CaregiverNCT03390283
A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids in a Comprehensive Cancer Center
An observational study of Caregiver and Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Malignant Neoplasm
- What is being tested?
- Survey Administration
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 17 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents/caregivers of a child (under 18) who has received an opioid prescription within the last 6 months
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Caregiver, Malignant Neoplasm
- Being tested
- Survey Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete online survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (Online survey) | Participants complete online survey on an iPad over 20 minutes. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (1)
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start20 Dec 2017
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kevin Madden, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390283
- Sponsor's protocol ID
- 2017-0396
- Other IDs
- NCI-2018-00986, 2017-0396
- Status last verified
- Nov 2023
- First submitted
- 28 Dec 2017
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids
- ClinicalTrials.gov ID
- NCT03390283
- Acronym / sponsor ID
- 2017-0396
- Conditions
- Caregiver, Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (Online survey) | – | Other: Survey AdministrationParticipants complete online survey on an iPad over 20 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents/caregivers of a child (under 18) who has received an opioid prescription within the last 6 months
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationComplete online survey | Other | Observational (Online survey) |
Primary outcome
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.
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.
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.
1 secondary outcome
Other covariates
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Madden principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver and Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported frequencies of unsafe storage of opioids (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.