Advanced CancerNCT00878267
Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to collect information to plan how to design a computer program for cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2011
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: UT MD Anderson Cancer Center (MDACC) cancer patients, 21 years of age or older, receiving palliative care, their caregivers, and UT MDACC physicians and nurses who work in palliative care.
Who may be able to join
- All patient/caregiver participants will be adults 21 years of age or older.
- Patient participants will be palliative care cancer patients and their caregivers.
- Participating patients should be receiving palliative care at the MD Anderson Cancer Center.
- Patient must be able to speak, read and write English
- Physician and nurse experts in palliative care will be eligible for participation on the study's expert panel. (For study purposes, a physician or nurse expert is defined as a physician or nurse with a minimum of four years experience working in a palliative care setting.
- Physician and nurse experts will be eligible for participation in study interviews if they have a minimum of four years experience working in a palliative care setting.
Who cannot join
- Patients who are not able to self-report their symptom status using either paper-and-pencil or electronic tools.
- Patients or caregivers who do not agree to sign the study's informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Qualitative Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record
The goal of this research study is to collect information to plan how to design a computer program for cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care. Researchers want to learn how to make this program practical for use by future patients, caregivers, doctors, and nurses.
Read the detailed description
The Computer Program:
In this study, researchers will interview cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care.
The computer program will be designed to help doctors and nurses monitor the symptoms of patients. The program will also be designed to help doctors and nurses make decisions about how to care for patients.
Interview Session:
If you agree to take part in this study, you will be interviewed by a research staff member. The study chair may also attend the interview. The interview will be held at the Palliative Care outpatient clinic.
The interview session will be done in 3 steps, which are described below. Each step will take about 10 minutes.
First, you will read questionnaires about patient symptoms. These questionnaires are drafts of the ones that will be included in the software program.
You will then look at a draft of the computer program's layout.
Last, you will be interviewed. You will be asked to discuss your experiences as a patient or caregiver in reporting symptoms and health status to doctors and nurses. You will also be asked to discuss what might make the program more usable.
During the interview, you may also be asked to answer sample questions on the draft questionnaires and discuss how readable you think the questions are. For example, you will discuss your opinion about the font size, text placement, and color scheme.
Study Data:
The interview session will be audio-taped. To protect your confidentiality, only your first name will be used during the interview session. Patients and their caregivers will also be interviewed separately to protect privacy.
Patient responses will not be disclosed to caregivers, and caregiver responses will not be disclosed to patients. The patient's palliative care doctor will be told, however, if patients or caregivers show signs of emotional difficulties.
When the audio recording is transcribed (typed) by the research staff, all names will be coded so that no one can be identified by name. The audio recordings will be stored in password-protected files that are available only to the study chair and staff.
After the results of the study are published, the audio recordings will be destroyed by the study staff.
Length of Study:
Your study participation will be over after the interview session.
This is an investigational study.
Up to 26 participants will be enrolled in this study. This includes up to 9 patients and 9 caregivers in this part of the study, and up to 4 doctors and 4 nurses in a second part of the study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Interview
- Keywords
- Cancer, Computer Program, Palliative Care, Patient-Reported Outcomes, PRO, Palliative and Hospice Care Practice, Electronic Health Record, EHR, Interview
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Also called Survey
3 step process including person to person meeting and questionnaires taking about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Interview | Not described Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define Patient-Reported Outcomes (PRO)-based Palliative/Hospice Care Model Integrating PRO Results with Evidence-based Treatment Guidelines and Pathways to Care
Through focused interviews with specific tasks: review PRO domains and questionnaires for the care mode; review user interface design and work flow; discuss user expectations of the system to assess the usability of a system's user interface design.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2011
- Study completionSep 2011
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A. Kallen, PhD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878267
- Sponsor's protocol ID
- 2008-0840
- Status last verified
- Sep 2011
- First submitted
- 7 Apr 2009
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record
- ClinicalTrials.gov ID
- NCT00878267
- Acronym / sponsor ID
- 2008-0840
- Conditions
- Advanced Cancer
- Keywords
- Cancer, Computer Program, Palliative Care, Patient-Reported Outcomes, PRO, Palliative and Hospice Care Practice, Electronic Health Record, EHR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Apr 2009 (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 collect information to plan how to design a computer program for cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care. Researchers want to learn how to make this program practical for use by future patients, caregivers, doctors, and nurses.
