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

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: Pain; Malignant Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Medical Chart Review

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

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (survey); Participants complete a survey over 5-10 minutes	Other: Survey Administration; Complete survey; Other: Medical Chart Review; Undergo medical chart review; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' perception of overall difficulties when filling opioid prescriptions	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

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eduardo Bruera, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

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: Neoplasms
• 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