A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids in a Comprehensive Cancer Center

November 20, 2023 updated by: M.D. Anderson Cancer Center

A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Parents/caregivers of a child (under 18) who has received an opioid prescription within the last 6 months

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observational (Online survey)
Participants complete online survey on an iPad over 20 minutes.
Other: Survey Administration
Complete online survey

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin Madden, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

No

Studies a U.S. FDA-regulated device product

No

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.

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