Self Reported Deviations From Opioid Analgesic Prescription

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00907192
First received: May 20, 2009
Last updated: June 14, 2013
Last verified: June 2013

May 20, 2009
June 14, 2013
May 2009
June 2012   (final data collection date for primary outcome measure)
Number of Persons with Advanced Cancer who Self-report Opioid Analgesics Over/Under [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Estimate the proportions of persons with advanced cancer who self-report over or under use of opioid analgesics. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00907192 on ClinicalTrials.gov Archive Site
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Self Reported Deviations From Opioid Analgesic Prescription
The Influence of Patients' Knowledge, Attitudes and Beliefs on Self Reported Deviations From Opioid Analgesic Prescription: an Exploratory Survey

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 abuse/chemical 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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients least 18 years old, diagnosised advanced cancer, and are taking narcotic pain drugs (opioids).

Advanced Cancers
  • Behavioral: Personal Interview
    Interview questions about use of pain drugs and other knowledge and/or attitudes about them. Take about 5-10 minutes to complete.
  • Behavioral: Questionnaire
    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.
    Other Name: Survey
Opioids
Personal Interview and Questionnaire of Advanced cancer patients, taking narcotic pain drugs (opioids).
Interventions:
  • Behavioral: Personal Interview
  • Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must be at least 18 years old and have a diagnosis of advanced cancer.
  2. 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.
  3. Patients must be able to understand, read, write, and speak English.
  4. Patients must have no clinical evidence of cognitive impairment, as determined by the primary palliative care physician.
  5. Patients must sign an informed consent.

Exclusion Criteria:

  1. 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00907192
2009-0019
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Study Chair: Eduardo Bruera, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP