Patient and Family Decision Making in the Palliative Care Setting - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00682994

Purpose

Primary Objective:

1. To determine the preferences regarding passive decision-making and information disclosure among Chilean, Guatemalan, and highly acculturated Hispanic-American cancer patients.

Secondary Objectives:

To determine the difference between patient and family preferences regarding passive decision making and disclosure of diagnostic and prognostic information.
To determine whether agreement between patients' passive decision making preference and actual decision making process influences their satisfaction with the care.
To explore whether patient and family passive preferences are related to variations in demographic factors.
To determine the differences in preferences regarding passive decision-making preferences and information disclosure between highly and lower acculturated Hispanic-Americans.

Condition	Intervention
Advanced Cancer	Behavioral: Interview Behavioral: Questionnaire

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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:

MedlinePlus related topics: Cancer Palliative Care

U.S. FDA Resources

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

Primary Outcome Measures:

To study any differences in certain health-related preferences between patients with cancer and their families. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	700
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2014 (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.

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Eligibility

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

Criteria

Inclusion Criteria:

Patient with advanced cancer (local recurrence or metastatic) at the time of their follow up 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 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 10 years.

Exclusion Criteria:

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

Contacts and Locations

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

Contacts

Contact: Eduardo Bruera, MD

713-792-6085

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Eduardo Bruera, MD
Chile
Dr. Sotero del Rio Hospital - Catholic University of Chile	Recruiting
Santiago, Chile, 8207257
Guatemala
Guatemalan Cancer Institute - INCAN	Recruiting
Guatemala City, Guatemala

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Eduardo Bruera, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Eduardo Bruera, MD/Professor )
Study ID Numbers:	2007-0667
Study First Received:	May 15, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00682994 History of Changes
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 10, 2009