End of Life Treatment Preferences of Latino Medicare Beneficiaries With Cancer
18 Years
N/A
Both
Advanced Cancers
Trial Information
End of Life Treatment Preferences of Latino Medicare Beneficiaries With Cancer
This study will determine if the combination of declining health, cultural factors (such as
language of choice) and meeting the cultural and language needs of Latino cancer patients
influence end-of-life treatment choices over time.
If you decide to take part in this study, you will complete a questionnaire once a month for
12 months, over the telephone. The questionnaire asks you about your end of life and
decision making preferences, as well as questions about your health status and other basic
questions about you such as your education level, age, and health insurance. The first phone
questionnaire, the one you will answer today, will take about 30 - 40 minutes to complete.
The monthly surveys after today will take about 20 - 30 minutes to complete each month. You
will be considered off of the study in one year.
Should you become too ill and are unable to complete the surveys we will ask a proxy to
respond on your behalf. A proxy in this case, should be someone you trust, who knows you
well enough to know how to answer the health questionnaire on your behalf. A proxy is
usually a spouse, child, other close family member or friend. This person will only have to
answer questions about you. He or she will not answer any questions about him or herself.
We will ask you to provide us with the contact information of the person you select as your
"questionnaire proxy" today at the end of this consent form. If you are able to complete all
12 surveys, we will not contact the proxy.
Information from this study will be used only for research purposes. All identifying
information such as your name and address will be kept private. This information may be kept
at MD Anderson and University of Houston (UH) forever. You will be assigned a code number
so that your name will not be used. The research team at MD Anderson and UH will be able to
link the code number to your name. We will take appropriate steps to keep your survey
responses confidential. However, there is no guarantee of absolute confidentiality. Your
information will be protected according to state and federal law. The research team may
share study information with certain individuals including the National Institutes of Health
and institutional study monitors who verify the accuracy of the information to see that the
research is being conducted in a safe and correct manner.
Answering the survey questions over the phone may cause you to feel tired. The
questionnaires may involve topics that are sensitive in nature. You may refuse to answer any
question that makes you feel uncomfortable. If you have concerns after completing the
survey, you are encouraged to contact your doctor, the study chair, or MD Anderson's
Institutional Review Board.
Although there may be no benefits for you in this study, future patients may benefit from
what is learned in this study. Your participation in this research study is strictly
voluntary and you may choose not to take part in this study and/or stop the interview at any
time or to not answer any questions that make you feel uncomfortable. If you choose not to
take part in this study, you will not be penalized or lose benefits that you are entitled
to. You may choose to withdraw your consent to participate in the study at any time, without
loss of benefit to you.
Inclusion Criteria:
1. (Inclusion Criteria of participants recruited from CPTD) Cancer and non-cancer
participants recruited to the study must have either been enrolled in either the
screening (cancer negative) or treatment (cancer positive) of the Centers for
Medicare and Medicaid Services Cancer Prevention and Treatment Demonstration Project
(CMS CPTD) (Protocol 2006-0419) or must be listed as a current patient from the
provided MD Anderson Tumor Registry list. All participants must meet the CPTD
eligibility criteria listed below.
2. (Inclusion Criteria of participants recruited from CPTD) Cancer patients must have a
stage III diagnosis or greater of cancer.
3. (Inclusion Criteria of participants recruited from the CPTD) Cancer patients must
designate a proxy respondent at the time of the baseline interview in the event that
a participant cannot complete subsequent phone interviews due to illness severity or
cognitive impairment.
4. (Inclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Be Latino
/ Hispanic American.
5. (Inclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Have
Medicare Part A and Part B.
6. (Inclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Be at
least 40 years of age.
7. (Inclusion Criteria of the CPTD, Protocol 2006-0419) All Cancer Screening Group
(cancer negative) participants must: Be a Medicare-eligible beneficiary from Region 6
(Central Gulf Coast) as defined by Texas Department of State Health Services.
8. (Inclusion Criteria of the CPTD, Protocol 2006-0419) All Cancer Treatment Group
(cancer positive) participants must: Have been diagnosed with breast, cervix,
prostate, colorectal, and/or lung cancer within the past 5 years. Be a
Medicare-eligible beneficiary from Texas.
9. (Inclusion Criteria of participants recruited from Tumor Registry) Be Latino /
Hispanic American.
10. (Inclusion Criteria of participants recruited from Tumor Registry) Have Medicare Part
A and Part B.
11. (Inclusion Criteria of participants recruited from Tumor Registry) Be at least 40
years of age.
12. (Inclusion Criteria of participants recruited from Tumor Registry) Must have a stage
3 diagnosis of cancer or greater.
13. (Inclusion Criteria of participants recruited from Tumor Registry) Must designate a
proxy respondent at the time of the baseline interview in the event that a
participant cannot complete subsequent phone interviews due to illness severity or
cognitive impairment.
Exclusion Criteria:
1. Participants refuse to participate in the study or are not competent to give informed
consent.
2. Participants who miss 3 or more answers on the Six-Item Screener to Identify
Cognitive Impairment.
3. Participants are not able to complete the baseline assessment forms.
4. (Exclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Not be
enrolled in a managed care plan (also called an HMO, Medicare + Choice, or Medicare
Advantage)
5. (Exclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Not be
enrolled in hospice
6. (Exclusion Criteria of the CPTD, Protocol 2006-0419): All Cancer Screening Group
(cancer negative) participants must: Not have been diagnosed with cancer within the
last 5 years.
7. (Exclusion Criteria of the CPTD, Protocol 2006-0419): All Cancer Treatment Group
(cancer positive) participants must: Not Be a Medicare-eligible beneficiary outside
of Region 6 (Central Gulf Coast) unless treated at MD Anderson.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
End of Life Treatment Preferences of Older Latinos With and Without Cancer (Survey Responses)
Outcome Description:
Survey of how changes in functional status influence End of Life (EOL) treatment preferences among older Latinos with cancer. EOL treatment preferences treated as a continuous variable (0-10) and functional status assessed using Patient-reported Eastern Cooperative Oncology Group (ECOG) Performance Scale where low functional status will be defined as an ECOG score of 3 or 4 and high as 0-2.
Outcome Time Frame:
Once a month for 12 months
Safety Issue:
No
Principal Investigator
Isabel Torres, MPH, DRPH
Investigator Role:
Study Chair
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2011-0436
NCT ID:
NCT01389830
Start Date:
June 2011
Completion Date:
Related Keywords:
- Advanced Cancers
- End of Life
- EOL
- Latinos
- Hispanic American
- Medicare beneficiaries
- stage III diagnosis
- Breast cancer
- Colorectal cancer
- Prostate cancer
- Lung cancer
- Cancer Prevention and Treatment Demonstration
- CPTD
- Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
