Survey of Cancer Patients' Perceptions of Difficulties Encountered When Filling Opioid Prescriptions
May 28, 2020 updated by: M.D. Anderson Cancer Center
A Survey to Determine Cancer Patients' Perceptions of the Difficulties Encountered When Filling Opioid Prescriptions
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cancer patients on opioids for pain management provided by the Supportive Care Center
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (survey)
Participants complete a survey over 5-10 minutes
|
Complete survey
Undergo medical chart review
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eduardo Bruera, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 23, 2019
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
January 1, 2021
Study Registration Dates
First Submitted
June 14, 2019
First Submitted That Met QC Criteria
June 14, 2019
First Posted (Actual)
June 18, 2019
Study Record Updates
Last Update Posted (Actual)
May 29, 2020
Last Update Submitted That Met QC Criteria
May 28, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0052 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2019-02912 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.