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

NCT03989128 | Unknown FDA Drug

• 3 other identifiers: 2019-0052NCI-2019-02912P30CA016672
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational (survey)

Participants complete a survey over 5-10 minutes

Other: Medical Chart Review; Other: Survey Administration

Interventions

Medical Chart Review OTHER

Undergo medical chart review

Also known as: Chart Review

Observational (survey)

Survey Administration OTHER

Complete survey

Observational (survey)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients on opioids for pain management provided by the Supportive Care Center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduardo Bruera

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: April 23, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

US (1)