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Clinical Trials/NCT00380055
NCT00380055CompletedNot Applicable

Reducing Cancer Disparities for American Indians in the Rural Intermountain West

University of Utah2 sites in 1 country1,800 target enrollmentStarted: October 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,800
Locations
2
Primary Endpoint
Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer.

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Have cancer other than study cancer
  • •Medicare Part C enrolled

Arms & Interventions

Screening Navigation

Experimental

Individuals without a study cancer who receive services of a navigator.

Intervention: Navigation Services (Behavioral)

Treatment Navigation

Experimental

Individuals with a study cancer who receive navigation services.

Intervention: Navigation Services (Behavioral)

Screening Education

Active Comparator

Rather than receiving navigation, these participants receive general cancer education appropriate to Medicare enrollees.

Intervention: Cancer education (Behavioral)

Treatment Education

Active Comparator

Rather than receiving navigation services, these participants receive cancer education appropriate to Medicare recipients.

Intervention: Cancer education (Behavioral)

Outcomes

Primary Outcomes

Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer.

Time Frame: four years

Secondary Outcomes

  • Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer.(four years)
  • Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer.(four years)
  • Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans.(10 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Randall W. Rupper

Assistant Professor

University of Utah

Study Sites (2)

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