Back to resultsReducing Cancer Disparities for American Indians in the Rural Intermountain West
Primary Purpose
Prostate Cancer, Colorectal Cancer, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Navigation Services
Cancer education
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer focused on measuring Cancer Screening, Navigators, Community Outreach, Behavioral Change, Access
Eligibility Criteria
Inclusion Criteria:
- Enrolled in Medicare Part B
- Self-reported American Indian
Exclusion Criteria:
- Have cancer other than study cancer
- Medicare Part C enrolled
Sites / Locations
- Sletten Cancer Institute
- Huntsman Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Screening Navigation
Treatment Navigation
Screening Education
Treatment Education
Arm Description
Individuals without a study cancer who receive services of a navigator.
Individuals with a study cancer who receive navigation services.
Rather than receiving navigation, these participants receive general cancer education appropriate to Medicare enrollees.
Rather than receiving navigation services, these participants receive cancer education appropriate to Medicare recipients.
Outcomes
Primary Outcome Measures
Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer.
Secondary Outcome Measures
Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer.
Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer.
Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans.
Full Information
NCT ID
NCT00380055
First Posted
September 22, 2006
Last Updated
September 19, 2011
Sponsor
University of Utah
Collaborators
Sletten Cancer Institute, Centers for Medicare and Medicaid Services
1. Study Identification
Unique Protocol Identification Number
NCT00380055
Brief Title
Reducing Cancer Disparities for American Indians in the Rural Intermountain West
Official Title
Reducing Cancer Disparities for American Indians in the Rural Intermountain West
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Sletten Cancer Institute, Centers for Medicare and Medicaid Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Colorectal Cancer, Breast Cancer, Cervical Cancer, Lung Cancer
Keywords
Cancer Screening, Navigators, Community Outreach, Behavioral Change, Access
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Screening Navigation
Arm Type
Experimental
Arm Description
Individuals without a study cancer who receive services of a navigator.
Arm Title
Treatment Navigation
Arm Type
Experimental
Arm Description
Individuals with a study cancer who receive navigation services.
Arm Title
Screening Education
Arm Type
Active Comparator
Arm Description
Rather than receiving navigation, these participants receive general cancer education appropriate to Medicare enrollees.
Arm Title
Treatment Education
Arm Type
Active Comparator
Arm Description
Rather than receiving navigation services, these participants receive cancer education appropriate to Medicare recipients.
Intervention Type
Behavioral
Intervention Name(s)
Navigation Services
Intervention Description
Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.
Intervention Type
Behavioral
Intervention Name(s)
Cancer education
Intervention Description
Community health workers provide cancer education appropriate for Medicare participants.
Primary Outcome Measure Information:
Title
Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer.
Time Frame
four years
Secondary Outcome Measure Information:
Title
Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer.
Time Frame
four years
Title
Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer.
Time Frame
four years
Title
Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans.
Time Frame
10 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Enrolled in Medicare Part B
Self-reported American Indian
Exclusion Criteria:
Have cancer other than study cancer
Medicare Part C enrolled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall W. Burt, MD
Organizational Affiliation
Huntsman Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reducing Cancer Disparities for American Indians in the Rural Intermountain West
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