Ignite Creation Date:
2024-05-05 @ 9:32 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00907192
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2009-05-20
Brief Title:
Self Reported Deviations From Opioid Analgesic Prescription
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
The Influence of Patients Knowledge Attitudes and Beliefs on Self Reported Deviations From Opioid Analgesic Prescription an Exploratory Survey
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 more than second line therapy locally advanced disease and metastatic disease
Secondary Objectives
1 To determine the association between patients knowledge attitudes and beliefs about opioids and frequency of deviation in opioid use with patients demographic information
2 To determine association between alcohol abusechemical coping and self-reported deviations in opioid use
3 To determine the association between the use of opioids and patient-related barriers to opioid use
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 more than second line therapy locally advanced disease and metastatic disease
Secondary Objectives
1 To determine the association between patients knowledge attitudes and beliefs about opioids and frequency of deviation in opioid use with patients demographic information
2 To determine association between alcohol abusechemical coping and self-reported deviations in opioid use
3 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 andor 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 doctors opinion about anything that is asked in the interview andor 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
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 andor 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 doctors opinion about anything that is asked in the interview andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None