Reducing Cancer Disparities for American Indians in the Rural Intermountain West
This study has been completed.
Sponsor:
University of Utah
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
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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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Cancer
Cervical Cancer
Colorectal Cancer
Lung Cancer
Medicare
Prostate Cancer
U.S. FDA Resources
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
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:
|
Breast Neoplasms Uterine Cervical Neoplasms Colorectal Neoplasms Lung Neoplasms Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Genital Neoplasms, Male Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013