Walking Forward: NIH Disparity Project to Lower Cancer Mortality Rates For American Indians in Weste

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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_at_rcrh.org
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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

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Key Elements of Disparity Project

• 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

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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
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Yearly Mileage for Walking Forward Team
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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.

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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
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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
  (N984)
• 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 NAs, 124 non-NA
• Interim analysis completed (see next slides)
  accrual ongoing
• Co-PI Ashleigh Guadagnolo, MD, MPH University
  of Texas MD Anderson Cancer Center

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Cancer Survey Mistrust and Satisfaction

• Data set N165 (52 Native Americans and 113
  non-Native)
• Native Americans expressed significantly higher
  levels of mistrust (p0.0001) 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.
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Cancer Survey Knowledge and Attitudes

• Native Americans scored lower on screening
  knowledge battery (p0.0001) and exhibited more
  negative attitudes about cancer treatment than
  non-NAs (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.
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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, p0.04.
• Of patients with screen-detectable cancer, the
  identifying diagnostic was a screening test for
  68 of white vs. 37 of Native American patients.
  (p0.006).

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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

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Community Survey Screening Rates (N900)

• Breast 61 (214/353)
• Cervix 49 (275/567)
• Prostate 32 (32/100)
• Colorectal
• females 24 (41/172)
• males14 (13/91)

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Community Survey Updated Results (N900)

• 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

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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

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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

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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 Tomé
University of Wisconsin Jack Fowler University
of Wisconsin Statistics Richard
Chappell University of Wisconsin
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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

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IMRT / Tomotherapy Prostate Trial
- Levels I/II completed, enrolling Level III
(N270) Level I 103 pts Level II 109
pts Level III 58pts - G2 GU 10 _at_ 4 months -
8.8 G2 rectal bleeding _at_ 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

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High-Risk Prostate IMRT Protocol

• Phase II
• 28 fractions
• 54 Gy pelvic LNs
• 70 Gy prostate (Kupelian regimen)
• Number of patients enrolled
• Rapid City 7
• UW, other gt 10

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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

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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.

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Variants with AA change
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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

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Grant Summary

• 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

• Phase II clinical trials (242)
• Prostate brachytherapy
• Breast brachytherapy
• Tomotherapy Prostate
• Tomotherapy Prostate (high risk)
• 75 other clinical trials (phase IIIII)
• Surveys (1326)
• General population
• Cancer population
• Male population eligible forscreening
• Navigator participants

As of September 2007, data hasbeen collected on
1936 participants
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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

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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

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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)

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N1064 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
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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
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Continuation of Walking Forward Program
Next Grant Proposal
Screening, EducationCancer ScreeningCoordinator
Radiogenomics
Patient NavigationExpansion
Clinical Trials
Palliation
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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

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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
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Walking Forward Navigator-Driven Community
Education and Screening

• Partners Native American Cancer Research
  (NACR), Aberdeen Area Tribal Chairmens 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 NACRs
  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

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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

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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)