NCT00385866

Brief Summary

To reduce Cancer health care disparities that exists among minority Medicare beneficiaries and to demonstrate cost effectiveness of patient navigation in reducing the burden of cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,272

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable cancer

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

October 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

3.9 years

First QC Date

October 10, 2006

Last Update Submit

April 19, 2016

Conditions

Cancer

Keywords

Patient NavigatorCommunity healthCommunication

Outcome Measures

Primary Outcomes (1)

  • Reduce the disparities observed in utilization of cancer screening services

    2-4 years

Secondary Outcomes (2)

  • Improve the time to diagnosis and treatment services (resulting in reduced cost of cancer care

    4 years

  • Improve patient satisfaction and informed decision making.

    4 years

Study Arms (2)

Comparison Group

ACTIVE COMPARATOR

The control or lesser intervention group, will receive cancer screening information on a quarterly basis, with no facilitation of services.

Behavioral: cancer screening and health education

Intervention group

ACTIVE COMPARATOR

The intervention group are those participants who were randomly assigned to receive facilitation of services in the form of patient navigation for the duration of the study.

Behavioral: cancer screening and health educationBehavioral: facilitation of Services to improve cancer screening

Interventions

cancer screening and health educationBEHAVIORAL

The control group will receive cancer screening and health education materials on a quarterly basis but will not have access to patient navigation services.

Also known as: patient navigation, cancer screening and education
Comparison GroupIntervention group
facilitation of Services to improve cancer screeningBEHAVIORAL

The intervention group will receive cancer education and faciliation of services in the form of patient navigation

Also known as: patient navigation, faciliation of services, screening
Intervention group

Eligibility Criteria

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

You may qualify if:

  • Cancer-Negative Group
  • Be of Hispanic/Latino Origin
  • Fluent in English and/or Spanish
  • Recipient of, Medicare Part A \& B, or combined Medicare/Medicaid
  • Not having a previous diagnosis of cancer
  • Be capable of giving written informed consent prior to any study related procedures.
  • Be available and willing to complete all study assessments as specified.
  • Cancer-Positive Group
  • Be of Hispanic/Latino Origin
  • Fluent in English and/or Spanish
  • Recipient of, Medicare Part A \& B, or combined Medicare/Medicaid
  • Having a previous diagnosis of cancer of the breast, cervix, colon and/or rectum, prostate, or lung.
  • Be capable of giving written informed consent prior to any study related procedures.
  • Be available and willing to complete all study assessments as specified.

You may not qualify if:

  • Member of the Medicare Advantage Plan, any Medicare managed care plan (Those who join the Medicare Advantage plan or a managed care plan during the course of the study will become ineligible to continue.)
  • Medicaid only beneficiaries
  • Institutionalized
  • Unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ

Newark, New Jersey, 07107, United States

Location

MeSH Terms

Conditions

NeoplasmsCommunication

Interventions

Mass ScreeningPatient NavigationEducational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticePatient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services AdministrationSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Ana Natale-Pereira, MD, MPH

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

US(1)