Advanced CancerNCT00385476
Cancer Patients' Medication Knowledge in the Emergency Center
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of the study is to learn about patients' knowledge of their medications in an outpatient acute care setting (such as the M. D. Anderson Emergency Center) and to learn about any clinical factors that affect patients' knowledge of their medications. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- PMKT Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Feb 2009
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants admitted to the UT MD Anderson Cancer Center Emergency Center.
Who may be able to join
- Patients admitted to the Emergency Center
- Patients must be able to read and write English
- Patients must agree to participate and sign informed consent
- Patients 16 years or above. (Age limit explained below)
- Patients must be able to complete the survey tool. They may have help from a caregiver in transcribing the information but the caregiver can not fill the tool independent of the patient. A research assistant will be trained to discriminate whether a caregiver is acting as a scriber or independently completing the tool. If the caregiver completes the tool independently, the patient will be excluded from the study.
Who cannot join
- Patients with altered mental status and those with an acute, emergent illness and hemodynamic instability (Examples: status epileptics, sepsis, and cardiac arrest)
- Employees of the institution with work-related injuries
- Visitors who are non-cancer patients
- Patients transferred directly from another hospital
- Patients will be excluded after their first enrollment during the study period. (Can only be enrolled once though may have multiple Emergency Center visits during study time frame).
- Patients will be excluded if all prescribed medications are filled at an external pharmacy and this pharmacy is not accessible.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of the study is to learn about patients' knowledge of their medications in an outpatient acute care setting (such as the M. D. Anderson Emergency Center) and to learn about any clinical factors that affect patients' knowledge of their medications.
Read the detailed description
You will be asked to list your prescription medicines, over-the-counter medicines, herbal preparations and vitamins, minerals and supplements that you take. Information about you (such as age or gender), the status of the disease (such as cancer diagnosis and extent of disease), and your Emergency Center visit (such as your reason for visit and discharge diagnosis) will be collected from your medical record.
To find out if your answers on the questionnaire are correct regarding the medications you take, researchers will check the pharmacy database for medications you fill at the M. D. Anderson pharmacy, your medical record, and contact any outside pharmacy that you may use to fill your medicines, with your permission. In order for outside pharmacies to release the requested medication information, you will need to sign an Authorization for Disclosure of Health Information from Pharmacy Records.
Your information will be kept confidential. All patient data will be reported and published as a group. You will not be individually identified. Data will be stored with patient codes so that your identity will be protected. In addition, the study database will be password protected.
You may be contacted in the future for more information; however, you are not obligated to answer any future questions just because you agreed to participate in this study.
This is an investigational study. About 350 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer
- Being tested
- PMKT Questionnaire
- Keywords
- Advanced Cancer, Medication Knowledge, Emergency Center, Questionnaire, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMKT QuestionnaireBehavioural
Patient Medication Knowledge Tool - Questionnaire entailing the medications the patient is currently taking.
| Study group | Role | What they receive |
|---|---|---|
| Patient Medication Knowledge Tool | Assessment of Cancer patients' knowledge of their medications in an outpatient acute care setting Receives: Behavioral: PMKT Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' knowledge of their medications in an outpatient acute care setting (such as the M. D. Anderson Emergency Center).
Measured: 4 Years
Secondary outcomes (1)
Results of the Patient Medication Knowledge Tool (Questionnaire)
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startAug 2005
- Primary completionFeb 2009
- Study completionFeb 2009
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-control
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Escalante, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385476
- Sponsor's protocol ID
- 2003-0526
- Status last verified
- Jul 2012
- First submitted
- 5 Oct 2006
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Patients' Medication Knowledge in the Emergency Center
- ClinicalTrials.gov ID
- NCT00385476
- Acronym / sponsor ID
- 2003-0526
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Medication Knowledge, Emergency Center, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Oct 2006 (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 the study is to learn about patients' knowledge of their medications in an outpatient acute care setting (such as the M. D. Anderson Emergency Center) and to learn about any clinical factors that affect patients' knowledge of their medications.
Detailed description
You will be asked to list your prescription medicines, over-the-counter medicines, herbal preparations and vitamins, minerals and supplements that you take. Information about you (such as age or gender), the status of the disease (such as cancer diagnosis and extent of disease), and your Emergency Center visit (such as your reason for visit and discharge diagnosis) will be collected from your medical record.
To find out if your answers on the questionnaire are correct regarding the medications you take, researchers will check the pharmacy database for medications you fill at the M. D. Anderson pharmacy, your medical record, and contact any outside pharmacy that you may use to fill your medicines, with your permission. In order for outside pharmacies to release the requested medication information, you will need to sign an Authorization for Disclosure of Health Information from Pharmacy Records.
Your information will be kept confidential. All patient data will be reported and published as a group. You will not be individually identified. Data will be stored with patient codes so that your identity will be protected. In addition, the study database will be password protected.
You may be contacted in the future for more information; however, you are not obligated to answer any future questions just because you agreed to participate in this study.
This is an investigational study. About 350 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Medication Knowledge Tool | – | Behavioral: PMKT QuestionnaireAssessment of Cancer patients' knowledge of their medications in an outpatient acute care setting |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants admitted to the UT MD Anderson Cancer Center Emergency Center.
Key inclusion criteria (5 listed)
- Patients admitted to the Emergency Center
- Patients must be able to read and write English
- Patients must agree to participate and sign informed consent
- Patients 16 years or above. (Age limit explained below)
- Patients must be able to complete the survey tool. They may have help from a caregiver in transcribing the information but the caregiver can not fill the tool independent of the patient. A research assistant will be trained to discriminate whether a caregiver is acting as a scriber or independently completing the tool. If the caregiver completes the tool independently, the patient will be excluded from the study.
Key exclusion criteria (6 listed)
- Patients with altered mental status and those with an acute, emergent illness and hemodynamic instability (Examples: status epileptics, sepsis, and cardiac arrest)
- Employees of the institution with work-related injuries
- Visitors who are non-cancer patients
- Patients transferred directly from another hospital
- Patients will be excluded after their first enrollment during the study period. (Can only be enrolled once though may have multiple Emergency Center visits during study time frame).
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 |
|---|---|---|
| PMKT QuestionnairePatient Medication Knowledge Tool - Questionnaire entailing the medications the patient is currently taking. | Behavioural | Patient Medication Knowledge Tool |
Primary outcome
Patients' knowledge of their medications in an outpatient acute care setting (such as the M. D. Anderson Emergency Center).
Time frame: 4 Years
1 secondary outcome
Results of the Patient Medication Knowledge Tool (Questionnaire)
Time frame: 4 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 1 Aug 2012.
- 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.
Carmen Escalante, MD principal investigator
M.D. 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 5 inclusion and 6 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 1 Aug 2012. 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?
Patients' knowledge of their medications in an outpatient acute care setting (such as the M. D. Anderson Emergency Center). (time frame: 4 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 1 Aug 2012.