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Patient and Family Decision Making and Information Disclosure Preferences in the Palliative Care Setting: a Multi-Center Survey in Chile, Guatemala, and U.S.


N/A
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

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Trial Information

Patient and Family Decision Making and Information Disclosure Preferences in the Palliative Care Setting: a Multi-Center Survey in Chile, Guatemala, and U.S.


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Differences in Proportions of Preference for Passive Decision Making

Outcome Time Frame:

6 Years

Safety Issue:

No

Principal Investigator

Eduardo Bruera, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0667

NCT ID:

NCT00682994

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Advanced Cancer
  • Advanced Cancer
  • Family Member
  • Palliative Care
  • Decision Making
  • Information Disclosure
  • Interview
  • Survey
  • Questionnaire
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030