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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03989128
Other study ID # 2019-0052
Secondary ID NCI-2019-0291220
Status Active, not recruiting
Phase
First received
Last updated
Start date April 23, 2019
Est. completion date January 1, 2021

Study information

Verified date May 2020
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Medical Chart Review
Undergo medical chart review
Survey Administration
Complete survey

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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