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Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, August 2009
First Received: March 27, 2007   Last Updated: August 14, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Centers for Medicare and Medicaid Services
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00453661
  Purpose

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.


Condition Intervention
Breast Cancer
Cervical Cancer
Prostate Cancer
Colorectal Cancer
Lung Cancer
Behavioral: Questionnaire
Behavioral: Patient Navigator (PN)

Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Cancer Prevention and Treatment Demonstration for Hispanic Medicare Eligible Beneficiaries - CMS

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Screening Rates [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance Rate Across 5 Cancer Types [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 11964
Study Start Date: March 2007
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention Group
Patient Navigator (PN) + Educational Materials + Annual Questionnaires
Behavioral: Questionnaire

Intervention Group:

Cancer Screening Assessment (CSA) questionnaire 45-60 minutes annually for 4 years + Exit Questionnaire at end of study.

Comparison Group:

Exit Questionnaire only.

Behavioral: Patient Navigator (PN)
Staff member, called patient navigator (PN), who assist with medical care and/or screenings, questionnaires.
Comparison Group
Educational Materials + Exit Questionnaire
Behavioral: Questionnaire

Intervention Group:

Cancer Screening Assessment (CSA) questionnaire 45-60 minutes annually for 4 years + Exit Questionnaire at end of study.

Comparison Group:

Exit Questionnaire only.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Hispanic American 40 Years + treated for cancer and Medicare eligible.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453661

Contacts
Contact: Lovell A. Jones, PhD 713-563-2724

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Lovell A. Jones, PhD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Centers for Medicare and Medicaid Services
Investigators
Principal Investigator: Lovell A. Jones, PhD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Lovell A. Jones, PhD/Professor )
Study ID Numbers: 2006-0419
Study First Received: March 27, 2007
Last Updated: August 14, 2009
ClinicalTrials.gov Identifier: NCT00453661     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Cervical Cancer
Prostate Cancer
Colorectal Cancer
Lung Cancer
Cancer Prevention
Treatment Demonstration for Ethnic and Racial Minorities
Centers for Medicare and Medicaid Services
CMS
Hispanic American
Cancer Screening Assessment
Annual Questionnaire
Patient Navigator
Educational Materials

Study placed in the following topic categories:
Thoracic Neoplasms
Digestive System Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Gastrointestinal Diseases
Colonic Diseases
Breast Neoplasms
Urogenital Neoplasms
Genital Diseases, Male
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Gastrointestinal Diseases
Colonic Diseases
Breast Neoplasms
Urogenital Neoplasms
Genital Diseases, Male
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009