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
  Purpose

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.

Condition Intervention
Advanced Cancers
Behavioral: Personal Interview
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Influence of Patients' Knowledge, Attitudes and Beliefs on Self Reported Deviations From Opioid Analgesic Prescription: an Exploratory Survey

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Persons with Advanced Cancer who Self-report Opioid Analgesics Over/Under [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: May 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Opioids
Personal Interview and Questionnaire of Advanced cancer patients, taking narcotic pain drugs (opioids).
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907192

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Eduardo Bruera, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00907192     History of Changes
Other Study ID Numbers: 2009-0019
Study First Received: May 20, 2009
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Opioid analgesic prescriptions
Narcotic pain drugs
Self-report
Questionnaire
Interview
Actual use
Doctor-prescribed use
Frequency of deviation

Additional relevant MeSH terms:
Neoplasms
Analgesics
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 23, 2014