Patient and Family Decision Making in the Palliative Care Setting
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
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
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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:
- 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.
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
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 |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013