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Reducing Cancer Disparities for American Indians in the Rural Intermountain West

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00380055
First Posted: September 25, 2006
Last Update Posted: September 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sletten Cancer Institute
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Randall W. Rupper, University of Utah
  Purpose
The purpose of this demonstration is to evaluate the effectiveness of using community outreach workers (navigators) to help American Indians living in rural areas overcome barriers to appropriate cancer screening, diagnosis, and treatment.

Condition Intervention
Prostate Cancer Colorectal Cancer Breast Cancer Cervical Cancer Lung Cancer Behavioral: Navigation Services Behavioral: Cancer education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Reducing Cancer Disparities for American Indians in the Rural Intermountain West

Resource links provided by NLM:


Further study details as provided by Randall W. Rupper, University of Utah:

Primary Outcome Measures:
  • Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer. [ Time Frame: four years ]

Secondary Outcome Measures:
  • Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer. [ Time Frame: four years ]
  • Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer. [ Time Frame: four years ]
  • Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans. [ Time Frame: 10 years ]

Estimated Enrollment: 1800
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Screening Navigation
Individuals without a study cancer who receive services of a navigator.
Behavioral: Navigation Services
Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.
Experimental: Treatment Navigation
Individuals with a study cancer who receive navigation services.
Behavioral: Navigation Services
Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.
Active Comparator: Screening Education
Rather than receiving navigation, these participants receive general cancer education appropriate to Medicare enrollees.
Behavioral: Cancer education
Community health workers provide cancer education appropriate for Medicare participants.
Active Comparator: Treatment Education
Rather than receiving navigation services, these participants receive cancer education appropriate to Medicare recipients.
Behavioral: Cancer education
Community health workers provide cancer education appropriate for Medicare participants.

Detailed Description:
Even for American Indians who have coverage with Medicare, disparities have been noted in the provision of cancer screening, diagnosis, and treatment. These disparities have been related to a variety of health-system, health-financing, geographic, and cultural barriers. We hypothesize that the use of lay community outreach workers will be an effective means of identifying and overcoming these barriers in order to improve the proportion of Medicare-eligible American Indians who receive recommended screening and diagnosis for prostate, breast, colon, and cervical cancer, and the proportion of individuals receiving appropriate treatment for prostate, breast, colon, cervical, and lung cancer. Community clusters randomized to this form of cancer navigation will be compared with community clusters randomized to receive educational outreach only.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled in Medicare Part B
  • Self-reported American Indian

Exclusion Criteria:

  • Have cancer other than study cancer
  • Medicare Part C enrolled
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380055


Locations
United States, Montana
Sletten Cancer Institute
Great Falls, Montana, United States, 59405
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Sletten Cancer Institute
Centers for Medicare and Medicaid Services
Investigators
Principal Investigator: Randall W. Burt, MD Huntsman Cancer Institute
  More Information

Responsible Party: Randall W. Rupper, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00380055     History of Changes
Other Study ID Numbers: 18388
1A0CMS300067
First Submitted: September 22, 2006
First Posted: September 25, 2006
Last Update Posted: September 21, 2011
Last Verified: September 2011

Keywords provided by Randall W. Rupper, University of Utah:
Cancer Screening
Navigators
Community Outreach
Behavioral Change
Access

Additional relevant MeSH terms:
Genital Neoplasms, Female
Genital Diseases, Female
Colorectal Neoplasms
Uterine Cervical Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases