An observational study in Caregiver and Malignant Neoplasm, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by M.D. Anderson Cancer Center · Observational
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.
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 115 is below the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Parents/caregivers of a child (under 18) who has received an opioid prescription within the last 6 months
Inclusion Criteria:
Participants complete online survey on an iPad over 20 minutes.
Other: Survey Administration
Complete online survey
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
Ran from Dec 2017 to primary completion in Nov 2023, 70 months.
Of 792 non-industry observational studies under Neoplasms, half reached primary completion within 102 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 352. This study's 70 months is below that.
Counting every sponsor, half of 884 studies reached it within 80 months; a quarter within 32 and three quarters within 318.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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