NCT01389830

Brief 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. 1.To determine if declining functional status influences the end-of-life treatment preferences of older Latino Medicare beneficiaries with cancer.
  2. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

11 years

First QC Date

July 6, 2011

Last Update Submit

July 16, 2019

Conditions

Keywords

End of LifeEOLLatinosHispanic AmericanMedicare beneficiariesstage III diagnosisBreast cancerColorectal cancerProstate cancerLung cancerCancer Prevention and Treatment DemonstrationCPTD

Outcome Measures

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.

    Once a month for 12 months

Study Arms (2)

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

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
Older Latinos With CancerOlder Latinos Without Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

DeathDiseaseBreast NeoplasmsColorectal NeoplasmsProstatic NeoplasmsLung Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Isabel Torres, MPH, DRPH

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 8, 2011

Study Start

June 30, 2011

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations