating need for hospitalization • new changes: allow IMRT and PSI

  17. Phase I/II Prostate Hypofractionation Trial University of Wisconsin (NIH CA 106835) Mark Ritter, MD, PhD, PI Collaborators: Clinical: Patrick Kupelian MD Anderson, Orlando Jeffrey Forman Wayne State University Dion Wang Medical College of Wisconsin Daniel Petereit Rapid City, S. Dakota Physics/Radiobiology: Wolfgang ToméUniversity of Wisconsin Jack Fowler University of Wisconsin Statistics: Richard Chappell University of Wisconsin

  18. ≤ 30 PTS ≤ 30 PTS ≤ 30 PTS IMRT / Tomotherapy Prostate Trial • Designed to yield predicted late toxicities equivalent to about 76 Gy in 2 Gy fractions • Image guided IMRT • Margins at 3 - 7 mm

  19. IMRT / Tomotherapy Prostate Trial - Levels I/II completed, enrolling Level III (N=270) Level I: 103 pts Level II: 109 pts Level III: 58pts - G2 GU 10% @ 4 months - 8.8% G2 rectal bleeding @ 2 years - No G3 toxicities - 93% nBED - Rapid City: 39 patients enrolled Most rapidly accruing trial ever opened Rapid City - Submitted ASCO GU 2008: Ritter, Mark, MD, PhD

  20. Phase II 28 fractions 54 Gy pelvic LNs 70 Gy prostate (Kupelian regimen) Number of patients enrolled Rapid City: 7 UW, other: > 10 High-Risk Prostate IMRT Protocol

  21. ATM mutations in Native Americans: Possible Association with Cancer and Radiotherapy Toxicities • PIs: Moser, A. & Petereit, D. • To determine the association between ATM heterozygosity and sensitivity to radiation • Gene sequencing underwayAmy Moser, PhD, UW • Rapid City enrollment: • 36 American Indians • 51 non-Natives

  22. ATM Preliminary Results • DNA was isolated from 53 NA and non-NA undergoing radiation therapy for various cancers • 26 of 28 AIs agreed to participate • Variants were identified in 14 of 61 sequenced exons-11 variants would result in an AA change, functional change protein- 3 variants would not change AA - 3 variants may be new compared to current database • Petereit DG, Burhansstipanov L. Establishing Trusting Partnerships for Successful Recruitment of American Indians to Clinical Trials. Cancer, Culture & Literacy feature of Cancer Control: Journal of the Moffitt Cancer Center. In Press - July 2008.

  23. Variants with AA change

  24. American Indians on Research Trials in Rapid CityWalking Forward Era • Official start of Program: June 2004 • CDRP treatment trials: 8 • Cooperative Group Trials: 21 • ATM: 36 • Patient Navigation: 254 • Cancer Survey: 80 • General Survey: 984 • Other surveys and data collections: 29 TOTAL: 1412

  25. Phase II clinical trials (242) Prostate brachytherapy Breast brachytherapy Tomotherapy Prostate Tomotherapy Prostate (high risk) 75 other clinical trials (phase II&III) Surveys (1326) General population Cancer population Male population eligible forscreening Navigator participants Patient Navigator Program (254) Community education Assistance with service and access issues Documentation and data collection ATM analysis (87) Assessment of radiosensitivity Establish baseline for ATM mutation Cheyenne River Screening (27) Prostate and colo-rectal screening event on the Cheyenne River Reservation May 2007 Grant Summary As of September 2007, data hasbeen collected on 1936 participants

  26. Successful Recruitment Clinical Trials • As of June 2007, 21% AIs who underwent patient navigation during radiation were enrolled on a clinical trial • Reasons for non-participation in clinical treatment trials for AIs • advanced stage and/or poor performance status (29%) • no trial available for cancer site (16%) • and other reasons for ineligibility after evaluation (15%) • only one patient refused participation in a clinical trial after being deemed potentially eligible

  27. Clinical Trials Operating Committee (CTOC) • “expanding current outreach programs to increase the recruitment of minority populations in clinical cancer trials” -NCI Clinical Trials Working Group Initiative • Supplement to current CDRP grant: awarded 9/06 • Identification of these clinical trials with a surgical and or medical oncology component • - Cooperative group trials • Recruitment and identification to clinical trials • Interaction with other research associates at cancer center

  28. Clinical Trials Operating Committee (CTOC) • Analysis of 1064 new patients since September 1st, 2006 • 8.3% of patients (88/1064) were enrolled on a clinical trial (not including ATM) • Reasons for non-participation in clinical trials: • trial tx not appropriate/physician judgment 22.5% (239/1064) • ineligible due to advanced stage/metastasis 15.6% (166/1064) • ineligible due to other reasons 19.7% (210/1064)"other reasons" include characteristics of the cancer itself, more than one primary cancer, previous procedures and tx, etc. • no trial available for cancer site 14.2% (151/1064) • eligible pt refused trial participation 2.7% (29/1064)

