Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries

Cancer Clinical Trial

Official title:

Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385866
• Other study ID #: 0120060236
• Status: Completed
• Phase: N/A
• First received: October 10, 2006
• Last updated: April 19, 2016
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: April 2016
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1272
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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.
• facilitation of Services to improve cancer screening
The intervention group will receive cancer education and faciliation of services in the form of patient navigation

Locations

Country	Name	City	State
United States	UMDNJ	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Centers for Medicare and Medicaid Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce the disparities observed in utilization of cancer screening services		2-4 years	No
Secondary	Improve the time to diagnosis and treatment services (resulting in reduced cost of cancer care		4 years	No
Secondary	Improve patient satisfaction and informed decision making.		4 years	No