Advanced CancerNCT00682994
Patient and Family Decision Making in the Palliative Care Setting
A study testing Interview and Questionnaire in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 4 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Interview and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Mar 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- Either patient or family member can not complete the assessments independently.
- Either patient or family member refuses to participate in the study.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Argentina1 site
Fundacion FEMEBA - Programa Argentino de Medicina Paliativa - Hospital Tornu
Buenos Aires
Chile1 site
Dr. Sotero del Rio Hospital - Catholic University of Chile
Santiago, 8207257
About this study
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.
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).
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- Interview, Questionnaire
- Keywords
- Advanced Cancer, Family Member, Palliative Care, Decision Making, Information Disclosure, Interview, Survey, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Interview lasting about 5-10 minutes.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking 20-30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Decision Making | Other | Questionnaire + Interview Receives: Behavioral: Interview; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Proportions of Preference for Passive Decision Making
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682994
- Sponsor's protocol ID
- 2007-0667
- Status last verified
- Aug 2012
- First submitted
- 15 May 2008
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00682994
- Acronym / sponsor ID
- 2007-0667
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Family Member, Palliative Care, Decision Making, Information Disclosure, Interview, Survey, Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Making | Other | Behavioral: Interview, Behavioral: QuestionnaireQuestionnaire + Interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- Either patient or family member can not complete the assessments independently.
- Either patient or family member refuses to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewInterview lasting about 5-10 minutes. | Behavioural | Decision Making |
| QuestionnaireAlso: SurveyQuestionnaires taking 20-30 minutes to complete. | Behavioural | Decision Making |
Primary outcome
Differences in Proportions of Preference for Passive Decision Making
Time frame: 6 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bruera, MD principal investigator
M.D. Anderson Cancer Center
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview and Questionnaire in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Argentina, Chile, Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Proportions of Preference for Passive Decision Making (time frame: 6 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.