Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries

NCT ID: NCT00385866

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-12-31

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.

Detailed Description

The Latino population is the fastest growing minority population in the United States . Cancer ranks as the second leading cause of death among Latinos in the United States (24%), second only to heart disease . This project will evaluate whether an innovative facilitation program (targeting cancers of the prostate, colon/rectum, breast, and cervix) will improve cancer outcomes among Latino Medicare beneficiaries in the city of Newark, New Jersey.

The overall aim of this project is to institute an innovative cancer care facilitation program for elderly Latinos in the city of Newark, NJ. The goal is to reduce the disparities observed in screening, time to diagnosis and treatment services, by utilizing a multidisciplinary team approach to health care, incorporating systems thinking methodology. Using the Multilevel Approach to Community Health (MATCH) planning model , the program will incorporate community outreach, education, and access to screening, and patient assistance in all aspects of the health care continuum. It will also include cultural and linguistic competency training for all those involved in the facilitation process. To accomplish this goal, we propose four objectives:

1. To establish a multidisciplinary team that will utilize a systems thinking approach to design and structure the delivery of cancer screening, diagnosis and treatment facilitation services.

2. To build a collaborative consortium between program partners to improve screening outcomes, that will encourage the utilization of services in the community.

3. To improve the delivery of cancer prevention and treatment facilitation by providing cultural and linguistic competency training to the multidisciplinary team, providers, and the community.

4. To demonstrate the effectiveness of the intervention in reducing the burden of cancer, by increasing screening rates, improving time to diagnosis and delivery of treatment services, patient satisfaction, and appropriate use of Medicare services.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Comparison Group

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

Group Type: ACTIVE_COMPARATOR

cancer screening and health education

Intervention Type: BEHAVIORAL

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

Intervention group

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.

Group Type: ACTIVE_COMPARATOR

cancer screening and health education

Intervention Type: BEHAVIORAL

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

facilitation of Services to improve cancer screening

Intervention Type: BEHAVIORAL

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

Interventions

cancer screening and health education

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

Intervention Type: BEHAVIORAL

facilitation of Services to improve cancer screening

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

Intervention Type: BEHAVIORAL

Other Intervention Names

patient navigation; cancer screening and education; patient navigation; faciliation of services; screening

Eligibility Criteria

Inclusion Criteria

Cancer-Negative Group

1. Be of Hispanic/Latino Origin

2. Fluent in English and/or Spanish

3. Recipient of, Medicare Part A & B, or combined Medicare/Medicaid

4. Not having a previous diagnosis of cancer

5. Be capable of giving written informed consent prior to any study related procedures.

6. Be available and willing to complete all study assessments as specified.

Cancer-Positive Group

1. Be of Hispanic/Latino Origin

2. Fluent in English and/or Spanish

3. Recipient of, Medicare Part A & B, or combined Medicare/Medicaid

4. Having a previous diagnosis of cancer of the breast, cervix, colon and/or rectum, prostate, or lung.

5. Be capable of giving written informed consent prior to any study related procedures.

6. Be available and willing to complete all study assessments as specified.

Exclusion Criteria

1. 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.)

2. Medicaid only beneficiaries

3. Institutionalized

4. Unable to provide written informed consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Natale-Pereira, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

UMDNJ

Newark, New Jersey, United States

Countries

United States

Other Identifiers

0120060236

Identifier Type: -

Identifier Source: org_study_id