NCT00380055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

4.2 years

First QC Date

September 22, 2006

Last Update Submit

September 19, 2011

Conditions

Keywords

Cancer ScreeningNavigatorsCommunity OutreachBehavioral ChangeAccess

Outcome Measures

Primary Outcomes (1)

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

    four years

Secondary Outcomes (3)

  • 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

Study Arms (4)

Screening Navigation

EXPERIMENTAL

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

Behavioral: Navigation Services

Treatment Navigation

EXPERIMENTAL

Individuals with a study cancer who receive navigation services.

Behavioral: Navigation Services

Screening Education

ACTIVE COMPARATOR

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

Behavioral: Cancer education

Treatment Education

ACTIVE COMPARATOR

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

Behavioral: Cancer education

Interventions

Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.

Screening NavigationTreatment Navigation

Community health workers provide cancer education appropriate for Medicare participants.

Screening EducationTreatment Education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsColorectal NeoplasmsBreast NeoplasmsUterine Cervical NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Randall W. Burt, MD

    Huntsman Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 25, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 21, 2011

Record last verified: 2011-09

Locations