Advanced CancersNCT01024166
Patient-Reported Outcomes-Based Palliative and Hospice Care Practice: A Usability Study
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn if palliative care patients or caregivers, and palliative care physicians or nurses can use a computer program designed to provide information about the symptoms and overall health of cancer patients. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Questionnaire and Review Session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2012
- 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: Palliative care patients receiving care at University of Texas MD Anderson Cancer Center and their caregivers, physicians and nurses, all over the age of 21.
Who may be able to join
- All patient/caregiver participants will be adults 21 years of age or older.
- Participants will be palliative care cancer patients and/or their designated caregivers.
- Participating patients should be receiving palliative care at the MD Anderson Cancer Center as an inpatient or have attended at least one outpatient appointment; participating caregivers should have provided care to their patient during an inpatient stay or have attended at least one outpatient appointment with their patient.
- Physicians and nurses who are experts in palliative care will be eligible for study participation. For this study's purposes, a physician or nurse with a minimum of four years of experience working in a palliative care setting will be considered an expert in palliative care.
Who cannot join
- Patients or caregivers who are not able to report on symptom status using the electronic measurement system.
- Patient, caregivers, physicians, or nurses who do not agree to sign the study's informed consent documents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Usability 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 learn if palliative care patients or caregivers, and palliative care physicians or nurses can use a computer program designed to provide information about the symptoms and overall health of cancer patients.
Read the detailed description
The Patient-Reported Outcomes (PRO) Computer System:
The PRO computer system used in this study has been designed to help doctors and nurses check the symptoms and overall health status of patients with cancer by reviewing the computer entries of patients and caregivers. The system has also been designed to help doctors and nurses make decisions about how to care for patients based on the computer entries.
Questionnaire and Review Session:
If you agree to take part in this study, you will have an questionnaire and review session at the Palliative Care outpatient clinic. The session will be conducted by a research staff member, but the study chair and/or other study staff members may also attend the session. The questionnaire and review session will have 3 steps, which are described below:
- If you are a patient receiving palliative care, you will use the PRO computer system to complete 2 questionnaires about any symptoms you may be experiencing and your overall health. If you are a caregiver for someone who is receiving palliative care, you will use the PRO computer system to complete 2 questionnaires about any symptoms that the patient you are caring for may be experiencing and their overall health. The study staff will instruct you on how to use the PRO computer system.
- If you are a physician or nurse, you will use the PRO computer system to complete 4 questionnaires about the symptoms and overall health of patients who are receiving palliative care. The study staff will instruct you on how to use the PRO computer system.
- You will then look at the results of the questionnaires you have completed, which will be shown to you in both number and graph form. You will also be shown other features and potential uses of the PRO computer system.
- Last, you will be asked about how easily you were able to use the computer system. You will also be asked about any changes you think could make the program easier to use.
The questionnaire and review session should take about 30 minutes to complete.
Study Data:
Your responses to the questionnaires will be destroyed after the questionnaire and review session. The responses you give when asked about the use of the PRO computer system will be kept after the questionnaire and review session. Only the study staff will have access to your responses. However, your responses will be coded with a study ID number, not by your name. Your saved responses will be stored in password-protected files that are available only to the study staff for 3 years.
Length of Study:
Your participation in this study will be over after you complete the questionnaire and review session.
This is an investigational study.
Up to 9 patients and 9 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
Up to 9 physicians and nurses (4-5 of each) will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Questionnaire and Review Session
- Keywords
- Cancer, Patient-Reported Outcomes Computer System, PRO, Palliative Care, Symptoms, Questionnaire, Patients, Caregivers, Palliative Care Physicians, Palliative Care Nurses
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Review SessionBehavioural
Also called Survey, Computer Program
Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete. Review session about use of computer system and suggested changes.
Questionnaire and Review SessionBehavioural
Also called Survey, Computer Program
Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete. Review session about use of computer system and suggested changes.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patient computer system use questionnaire Receives: Behavioral: Questionnaire and Review Session | |
| Caregiver | Caregiver computer system use questionnaire Receives: Behavioral: Questionnaire and Review Session | |
| Healthcare Provider | Physician and Nurse computer system use questionnaire Receives: Behavioral: Questionnaire and Review Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)
Measured: Single assessment point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies 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
- Time perspective
- Prospective
- Enrolment
- 18 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, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024166
- Sponsor's protocol ID
- 2009-0776
- Status last verified
- Jun 2013
- First submitted
- 30 Nov 2009
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Usability Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record
- ClinicalTrials.gov ID
- NCT01024166
- Acronym / sponsor ID
- 2009-0776
- Conditions
- Advanced Cancers
- Keywords
- Cancer, Patient-Reported Outcomes Computer System, PRO, Palliative Care, Symptoms, Questionnaire, Patients, Caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Dec 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 learn if palliative care patients or caregivers, and palliative care physicians or nurses can use a computer program designed to provide information about the symptoms and overall health of cancer patients.
