End of Life Treatment Preferences of Latino Medicare Beneficiaries With Cancer

NCT ID: NCT01389830

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Advanced Cancers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Older Latinos With Cancer

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

Telephone Survey

Intervention Type BEHAVIORAL

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.

Older Latinos Without Cancer

Single Telephone Survey of Cohort without a history of cancer.

Telephone Survey

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Interviews

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabel Torres, MPH, DRPH

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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7K01CA151785-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-0436

Identifier Type: -

Identifier Source: org_study_id

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