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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03390283
Other study ID # 2017-0396
Secondary ID NCI-2018-0098620
Status Completed
Phase
First received
Last updated
Start date December 20, 2017
Est. completion date November 17, 2023

Study information

Verified date November 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This trial uses a survey to study parent and caregiver practices on the storage, use, and disposal of opioids in a comprehensive cancer center. It is not known if parents and/or caregivers are aware of the guidelines and recommendations for proper and safe disposal of opioids. This survey will help health care providers assess the needs and improve the safety of patients and their families from the potential dangers of misuse and abuse of prescription opioid medications.


Description:

PRIMARY OBJECTIVES: I. To determine the frequency of unsafe storage, use, and disposal of unused and currently used opioids by parents and/or caregivers of patients 18 years and younger at MD Anderson Cancer Center. II. To explore potential association between other covariates with the unsafe storage, use, and disposal of opioids. OUTLINE: Participants complete online survey on an iPad over 20 minutes.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date November 17, 2023
Est. primary completion date November 17, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - PARENTS/CAREGIVERS: Must be at least 18 years old (a. The child of the parents/caregivers must be 18 years old or younger; b. The child of the parents/caregivers must have received an opioid prescription within the last six months.) - PARENTS/CAREGIVERS: Must be able to understand, read, write, and speak English. - PARENTS/CAREGIVERS: Parent/caregiver must sign an informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey Administration
Complete online 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 Reported frequencies of unsafe storage of opioids The unsafe storage of opioids is defined as having opioids in the open where anyone can see it, in a medicine cabinet that is not locked, or hidden but not locked. Will estimate the proportion along with a 95% confidence interval. The distribution of the primary outcome by demographic information will be presented in cross tabulations. The association between the primary outcomes and demographic information/other behavior will be explored by Chi-Squared test or Fisher's exact test when appropriate. Logistic regression models may be employed to assess the effect of demographic factors on the unsafe storage of opioids. Other statistics methods may be used when appropriate. Up to 2 years
Primary Reported frequencies of unsafe use of opioids This is defined as giving more opioid than prescribed to the child very frequently, frequently, occasionally, infrequently, or very infrequently. Will estimate the proportion along with a 95% confidence interval. The distribution of the primary outcome by demographic information will be presented in cross tabulations. The association between the primary outcomes and demographic information/other behavior will be explored by Chi-Squared test or Fisher's exact test when appropriate. Logistic regression models may be employed to assess the effect of demographic factors on the unsafe storage of opioids. Other statistics methods may be used when appropriate. Up to 2 years
Primary Reported frequencies of unsafe disposal of opioids This is defined as throwing unused pills in the trash without any modification. Will estimate the proportion along with a 95% confidence interval. The distribution of the primary outcome by demographic information will be presented in cross tabulations. The association between the primary outcomes and demographic information/other behavior will be explored by Chi-Squared test or Fisher's exact test when appropriate. Logistic regression models may be employed to assess the effect of demographic factors on the unsafe storage of opioids. Other statistics methods may be used when appropriate. Up to 2 years
Secondary Other covariates The association between unsafe storage, use and disposal and other variables including the presence of other children living in the home [defined as answering Question 9 as having minor children (age < 18 years) in the home], a family history of misuse of prescription drugs, street drugs or alcohol, a family history of psychiatric illness or other unsafe uses of opioid medications that do not relate directly to the child, such as if a caregiver takes or sells the child's medication will be analyzed. Demographic variables collected in the first part of the survey will be used to explore possible associations with unsafe storage, use or disposal of opioids. Up to 2 years
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