Detailed description
The Patient-Reported Outcomes (PRO) Computer System:
The PRO computer system used in this study has been designed to help doctors and nurses check the symptoms and overall health status of patients with cancer by reviewing the computer entries of patients and caregivers. The system has also been designed to help doctors and nurses make decisions about how to care for patients based on the computer entries.
Questionnaire and Review Session:
If you agree to take part in this study, you will have an questionnaire and review session at the Palliative Care outpatient clinic. The session will be conducted by a research staff member, but the study chair and/or other study staff members may also attend the session. The questionnaire and review session will have 3 steps, which are described below:
- If you are a patient receiving palliative care, you will use the PRO computer system to complete 2 questionnaires about any symptoms you may be experiencing and your overall health. If you are a caregiver for someone who is receiving palliative care, you will use the PRO computer system to complete 2 questionnaires about any symptoms that the patient you are caring for may be experiencing and their overall health. The study staff will instruct you on how to use the PRO computer system.
- If you are a physician or nurse, you will use the PRO computer system to complete 4 questionnaires about the symptoms and overall health of patients who are receiving palliative care. The study staff will instruct you on how to use the PRO computer system.
- You will then look at the results of the questionnaires you have completed, which will be shown to you in both number and graph form. You will also be shown other features and potential uses of the PRO computer system.
- Last, you will be asked about how easily you were able to use the computer system. You will also be asked about any changes you think could make the program easier to use.
The questionnaire and review session should take about 30 minutes to complete.
Study Data:
Your responses to the questionnaires will be destroyed after the questionnaire and review session. The responses you give when asked about the use of the PRO computer system will be kept after the questionnaire and review session. Only the study staff will have access to your responses. However, your responses will be coded with a study ID number, not by your name. Your saved responses will be stored in password-protected files that are available only to the study staff for 3 years.
Length of Study:
Your participation in this study will be over after you complete the questionnaire and review session.
This is an investigational study.
Up to 9 patients and 9 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
Up to 9 physicians and nurses (4-5 of each) will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Behavioral: Questionnaire and Review SessionPatient computer system use questionnaire |
| Caregiver | – | Behavioral: Questionnaire and Review SessionCaregiver computer system use questionnaire |
| Healthcare Provider | – | Behavioral: Questionnaire and Review SessionPhysician and Nurse computer system use questionnaire |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Palliative care patients receiving care at University of Texas MD Anderson Cancer Center and their caregivers, physicians and nurses, all over the age of 21.
Key inclusion criteria (4 listed)
- All patient/caregiver participants will be adults 21 years of age or older.
- Participants will be palliative care cancer patients and/or their designated caregivers.
- Participating patients should be receiving palliative care at the MD Anderson Cancer Center as an inpatient or have attended at least one outpatient appointment; participating caregivers should have provided care to their patient during an inpatient stay or have attended at least one outpatient appointment with their patient.
- Physicians and nurses who are experts in palliative care will be eligible for study participation. For this study's purposes, a physician or nurse with a minimum of four years of experience working in a palliative care setting will be considered an expert in palliative care.
Key exclusion criteria (2 listed)
- Patients or caregivers who are not able to report on symptom status using the electronic measurement system.
- Patient, caregivers, physicians, or nurses who do not agree to sign the study's informed consent documents.
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 |
|---|---|---|
| Questionnaire and Review SessionAlso: Survey, Computer ProgramUse PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete. Review session about use of computer system and suggested changes. | Behavioural | Caregiver, Patient |
| Questionnaire and Review SessionAlso: Survey, Computer ProgramUse PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete. Review session about use of computer system and suggested changes. | Behavioural | Healthcare Provider |
Primary outcome
Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)
Time frame: Single assessment point
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 7 Jun 2013.
- 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 study chair
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 Cancers, 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 4 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 7 Jun 2013. 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?
Evaluation of System Usability of the Prototype Solution (Questionnaire Responses) (time frame: Single assessment point). 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 7 Jun 2013; AzTrials last refreshed its copy on 1 Nov 2026.