- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05055011
Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children With Cancer
Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To determine parents' level of concern regarding the use of opioids for pain in their children.
SECONDARY OBJECTIVES:
I. To explore differences in parents' level of concern regarding the use of opioids for pain in their children as well as level of concern for side effect of opioids between the opioid subgroup and non-opioid subgroup.
II. To explore differences in other parental attitudes and beliefs between the opioid subgroup and the non-opioid subgroup.
III. For each concern, associations between:
IIIa. Level of concern regarding the use of opioids and the age and disease of the child.
IIIb. Level of concern regarding the use of opioids and parental history of addiction.
IIIc. Level of concern regarding the use of opioids and a family history of addiction.
OUTLINE:
Parents complete survey over 20 minutes. Patients' medical records are reviewed.
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
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Parents must be at least 18 years old
- The parent must be able to understand, read, write, and speak English
- The parent must provide verbal informed consent
- The child of the parents must be 18 years old or younger
- The child must have a diagnosis of cancer
Exclusion Criteria:
A non-cancer diagnosis (neurofibromatosis, Li-Fraumeni syndrome for example).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (survey, medical record review)
Parents complete survey over 20 minutes.
Patients' medical records are reviewed.
|
Complete survey
Review of medical records
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parents' level of concern regarding the use of opioids for pain in their children.
Time Frame: through study completion, an average of 1 year
|
Will be summarized using proportion along with a 95% confidence interval in opioid subgroup and non-opioid subgroup separately.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kevin Madden, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-1169 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-01159 (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
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