End of Life Treatment Preferences of Latino Medicare Beneficiaries With Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/8/2018 |
| Start Date: | June 2011 |
| End Date: | June 2019 |
Objectives:
The primary objective of the research project is to investigate how declining health status
influences the end-of-life (EOL) treatment preferences in Latino Medicare beneficiaries with
cancer and to examine if and how these preferences are modified by predisposing
characteristics (i.e., acculturation, education, medical mistrust, perceived racism) and/or
provider-related characteristics (i.e., ethnicity, language used, provision of interpreters,
or patient navigators). The specific aims are:
1. To determine if declining functional status influences the end-of-life treatment
preferences of older Latino Medicare beneficiaries with cancer.
2. To determine if predisposing characteristics (i.e., acculturation, age, education,
medical mistrust, perceived racism) and/or provider-related characteristics (i.e.,
ethnicity, language used, provision of interpreters, or patient navigators) modify the
association between end-of-life treatment preferences and declining health status in
older Latino Medicare beneficiaries with cancer.
3. To identify if the end-of-life treatment preferences of Latino Medicare beneficiaries
with cancer differ from those of older Medicare beneficiaries without cancer.
The primary objective of the research project is to investigate how declining health status
influences the end-of-life (EOL) treatment preferences in Latino Medicare beneficiaries with
cancer and to examine if and how these preferences are modified by predisposing
characteristics (i.e., acculturation, education, medical mistrust, perceived racism) and/or
provider-related characteristics (i.e., ethnicity, language used, provision of interpreters,
or patient navigators). The specific aims are:
1. To determine if declining functional status influences the end-of-life treatment
preferences of older Latino Medicare beneficiaries with cancer.
2. To determine if predisposing characteristics (i.e., acculturation, age, education,
medical mistrust, perceived racism) and/or provider-related characteristics (i.e.,
ethnicity, language used, provision of interpreters, or patient navigators) modify the
association between end-of-life treatment preferences and declining health status in
older Latino Medicare beneficiaries with cancer.
3. To identify if the end-of-life treatment preferences of Latino Medicare beneficiaries
with cancer differ from those of older Medicare beneficiaries without cancer.
Latino Medicare Beneficiary 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 participant decides to take part in this study, participant will complete a questionnaire
once a month for 9 months, over the telephone. The questionnaire asks participant about
participant's end of life and decision making preferences, as well as questions about
participant's health status and other basic questions about participant such as participant's
education level, age, and health insurance. The first phone questionnaire, the one
participant 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. Participant will
be considered off of the study in nine months.
Should participant become too ill and are unable to complete the surveys, researchers will
ask a proxy to respond on participant's behalf. A proxy in this case, should be someone
participant trusts, who knows participant well enough to know how to answer the health
questionnaire on participant's behalf. A proxy is usually a spouse, child, other close family
member or friend. This person will only have to answer questions about participant. He or she
will not answer any questions about him or herself. Researchers will ask participant to
provide researchers with the contact information of the person participant selects as
participant's "questionnaire proxy" today at the end of this consent form. If participant is
able to complete all 9 surveys, researchers will not contact the proxy.
Information from this study will be used only for research purposes. All identifying
information such as participant's name and address will be kept private. This information may
be kept at MD Anderson and University of Houston (UH) forever. Participant will be assigned a
code number so that participant's name will not be used. The research team at MD Anderson and
UH will be able to link the code number to participant's name. Researchers will take
appropriate steps to keep participant's survey responses confidential. However, there is no
guarantee of absolute confidentiality. Participant's 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 participant to feel tired. The
questionnaires may involve topics that are sensitive in nature. Participant may refuse to
answer any question that makes participant feel uncomfortable. If participant has concerns
after completing the survey, participant is encouraged to contact participant's doctor, the
study chair, or MD Anderson's Institutional Review Board.
Latino Medicare Beneficiary Without 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
(provider ethnicity, use of interpreters), influence end-of-life treatment choices over time.
