Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Survey of Cancer Patients' Perceptions of Difficulties Encountered When Filling Opioid Prescriptions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03989128
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies the problems that cancer patients face when filling prescriptions for opioids (medications that are used to manage pain). Pain is one of the most common symptoms among cancer patients. Opioid therapy is generally the treatment of choice for adequate management of cancer-related pain. Knowledge of these problems may help health care providers assess the most effective treatment options for cancer patients, and inform policy makers of the adjustments that need to be made to regulations to ensure cancer patients don't lose their access to opioids.

Condition or disease Intervention/treatment
Malignant Neoplasm Pain Other: Medical Chart Review Other: Survey Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate patients' perceptions of overall difficulties when filling their opioid prescription.

SECONDARY OBJECTIVES:

I. To determine cancer patients' perceptions of financial, logistical, and psychosocial difficulties when filling their opioid prescription.

II. To evaluate the association between patient characteristics and patient difficulty filling opioid prescriptions.

OUTLINE:

Participants complete a survey over 5-10 minutes.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Survey to Determine Cancer Patients' Perceptions of the Difficulties Encountered When Filling Opioid Prescriptions
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Group/Cohort Intervention/treatment
Observational (survey)
Participants complete a survey over 5-10 minutes
Other: Medical Chart Review
Undergo medical chart review
Other Name: Chart Review

Other: Survey Administration
Complete survey




Primary Outcome Measures :
  1. Patients' perception of overall difficulties when filling opioid prescriptions [ Time Frame: 2 years ]
    The proportion of patients who have experienced any difficulty when filling their prescription will be reported along 95% confidence intervals. Association of patients' characteristics with experiencing difficulty will be evaluated by Wilcoxon rank sum test and chi-square (Fisher's exact) test for continuous and categorical variables, respectively.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients on opioids for pain management provided by the Supportive Care Center
Criteria

Inclusion Criteria:

  • Patients must be on opioids provided by the Supportive Care Center (SCC), and must have visited the SCC 2 previous times for the purpose of opioid pain management. This will ensure that 1) patients will have been told that they are being prescribed an opioid as a treatment for pain, and 2) patients will have gone to a pharmacy to fill their opioid prescription a minimum of one time.
  • Patients must be able to understand, read, write, and speak English.
  • Patients must sign an informed consent document.
  • Patients must have a cancer diagnosis.

Exclusion Criteria:

  • Patients who have clinical evidence of cognitive impairment (Memorial Delirium Assessment Scale [MDAS] score of >= 13) as determined by the research staff, treating physician, or nurse.
  • Patients who are considered to be in severe physical or emotional distress based on the assessment by the research staff.
  • Patients who refuse to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989128


Contacts
Layout table for location contacts
Contact: Eduardo Bruera 713-792-6084 ebruera@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Eduardo Bruera    713-792-6082      
Principal Investigator: Eduardo Bruera         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Eduardo Bruera M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03989128     History of Changes
Other Study ID Numbers: 2019-0052
NCI-2019-02912 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0052 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms