Advanced CancersNCT01389830
End of Life Treatment Preferences of Latino Medicare Beneficiaries With Cancer
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Telephone Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2011to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- (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.
- (Inclusion Criteria of participants recruited from CPTD) Cancer patients must have a stage III diagnosis or greater of cancer.
- (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.
- (Inclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Be Latino / Hispanic American.
- (Inclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Have Medicare Part A and Part B.
- (Inclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Be at least 40 years of age.
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- (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.
- (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.
- (Inclusion Criteria of participants recruited from Tumor Registry) Be Latino / Hispanic American.
- (Inclusion Criteria of participants recruited from Tumor Registry) Have Medicare Part A and Part B.
- (Inclusion Criteria of participants recruited from Tumor Registry) Be at least 40 years of age.
- (Inclusion Criteria of participants recruited from Tumor Registry) Must have a stage 3 diagnosis of cancer or greater.
- (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.
Who cannot join
- Participants refuse to participate in the study or are not competent to give informed consent.
- Participants who miss 3 or more answers on the Six-Item Screener to Identify Cognitive Impairment.
- Participants are not able to complete the baseline assessment forms.
- (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)
- (Exclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Not be enrolled in hospice
- (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.
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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:
- To determine if declining functional status influences the end-of-life treatment preferences of older Latino Medicare beneficiaries with cancer.
- 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.
- 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.
- Conditions
- Advanced Cancers
- Being tested
- Telephone Survey
- 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
- Medical subject headings
- Death, Disease, Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone SurveyBehavioural
Also called Interviews
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.
| Study group | Role | What they receive |
|---|---|---|
| Older Latinos With Cancer | Monthly Telephone Survey of Cohort with stage III or greater of breast, colorectal, or prostate cancer up until 12 months. Receives: Behavioral: Telephone Survey | |
| Older Latinos Without Cancer | Single Telephone Survey of Cohort without a history of cancer. Receives: Behavioral: Telephone Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once a month for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study start30 Jun 2011
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Isabel Torres, MPH, DRPH, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389830
- Sponsor's protocol ID
- 2011-0436
- Other IDs
- 7K01CA151785-02
- Status last verified
- Jul 2019
- First submitted
- 6 Jul 2011
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End of Life Treatment Preferences of Latino Medicare Beneficiaries With Cancer
- ClinicalTrials.gov ID
- NCT01389830
- Acronym / sponsor ID
- 2011-0436
- Conditions
- Advanced Cancers
- Keywords
- End of Life, EOL, Latinos, Hispanic American, Medicare beneficiaries, stage III diagnosis, Breast cancer, Colorectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Jun 2011 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine if declining functional status influences the end-of-life treatment preferences of older Latino Medicare beneficiaries with cancer.
- 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.
- 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Latinos With Cancer | – | Behavioral: Telephone SurveyMonthly Telephone Survey of Cohort with stage III or greater of breast, colorectal, or prostate cancer up until 12 months. |
| Older Latinos Without Cancer | – | Behavioral: Telephone SurveySingle Telephone Survey of Cohort without a history of cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (13 listed)
- (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.
- (Inclusion Criteria of participants recruited from CPTD) Cancer patients must have a stage III diagnosis or greater of cancer.
- (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.
- (Inclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Be Latino / Hispanic American.
- (Inclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Have Medicare Part A and Part B.
Key exclusion criteria (7 listed)
- Participants refuse to participate in the study or are not competent to give informed consent.
- Participants who miss 3 or more answers on the Six-Item Screener to Identify Cognitive Impairment.
- Participants are not able to complete the baseline assessment forms.
- (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)
- (Exclusion Criteria of the CPTD, Protocol 2006-0419) All participants must: Not be enrolled in hospice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone SurveyAlso: InterviewsTelephone 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. | Behavioural | Older Latinos With Cancer, Older Latinos Without Cancer |
Primary outcome
End of Life Treatment Preferences of Older Latinos With and Without Cancer (Survey Responses)
Time frame: Once a month for 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Torres, MPH, DRPH study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.