- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03390283
A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids in a Comprehensive Cancer Center
A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (Online survey)
Participants complete online survey on an iPad over 20 minutes.
|
Complete online survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reported frequencies of unsafe storage of opioids
Time Frame: Up to 2 years
|
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
|
|
Reported frequencies of unsafe use of opioids
Time Frame: Up to 2 years
|
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
|
|
Reported frequencies of unsafe disposal of opioids
Time Frame: Up to 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Other covariates
Time Frame: Up to 2 years
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin Madden, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-0396 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-00986 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Neoplasm
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedMetastatic Malignant Neoplasm | Unresectable Malignant Neoplasm | Advanced Malignant NeoplasmUnited States
-
Mayo ClinicRecruitingMalignant Abdominal Neoplasm | Malignant Pelvic Neoplasm | Childhood Malignant Solid Neoplasm | Childhood Malignant Thoracic Neoplasm | Malignant Neck Neoplasm | Metastatic Childhood Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterTerminatedLocally Advanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Unresectable Solid NeoplasmUnited States, Canada
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Rare Malignant Solid Neoplasm | Rare Malignant Solid Neoplasm | Refractory Rare Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant Neoplasm | Metastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMetastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Refractory Malignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Refractory Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedAdvanced Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
Clinical Trials on Survey Administration
-
Boston UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHepatocellular CarcinomaUnited States
-
Thomas Jefferson UniversityWithdrawnMalignant Head and Neck NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSarcoma | Breast Carcinoma | Head and Neck CarcinomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMalignant Vascular NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMelanoma | COVID-19 InfectionUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)WithdrawnMelanoma | Breast Carcinoma | Lung Carcinoma | Colorectal Carcinoma | Community Practice | Solid NeoplasmUnited States