clinical trials that address health care disparities
DESCRIPTION
R APID C ITY R EGIONAL H OSPITAL. John T. Vucurevich Cancer Care Institute. Clinical Trials that Address Health Care Disparities. Daniel G. Petereit, MD Department of Radiation Oncology University of Wisconsin Medical School University of South Dakota Medical School - PowerPoint PPT PresentationTRANSCRIPT
![Page 1: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/1.jpg)
Clinical Trials that Address Health Care Disparities
Daniel G. Petereit, MDDepartment of Radiation Oncology
University of Wisconsin Medical SchoolUniversity of South Dakota Medical School
Rapid City, South Dakotae-mail: [email protected]
John T. Vucurevich Cancer Care Institute
RAPID CITYREGIONAL HOSPITAL
![Page 2: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/2.jpg)
???
AnyRelationship?
![Page 3: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/3.jpg)
Clinical Trials that Address Health Care Disparities
Historical background– Minority mistrust research
CDRP Trials– Cooperative Group– CDRP trials– Other: behavioral, molecular
Successful Recruitment Clinical Trials Future trials
![Page 4: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/4.jpg)
Tuskeegee Syphilis StudyPurpose: To observe the natural history of syphilis
Subjects: African American men in rural Alabama (N=405, 1932-72)
Men diagnosed with syphilis were enrolled and examined periodically, but not given treatment for their disease
Treatment was withheld to preserve the study even after it became generally available
No informed consent for participants
![Page 5: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/5.jpg)
Removal Policy: Eastern Tribes
“Trail of Tears”
![Page 6: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/6.jpg)
Trail of Tears• Federal relocation program of American Indians
to Oklahoma
• 1830-1860• Majority relocated under President Andrew Jackson
• 60 Tribes, including 5 “civilized tribes”
• Tens of Thousands died in route
• Historical trauma
• Massacre at Wounded Knee, SD– Recent memory?
![Page 7: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/7.jpg)
1960-1970s Sterilization of AI Women
American Indian women were sterilized at selected IHS clinics during the 1960s and 1970s
3,406 sterilizations in 3 IHS Areas between 1973 and 1976
No informed consent, no 72H waiting period, no right to withdraw
• US Department of Health, Education, and Welfare, Office of the Secretary “Sterilization Guidelines,” Federal Register 38 August 3, 1973; pp. 20 930-31 and September 21, 1973, pp. 26 459-61. Also Federal Register 39 April 18, 1974. pp.13 873
• Government Accounting Office (GAO), Comptroller of the United States, Investigations of Allegations Concerning Indian Health Services; Washington, DC. US Government Printing Office, November 4, 1976.
![Page 8: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/8.jpg)
Native American Cancer Research http://www.NatAmCancer.org
Linda Burhansstipanov, MSPH, DrPH
![Page 9: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/9.jpg)
CDRP: Supporting the Nation’s Goal of Eliminating Cancer Health Disparities
• Increase minority access to and participation in radiation oncology clinical trials
• Increase the number of clinical and translational scientists studying cancer disparities
• Develop new institutions’ ability to engage in long-term research efforts
• Investigate new areas of health disparities research
![Page 10: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/10.jpg)
Clinical Trials that Address Health Care Disparities
Historical background– Minority mistrust research
CDRP Trials– Cooperative Group
• RTOG, ECOG, NSABP, NCCTG, GOG– CDRP trials: PI initiated– Other: behavioral, molecular
Successful Recruitment Clinical Trials Future trials
![Page 11: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/11.jpg)
Successful Cooperative Group Trials: Recruitment CDRP Sites
• NSABP 35: anastrozole vs tamoxifen in postmenopausal DCIS patients undergoing lumpectomy & radiation therapy
• RTOG 245: PET pre and post treatment assessment for locally advanced NSCLC
• RTOG 0315: Phase III Study to Determine the Efficacy of Octreotide in Reducing Severity of CT/XRT-Induced Diarrhea Anal or Rectal Cancer
• RTOG 0321: Phase II Trial of HDR and EBRT Prostate CA
• NSABP, CALBG Breast cancer studies that include a radiation component
![Page 12: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/12.jpg)
Moderately Successful Cooperative Group Trials: Recruitment CDRP Sites
• RTOG 9804: Phase III Trial Observation +/- Tamoxifen vs. RT +/- Tamoxifen for Good Risk DCIS
• NSABP B-39: Phase III Trial WBRT vs APBI
• RTOG 0232: A Phase III Study EBRT & PSI vs PSI Alone for Intermediate Risk Prostate CA Carcinoma
• NCIC MA20: A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
• RTOG 0247: Phase II Trial of Neoadjuvant Combined Modality Therapy for Locally Advanced Rectal Cancer
