Patient and Family Decision Making in the Palliative Care Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00682994
First received: May 15, 2008
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention
Advanced Cancer
Behavioral: Interview
Behavioral: Questionnaire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Patient and Family Decision Making and Information Disclosure Preferences in the Palliative Care Setting: a Multi-Center Survey in Chile, Guatemala, and U.S.

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Differences in Proportions of Preference for Passive Decision Making [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Enrollment: 780
Study Start Date: March 2008
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Decision Making
Questionnaire + Interview
Behavioral: Interview
Interview lasting about 5-10 minutes.
Behavioral: Questionnaire
Questionnaires taking 20-30 minutes to complete.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Patient is 18 years of age or older (as the assessment tools used in this study have not been validated in the pediatric population).
  4. 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.
  5. Patient willing to participate in the study and sign informed consent.
  6. 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).
  7. 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.
  8. Family member willing to participate in the study and sign informed consent.
  9. All participants in the international centers must be from Argentinian, Chilean, or Guatemalan descendence respectively.
  10. 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.

Exclusion Criteria:

  1. Either patient or family member can not complete the assessments independently.
  2. Either patient or family member refuses to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682994

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Argentina
Fundacion FEMEBA - Programa Argentino de Medicina Paliativa - Hospital Tornu
Buenos Aires, Argentina
Chile
Dr. Sotero del Rio Hospital - Catholic University of Chile
Santiago, Chile, 8207257
Guatemala
Guatemalan Cancer Institute - INCAN
Guatemala City, Guatemala
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Eduardo Bruera, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00682994     History of Changes
Other Study ID Numbers: 2007-0667
Study First Received: May 15, 2008
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Family Member
Palliative Care
Decision Making
Information Disclosure
Interview
Survey
Questionnaire

ClinicalTrials.gov processed this record on September 22, 2014