Reducing Cancer Disparities for American Indians in the Rural Intermountain West

This study has been completed.
Sponsor:
Collaborators:
Sletten Cancer Institute
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Randall W. Rupper, University of Utah
ClinicalTrials.gov Identifier:
NCT00380055
First received: September 22, 2006
Last updated: September 19, 2011
Last verified: September 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Utah:

Primary Outcome Measures:
  • Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer. [ Time Frame: four years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer. [ Time Frame: four years ] [ Designated as safety issue: No ]
  • Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer. [ Time Frame: four years ] [ Designated as safety issue: No ]
  • Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Randall W. Rupper, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00380055     History of Changes
Other Study ID Numbers: 18388, 1A0CMS300067
Study First Received: September 22, 2006
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Cancer Screening
Navigators
Community Outreach
Behavioral Change
Access

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

ClinicalTrials.gov processed this record on September 30, 2014