Reducing Cancer Disparities for American Indians in the Rural Intermountain West

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Cancer Disparities for American Indians in the Rural Intermountain West

Conditions
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Prostate Cancer, Colorectal Cancer, Breast Cancer, Cervical Cancer, Lung Cancer

Intervention / Treatment
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* Behavioral: Navigation Services
* Behavioral: Cancer education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in Medicare Part B Self-reported American Indian Exclusion Criteria: Have cancer other than study cancer Medicare Part C enrolled
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening Navigation<br>Individuals without a study cancer who receive services of a navigator. | Behavioral: Navigation Services<br>* Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.<br>|
| Experimental: Treatment Navigation<br>Individuals with a study cancer who receive navigation services. | Behavioral: Navigation Services<br>* Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.<br>|
| Active Comparator: Screening Education<br>Rather than receiving navigation, these participants receive general cancer education appropriate to Medicare enrollees. | Behavioral: Cancer education<br>* Community health workers provide cancer education appropriate for Medicare participants.<br>|
| Active Comparator: Treatment Education<br>Rather than receiving navigation services, these participants receive cancer education appropriate to Medicare recipients. | Behavioral: Cancer education<br>* Community health workers provide cancer education appropriate for Medicare participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer. |  | four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Screening, Navigators, Community Outreach, Behavioral Change, Access