NCT00682994

Brief Summary

The goal of this research study is to learn about any differences in certain health-related preferences between patients with cancer and their families. The main preferences being studied are how decisions are made about healthcare, as well as how much information people want to know about cancer. Specifically, researchers will compare questionnaire and interview data from Hispanic-Americans living in the United States (the M. D. Anderson part of this multicenter study) with Hispanics living in Latin America (in particular, Argentina, Chile, and Guatemala).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
780

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

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

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 19, 2016

Status Verified

August 1, 2012

Enrollment Period

4.4 years

First QC Date

May 15, 2008

Last Update Submit

February 17, 2016

Conditions

Advanced Cancer

Keywords

Advanced CancerFamily MemberPalliative CareDecision MakingInformation DisclosureInterviewSurveyQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Differences in Proportions of Preference for Passive Decision Making

    6 Years

Study Arms (1)

Decision Making

OTHER

Questionnaire + Interview

Behavioral: InterviewBehavioral: Questionnaire

Interventions

InterviewBEHAVIORAL

Interview lasting about 5-10 minutes.

Decision Making
QuestionnaireBEHAVIORAL

Questionnaires taking 20-30 minutes to complete.

Also known as: Survey
Decision Making

Eligibility Criteria

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

You may qualify if:

  • Patient with advanced cancer (local recurrence or metastatic) at the time of their follow up visit to the outpatient palliative care clinic or at an agreed date after the first visit to the outpatient palliative care clinic.
  • Patient designates a family member who is a patient's parent, spouse, adult child, sibling, other relative, or significant other (any other person defined by the patient as a partner) to answer the family questionnaire.
  • Patient is 18 years of age or older (as the assessment tools used in this study have not been validated in the pediatric population).
  • Patient with normal cognitive status as determined by the interviewer and by her/his ability to understand the nature of the study and consent process.
  • Patient willing to participate in the study and sign informed consent.
  • Family member is 18 years of age or older (as the assessment tools used in this study have not been validated in the pediatric population).
  • Family member with normal cognitive status as determined by the interviewer and by her/his ability to understand the nature of the study and consent process.
  • Family member willing to participate in the study and sign informed consent.
  • All participants in the international centers must be from Argentinian, Chilean, or Guatemalan descendence respectively.
  • All participants in the U.S. must be from self-reported Hispanic descendence, first or second generation immigrants, and reside in the U.S. for at least 5 years.

You may not qualify if:

  • Either patient or family member can not complete the assessments independently.
  • Either patient or family member refuses to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fundacion FEMEBA - Programa Argentino de Medicina Paliativa - Hospital Tornu

Buenos Aires, Argentina

Location

Dr. Sotero del Rio Hospital - Catholic University of Chile

Santiago, 8207257, Chile

Location

Guatemalan Cancer Institute - INCAN

Guatemala City, Guatemala

Location

Related Links

MeSH Terms

Interventions

Interviews as TopicSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Eduardo Bruera, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 23, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 19, 2016

Record last verified: 2012-08

Locations

US(1)GU(1)AR(1)CL(1)