NCT00453661

Brief Summary

The goal of this behavioral research study is to improve the use of cancer prevention services, increase early detection, and treatment of cancer. A secondary outcome of this demonstration project proposes that a structured patient navigator (PN) will reduce the cost of Medicare services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,472

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

13.6 years

First QC Date

March 27, 2007

Last Update Submit

October 27, 2020

Conditions

Breast CancerCervical CancerProstate CancerColorectal CancerLung Cancer

Keywords

Breast CancerCervical CancerProstate CancerColorectal CancerLung CancerCancer PreventionTreatment Demonstration for Ethnic and Racial MinoritiesCenters for Medicare and Medicaid ServicesCMSHispanic AmericanCancer Screening AssessmentAnnual QuestionnairePatient NavigatorEducational Materials

Outcome Measures

Primary Outcomes (1)

  • Screening Rates

    4 Years

Secondary Outcomes (1)

  • Compliance Rate Across 5 Cancer Types

    4 Years

Study Arms (2)

Intervention Group

Patient Navigator (PN) + Educational Materials + Annual Questionnaires

Behavioral: QuestionnaireBehavioral: Patient Navigator (PN)

Comparison Group

Educational Materials + Exit Questionnaire

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Intervention Group: Cancer Screening Assessment (CSA) questionnaire 45-60 minutes annually for 4 years + Exit Questionnaire at end of study. Comparison Group: Exit Questionnaire only.

Also known as: Survey
Comparison GroupIntervention Group
Patient Navigator (PN)BEHAVIORAL

Staff member, called patient navigator (PN), who assist with medical care and/or screenings, questionnaires.

Intervention Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hispanic American 40 Years + treated for cancer and Medicare eligible.

You may qualify if:

  • All participants must have Medicare Part A and Part B
  • All participants must be Latino / Hispanic American
  • All participants must be at least 40 years of age
  • All Cancer Screening Group participants must be a Medicare-eligible beneficiary from Region 6 (Central Gulf Coast) as defined by Texas Department of State Health Services.
  • All Cancer Treatment Group participants must have been diagnosed with breast, cervix, prostate, colorectal, and/or lung cancer within the past 5 years.
  • All Cancer Treatment Group participants must be a Medicare-eligible beneficiary from Texas.

You may not qualify if:

  • All participants must not be enrolled in a managed care plan (also called an HMO, Medicare + Choice, or Medicare Advantage)
  • All participants must not be enrolled in hospice
  • All Cancer Screening Group participants must not have been diagnosed with cancer within the last 5 years.
  • All Cancer Treatment Group participants must not be a Medicare-eligible beneficiary outside of Region 6 (Central Gulf Coast) unless treated at MD Anderson.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsProstatic NeoplasmsColorectal NeoplasmsLung Neoplasms

Interventions

Surveys and QuestionnairesPatient Navigation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPatient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Isabel Torres, DRPH,MPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 29, 2007

Study Start

March 1, 2007

Primary Completion

September 28, 2020

Study Completion

September 28, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Locations

US(1)