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End of Life Treatment Preferences

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01389830
First received: July 6, 2011
Last updated: October 9, 2014
Last verified: October 2014

July 6, 2011
October 9, 2014
June 2011
June 2016   (final data collection date for primary outcome measure)
End of Life Treatment Preferences of Older Latinos With and Without Cancer (Survey Responses) [ Time Frame: Once a month for 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01389830 on ClinicalTrials.gov Archive Site
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Not Provided
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End of Life Treatment Preferences
End of Life Treatment Preferences of Latino Medicare Beneficiaries With Cancer

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.

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 you decide to take part in this study, you will complete a questionnaire once a month for 9 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 nine months. To compensate your time and efforts, we will send you $20 for your first survey and then $60 over the next 8 months for additional surveys ($20 for surveys 2-3; $20 for surveys 4-6; and $20 for surveys 7-9), totaling $80.00 over the course of nine months.

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 9 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.

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 you decide to take part in this study, you will complete a one-time questionnaire today, 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. This questionnaire will take about 30 - 40 minutes to complete. You will be considered off the study after you complete this one-time questionnaire. Upon completion of the questionnaire, you will be mailed a $20 gift card.

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 questionnaires and interviews, you are encouraged to contact your doctor or the study chair.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Advanced Cancers
Behavioral: Telephone 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.
Other Name: Interviews
  • Older Latinos With Cancer
    Monthly Telephone Survey of Cohort with stage III or greater of breast, colorectal, or prostate cancer up until 12 months.
    Intervention: Behavioral: Telephone Survey
  • Older Latinos Without Cancer
    Single Telephone Survey of Cohort without a history of cancer.
    Intervention: Behavioral: Telephone Survey
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
Not Provided
June 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Isabel Torres, MPH, DRPH 713-563-4125
United States
 
NCT01389830
2011-0436, 7 K01 CA151785-02
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Isabel Torres, MPH, DRPH M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP