Advanced CancersNCT00907192
Self Reported Deviations From Opioid Analgesic Prescription
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To determine the frequency of self-reported over and under use of opioid analgesics in patients with advanced cancer. Patients with advanced cancer are those patients who have been described to have either one of the following: recurrent disease, those that have failed multiple chemotherapies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Personal Interview and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients least 18 years old, diagnosised advanced cancer, and are taking narcotic pain drugs (opioids).
Who may be able to join
- Patients must be at least 18 years old and have a diagnosis of advanced cancer.
- Patients must be given prescriptions for around the clock (ATC) and as needed (for breakthrough pain) oral opioids for cancer pain on the previous visit to the Palliative Care Clinic.
- Patients must be able to understand, read, write, and speak English.
- Patients must have no clinical evidence of cognitive impairment, as determined by the primary palliative care physician.
- Patients must sign an informed consent.
Who cannot join
- Patients who have the caregiver as the primary person that does the management of opioid medication intake will be excluded as analysis is focused on patients' and not the family or caregivers' knowledge, attitudes and beliefs as it relates to the primary objective.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Patients' Knowledge, Attitudes and Beliefs on Self Reported Deviations From Opioid Analgesic Prescription: an Exploratory Survey
Primary Objective:
- To determine the frequency of self-reported over and under use of opioid analgesics in patients with advanced cancer. Patients with advanced cancer are those patients who have been described to have either one of the following: recurrent disease, those that have failed multiple chemotherapies (more than second line therapy), locally advanced disease, and metastatic disease.
Read more
Secondary Objectives:
- To determine the association between patients' knowledge, attitudes and beliefs about opioids, and frequency of deviation in opioid use with patients' demographic information.
- To determine association between alcohol abuse/chemical coping and self-reported deviations in opioid use.
- To determine the association between the use of opioids and patient-related barriers to opioid use.
Read the detailed description
Screening:
Before you start the study, the research nurse will check your medical record to see if you are eligible to take part in this study. Information will be recorded about your demographics (such as age, marital status, ethnicity, education level, and gender), medical history (such as the type of cancer and level of pain), and prescriptions (such as the name of any opioid drugs, doses, and schedule).
Interview Process:
If you are found to be eligible to take part in this study, you will be interviewed by the study staff before a regular visit with your doctor. You will be asked some questions about your use of pain drugs and other knowledge and/or attitudes that you may have about them. You may also be asked for general information (such as your age, marital status, or educational level) if it was not available in your chart and medical record.
Questionnaires:
After the interview, you will complete 5 short questionnaires about your use of pain drugs, your attitudes about the pain drugs and their use, and concerns that you may have about your use of these pain drugs.
It will take about 5-10 minutes for the interview and another 10-15 minutes to complete all the questionnaires.
Your interview and questionnaire responses will not be shared with your regular doctor unless the study staff feels that you maybe be at harm. If you feel you need a doctor's opinion about anything that is asked in the interview and/or questionnaires, please contact your doctor.
Confidentiality:
Your interview and questionnaire responses will only be used for this research study and will not be shared with your family members.
Length of Study:
After completing the interview and questionnaires, your participation in this study will be over.
This is an investigational study. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Personal Interview, Questionnaire
- Keywords
- Cancer, Opioid analgesic prescriptions, Narcotic pain drugs, Self-report, Questionnaire, Interview, Actual use, Doctor-prescribed use, Frequency of deviation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal InterviewBehavioural
Interview questions about use of pain drugs and other knowledge and/or attitudes about them. Take about 5-10 minutes to complete.
QuestionnaireBehavioural
Also called Survey
5 short questionnaires about use of pain drugs, attitudes about the pain drugs and their use, and concerns about use of these pain drugs. Take about 10-15 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Opioids | Personal Interview and Questionnaire of Advanced cancer patients, taking narcotic pain drugs (opioids). Receives: Behavioral: Personal Interview; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Persons with Advanced Cancer who Self-report Opioid Analgesics Over/Under
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 posted22 May 2009 (estimated)
- Study startMay 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 201 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, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907192
- Sponsor's protocol ID
- 2009-0019
- Status last verified
- Jun 2013
- First submitted
- 20 May 2009
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Patients' Knowledge, Attitudes and Beliefs on Self Reported Deviations From Opioid Analgesic Prescription: an Exploratory Survey
- ClinicalTrials.gov ID
- NCT00907192
- Acronym / sponsor ID
- 2009-0019
- Conditions
- Advanced Cancers
- Keywords
- Cancer, Opioid analgesic prescriptions, Narcotic pain drugs, Self-report, Questionnaire, Interview, Actual use, Doctor-prescribed use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 May 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.
Primary Objective:
- To determine the frequency of self-reported over and under use of opioid analgesics in patients with advanced cancer. Patients with advanced cancer are those patients who have been described to have either one of the following: recurrent disease, those that have failed multiple chemotherapies (more than second line therapy), locally advanced disease, and metastatic disease.
Secondary Objectives:
- To determine the association between patients' knowledge, attitudes and beliefs about opioids, and frequency of deviation in opioid use with patients' demographic information.
- To determine association between alcohol abuse/chemical coping and self-reported deviations in opioid use.
- To determine the association between the use of opioids and patient-related barriers to opioid use.
Detailed description
Screening:
Before you start the study, the research nurse will check your medical record to see if you are eligible to take part in this study. Information will be recorded about your demographics (such as age, marital status, ethnicity, education level, and gender), medical history (such as the type of cancer and level of pain), and prescriptions (such as the name of any opioid drugs, doses, and schedule).
Interview Process:
If you are found to be eligible to take part in this study, you will be interviewed by the study staff before a regular visit with your doctor. You will be asked some questions about your use of pain drugs and other knowledge and/or attitudes that you may have about them. You may also be asked for general information (such as your age, marital status, or educational level) if it was not available in your chart and medical record.
Questionnaires:
After the interview, you will complete 5 short questionnaires about your use of pain drugs, your attitudes about the pain drugs and their use, and concerns that you may have about your use of these pain drugs.
It will take about 5-10 minutes for the interview and another 10-15 minutes to complete all the questionnaires.
Your interview and questionnaire responses will not be shared with your regular doctor unless the study staff feels that you maybe be at harm. If you feel you need a doctor's opinion about anything that is asked in the interview and/or questionnaires, please contact your doctor.
Confidentiality:
Your interview and questionnaire responses will only be used for this research study and will not be shared with your family members.
Length of Study:
After completing the interview and questionnaires, your participation in this study will be over.
This is an investigational study. Up to 200 patients will take part in this 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 |
|---|---|---|
| Opioids | – | Behavioral: Personal Interview, Behavioral: QuestionnairePersonal Interview and Questionnaire of Advanced cancer patients, taking narcotic pain drugs (opioids). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients least 18 years old, diagnosised advanced cancer, and are taking narcotic pain drugs (opioids).
Key inclusion criteria (5 listed)
- Patients must be at least 18 years old and have a diagnosis of advanced cancer.
- Patients must be given prescriptions for around the clock (ATC) and as needed (for breakthrough pain) oral opioids for cancer pain on the previous visit to the Palliative Care Clinic.
- Patients must be able to understand, read, write, and speak English.
- Patients must have no clinical evidence of cognitive impairment, as determined by the primary palliative care physician.
- Patients must sign an informed consent.
Key exclusion criteria (1 listed)
- Patients who have the caregiver as the primary person that does the management of opioid medication intake will be excluded as analysis is focused on patients' and not the family or caregivers' knowledge, attitudes and beliefs as it relates to the primary objective.
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 |
|---|---|---|
| Personal InterviewInterview questions about use of pain drugs and other knowledge and/or attitudes about them. Take about 5-10 minutes to complete. | Behavioural | Opioids |
| QuestionnaireAlso: Survey5 short questionnaires about use of pain drugs, attitudes about the pain drugs and their use, and concerns about use of these pain drugs. Take about 10-15 minutes to complete. | Behavioural | Opioids |
Primary outcome
Number of Persons with Advanced Cancer who Self-report Opioid Analgesics Over/Under
Time frame: 2 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 18 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.
Eduardo Bruera, MD 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 5 inclusion and 1 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 18 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?
Number of Persons with Advanced Cancer who Self-report Opioid Analgesics Over/Under (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 18 Jun 2013.