If participant decides to take part in this study, participant will complete a one-time
questionnaire today, over the telephone. The questionnaire asks participant about
participant's end of life and decision making preferences, as well as questions about
participant's health status and other basic questions about participant such as participant's
education level, age, and health insurance. This questionnaire will take about 30 - 40
minutes to complete. Participant will be considered off the study after participant completes
this one-time questionnaire.
Information from this study will be used only for research purposes. All identifying
information such as participant's name and address will be kept private. This information may
be kept at MD Anderson and University of Houston (UH) forever. Participant will be assigned a
code number so that participant's name will not be used. The research team at MD Anderson and
UH will be able to link the code number to participant's name. Researchers will take
appropriate steps to keep participant's survey responses confidential. However, there is no
guarantee of absolute confidentiality. Participant's 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 participant to feel tired. The
questionnaires may involve topics that are sensitive in nature. Participant may refuse to
answer any question that makes participant feel uncomfortable. If participant has concerns
after completing the questionnaires and interviews, participant is encouraged to contact
participant's doctor or the study chair.
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 participant decides to take part in this study, participant will complete a questionnaire
once a month for 9 months, over the telephone. The questionnaire asks participant about
participant's end of life and decision making preferences, as well as questions about
participant's health status and other basic questions about participant such as participant's
education level, age, and health insurance. The first phone questionnaire, the one
participant 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. Participant will
be considered off of the study in nine months.
Should participant become too ill and are unable to complete the surveys, researchers will
ask a proxy to respond on participant's behalf. A proxy in this case, should be someone
participant trusts, who knows participant well enough to know how to answer the health
questionnaire on participant's behalf. A proxy is usually a spouse, child, other close family
member or friend. This person will only have to answer questions about participant. He or she
will not answer any questions about him or herself. Researchers will ask participant to
provide researchers with the contact information of the person participant selects as
participant's "questionnaire proxy" today at the end of this consent form. If participant is
able to complete all 9 surveys, researchers will not contact the proxy.
Information from this study will be used only for research purposes. All identifying
information such as participant's name and address will be kept private. This information may
be kept at MD Anderson and University of Houston (UH) forever. Participant will be assigned a
code number so that participant's name will not be used. The research team at MD Anderson and
UH will be able to link the code number to participant's name. Researchers will take
appropriate steps to keep participant's survey responses confidential. However, there is no
guarantee of absolute confidentiality. Participant's 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 participant to feel tired. The
questionnaires may involve topics that are sensitive in nature. Participant may refuse to
answer any question that makes participant feel uncomfortable. If participant has concerns
after completing the survey, participant is encouraged to contact participant's doctor, the
study chair, or MD Anderson's Institutional Review Board.
Latino Medicare Beneficiary Without 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
(provider ethnicity, use of interpreters), influence end-of-life treatment choices over time.
If participant decides to take part in this study, participant will complete a one-time
questionnaire today, over the telephone. The questionnaire asks participant about
participant's end of life and decision making preferences, as well as questions about
participant's health status and other basic questions about participant such as participant's
education level, age, and health insurance. This questionnaire will take about 30 - 40
minutes to complete. Participant will be considered off the study after participant completes
this one-time questionnaire.
Information from this study will be used only for research purposes. All identifying
information such as participant's name and address will be kept private. This information may
be kept at MD Anderson and University of Houston (UH) forever. Participant will be assigned a
code number so that participant's name will not be used. The research team at MD Anderson and
UH will be able to link the code number to participant's name. Researchers will take
appropriate steps to keep participant's survey responses confidential. However, there is no
guarantee of absolute confidentiality. Participant's 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 participant to feel tired. The
questionnaires may involve topics that are sensitive in nature. Participant may refuse to
answer any question that makes participant feel uncomfortable. If participant has concerns
after completing the questionnaires and interviews, participant is encouraged to contact
participant's doctor or the study chair.
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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: Isabel Torres, MPH, DRPH
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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