Detailed description
The Computer Program:
In this study, researchers will interview cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care.
The computer program will be designed to help doctors and nurses monitor the symptoms of patients. The program will also be designed to help doctors and nurses make decisions about how to care for patients.
Interview Session:
If you agree to take part in this study, you will be interviewed by a research staff member. The study chair may also attend the interview. The interview will be held at the Palliative Care outpatient clinic.
The interview session will be done in 3 steps, which are described below. Each step will take about 10 minutes.
First, you will read questionnaires about patient symptoms. These questionnaires are drafts of the ones that will be included in the software program.
You will then look at a draft of the computer program's layout.
Last, you will be interviewed. You will be asked to discuss your experiences as a patient or caregiver in reporting symptoms and health status to doctors and nurses. You will also be asked to discuss what might make the program more usable.
During the interview, you may also be asked to answer sample questions on the draft questionnaires and discuss how readable you think the questions are. For example, you will discuss your opinion about the font size, text placement, and color scheme.
Study Data:
The interview session will be audio-taped. To protect your confidentiality, only your first name will be used during the interview session. Patients and their caregivers will also be interviewed separately to protect privacy.
Patient responses will not be disclosed to caregivers, and caregiver responses will not be disclosed to patients. The patient's palliative care doctor will be told, however, if patients or caregivers show signs of emotional difficulties.
When the audio recording is transcribed (typed) by the research staff, all names will be coded so that no one can be identified by name. The audio recordings will be stored in password-protected files that are available only to the study chair and staff.
After the results of the study are published, the audio recordings will be destroyed by the study staff.
Length of Study:
Your study participation will be over after the interview session.
This is an investigational study.
Up to 26 participants will be enrolled in this study. This includes up to 9 patients and 9 caregivers in this part of the study, and up to 4 doctors and 4 nurses in a second part of the study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview | – | Behavioral: Interview |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- UT MD Anderson Cancer Center (MDACC) cancer patients, 21 years of age or older, receiving palliative care, their caregivers, and UT MDACC physicians and nurses who work in palliative care.
Key inclusion criteria (6 listed)
- All patient/caregiver participants will be adults 21 years of age or older.
- Patient participants will be palliative care cancer patients and their caregivers.
- Participating patients should be receiving palliative care at the MD Anderson Cancer Center.
- Patient must be able to speak, read and write English
- Physician and nurse experts in palliative care will be eligible for participation on the study's expert panel. (For study purposes, a physician or nurse expert is defined as a physician or nurse with a minimum of four years experience working in a palliative care setting.
Key exclusion criteria (2 listed)
- Patients who are not able to self-report their symptom status using either paper-and-pencil or electronic tools.
- Patients or caregivers who do not agree to sign the study's informed consent document.
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 |
|---|---|---|
| InterviewAlso: Survey3 step process including person to person meeting and questionnaires taking about 30 minutes. | Behavioural | Interview |
Primary outcome
Define Patient-Reported Outcomes (PRO)-based Palliative/Hospice Care Model Integrating PRO Results with Evidence-based Treatment Guidelines and Pathways to Care
Time frame: 2 Years
Through focused interviews with specific tasks: review PRO domains and questionnaires for the care mode; review user interface design and work flow; discuss user expectations of the system to assess the usability of a system's user interface design.
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 21 Sep 2011.
- UT MD Anderson Cancer Center websiteLink 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.
Michael A. Kallen, PhD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 6 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 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Define Patient-Reported Outcomes (PRO)-based Palliative/Hospice Care Model Integrating PRO Results with Evidence-based Treatment Guidelines and Pathways to Care (time frame: 2 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 21 Sep 2011.