NCT00907192

Brief Summary

Primary Objective:

  1. 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.
  2. 2.To determine the association between patients' knowledge, attitudes and beliefs about opioids, and frequency of deviation in opioid use with patients' demographic information.
  3. 3.To determine association between alcohol abuse/chemical coping and self-reported deviations in opioid use.
  4. 4.To determine the association between the use of opioids and patient-related barriers to opioid use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

3.1 years

First QC Date

May 20, 2009

Last Update Submit

June 14, 2013

Conditions

Advanced Cancers

Keywords

CancerOpioid analgesic prescriptionsNarcotic pain drugsSelf-reportQuestionnaireInterviewActual useDoctor-prescribed useFrequency of deviation

Outcome Measures

Primary Outcomes (1)

  • Number of Persons with Advanced Cancer who Self-report Opioid Analgesics Over/Under

    2 Years

Study Arms (1)

Opioids

Personal Interview and Questionnaire of Advanced cancer patients, taking narcotic pain drugs (opioids).

Behavioral: Personal InterviewBehavioral: Questionnaire

Interventions

Personal InterviewBEHAVIORAL

Interview questions about use of pain drugs and other knowledge and/or attitudes about them. Take about 5-10 minutes to complete.

Opioids
QuestionnaireBEHAVIORAL

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.

Also known as: Survey
Opioids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eduardo Bruera, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 22, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(1)