Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries

This study has been completed.
Sponsor:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00385866
First received: October 10, 2006
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Cancer
Behavioral: cancer screening and health education
Behavioral: facilitation of Services to improve cancer screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Reduce the disparities observed in utilization of cancer screening services [ Time Frame: 2-4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improve the time to diagnosis and treatment services (resulting in reduced cost of cancer care [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Improve patient satisfaction and informed decision making. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 1272
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
The control or lesser intervention group, will receive cancer screening information on a quarterly basis, with no faciliation of services.
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.
Other Names:
  • patient navigation
  • cancer screening and education
Active Comparator: Intervention group
The intervention group are those participants who were randomly assigned to receive faciliation of services in the form of patient navigation for the duration of the study.
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
Other Names:
  • patient navigation
  • faciliation of services
  • screening

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385866

Locations
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07107
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Centers for Medicare and Medicaid Services
Investigators
Principal Investigator: Ana Natale-Pereira, MD, MPH Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00385866     History of Changes
Other Study ID Numbers: 0120060236
Study First Received: October 10, 2006
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Patient Navigator
Community health
Communication

ClinicalTrials.gov processed this record on September 18, 2014