  29. N=1064 Pts Evaluated for Clinical Trial Participation (not ATM) Seen in Evaluation at CCI between 09/01/06 and 12/31/07 Reason for non-participation in clinical trial Number of patients

  30. TELESYNERGY® Redeployment to Pine Ridge, SD Rapid City • TELESYNERGY® system (TS) atthe University Wisconsin wasredeployed to Pine Ridge Hospital May 2006 • Plans underway to rapidly increase TS use through nephrology initiative (Chet Roberts, PhD) result of initiative: 1380 patient consults since 4/2007 • Ultimate goal: increase access of American Indian pts to health care Pine Ridge Hospital

  31. Continuation of Walking Forward Program Next Grant Proposal Screening, EducationCancer ScreeningCoordinator Patient NavigationExpansion Radiogenomics Clinical Trials Palliation

  32. Predictors of Radiosensitivity through Genomics • Using gene array technology, gene expression changes in lymphocytes after radiation exposure will be characterized as a surrogate to determine whether the expression pattern differs between AI patients who experienced adverse reactions, as compared with those who did not • 20 AI cancer patients: 10 with and 10 without radiation sides effects • Goal: identify markers that might be used to identify AI patients who are likely to suffer adverse reactions due to radiotherapy, and to begin to understand the genetic basis of adverse reactions • Funding source: University of Wisconsin

  33. Walking Forward Navigator-Driven Community Education and Screening • Goal: Expand and enhance a Navigator-driven cancer education and screening program with American Indians (AIs) in the Northern Plains • Aim: Increase AI screening for breast, cervix, colorectal, and prostate cancers by 20% • The goal of this 12-month supplement is to expand and enhance a Navigator-driven cancer education and screening program with AIs in the Northern Plains • Project builds upon the ongoing Walking Forward Study to expand the Community Research Representatives’ (CCR) roles to become cancer screening coordinators Funding source: NCI

  34. Walking Forward Navigator-Driven Community Education and Screening • Partners: Native American Cancer Research (NACR), Aberdeen Area Tribal Chairmen’s Health Board, University of Wisconsin Cancer Information Service and Cancer Division, and Spirit of Eagles Program • CCRs trained to coordinate, implement and evaluate community cancer workshops to increase knowledge and recruitment to appropriate breast, cervix, colon, and prostate cancer screenings • Community workshops will be based on NACR’s validated, intertribal "Get on the Path to Health" curricula (i.e., specific six-part curricula on (a) breast, (b) cervix, (c) colon, and (d) prostate

  35. Next Grant Rapid City and UW • Need to expand Patient Navigation • UW School of Public Health • Need to Promote Cancer Screening & Education • UW School of Public Health • Desperately need to implement Hospice • James Clearly, MD • Lessons learned in Western, SD, could easily be applied to other disparate and rural populations - Wisconsin, elsewhere

  36. Manuscripts in the Last 6 Months • • Petereit, DG, Burhansstipanov, L. Establishing Trusting Partnerships for Successful Recruitment of American Indians to Clinical Trials. (Submitted to the Cancer Journal of the Moffitt Cancer Center) 2007. • • Petereit, DG, Molloy, K, Reiner, M, Helbig, P, Cina, K, Miner, R, Spotted Tail, C, Conroy, P, Roberts, C. Patient Navigator Program to Reduce Cancer Disparities in the American Indian Communities of Western, South Dakota. (Submitted to the Cancer Journal of the Moffitt Cancer Center) 2007. • • Molloy, K, Reiner, M, Ratteree, K, Cina, K, Helbig, P, Miner, R, Lone Elk, D, Spotted Tail, C, Sparks, S, Tiger, S, Esmond, S, Petereit, DG, Cultural Competency in Cancer Care: Developing and Implementing a Patient Navigator Program in American Indian Communities. Association of Community Cancer Centers, 22(5), Sept/Oct 2007. • • Guadagnolo, B A, Cina, K, Helbig, P, Molloy, K, Reiner, M, Cook, E F, Petereit, D G. Racial Disparities in Trust and Satisfaction with Health Care Among Native Americans Presenting for Cancer Treatment. Submitted to Ethnicity & Disease (September 2007). • • Guadagnolo, B A, Cina, K, Helbig, P, Molloy, K, Reiner, M, Cook, E F, Petereit, D G. Assessing cancer stage and screening disparities among Native American cancer patients. When free primary care is not enough. Submitted to Public Health Reports (November 2007). • • Clemments, P, Crilly, R, Petereit, DG. Implementing Tomotherapy in a Community Setting. Oncology Issues Nov/Dec 2007. • • Koscik, R L, Sparks, S M A, Guadagnolo, B A, Miner, R, Reiner, M, Helbig, P, Molloy, K, Spotted Tail, C, Cina, K, Lone Elk, D, Petereit, D G. Use of Community-Based Participatory Research to Investigate Factors Contributing to Cancer Disparities Among Native Americans in South Dakota. (Manuscript in Progress)

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