Clinical trial NCT00453661: Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities
Official title: Cancer Prevention and Treatment Demonstration for Hispanic Medicare Eligible Beneficiaries - CMS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Cervical Cancer
Prostate Cancer
Colorectal Cancer
Lung Cancer
Keywords: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
First posted: 2007-03-29
Enrollment: 2472
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hispanic American 40 Years + treated for cancer and Medicare eligible.

Brief summary: 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.

Detailed description: Screening Questionnaire:

Before you can start on this study, you will answer a 20 minute Triage questionnaire. The questionnaire will ask you if you have had cancer, what type of cancer, and when you were last treated.

Cancer-Screening Groups and Treatment Groups:

Once you answer the Triage questionnaire and if you are found to be eligible to take part in this study, you will be placed in the Cancer Screening Group or the Treatment Group based on your answers to the Triage questionnaire.

If you have not been treated for cancer in the past or if it has been more than 5 years since you were last treated, you will be in the Cancer Screening Group and you will complete the screening Cancer Screening Assessment (CSA). The CSA will ask you about cancer screenings, lifestyle, and other health related items. The questionnaire should take about a total of 45-60 minutes to complete.

If you have been treated for cancer in the past 5 years, you will be in the Treatment Group. The CSA will ask you about cancer screenings, cancer treatment, and other health related items. The questionnaire should take about a total of 45-60 minutes to complete.

After completion of the Cancer Screening Assessment (CSA) for either the Cancer Screening Group or the Treatment Group, you will complete a CSA addendum questionnaire. This CSA addendum questionnaire will ask you about barriers and factors that may influence your health related decisions. The questionnaire should take 15-20 minutes to complete.

Intervention and Comparison Groups:

Participants in either the cancer-screening group or the treatment group will be randomly assigned (as in the flip of a coin) to one of 2 additional groups, the "Intervention group" or the "Comparison" group. You will have an equal chance of being in either group.

If you are in the Intervention Group, you will work with a staff member, called a patient navigator (PN), who will assist with medical care and/or screenings (intervention group). For example, the staff member may help schedule screening appointments, medical care appointments, or any other necessary assistance to meet health care needs. The PN will be responsible for recording information about your care and any cancer treatment, should that be necessary.

You will complete a CSA questionnaire 1 time a year for up to 4 years. A staff member will contact you by phone to set up an appointment to give you the CSA questionnaires. All questionnaires will be completed at a time and place that you and the study staff agree upon. For example, the study staff may meet you at a community center, independent-living center, or another agreed upon location. The questionnaire should take about 45-60 minutes to complete.

If you are in the Comparison Group, you will not work with a staff member and you will not complete any additional questionnaires during the 4 years on study.

Both the intervention group and the comparison group will receive educational materials.

Exit Questionnaire:

About 4 years after you join the study, you will be contacted by a staff member and you will set up an exit questionnaire meeting. This questionnaire will be completed at a time and place that you and the staff member agree upon. This questionnaire will contain similar questions to those you have been answering since your participation in the study. The questionnaire will take about 45-60 minutes to complete.

Length of Study:

You will be considered off-study after 4 years.

This is an investigational study. Up to 11,964 participants will take part in this study. A total of 2,812 will be enrolled at M. D. Anderson.

Eligibility 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.

Primary outcomes:
measure: Screening Rates
timeFrame: 4 Years
Secondary outcomes:
measure: Compliance Rate Across 5 Cancer Types
timeFrame: 4 Years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Isabel Torres, DRPH,MPH
role: PRINCIPAL_INVESTIGATOR
References: