Reducing Cancer Disparities for American Indians in the Rural Intermountain West

Breast Cancer Clinical Trial

Official title:

Reducing Cancer Disparities for American Indians in the Rural Intermountain West

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380055
• Other study ID #: 18388
• Secondary ID: 1A0CMS300067
• Status: Completed
• Phase: N/A
• First received: September 22, 2006
• Last updated: September 19, 2011
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Enrolled in Medicare Part B

• Self-reported American Indian

Exclusion Criteria:

• Have cancer other than study cancer

• Medicare Part C enrolled

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Lung Cancer
• Prostate Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Navigation Services
Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.
• Cancer education
Community health workers provide cancer education appropriate for Medicare participants.

Locations

Country	Name	City	State
United States	Sletten Cancer Institute	Great Falls	Montana
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Centers for Medicare and Medicaid Services, Sletten Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer.		four years	No
Secondary	Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer.		four years	No
Secondary	Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer.		four years	No
Secondary	Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans.		10 years	No