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

  Hide Detailed Description

Detailed Description:

Study Background:

People from different cultures may have different preferences in the way decisions about their healthcare are made, as well as how much information they may want to know about the diseases they may have. However, patients and families sometimes disagree about these preferences. In this study, researchers want to learn about any differences in healthcare decision-making and information-sharing preferences between patients and their families, among a group of people from different Hispanic backgrounds.

(Please note that the phrase "family member" has been used in this consent form for short, but the definition includes non-family members that you may consider a "significant other").

Screening Procedures:

Participants in this study must also agree to give the name of a family member (a parent, spouse, adult child, sibling, other family member, or a non-family member that you consider a "significant other") that researchers can ask to participate in a separate part of this study that will require signing a separate consent form. (If the person of your choice is not with you at the time of joining the study, he/she may come back to the clinic at your next follow-up visit.)

If the family member agrees, he/she will complete a similar series of questionnaires about his/her preferences in decisions about your healthcare, what information he/she might want you to know about the disease, and what information he/she might want to know about the disease him/herself. Like you, he/she will also be asked how decisions about your healthcare have been made, his/her satisfaction with those decisions and your healthcare, and his/her sense of connection with what he/she defines to be the overall Hispanic culture. He/she will also complete a similar interview on general information (such as marital status and educational level).

Study Visit:

If you agree to take part in this study and you have given the name of a family member, you will be interviewed to ask for general information about yourself ("demographic" information such as marital status and educational level).

After that, you will complete a series of questionnaires that ask about your preferences in decisions about your healthcare and what information you may want to know about the disease, how decisions about your healthcare have been made, your satisfaction with those decisions and your healthcare, and your sense of connection with what you define to be the overall Hispanic culture.

It should take about 5-10 minutes for the interview and another 20-30 minutes to complete the questionnaires.

Your interview and questionnaire responses will not be shared with your regular doctor. If you feel you need a doctor's opinion about anything that is asked about in the interview and/or questionnaires, please contact your doctor.

Family Member's Participation:

Your family member would complete the questionnaires separately and be interviewed separately from you. You may ask as many additional family members as needed, until one agrees. However, if the family member is scheduled for his/her study visit but does not end up completing the study procedures (interview and questionnaires), your interview and questionnaire data will be destroyed without being used in this study.

Confidentiality:

Your interview and questionnaire responses will only be used for this research study, and will not be shared with your family member.

Length of Study Participation:

After completing the interview and questionnaires, your participation in this study will be over.

This is an investigational study. In total, up to 900 patients and family members will take part in this multicenter study. Up to 300 will be enrolled at M. D. Anderson.

  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 October 23, 2014