MDACC Study Summary 2006-0419

Study Summary
No. 2006-0419:.......Cancer Prevention......Lovell A. Jones......Health Disparities Research

Study Summary Title



Study Summary Number:	2006-0419

Study Title:	Cancer Prevention and Treatment Demonstration for Hispanic Medicare Eligible Beneficiaries -CMS

Physician

New Patient Referral



Name:	Lovell A. Jones	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Health Disparities Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2724 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Once a participant has been identified, the CSA may done off site or on site at least once every year for up to four years for the intervention group. The comparison group will receive an initial and an exit CSA.

Treatment Agents:	None	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	None


Description/ Intervention:	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.

Study Objectives / Outcomes

This demonstration project funded by the Centers for Medicare and Medicaid Services (CMS) will focus on new, evidence-based, culturally competent intervention model. CMS was given a Congressional mandate for this project, as referenced by Section 122 of the BIPA legislation. This multi-site demonstration project is taking place at 6 sites across the country, to increase cancer-screening rates, and provide access to treatment for cancers of the breast, cervix, colon, or prostate among a selected population through facilitated patient navigation services. Participants will be recruited from various venues, be screened for eligibility, and be given a triage tool that will assess which Cancer Screening Assessment (CSA) they receive.

The demonstration project includes access and follow-up to lung cancer treatment. The overall objective of the demonstration project will be to evaluate patient navigation services by showing an improvement in the utilization of cancer prevention services, specifically by increasing screening and treatment compliance. The objective of this study is to increase screening rates by 10-15% in the intervention group and compare the rates with the control group. Screening and treatment compliance is defined in the Protocol Section E1 and E2, respectively. A secondary outcome of this project proposes that a structured patient navigation program will reduce the cost of Medicare services. Therefore, the demonstration project will conduct a cost analysis to estimate Medicare cancer spending of study participants. A difference of a dollar will be considered a reduction. The targeted population for this project is Medicare-eligible Latino / Hispanic Americans from the 13 counties surrounding M. D. Anderson for a Cancer Screening Group and the State of Texas for a Cancer Treatment Group. Selected demonstration participants will then be randomized into one of two groups; 1) An intervention group that will receive facilitated care via a trained patient navigator and 2) A comparison group that will receive standard care according to MD Anderson Care guidelines.

Study Status Information



Study Activation / Registration Date:	03/16/2007

IRB Review and Approval Date:	02/07/2007

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	11964

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) All participants must have Medicare Part A and Part B

2) All participants must be Latino / Hispanic American

3) All participants must be at least 40 years of age

4) 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.

5) All Cancer Treatment Group participants must have been diagnosed with breast, cervix, prostate, colorectal, and/or lung cancer within the past 5 years.

6) All Cancer Treatment Group participants must be a Medicare-eligible beneficiary from Texas.

Exclusion Criteria:

1) All participants must not be enrolled in a managed care plan (also called an HMO, Medicare + Choice, or Medicare Advantage)

2) All participants must not be enrolled in hospice

3) All Cancer Screening Group participants must not have been diagnosed with cancer within the last 5 years.

4) All Cancer Treatment Group participants must not be a Medicare-eligible beneficiary outside of Region 6 (Central Gulf Coast) unless treated at MD Anderson

Links

Registration Number: NCT00453661
Study Information on Clinical Trials Registry (clinicaltrials.gov)