Trial Information

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

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.