![Page 13: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/13.jpg)
Moderately Successful Cooperative Group Trials: Recruitment CDRP Sites
• RTOG 0433: Phase III Trial of Single Versus Multiple Fractions for Re-Irradiation of Painful Bone Metastases
• RTOG 0215: Treatment of Erectile Dysfunction in Patients Treated with Neoadjuvant Androgen Suppression and Radiotherapy for Prostate Cancer: Impact on Patient and Partner Quality of Life
• RTOG 9813: Phase III Study of EBRT & TMZ vs EBRT and Nitrosourea for Anaplastic Astrocytoma and Mixed Anaplastic Oligoastrocytoma
• RTOG 0229: Phase II Trial of Neoadjuvant Therapy with Concurrent Chemotherapy and High Dose Radiotherapy Followed by Surgical Resection and Consolidative Therapy for Locally Advanced Non-Small Cell Lung Carcinoma
![Page 14: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/14.jpg)
Successful CDRP Trials: Recruitment
• IMRT H&N Trial – PI: Patrick Maguire, MD– New Hanover Regional Medical Center
• Phase II Trial APBI for DCIS using MammoSite brachytherapy– PI: Oscar Streeter, MD– USC, Centinela Freeman: David Khan, MD
• Rapid City Trials:• PI: Daniel Petereit, MD• Surveys: general, cancer, navigation• IMRT / Tomotherapy Prostate Trial• HDR Prostate Trial• HDR Breast Trial• ATM Trial
![Page 15: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/15.jpg)
Phase II Trial of Hyperfractionated IMRT with Concurrent Weekly Cisplatin for Stage III & IVa Head & Neck Cancer
• PI: Patrick D. Maguire, M.D.• New Hanover Radiation Oncology
• Designed & opened in community with IMRT planning advice from university
![Page 16: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/16.jpg)
Breast Brachytherapy
![Page 17: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/17.jpg)
Partial Breast Irradiation for DCIS Using MammoSite Brachytherapy: A
Phase II Trial • Oscar Streeter, Pamela Benitez, Frank Vicini et al.
• N =133 patients enrolled, Eligibility criteria: age > 45, unicentric DCIS, m size < 3 cm, negative margin 1mm
• 34 Gy in 10 fractions BID, 1 cm peripheral to the balloon surface
• 133 patients enrolled, MammoSite was placed in 117 patients, and 17 explanted – 25% not eligible for intracavitary method– < 5 mm skin bridge (5%), poor cavity conformance (5%),
positive margin (3%), final histology (1%), MD decision (1%)
![Page 18: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/18.jpg)
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 acute, late toxicities • Efficacy, local control, cosmesis
• 16 pts enrolled out of 100 (3 AIs)• Majority interstitial technique• 2 G3 toxicity: recurrent infection requiring drainage
• Mammosite technique• Mainly interstitial technique
![Page 19: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/19.jpg)
Phase II Study HDR Brachytherapy Intermediate Risk Prostate Cancer – Rapid City PI Petereit
• Patient eligibility: intermediate, high-risk prostate cancer
• Androgen ablation: 6 to 12 months
• EBRT: 2.2 Gy X 16 over 15 treatment days, HDR 6.5 Gy X 3
• Endpoints:• Evaluate the rate acute, late toxicities • Efficacy HDR boost
• 4 patients enrolled (0 AIs) out of 100
• No G3 toxicities
• Lower accrual because of tomotherapy trial
• HDR FX schedule recently changed from 6.5 x 3, to 9 Gy x 2 to increase accrual by eliminating need for hospitalization
![Page 20: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/20.jpg)
TOMOTHERAPY PROSTATE TRIAL Rapid City PI Petereit
4.3
Š 50 PTS Š 50 PTS Š 50 PTS
Phase I/II Hypofractionation Trial
Multi-institutional Phase I/II trial (PI: Mark Ritter, MD, PhD)-Level I/II completed (2006 ASTRO abstract #19)-160 patients: No G3 toxicities Rapid City: 30 patients enrolled (2 AIs) minimal toxicities, no G3-Most rapidly accruing trial ever opened
Level I nearly completed in Rapid City, adding 20 patients
![Page 21: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/21.jpg)
ATM MUTATIONS in Native Americans: Possible Association with Cancer and Radiotherapy Toxicities
• PI: Petereit, DG
• To determine the association between ATM heterozygosity and sensitivity to radiation
• Gene sequencing underway
• Amy Moser, PhD
• 20 American Indians, 39 non-Natives
![Page 22: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/22.jpg)
American Indians Entered on Research Trials Rapid City CDRP Era
Official start of Program: June 2004– General Survey: 713– Patient navigation: 181– Cancer Survey: 24– ATM: 20– CDRP treatment trials: 6– Cooperative Group Trials: 6– TOTAL: 769 - 950 if navigated pts included
Number of AIs on clinical trials nationally: 7– AACR 2006, Washington, DC
![Page 23: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/23.jpg)
CDRP Enrollment Clinical TrialsCentinela Freeman (PI: Steinberg, M)
– 26 patients on clinical trials; 208* patients navigated
UPMC McKeesport (PI: Heron, D)– 20 patients on clinical trials; 34 on behavioral trial; 261* patients
navigated
