CClinicalTrials.gg
Status unknownNCT01389830Updated Jul 18, 2019

End of Life Treatment Preferences of Latino Medicare Beneficiaries With Cancer

An observational study in Advanced Cancers, sponsored by M.D. Anderson Cancer Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-18.

Sponsored by M.D. Anderson Cancer Center · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
230
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the detailed description

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.

02

Conditions studied

  • Advanced Cancers

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Keywords

  • 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
03

In context

Death

572 studies on the registry are indexed under Death; 111 are open to participants now.

This study's planned enrollment of 230 is below the median of 314 across 293 observational studies indexed under Death.

Browse Death studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Survey of 200 older Latino Medicare beneficiaries from the greater Houston area enrolled in a larger national Cancer Prevention and Treatment Demonstration Project (CPTD).

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
230 participants (estimated)
Patient registry
No

Groups and cohorts

  • Older Latinos With Cancer

    Monthly Telephone Survey of Cohort with stage III or greater of breast, colorectal, or prostate cancer up until 12 months.

    Behavioral: Telephone Survey

  • Older Latinos Without Cancer

    Single Telephone Survey of Cohort without a history of cancer.

    Behavioral: Telephone Survey

Interventions

  • BehavioralTelephone Survey

    Telephone interviews (survey) at baseline taking approximately 30-40 minutes to complete; follow-up monthly surveys for cancer patients take 20-30 minutes to complete, follow ups until 12 months or death.

    Also known as: Interviews

06

What researchers measure

Primary outcomes

  1. End of Life Treatment Preferences of Older Latinos With and Without Cancer (Survey Responses)

    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.

    Time frame: Once a month for 12 months

07

Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01389830
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 8, 2011
Start date
Jun 30, 2011
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Jul 18, 2019

Study contacts

Isabel Torres, MPH, DRPH
study chair · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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