Rapid City (PI: Petereit, D)– 769 patients on clinical trials (includes behavioral); 181* patients
navigated
Singing River (PI: Dennis, S)– 6 patients on clinical trials; 353* patients navigated– Complete recovery from setbacks from hurricane Katrina
![Page 24: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/24.jpg)
Clinical Trials that Address Health Care Disparities
Historical background– Minority mistrust research
CDRP Trials– Cooperative Group
• RTOG, ECOG, NSABP, NCCTG, GOG– CDRP trials: PI driven– Other: behavioral, molecular
Successful Recruitment Clinical Trials Future trials
![Page 25: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/25.jpg)
Successful Recruitment Clinical TrialsPatient considerations
– Patient preference: randomized trial often difficult (RTOG 9804), no treatment or treatment not desired
– Convenience, effectiveness• HDR prostate, IMRT prostate, partial breast radiation
– Stage at presentation, co-morbidities, performance status
MD consideration– Most effective and current regimens– B-39: surgeons preference Mammosite device– RTOG 9804- Med Oncs prefer aromotase inhibitors– NCIC MA.20: regional nodal RT: RO preference– Complexity of trial– RTOG 0229: difficulty in obtaining tissue from N2 nodes via
mediastinoscopy• RTOG 0412 allows for trans-esophageal biopsy
![Page 26: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/26.jpg)
Successful Recruitment Clinical Trials
• Quality of life studies, accrual easier• Non-invasive
• Investigator ownership • RTOG 0245 study PI UPMC McKeesport
Special considerations– Disparate populations
• Phase II: limited institutional basis
• Often difficult commit randomized trial, eg RTOG 0232 – Unforeseen: Katrina! Singing River
![Page 27: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/27.jpg)
Successful Recruitment Clinical Trials
• Good studies for common cancers– How does it “fit” into community standards
• Community-Based Participatory Research• Key to successfully enrolling AIs Western, SD
• Community trust is the critical issue!
• ATM study» Evidence of trust established AI community
![Page 28: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/28.jpg)
Timeline IRB Approval 2003 - 2004A
AIR
B
Prot 6: Tomo Prostate
Prot 3: Community SurveyProt 4: Navigator
Prot 2/1: Breast Brachy - NAI
Prot 5: Tomo Bone
Prot 1/1: Prostate Brachy - NAI
Prot 3: Community Survey
Nat
.IRB
Prot 2/1: Breast Brachy - NAI
Prot 4: NavigatorProt 5: Tomo Bone
Prot 1/1: Prostate Brachy - NAI
Prot 6: Tomo Prostate
UW
IRB
Prot 2/1: Breast Brachy - NAI
Prot 5: Tomo BoneProt 2/2: Breast Brachy
Prot 1/1: Prostate Brachy - NAIProt 1/2: Prostate Brachy
Prot 6: Tomo Prostate
Prot 2/1: Breast Brachy - NAI
RC
RH
IRB
Prot 1/1: Prostate Brachy - NAI
Prot 5: Tomo Bone
Prot 3: Community SurveyProt 4: Navigator
Prot 2/2: Breast Brachy
Prot 1/2: Prostate Brachy
Prot 6: Tomo Prostate
Submitted
Approved withfinal letter
Ready to enroll after NCI appr.
Sep
tem
ber 0
3
Oct
ober
03
Febr
uary
04
Mar
ch 0
4
Apr
il 04
Nov
embe
r 03
Dec
embe
r 03
Janu
ary
0 4
May
04
June
04
Aug
ust 0
3
July
03
June
03
Sep
/Oct
04
Aug
ust 0
4
July
04
![Page 29: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/29.jpg)
Clinical Trials that Address Health Care Disparities
Historical background– Minority mistrust research
CDRP Trials– Cooperative Group
• RTOG, ECOG, NSABP, NCCTG, GOG– CDRP trials: PI driven– Other: behavioral, molecular
Successful Recruitment Clinical Trials Future trials
![Page 30: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/30.jpg)
Considerations Future Clinical Trials
• “With precise, treatment delivery systems, cooperative groups need to think about hypofractionation rather than delivering a higher total dose over a longer period of time”– Michael Steinberg, MD, Centinela Freeman
• Patients are asking for more convenient, cost effective and equally effective treatments
![Page 31: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/31.jpg)
Considerations Future Clinical Trials
• Presenting randomized study is difficult because patients want to choose their treatment
• Phase II trials might be a better option for these special populations- American Indians Western, SD, choice is often
mastectomy or brachytherapy, situation in Anchorage, Al, magnified by factor of 10
– Strong rationale for offering phase II trials limited institutional basis through cooperative group mechanism
• NCCTG proposal
![Page 32: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/32.jpg)
Geographic Distance from The Cancer Center in Western, SD
Live 70 to 180 miles away (Median 140 miles)
![Page 33: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/33.jpg)
Travel Distances Alaskan Natives
![Page 34: Clinical Trials that Address Health Care Disparities](https://reader036.vdocuments.site/reader036/viewer/2022062520/56815ce2550346895dcae538/html5/thumbnails/34.jpg)
To'katakiya zanniyan omani pi ye/yo